Re: [nexa] R: proprietà intellettuale sul prodotto industriale
Caro Marco, non entro nel merito della prima parte del tuo mail perchè proprio di questo vorrei parlare in Nexa. Peraltro, tu sai benissimo cosa pensano i fanatici estremisti come me di WIPO e delle sue iniziative, per non parlare di quella che consideriamo la grande truffa dell' "allargamento delle regole sui farmaci salva vita". Entro invece sul merito della "competenza dell'argomento". Perchè il prodotto artistico rientra e quello industriale no? Solo perchè sembra più facile diffondere il primo via Rete? Ma la Rete è ormai lo strumento principale per la diffusione del sapere scientifico che poi diventa brevetto. Per non parlare delle molte migliaia di brevetti su Internet (c'è una causa legale nella quale si sostiene che tutta l'attività della Rete è una violazione di brevetti precedenti) e dei prodotti proprietari che la Rete ospita, in contrapposizione con i suoi standard aperti. Comunque, se i due direttori concordano, ritiro la mia richiesta, senza far perdere tempo ad altri. Scusa ancora la mia assenza alla riunione di oggi che mi pare molto importante. Raf On Tue, 12 Jan 2010 19:20:43 +0100, "Marco Ricolfi" <marco.ricolfi@studiotosetto.it> wrote:
Caro Raffaele, peccato non averti con noi. Rispetto al tema. Condivido - come, penso, anche Juan Carlos - la tua affermazione che "la proprietà intellettuale industriale è un freno allo sviluppo, fattore di disuguaglianze fra imprese grandi e piccole, fra paesi forti e deboli, e ragione della morte di decine di milioni di uomini, ogni anno, come illustrato da Medici senza Frontiere". Penso che si possa dire che pochi come noi, a Torino, abbiano dato un contributo sul tema. Pensa che in 8 anni di Master sulla proprietà intellettuale abbiamo lavorato su questo tema; che ci abbiamo formato più di 200 candidati, più della metà dei quali proviene dai paesi in via di sviluppo; e che, siccome moltissimi - decine - di questi sono delegati dei loro governi nelle istituzioni internazionali, abbiamo contribuito agli sviluppi in questo settore. La nostra Vanessa Lowenstein è stata tra le prima a lavorare alla Development Agenda del WIPO (una serie di iniziative richieste dai paesi in via di sviluppo per contrastare la deriva iper-protezionista della proprietà intellettuale); e l'allargamento delle regole sui farmaci salva vita ci ha visto particolarmente attivi. Occorre però anche rispettare un principio di competenza e di specializzazione delle competenze. Da questo punto di vista, quello che non è facile capire è come questo tema - prioritario - trovi collocazione in un centro che si occupa della rete internet, salvo che per il profilo del brevetto di software, sul quale abbiamo posizioni chiare e costanti (nel senso che va, in linea generale, evitato e combattuto). Possiamo ritornare quando vuoi sul tema. Sulla base però di un'argomentazione almeno ipotetica della rilevanza ai fini di una riflessione sistematica specificamente riferita alla rete. Dico bene, Juan Carlos? m.
-----Messaggio originale----- Da: nexa-bounces@server-nexa.polito.it [mailto:nexa-bounces@server-nexa.polito.it] Per conto di Angelo Raffaele Meo Inviato: lunedì 11 gennaio 2010 16.37 A: nexa@server-nexa.polito.it Oggetto: [nexa] proprietà intellettuale sul prodotto industriale
Carissimi, desidero scusare la mia assenza all'incontro Nexa previsto per mercoledì 13. Come nel caso dei precedenti mercoledì, debbo partecipare alla seduta mensile dell'Accademia delle Scienze, ove, tra l'altro, dobbiamo discutere di un convegno sulla ricerca industriale che intendiamo organizzare. Avanzo comunque una richiesta relativa alla roadmap 2010. Mi piacerebbe, come anticipai in un incontro lontano, che Nexa affrontasse anche la questione della proprietà intellettuale sui prodotti industriali e dei brevetti in particolare. Quel giorno Marco (Ricolfi, non Ciurcina) mi rispose che quella questione non rientrava negli obiettivi di Nexa e oggi, in un incontro privato, Juan Carlos mi ha ribadito la posizione di Marco. Se questa è la posizione di tutti, accetto disciplinatamente la decisione collegiale. Tuttavia, mi sia consentito ricordare l'opinione di un numero rapidamente crescente di studiosi, secondo la quale la questione della proprietà intellettuale sul prodotto industriale è molto più importante della questione della proprietà sul prodotto artistico, perchè la proprietà intellettuale industriale è un freno allo sviluppo, fattore di disuguaglianze fra imprese grandi e piccole, fra paesi forti e deboli, e ragione della morte di decine di milioni di uomini, ogni anno, come illustrato da Medici senza Frontiere. Grazie per l'attenzione. Colgo l'occasione per associarmi alle congratulazioni di Marco R. a Marco C. Raf
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Caro Angelo, grazie del tuo e-mail. Quanto al master che dirigo, e di cui ho la responsabilità scientifica, potrà interessarti venire ad assistere alle lezioni, specie quelle sui brevetti che ti interessano; e sono sicuro che avrai sorprese se parti dallassunto che meritino il giudizio che riservi alle iniziative WIPO. A me invece interessa sapere se hai evidenze empiriche su quella che tu consideri la grande truffa dellallargamento delle regole sui farmaci salva vita, che è stata fortemente voluta dai paesi in via di sviluppo. E infatti venuto il momento non per Nexa, peraltro per fare un bilancio su questo argomento. Hai invece ragione di insistere sulla rilevanza del tema dei brevetti per la rete; e precisamente sotto i due profili che ti indichi. Di uno mi sono occupato anchio, forse un po incidentalmente, come mostra il testo della conferenza che ho tenuto ad Ottobre a Ginevra nellambito del Master e che riproduco qui sotto. Il brevetto è stato pensato per leconomia classica; oggi la rete apre possibilità di cooperazione per le quali il brevetto rischia di divenire un ostacolo invece che un incentivo. Dellaltro che definirei più che i brevetti su internet i brevetti sugli strumenti di comunicazione e condivisione del sapere in forma digitale, ivi incluso lo strumento di internet, già ci occupiamo, occupandoci di brevetti di software; e lattenzione potrebbe (e forse dovrebbe, risorse permettendo) estendersi a brevetti su protocolli e formati, come già segnalato da Juan Carlos. Condivido anche lidea di JC secondo cui il tema dellinteroperabilità merita di essere particolarmente sviluppato, essendo del resto al centro della tesi di dottorato del nostro managing director Federico Morando. Mettendo insieme questi due pezzi, risulta un quadro non diverso da quello cui dirigono le tue osservazioni. Grazie dunque per lo stimolo, che insieme con Juan Carlos non lasceremo cadere, nei limiti delle risorse e del tempo a disposizione. Ma comunque tenendo conto dellesigenza di rifocalizzare lattenzione anche su temi importanti come quelli che tu segnali. m. 20/01/2010 Genevatex Genetic Engineering: Where is the Innovation?* Summary: § 1. Which Innovation? § 2. Patent law and genetic engineering. § 3. The tragedy of the commons and the tragedy of the anticommons. § 4. Two emerging paradigms: contractually reconstructed commons and open source biotechnology. § 5. Concluding remarks. § 1. Which Innovation? There is a certain ambiguity in the title of the presentation which was allotted to me. One possible way to read the question Where is the Innovation? is to ask whether the requirement for patentability which in the US legal system is referred as non obviousness and in Europe as inventive step is in some way different in the field of genetic engineering as opposed to general patent law. This would certainly be an interesting issue to research. Indeed, it is arguable that in this regard genetic engineering is a pretty special case: just to mention the first differences which occur to me, the standard used in this area is lower than the one used in more traditional fields, such as mechanics, chemistry and pharmaceuticals; when it comes to the field of biotech, the notion of person skilled in the art, against which the inventiveness of each invention is tested, is a specialized one; and so on. There are even more interesting ways to read the question in the title, however. The title might refer either to the identification of the genetic engineering areas in which innovation would appear most promising; or even to the issue whether the legal rules governing the protection of genetic engineering research and investment should they themselves be innovated, that is adapted or changed. I find this perspective even more challenging than the one I mentioned at the outset, so that I chose to explore it rather than elaborating on the notion of inventive step. I must also add that, being a lawyer rather than a scientist or a technologist, I will mainly look at the second strand of the second issue, asking what is the legal innovation to be expected in this field, rather than trying to fathom what the technological innovation will be. I am afraid, however, that as a lawyer I cannot totally avoid the necessity of also dealing, if only to a certain extent, with the first strand of the same question. The nature of the legal profession is such that lawyers cannot stand totally separate from the non-legal issues to which they apply their analytical skills; and I am sure that the participants in this eight edition of the Turin-WIPO LL. M. program will by now have become acutely aware that in IP law the interpenetration of technical aspect and legal rules is even more advanced than in other areas of the law. Taking this to account, in the final part of my presentation (at § 5) I will ask whether there is any relationship between proposed changes concerning the legal rules and changes underway in the actual technological reality of genetic engineering research and development. § 2. Patent law and genetic engineering. Now, concerning the question whether changes are required in the legal protection of genetic engineering innovation, it would appear that the question really has two sides to it. The first one is to ask whether we do have empirical evidence confirming the hypothesis, sometimes described with reference to the notion of the tragedy of the anticommons, that protection of genetic engineering innovation via patent law does in fact entail an increase in transaction costs and encourages opportunistic and strategic behaviour. The second one is to ask whether there are mechanisms which conceivably could be adopted to foster research and innovation in the field of genetic engineering which are promising enough and sufficiently tested to warrant consideration as alternatives to patent protection or possibly as complements to it. A few words may be in place to elucidate the first question. At some point in the late Seventies or in the early Eighties of last century biotechnology emerged as a revolutionary technological approach based on i. the identification of the DNA sequences responsible for certain traits of living organism, e.g. coding for a protein making the plant resistant to salinity; and ii. the cutting and pasting of the relevant sequence from an original living organism to the receiving cell of a different target organism. (That the cutting of the DNA sequence usually took place through so called restriction enzymes and that its splicing on the receiving cell usually was effected by means of a virus are details which even today may sound extraordinary to the non-specialist but in the present context do not seem to have particular implications). In many ways, this kind of innovation was very different from the innovation we had been accustomed to through the previous centuries and decades, in areas such as mechanics first, chemistry and pharmaceuticals later. This discontinuity between prior forms of innovation and biotechnology called in question the advisability of pouring new wine in old bottles by protecting biotech innovation through patent laws; nevertheless the various legal systems of advanced economies came more or less in unison to the conclusion that patent protection was the most appropriate tool to provide an incentive for the creation and dissemination of a technological innovation in general and that this applied also to biotech innovation. In fact, some jurisdictions incorporated biotech into patent laws by means of case law; others went all the way and changed patent rules to specifically accommodate biotechnological innovation. In the end the outcome was the same: currently the job of providing the appropriate incentive to originate, disclose, and disseminate biotech innovation lays with patent laws in most of the advanced economies. § 3. The tragedy of the commons and the tragedy of the anticommons. When the adoption of the EU Directive on the legal protection of biotechnological inventions was discussed, I was in the camp of the sceptics. Today, I might recollect some of the doubts I then harboured; for the present purposes I find it more relevant, however, to look at the kind of critique to patent protection of biotech innovation which currently is described as the anticommons argument. We may begin to understand what the anticommons argument means by considering it turns on its head the theory of the tragedy of the commons, originally advocated by an important article written in the early Sixties by a scientist, Garrett Hardin. In the Middle Ages, he had remarked, stretches of land held in common by the local population were gradually depleted, as they were overgrazed (too much cattle over the same fields) and deforested (too much wood extraction from the communal woods). In his account, an optimal allocation was restored by enclosures such as the ones which took place in Sixteenth Century England: as soon as individual owners obtained undivided title over the land, depletion stopped. An individual owner would not disregard the long term implications of depletion, as he himself would bear all the future costs of inefficient use; while, as long as short term benefits were reaped by the commoners individually while the corresponding costs were born by the whole community, the same long term costs were disregarded. A similar situation applied to fisheries, which were running and indeed still are running, in spite of quotas the risk of depletion of stock as each fishing fleet ignores the long term implications of overfishing. In this perspective, the commons, appealing as they may sound to the romantics and to the left leaning, in reality are a tragedy; their opposite number, property rights, are efficient. You may wonder what this all has to do with biotech patents. The connection may become a bit clearer when I mention that about in the same years one of the most powerful minds behind the Law and Economics movement, professor Ronald Coase, was bent on proving that, by protecting the resource with a property right, the law combines the static efficiency Garret Hardin was talking about with dynamic efficiency, as it enables market transactions whereby the resource may move to its highest valued use. From there the argument migrated to intellectual property rights: also protection of IPRs by means of property rights contributes to the optimal allocation of resources; therefore biotechnological innovation too should be protected by means of patent rights. Fundamental research concerning the double helix may well have originated within the commons of the public, academic research; but when it came to reaping the fruits of the tree of knowledge, property rights, not the commons, would be the most appropriate regime. Now, this line of argument is, as I was saying, literally turned on its head by those scholars who have argued that protecting innovation by means of property rights may lead to a tragedy opposite and symmetrical to the one elucidated by Garrett Hardin, the tragedy of the anticommons; and that this may specially be the case in novel fields like digital technology and indeed genetic engineering. According to this viewpoint, while traditionally basic scientific research in agriculture and medicine had for a long time been open and the information resources widely shared by the scientific community, propertization of research outcomes by the grant of patents on agricultural and medical innovation as initiated in the late Seventies or early Eighties must be seen as apt to build up barriers to the access ad reuse of information and of information-carrying assets and is thus liable to endanger the enormous benefits which scientific cooperation entails. Let us examine more closely the reasons which usually are given to account for the emergence of the phenomenon described as the tragedy of the anticommons and for the outcomes which are said to derive from it. The first reason resides in the nature of technological innovation in genetic engineering: the originally extended trajectory which leads from the scientific enterprise to its commercial application has in the last decades to a large extent collapsed and shrunk. The second reason resides in the fact that this novel type of technical innovation exactly as it is the case in connection with digital technology tends to bear the know-how which makes it valuable on its face. Both aspects can be simultaneously illustrated by an example drawn from the here relevant field of genetic engineering. The difficult thing in devising an emergency treatment for a heart attack based on tissue plasminogen activator (TPA), a known substance produced by the body to help the heart to revascularize in the first hours after the event, was to identify the DNA sequence which codes for this protein with a view to synthetically producing the protein itself and administering it to early stage patients. Once the TPA sequence is identified, it becomes quite easy to synthesize the desired amount of this protein for treatment of heart attacks; in turn the scientific knowledge obtained in the sequencing is immediately available to other entities which may wish to manufacture and sell the protein. Thus, theoretical knowledge of the sequence entails as a matter of course ease of manufacture of the protein for which it codes; and this activity may be replicated by any entity possessing the knowledge of the sequence, without the efforts, such as the costs of reverse engineering, usually associated with imitation of products available on the market. Now, while it is quite predictable that, in such a context, no institution would engage in investment unless it can obtain a legal monopoly on its research outputs, exactly as posited by the supporters of patent protection, several commentators have also noted that an analysis of the costs and benefits of patent protection for genetic engineering should never forget that, as a result of the just illustrated features, propertization may also have severely adverse impact upstream and downstream on the innovation process. Upstream the very possibility of obtaining property rights over research outcomes suggests to all the players that it is advisable for them to avoid organizational arrangements which entail sharing of information with third parties. Therefore, if the grant of a patent is possible, all interim steps, including materials obtained in the preliminary stages of a research trial or information pertaining thereto tend not to cross the door of the laboratory, to avoid making disclosures which may prevent patentability and give leads to potential competitors. Even presentation of ongoing research at academic meetings and publication of research findings before patent filings recede for exactly the same reasons. Exchanges may in to some extent continue, e.g. in terms of material transfer agreements; but then they tend to be governed by restrictive terms, intended to reserve the transferor entitlements over downstream innovation. In turn, the process may trigger domino effects: any initial move by one of the players to obtain exclusive right and to leverage them to secure contractual privileges is bound to trigger defensive reactions by similarly situated players. A similar analysis applies to downstream outcomes. Research outputs tend to be complementary in nature. Marketable end products may incorporate a number of contributions, which may be a method of sequencing, a research tool, a DNA sequence. To the extent complementary items are covered by separate property rights and these belong to different entities, a powerful incentive is given to each player to hold out contributing her asset as a bargaining chip to extract the highest possible share of downstream profits to be derived from marketable end products. An increasing number of commentators have therefore expressed fears that patent protection, when applied to genetic engineering innovation, may entail costs greater than the expected benefits. While in principle property rights are seen as an efficient tool to induce innovation and enhance market based exchanges over it, it is often feared that the specificity of some areas, including biomedical research and biotech, may lead to the adoption of strategic behaviour and to an unacceptable increase of transaction costs. § 4. Two emerging paradigms: contractually reconstructed commons and open source biotechnology. I do not know whether the anticommons argument is true or not. Actually, this is a matter of empirical evidence rather than of pure theory, even though of course theory may help us to make educated guesses and even to build parameters and benchmarks against which to test the hypothesis. I will therefore come back to say something about the empirical evidence as to the failure or success of the current regime in a short while. For the moment, I would rather like to point out that it may be of some significance that in the last decade we witnessed to the emergence of paradigms which in many ways are radically different from patent law and which may be described for the sake of convenience as contractually reconstructed commons and open source biotechnology. Let me say just a few words about each. The first one, i.e. the proposed contractually reconstructed commons paradigm, recognizes the benefits which can accrue if innovators are granted property rights over their research contributions and assets; but advocates contractual arrangements which may ex ante take care of the risk that players in the research community may engage in strategic behavior of the kind described by anticommons theory. A variety of mechanisms is proposed, depending on the specific technological sector to which the arrangements are to apply, which may from case to case be drugs discovery or microbial research. There are recurring features in the design however, among which I should mention the adoption by the different players of standard contractual forms, which contemplate non-exclusive use and access to information resources and research inputs that either are covered by some form of exclusive rights or are de facto in exclusive possession of one of the parties; extensive confidentiality agreements limiting access by third parties to the resource; a dichotomy between non commercial, research uses, for all purposes free and commercial uses, subject to a contractual liability rule whereby the party first bringing to the market a commercially valuable end-product is enabled to do so subject to a duty of compensation of the provider of the different inputs which may go into the end product in accordance with a predetermined scale of royalties. These are complex concepts, which, I submit, we may start to understand better if we think of them by analogy to well known organizational paradigms in IP such as patent pools and even collective management organizations in the field of copyright. I must however confess that I do have even more difficulties in elucidating the open source biotechnology proposal, as I cannot fully understand how this concept can work in the absence of legislative changes. The basic notion derives from open source software or, to be more specific, from the mechanism of copyleft on which open source licenses, including the GPL, are based. Under current copyright laws, software is protected and so are all additions to it which have a minimum of significance. It is well possible for the initiators of a project, which usually form a community, to provide for the initial body of code making it available both in source and object code (hence the designation as open source software) and release it on the condition that the copyright license granted to any subsequent user is subject to compliance with a set of conditions, including the so called copyleft clause, which requires the licensee to make all his additions available under the same open access conditions to all subsequent users. Much has been written about this viral feature in software licenses, whereby the original condition imposed by the first licensor to the first licensees is propagated by the latter downstream, exactly as a virus would do, to cover each and all pieces of software building on the basis of the initial chunks of programming. Therefore for present purposes I do not need to add much, except to highlight that the whole mechanism is built on the solid foundation of copyright protection. If subsequent licensees do not abide by the copyleft clause, they are plain infringers; therefore it is copyright protection which makes sure that downstream innovation is kept open and is not enclosed by downstream innovators. This solution originates in the digital environment, where lawmakers, about three decades ago, saw fit to innovate and to adopt a rule whereby software programs are protected by copyright. I am not yet able to see how this approach can be extended to biotechnology, however. I am aware, of course within the limits accessible to a lawyer and, I should add, to an old timer who has not yet had much time to devote to understanding the technological evolution that there are new fields as the one referred to as synthetic biology; that these are a fertile ground for the emergence of distributed collective cooperation efforts, in which the innovation does not resemble the classical cherry on the pie which was the original genetic engineering innovation and may be analogized to having the different parties constructing the bricks, i.e. the building blocks which go into the larger blueprint agreed among them. What I miss is to see how there the individual building blocks may enjoy some legal protection. Neither patent nor copyright would seem to fit here; the first one because, even if we were to admit that all the requirements for patent protection are met, the costs and time of patenting would be devastating for any project; the latter one, because frankly I do not see any creative work as yet in the bricks, at least until lawmakers do not step in and choose to indicate otherwise, as they did when they legislated on copyright protection of software. But then, if the individual blocks are not IP protected, it would seem to me that the very basis for copyleft licensing is missing. My provisional conclusion therefore is that open source biotechnology still misses a legislative starting point. § 5. Concluding remarks. Is there any relationship between the emergence of the two paradigms I just referred to and the difficulties allegedly faced by traditional patent law in providing an appropriate regime for genetic engineering innovation? Quite frankly, I must say that I do not know and, even more frankly, that I would not be the one to know. What I can do is to make a few guesses, for what they may be worth. The first one is that it would appear to me that one of the most fundamental reasons for the emergence of the two innovative paradigms I dealt with in § 4 is to be found in the changes which the web is undergoing. The web no longer is just a vast library; it has in the meantime become a user driven collaborative workplace. It therefore stands to reason that the possibility of myriad cooperative research enterprises in the field of biotechnology, using the web as an instrument to bring together vast data sets accumulated by the different players, has in the meantime emerged and that this distributed collective intelligence is now looking for sets of rules which may provide a finely balanced mechanism to optimize cooperation and cooperation results. Both contractually reconstructed commons and open source biotechnology would appear to be plausible candidates. Am I therefore saying that what accounts for the emergence of these two paradigms is the success of the web, rather than the putative failure of patent law in governing biotech innovation? Not quite. In fact, it would indeed appear, at least to my naïve eyes, that there are signs which show that indeed the model on which much of the initial successes in genetic engineering was based are no longer functioning. The number of blockbuster drugs is dramatically declining; the number of drugs in the pipelines is decreasing. Just a few years ago the future of bioinformatics was all the rage; today it would appear that the promises of what is referred to as High-Throughput-Screening have not come true if not to a very small extent. Therefore, we cannot rule out that the story according to which in the first years of genetic engineering our patent-driven research has been able to reap the lower hanging fruits of the tree of knowledge is correct after all. It may also well be that, to reach the fruits which hang from the higher branches, the effort of a given, specific laboratory alone is no longer sufficient; and that a cooperative effort, among firms and between firms and public research institutions and possibly even with regulatory authorities. After all it appears that gene expression is not confined to the standard linear model of one gene-one protein; but is a complex non linear process involving not just the coding of genes for individual proteins (the cDNA segments), but also the DNA involved in gene regulation and organization; I do not know whether this the case, for the simple reason that I possess neither the necessary empirical data nor the required skills to assess them. What I know is that, if this is the case, the role of cooperative arrangements will increase; but I also expect that these arrangements will not replace IPRs but will build on patent protection while trying to take care ex ante of several of the problems highlighted by the scholars who have described the dangers associated with the tragedy of the anticommons. * This draft paper is released under a Creative Commons Attribution 3.0 unported license (http://creativecommons.org/licenses/by/3.0/). On the first issue see among others R.P. MERGES, One Hundred Years of Solicitude. Intellectual Property Law, 1900-2000, in 88 Cal. L. Rev., 2000, 2189 ff., 2224 ff.; on the second one S.J.R. BOSTYN, Enabling Biotechnological Inventions in Europe and the United States. A study of the patentability of proteins and DNA sequences with special emphasis on the disclosure requirement, European Patent Office, München, 2001, 72 ff. Throughout this paper I shall use biotechnology and genetic engineering as equivalents. The corresponding notion was originally introduced into the debate by M.A. HELLER, The Tragedy of the Anticommons: Property in the Transition from Marx to Markets, in 111 Harvard Law Review, 1998, 111 ff. and M.A. HELLER-R.S. EISENBERG, Can Patents Deter Innovation? The Anticommons in Biomedical Research, in Science 280, 1998, 698-701 and in F.H. MILLER ed., Rights and Resources, Ashgate, Dartmouth, 2003, 401-404. An excellent treatment is in E. BERTACCHINI, Contractually Constructed Research Commons: a Critical Economic Appraisal, ##. Wonderfully illustrated by J.H. REICHMAN, Legal Hybrids Between the Patent and Copyright Paradigms, in 94 Columbia L. Rev., 1994, 2432 ff. For a thorough discussion of the costs and benefits of patenting, including a discussion of the different incentives (to generate innovation, to disclose it and to disseminate it before and after the term of the patent), also with specific reference to special industries such as biotech see R. MAZZOLENI, R. NELSON, Economic Theories about the Benefits and Costs of Patents, in XXXII Journal of Economic Issues, 1998, 1031 ff. Diamond v. Chakrabarty, in 447 U.S. 303 (1980). Directive No 98/44 of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions, in OJ 2000, L 213, 13 ff. But see Art. 27(3)(b) of the Agreement on Trade Related Aspects of Intellectual Property Rights, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, LEGAL INSTRUMENTSRESULTS OF THE URUGUAY ROUND vol. 3, 1869 U.N.T.S., 33 I.L.M. 81 (1994) [hereinafter TRIPS Agreement]. See my La proposta di direttiva del Consiglio sulla protezione giuridica delle invenzioni biotecnologiche, in Giur. Comm., 1991, I, 918 ff. and Bioethics Markets and Morals: The Case of Biotechnological Patents, in a cura di C.M. Mazzoni A Legal Framework for Bioethics, Kluwer, Dordrecht, 1998, 131 ff. and for commentary after the enactment of Directive 98/44 Biotechnology, Patents and Epistemic Approaches, in The journal of Biolaw and Business, Special Supplement, 2002, 77-90. For a classical account of this position see H. DEMSETZ, Toward a Theory of Property Rights, in American Economic Review, 1967, 347 ff. See R. COASE, The Problem of Social Cost, in 3 Journal of Law & Economics, 1960, 1 ff. For a brilliant treatment see R.P. MERGES, Of Property Rules, Coase and Intellectual Property Law, in 94 Colum. L. Rev., 1994, 2655 ff. An offspring of this conception was the adoption of rules providing incentives to patenting by Universities, such as the U.S. Bayh-Dole Act of 1980, Publ. L. No. 96-517, 94 Stat. 3015 (codified as amended at 35 U.S.A. §§ 200-212 (2000)), for an assessment of which see A. K. RAI & R.S. EISENBERG, Bayh-Dole Reform and the Progress of Biomedicine, in 66 Law & Contemp. Probs., 2003, 289 ff. and R.R. NELSON, Observations on the Post-Bayh-Dole Rise of Patenting at American Universities, in IPQ 2001, 1 ff. G.B. DINWOODIE & R. COOPER DREYFUSS, International Intellectual Property Law and the Public Domain of Science, in 7 Journal of Int. Ec. Law 2004, 431 ff., 433 and, in specific connection with the process of extension of protectable subject matter to disembodied knowledge, H. ULLRICH, Expansionist Intellectual Property and Reductionist Competition Rules, in 7 Journal of Int. Ec. Law 2004, 401 ff. As shown in the case not only of genetic engineering but also of plant varieties, semiconductor chips and data bases. For a full treatment of this line of thought see the abundant work of Jerome H. Reichman, from Legal Hybrids Between the Patent and Copyright Paradigms, above at note # to The Globalization of Private Knowledge Goods and the Privatization of Global Public Goods, in 7 Journal of Int. Ec. Law, 2004, 279 (written with Keith E. Maskus). E. BERTACCHINI, Contractually Constructed Research Commons: a Critical Economic Appraisal, quoted above at note #, E. BERTACCHINI, Contractually Constructed Research Commons: a Critical Economic Appraisal, quoted above at note #, § 2. M.A. HELLER-R.S. EISENBERG, Can Patents Deter Innovation? The Anticommons in Biomedical Research, above at note #. In this connection see E. BERTACCHINI, Contractually Constructed Research Commons: a Critical Economic Appraisal, quoted above at note #, § 3.1. The approach originally advocated by J. H. REICHMAN & P. UHLIR, A Contractually Reconstructed Research Commons for Scientific Data in a Highly Protectionist Intellectual Property Environment, in 66 Law & Contemp. Probs. 2003, 315 ff. has been refined and adapted to a number of specific contexts by A.K. RAI-J.H. REICHMAN-P.F. UHLIR-C. CROSSMAN, Pathways Across the Valley of Death: Novel Intellectual Property Strategies for Accelerated Drug Discovery, in VIII Yale Journal of Health Policy, Law, and Ethics, 2008, 1 ff. (in connection with drug discovery) and J.H. REICHMAN-T. DEDEURWAERDERE-P.F. UHLIR, Designing the Microbial Research Commons: Strategies for Accessing, Managing and Using Essential Public Knowledge, unpublished presentation to the Turin Communia Conference of June 26, 2009 (in connection with microbial collections). Except to the extent required by confidentiality agreements; in connection with publications see the balancing suggested by #. Indeed, the notion of contracting into liability advocated by R.P. MERGES, Contracting Into Liability Rules: Intellectual Property Rights and Collective Rights Organisations, in 84 Cal. L. Rev., 1996, 1293 ff. seems to emerge in several crucial points of the proposals concerning contractually reconstructed commons. I have not yet read the work by B. Demil & X. Lecoq, Neither market nor hierarchy nor network: the emergence of bazaar governance, in 27 Organization studies 2006, 1447-1466 and by Janet Hope, Biobazaar. The Open Source Revolution and Biotechnology, Harvard University Press, 2008, which might contain replies to the questions indicated below. On which see I.V. HEFFAN, Copyleft: Licensing Collaborative Works in the Digital Age, in 49 Stanford Law Rev. 1997, 1487 ss. C. PATTERSON, Copyright Misuse and Modified Copyleft: New Solutions to the Challenges of Internet Standardization, in 98 Michigan Law Review, 2000, 1351 ff. See Wikipedia, item Synthetic biology, last visited August 21, 2009. A similar view is expressed by A. RAI & J. BOYLE, Synthetic Biology: Caught between Property Rights, the Public Domain and the Commons, in Plos Biology March 2007, Vol. 5, Issue 3, 389-393, at 391. Which would seem a dubious proposition to begin with because no component does have utility or, in European parlance, industrial application and therefore it also is very difficult to speak of originality. The point is made, in a slightly different context (astronomy) by L. LESSIG, Remix. Making Art and Commerce Thrive in the Hybrid Economy, The Penguin Press, 2008, 170. As related by A.K. RAI-J.H. REICHMAN-P.F. UHLIR-C. CROSSMAN, Pathways Across the Valley of Death, above at note #, 3, an average of only three drugs that act on novel targets, i.e. proteins implicated in disease pathways, have reached the market in recent years. On the features of high throughput screening of molecule libraries against assays containing target proteins to identify promising compounds which may lead to patentable drugs see A.K. RAI-J.H. REICHMAN-P.F. UHLIR-C. CROSSMAN, Pathways Across the Valley of Death, above at note #, 7. For a thoughtful comment on this possibility see A. JACK, Remedy for a malady, Financial Times August 15-16, 2009, page 8. Marco Ricolfi Torino Law School -----Messaggio originale----- Da: meo [mailto:meo@polito.it] Inviato: mercoledì 13 gennaio 2010 12.25 A: Marco Ricolfi Cc: nexa@server-nexa.polito.it Oggetto: Re: R: [nexa] proprietà intellettuale sul prodotto industriale Caro Marco, non entro nel merito della prima parte del tuo mail perchè proprio di questo vorrei parlare in Nexa. Peraltro, tu sai benissimo cosa pensano i fanatici estremisti come me di WIPO e delle sue iniziative, per non parlare di quella che consideriamo la grande truffa dell' "allargamento delle regole sui farmaci salva vita". Entro invece sul merito della "competenza dell'argomento". Perchè il prodotto artistico rientra e quello industriale no? Solo perchè sembra più facile diffondere il primo via Rete? Ma la Rete è ormai lo strumento principale per la diffusione del sapere scientifico che poi diventa brevetto. Per non parlare delle molte migliaia di brevetti su Internet (c'è una causa legale nella quale si sostiene che tutta l'attività della Rete è una violazione di brevetti precedenti) e dei prodotti proprietari che la Rete ospita, in contrapposizione con i suoi standard aperti. Comunque, se i due direttori concordano, ritiro la mia richiesta, senza far perdere tempo ad altri. Scusa ancora la mia assenza alla riunione di oggi che mi pare molto importante. Raf On Tue, 12 Jan 2010 19:20:43 +0100, "Marco Ricolfi" <marco.ricolfi@studiotosetto.it> wrote:
Caro Raffaele, peccato non averti con noi. Rispetto al tema. Condivido - come, penso, anche Juan Carlos - la tua affermazione che "la proprietà intellettuale industriale è un freno allo sviluppo, fattore di disuguaglianze fra imprese grandi e piccole, fra paesi forti e deboli, e ragione della morte di decine di milioni di uomini, ogni anno, come illustrato da Medici senza Frontiere". Penso che si possa dire che pochi come noi, a Torino, abbiano dato un contributo sul tema. Pensa che in 8 anni di Master sulla proprietà intellettuale abbiamo lavorato su questo tema; che ci abbiamo formato più di 200 candidati, più della metà dei quali proviene dai paesi in via di sviluppo; e che, siccome moltissimi - decine - di questi sono delegati dei loro governi nelle istituzioni internazionali, abbiamo contribuito agli sviluppi in questo settore. La nostra Vanessa Lowenstein è stata tra le prima a lavorare alla Development Agenda del WIPO (una serie di iniziative richieste dai paesi in via di sviluppo per contrastare la deriva iper-protezionista della proprietà intellettuale); e l'allargamento delle regole sui farmaci salva vita ci ha visto particolarmente attivi. Occorre però anche rispettare un principio di competenza e di specializzazione delle competenze. Da questo punto di vista, quello che non è facile capire è come questo tema - prioritario - trovi collocazione in un centro che si occupa della rete internet, salvo che per il profilo del brevetto di software, sul quale abbiamo posizioni chiare e costanti (nel senso che va, in linea generale, evitato e combattuto). Possiamo ritornare quando vuoi sul tema. Sulla base però di un'argomentazione almeno ipotetica della rilevanza ai fini di una riflessione sistematica specificamente riferita alla rete. Dico bene, Juan Carlos? m.
-----Messaggio originale----- Da: nexa-bounces@server-nexa.polito.it [mailto:nexa-bounces@server-nexa.polito.it] Per conto di Angelo Raffaele Meo Inviato: lunedì 11 gennaio 2010 16.37 A: nexa@server-nexa.polito.it Oggetto: [nexa] proprietà intellettuale sul prodotto industriale
Carissimi, desidero scusare la mia assenza all'incontro Nexa previsto per mercoledì 13. Come nel caso dei precedenti mercoledì, debbo partecipare alla seduta mensile dell'Accademia delle Scienze, ove, tra l'altro, dobbiamo discutere di un convegno sulla ricerca industriale che intendiamo organizzare. Avanzo comunque una richiesta relativa alla roadmap 2010. Mi piacerebbe, come anticipai in un incontro lontano, che Nexa affrontasse anche la questione della proprietà intellettuale sui prodotti industriali e dei brevetti in particolare. Quel giorno Marco (Ricolfi, non Ciurcina) mi rispose che quella questione non rientrava negli obiettivi di Nexa e oggi, in un incontro privato, Juan Carlos mi ha ribadito la posizione di Marco. Se questa è la posizione di tutti, accetto disciplinatamente la decisione collegiale. Tuttavia, mi sia consentito ricordare l'opinione di un numero rapidamente crescente di studiosi, secondo la quale la questione della proprietà intellettuale sul prodotto industriale è molto più importante della questione della proprietà sul prodotto artistico, perchè la proprietà intellettuale industriale è un freno allo sviluppo, fattore di disuguaglianze fra imprese grandi e piccole, fra paesi forti e deboli, e ragione della morte di decine di milioni di uomini, ogni anno, come illustrato da Medici senza Frontiere. Grazie per l'attenzione. Colgo l'occasione per associarmi alle congratulazioni di Marco R. a Marco C. Raf
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Marco Ricolfi ha scritto:
Caro Angelo, grazie del tuo e-mail. Quanto al master che dirigo, e di cui ho la responsabilità scientifica, potrà interessarti venire ad assistere alle lezioni, specie quelle sui brevetti che ti interessano; e sono sicuro che avrai sorprese se parti dall'assunto che meritino il giudizio che riservi alle 'iniziative WIPO'. A me invece interessa sapere se hai evidenze empiriche su quella che tu consideri la grande truffa dell'"allargamento delle regole sui farmaci salva vita", che è stata fortemente voluta dai paesi in via di sviluppo. E' infatti venuto il momento -- non per Nexa, peraltro -- per fare un bilancio su questo argomento. Hai invece ragione di insistere sulla rilevanza del tema dei brevetti per la rete; e precisamente sotto i due profili che ti indichi. Di uno mi sono occupato anch'io, forse un po' incidentalmente, come mostra il testo della conferenza che ho tenuto ad Ottobre a Ginevra nell'ambito del Master e che riproduco qui sotto. Il brevetto è stato pensato per l'economia classica; oggi la rete apre possibilità di cooperazione per le quali il brevetto rischia di divenire un ostacolo invece che un incentivo. Dell'altro -- che definirei più che i brevetti su internet -- i brevetti sugli strumenti di comunicazione e condivisione del sapere in forma digitale, ivi incluso lo strumento di internet, già ci occupiamo, occupandoci di brevetti di software; e l'attenzione potrebbe (e forse dovrebbe, risorse permettendo) estendersi a brevetti su protocolli e formati, come già segnalato da Juan Carlos. Condivido anche l'idea di JC secondo cui il tema dell'interoperabilità merita di essere particolarmente sviluppato, essendo del resto al centro della tesi di dottorato del nostro managing director Federico Morando. Mettendo insieme questi due pezzi, risulta un quadro non diverso da quello cui dirigono le tue osservazioni. Grazie dunque per lo stimolo, che insieme con Juan Carlos non lasceremo cadere, nei limiti delle risorse e del tempo a disposizione. Ma comunque tenendo conto dell'esigenza di rifocalizzare l'attenzione anche su temi importanti come quelli che tu segnali. m.
20/01/2010
Genevatex
Genetic Engineering: Where is the Innovation?*
Summary: § 1. Which Innovation? -- § 2. Patent law and genetic engineering. -- § 3. The tragedy of the commons and the tragedy of the anticommons. -- § 4. Two emerging paradigms: contractually reconstructed commons and open source biotechnology. -- § 5. Concluding remarks. --
§ 1. Which Innovation? There is a certain ambiguity in the title of the presentation which was allotted to me. One possible way to read the question "Where is the Innovation?" is to ask whether the requirement for patentability which in the US legal system is referred as non obviousness and in Europe as inventive step is in some way different in the field of genetic engineering as opposed to general patent law. This would certainly be an interesting issue to research. Indeed, it is arguable that in this regard genetic engineering is a pretty special case: just to mention the first differences which occur to me, the standard used in this area is lower than the one used in more traditional fields, such as mechanics, chemistry and pharmaceuticals; when it comes to the field of biotech, the notion of person skilled in the art, against which the inventiveness of each invention is tested, is a specialized one; and so on. There are even more interesting ways to read the question in the title, however. The title might refer either to the identification of the genetic engineering areas in which innovation would appear most promising; or even to the issue whether the legal rules governing the protection of genetic engineering research and investment should they themselves be innovated, that is adapted or changed. I find this perspective even more challenging than the one I mentioned at the outset, so that I chose to explore it rather than elaborating on the notion of inventive step. I must also add that, being a lawyer rather than a scientist or a technologist, I will mainly look at the second strand of the second issue, asking what is the legal innovation to be expected in this field, rather than trying to fathom what the technological innovation will be. I am afraid, however, that as a lawyer I cannot totally avoid the necessity of also dealing, if only to a certain extent, with the first strand of the same question. The nature of the legal profession is such that lawyers cannot stand totally separate from the non-legal issues to which they apply their analytical skills; and I am sure that the participants in this eight edition of the Turin-WIPO LL. M. program will by now have become acutely aware that in IP law the interpenetration of technical aspect and legal rules is even more advanced than in other areas of the law. Taking this to account, in the final part of my presentation (at § 5) I will ask whether there is any relationship between proposed changes concerning the legal rules and changes underway in the actual technological reality of genetic engineering research and development.
§ 2. Patent law and genetic engineering. -- Now, concerning the question whether changes are required in the legal protection of genetic engineering innovation, it would appear that the question really has two sides to it. The first one is to ask whether we do have empirical evidence confirming the hypothesis, sometimes described with reference to the notion of the tragedy of the anticommons, that protection of genetic engineering innovation via patent law does in fact entail an increase in transaction costs and encourages opportunistic and strategic behaviour. The second one is to ask whether there are mechanisms which conceivably could be adopted to foster research and innovation in the field of genetic engineering which are promising enough and sufficiently tested to warrant consideration as alternatives to patent protection or possibly as complements to it. A few words may be in place to elucidate the first question. At some point in the late Seventies or in the early Eighties of last century biotechnology emerged as a revolutionary technological approach based on i. the identification of the DNA sequences responsible for certain traits of living organism, e.g. coding for a protein making the plant resistant to salinity; and ii. the cutting and pasting of the relevant sequence from an original living organism to the receiving cell of a different target organism. (That the cutting of the DNA sequence usually took place through so called restriction enzymes and that its splicing on the receiving cell usually was effected by means of a virus are details which even today may sound extraordinary to the non-specialist but in the present context do not seem to have particular implications). In many ways, this kind of innovation was very different from the innovation we had been accustomed to through the previous centuries and decades, in areas such as mechanics first, chemistry and pharmaceuticals later. This discontinuity between prior forms of innovation and biotechnology called in question the advisability of pouring new wine in old bottles by protecting biotech innovation through patent laws; nevertheless the various legal systems of advanced economies came more or less in unison to the conclusion that patent protection was the most appropriate tool to provide an incentive for the creation and dissemination of a technological innovation in general and that this applied also to biotech innovation. In fact, some jurisdictions incorporated biotech into patent laws by means of case law; others went all the way and changed patent rules to specifically accommodate biotechnological innovation. In the end the outcome was the same: currently the job of providing the appropriate incentive to originate, disclose, and disseminate biotech innovation lays with patent laws in most of the advanced economies.
§ 3. The tragedy of the commons and the tragedy of the anticommons. -- When the adoption of the EU Directive on the legal protection of biotechnological inventions was discussed, I was in the camp of the sceptics. Today, I might recollect some of the doubts I then harboured; for the present purposes I find it more relevant, however, to look at the kind of critique to patent protection of biotech innovation which currently is described as the anticommons argument. We may begin to understand what the anticommons argument means by considering it turns on its head the theory of the tragedy of the commons, originally advocated by an important article written in the early Sixties by a scientist, Garrett Hardin. In the Middle Ages, he had remarked, stretches of land held in common by the local population were gradually depleted, as they were overgrazed (too much cattle over the same fields) and deforested (too much wood extraction from the communal woods). In his account, an optimal allocation was restored by enclosures such as the ones which took place in Sixteenth Century England: as soon as individual owners obtained undivided title over the land, depletion stopped. An individual owner would not disregard the long term implications of depletion, as he himself would bear all the future costs of inefficient use; while, as long as short term benefits were reaped by the commoners individually while the corresponding costs were born by the whole community, the same long term costs were disregarded. A similar situation applied to fisheries, which were running -- and indeed still are running, in spite of quotas -- the risk of depletion of stock as each fishing fleet ignores the long term implications of overfishing. In this perspective, the commons, appealing as they may sound to the romantics and to the left leaning, in reality are a tragedy; their opposite number, property rights, are efficient. You may wonder what this all has to do with biotech patents. The connection may become a bit clearer when I mention that about in the same years one of the most powerful minds behind the Law and Economics movement, professor Ronald Coase, was bent on proving that, by protecting the resource with a property right, the law combines the static efficiency Garret Hardin was talking about with dynamic efficiency, as it enables market transactions whereby the resource may move to its highest valued use. From there the argument migrated to intellectual property rights: also protection of IPRs by means of property rights contributes to the optimal allocation of resources; therefore biotechnological innovation too should be protected by means of patent rights. Fundamental research concerning the double helix may well have originated within the commons of the public, academic research; but when it came to reaping the fruits of the tree of knowledge, property rights, not the commons, would be the most appropriate regime. Now, this line of argument is, as I was saying, literally turned on its head by those scholars who have argued that protecting innovation by means of property rights may lead to a tragedy opposite and symmetrical to the one elucidated by Garrett Hardin, the tragedy of the anticommons; and that this may specially be the case in novel fields like digital technology and -- indeed -- genetic engineering. According to this viewpoint, while traditionally basic scientific research in agriculture and medicine had for a long time been open and the information resources widely shared by the scientific community, propertization of research outcomes by the grant of patents on agricultural and medical innovation as initiated in the late Seventies or early Eighties must be seen as apt to build up barriers to the access ad reuse of information and of information-carrying assets and is thus liable to endanger the enormous benefits which scientific cooperation entails. Let us examine more closely the reasons which usually are given to account for the emergence of the phenomenon described as the tragedy of the anticommons and for the outcomes which are said to derive from it. The first reason resides in the nature of technological innovation in genetic engineering: the originally extended trajectory which leads from the scientific enterprise to its commercial application has in the last decades to a large extent collapsed and shrunk. The second reason resides in the fact that this novel type of technical innovation -- exactly as it is the case in connection with digital technology -- tends to bear the know-how which makes it valuable "on its face". Both aspects can be simultaneously illustrated by an example drawn from the here relevant field of genetic engineering. The difficult thing in devising an emergency treatment for a heart attack based on tissue plasminogen activator (TPA), a known substance produced by the body to help the heart to revascularize in the first hours after the event, was to identify the DNA sequence which codes for this protein with a view to synthetically producing the protein itself and administering it to early stage patients. Once the TPA sequence is identified, it becomes quite easy to synthesize the desired amount of this protein for treatment of heart attacks; in turn the scientific knowledge obtained in the sequencing is immediately available to other entities which may wish to manufacture and sell the protein. Thus, theoretical knowledge of the sequence entails as a matter of course ease of manufacture of the protein for which it codes; and this activity may be replicated by any entity possessing the knowledge of the sequence, without the efforts, such as the costs of reverse engineering, usually associated with imitation of products available on the market. Now, while it is quite predictable that, in such a context, no institution would engage in investment unless it can obtain a legal monopoly on its research outputs, exactly as posited by the supporters of patent protection, several commentators have also noted that an analysis of the costs and benefits of patent protection for genetic engineering should never forget that, as a result of the just illustrated features, propertization may also have severely adverse impact upstream and downstream on the innovation process. Upstream the very possibility of obtaining property rights over research outcomes suggests to all the players that it is advisable for them to avoid organizational arrangements which entail sharing of information with third parties. Therefore, if the grant of a patent is possible, all interim steps, including materials obtained in the preliminary stages of a research trial or information pertaining thereto tend not to cross the door of the laboratory, to avoid making disclosures which may prevent patentability and give leads to potential competitors. Even presentation of ongoing research at academic meetings and publication of research findings before patent filings recede for exactly the same reasons. Exchanges may in to some extent continue, e.g. in terms of material transfer agreements; but then they tend to be governed by restrictive terms, intended to reserve the transferor entitlements over downstream innovation. In turn, the process may trigger domino effects: any initial move by one of the players to obtain exclusive right and to leverage them to secure contractual privileges is bound to trigger defensive reactions by similarly situated players. A similar analysis applies to downstream outcomes. Research outputs tend to be complementary in nature. Marketable end products may incorporate a number of contributions, which may be a method of sequencing, a research tool, a DNA sequence. To the extent complementary items are covered by separate property rights and these belong to different entities, a powerful incentive is given to each player to hold out contributing her asset as a bargaining chip to extract the highest possible share of downstream profits to be derived from marketable end products. An increasing number of commentators have therefore expressed fears that patent protection, when applied to genetic engineering innovation, may entail costs greater than the expected benefits. While in principle property rights are seen as an efficient tool to induce innovation and enhance market based exchanges over it, it is often feared that the specificity of some areas, including biomedical research and biotech, may lead to the adoption of strategic behaviour and to an unacceptable increase of transaction costs.
§ 4. Two emerging paradigms: contractually reconstructed commons and open source biotechnology. -- I do not know whether the anticommons argument is true or not. Actually, this is a matter of empirical evidence rather than of pure theory, even though of course theory may help us to make educated guesses and even to build parameters and benchmarks against which to test the hypothesis. I will therefore come back to say something about the empirical evidence as to the failure or success of the current regime in a short while. For the moment, I would rather like to point out that it may be of some significance that in the last decade we witnessed to the emergence of paradigms which in many ways are radically different from patent law and which may be described -- for the sake of convenience -- as "contractually reconstructed commons" and "open source biotechnology". Let me say just a few words about each. The first one, i.e. the proposed "contractually reconstructed commons" paradigm, recognizes the benefits which can accrue if innovators are granted property rights over their research contributions and assets; but advocates contractual arrangements which may ex ante take care of the risk that players in the research community may engage in strategic behavior of the kind described by anticommons theory. A variety of mechanisms is proposed, depending on the specific technological sector to which the arrangements are to apply, which may from case to case be drugs discovery or microbial research. There are recurring features in the design however, among which I should mention the adoption by the different players of standard contractual forms, which contemplate non-exclusive use and access to information resources and research inputs that either are covered by some form of exclusive rights or are de facto in exclusive possession of one of the parties; extensive confidentiality agreements limiting access by third parties to the resource; a dichotomy between non commercial, research uses, for all purposes free and commercial uses, subject to a contractual liability rule whereby the party first bringing to the market a commercially valuable end-product is enabled to do so subject to a duty of compensation of the provider of the different inputs which may go into the end product in accordance with a predetermined scale of royalties. These are complex concepts, which, I submit, we may start to understand better if we think of them by analogy to well known organizational paradigms in IP such as patent pools and even collective management organizations in the field of copyright. I must however confess that I do have even more difficulties in elucidating the "open source biotechnology proposal", as I cannot fully understand how this concept can work in the absence of legislative changes. The basic notion derives from open source software or, to be more specific, from the mechanism of "copyleft" on which open source licenses, including the GPL, are based. Under current copyright laws, software is protected and so are all additions to it which have a minimum of significance. It is well possible for the initiators of a project, which usually form a community, to provide for the initial body of code making it available both in source and object code (hence the designation as 'open source' software) and release it on the condition that the copyright license granted to any subsequent user is subject to compliance with a set of conditions, including the so called "copyleft clause", which requires the licensee to make all his additions available under the same open access conditions to all subsequent users. Much has been written about this 'viral' feature in software licenses, whereby the original condition imposed by the first licensor to the first licensees is propagated by the latter downstream, exactly as a virus would do, to cover each and all pieces of software building on the basis of the initial chunks of programming. Therefore for present purposes I do not need to add much, except to highlight that the whole mechanism is built on the solid foundation of copyright protection. If subsequent licensees do not abide by the copyleft clause, they are plain infringers; therefore it is copyright protection which makes sure that downstream innovation is kept open and is not enclosed by downstream innovators. This solution originates in the digital environment, where lawmakers, about three decades ago, saw fit to innovate and to adopt a rule whereby software programs are protected by copyright. I am not yet able to see how this approach can be extended to biotechnology, however. I am aware, of course within the limits accessible to a lawyer -- and, I should add, to an old timer who has not yet had much time to devote to understanding the technological evolution -- that there are new fields as the one referred to as synthetic biology; that these are a fertile ground for the emergence of distributed collective cooperation efforts, in which the innovation does not resemble the classical cherry on the pie which was the original genetic engineering innovation and may be analogized to having the different parties constructing the bricks, i.e. the building blocks which go into the larger blueprint agreed among them. What I miss is to see how there the individual building blocks may enjoy some legal protection. Neither patent nor copyright would seem to fit here; the first one because, even if we were to admit that all the requirements for patent protection are met, the costs and time of patenting would be devastating for any project; the latter one, because frankly I do not see any 'creative work' as yet in the bricks, at least until lawmakers do not step in and choose to indicate otherwise, as they did when they legislated on copyright protection of software. But then, if the individual blocks are not IP protected, it would seem to me that the very basis for copyleft licensing is missing. My provisional conclusion therefore is that open source biotechnology still misses a legislative starting point.
§ 5. Concluding remarks. -- Is there any relationship between the emergence of the two paradigms I just referred to and the difficulties allegedly faced by traditional patent law in providing an appropriate regime for genetic engineering innovation? Quite frankly, I must say that I do not know and, even more frankly, that I would not be the one to know. What I can do is to make a few guesses, for what they may be worth. The first one is that it would appear to me that one of the most fundamental reasons for the emergence of the two innovative paradigms I dealt with in § 4 is to be found in the changes which the web is undergoing. The web no longer is just a vast library; it has in the meantime become a user driven collaborative workplace. It therefore stands to reason that the possibility of myriad cooperative research enterprises in the field of biotechnology, using the web as an instrument to bring together vast data sets accumulated by the different players, has in the meantime emerged and that this distributed collective intelligence is now looking for sets of rules which may provide a finely balanced mechanism to optimize cooperation and cooperation results. Both contractually reconstructed commons and open source biotechnology would appear to be plausible candidates. Am I therefore saying that what accounts for the emergence of these two paradigms is the success of the web, rather than the putative failure of patent law in governing biotech innovation? Not quite. In fact, it would indeed appear, at least to my naïve eyes, that there are signs which show that indeed the model on which much of the initial successes in genetic engineering was based are no longer functioning. The number of blockbuster drugs is dramatically declining; the number of drugs in the pipelines is decreasing. Just a few years ago the future of bioinformatics was all the rage; today it would appear that the promises of what is referred to as High-Throughput-Screening have not come true if not to a very small extent. Therefore, we cannot rule out that the story according to which in the first years of genetic engineering our patent-driven research has been able to reap the lower hanging fruits of the tree of knowledge is correct after all. It may also well be that, to reach the fruits which hang from the higher branches, the effort of a given, specific laboratory alone is no longer sufficient; and that a cooperative effort, among firms and between firms and public research institutions and possibly even with regulatory authorities. After all it appears that gene expression is not confined to the standard linear model of one gene-one protein; but is a complex non linear process involving not just the coding of genes for individual proteins (the cDNA segments), but also the DNA involved in gene regulation and organization; I do not know whether this the case, for the simple reason that I possess neither the necessary empirical data nor the required skills to assess them. What I know is that, if this is the case, the role of cooperative arrangements will increase; but I also expect that these arrangements will not replace IPRs but will build on patent protection while trying to take care ex ante of several of the problems highlighted by the scholars who have described the dangers associated with the tragedy of the anticommons.
* This draft paper is released under a Creative Commons Attribution 3.0 unported license (http://creativecommons.org/licenses/by/3.0/). On the first issue see among others R.P. MERGES, One Hundred Years of Solicitude. Intellectual Property Law, 1900-2000, in 88 Cal. L. Rev., 2000, 2189 ff., 2224 ff.; on the second one S.J.R. BOSTYN, Enabling Biotechnological Inventions in Europe and the United States. A study of the patentability of proteins and DNA sequences with special emphasis on the disclosure requirement, European Patent Office, München, 2001, 72 ff. Throughout this paper I shall use biotechnology and genetic engineering as equivalents. The corresponding notion was originally introduced into the debate by M.A. HELLER, The Tragedy of the Anticommons: Property in the Transition from Marx to Markets, in 111 Harvard Law Review, 1998, 111 ff. and M.A. HELLER-R.S. EISENBERG, Can Patents Deter Innovation? The Anticommons in Biomedical Research, in Science 280, 1998, 698-701 and in F.H. MILLER ed., Rights and Resources, Ashgate, Dartmouth, 2003, 401-404. An excellent treatment is in E. BERTACCHINI, Contractually Constructed Research Commons: a Critical Economic Appraisal, ##. Wonderfully illustrated by J.H. REICHMAN, Legal Hybrids Between the Patent and Copyright Paradigms, in 94 Columbia L. Rev., 1994, 2432 ff. For a thorough discussion of the costs and benefits of patenting, including a discussion of the different incentives (to generate innovation, to disclose it and to disseminate it before and after the term of the patent), also with specific reference to special industries such as biotech see R. MAZZOLENI, R. NELSON, Economic Theories about the Benefits and Costs of Patents, in XXXII Journal of Economic Issues, 1998, 1031 ff. Diamond v. Chakrabarty, in 447 U.S. 303 (1980). Directive No 98/44 of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions, in OJ 2000, L 213, 13 ff. But see Art. 27(3)(b) of the Agreement on Trade Related Aspects of Intellectual Property Rights, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, LEGAL INSTRUMENTS---RESULTS OF THE URUGUAY ROUND vol. 3, 1869 U.N.T.S., 33 I.L.M. 81 (1994) [hereinafter TRIPS Agreement]. See my La proposta di direttiva del Consiglio sulla protezione giuridica delle invenzioni biotecnologiche, in Giur. Comm., 1991, I, 918 ff. and Bioethics Markets and Morals: The Case of Biotechnological Patents, in -- a cura di C.M. Mazzoni -- A Legal Framework for Bioethics, Kluwer, Dordrecht, 1998, 131 ff. and for commentary after the enactment of Directive 98/44 Biotechnology, Patents and Epistemic Approaches, in The journal of Biolaw and Business, Special Supplement, 2002, 77-90. For a classical account of this position see H. DEMSETZ, Toward a Theory of Property Rights, in American Economic Review, 1967, 347 ff. See R. COASE, The Problem of Social Cost, in 3 Journal of Law & Economics, 1960, 1 ff. For a brilliant treatment see R.P. MERGES, Of Property Rules, Coase and Intellectual Property Law, in 94 Colum. L. Rev., 1994, 2655 ff. An offspring of this conception was the adoption of rules providing incentives to patenting by Universities, such as the U.S. Bayh-Dole Act of 1980, Publ. L. No. 96-517, 94 Stat. 3015 (codified as amended at 35 U.S.A. §§ 200-212 (2000)), for an assessment of which see A. K. RAI & R.S. EISENBERG, Bayh-Dole Reform and the Progress of Biomedicine, in 66 Law & Contemp. Probs., 2003, 289 ff. and R.R. NELSON, Observations on the Post-Bayh-Dole Rise of Patenting at American Universities, in IPQ 2001, 1 ff. G.B. DINWOODIE & R. COOPER DREYFUSS, International Intellectual Property Law and the Public Domain of Science, in 7 Journal of Int. Ec. Law 2004, 431 ff., 433 and, in specific connection with the process of extension of protectable subject matter to disembodied knowledge, H. ULLRICH, Expansionist Intellectual Property and Reductionist Competition Rules, in 7 Journal of Int. Ec. Law 2004, 401 ff. As shown in the case not only of genetic engineering but also of plant varieties, semiconductor chips and data bases. For a full treatment of this line of thought see the abundant work of Jerome H. Reichman, from Legal Hybrids Between the Patent and Copyright Paradigms, above at note # to The Globalization of Private Knowledge Goods and the Privatization of Global Public Goods, in 7 Journal of Int. Ec. Law, 2004, 279 (written with Keith E. Maskus). E. BERTACCHINI, Contractually Constructed Research Commons: a Critical Economic Appraisal, quoted above at note #, E. BERTACCHINI, Contractually Constructed Research Commons: a Critical Economic Appraisal, quoted above at note #, § 2. M.A. HELLER-R.S. EISENBERG, Can Patents Deter Innovation? The Anticommons in Biomedical Research, above at note #. In this connection see E. BERTACCHINI, Contractually Constructed Research Commons: a Critical Economic Appraisal, quoted above at note #, § 3.1. The approach originally advocated by J. H. REICHMAN & P. UHLIR, A Contractually Reconstructed Research Commons for Scientific Data in a Highly Protectionist Intellectual Property Environment, in 66 Law & Contemp. Probs. 2003, 315 ff. has been refined and adapted to a number of specific contexts by A.K. RAI-J.H. REICHMAN-P.F. UHLIR-C. CROSSMAN, Pathways Across the Valley of Death: Novel Intellectual Property Strategies for Accelerated Drug Discovery, in VIII Yale Journal of Health Policy, Law, and Ethics, 2008, 1 ff. (in connection with drug discovery) and J.H. REICHMAN-T. DEDEURWAERDERE-P.F. UHLIR, Designing the Microbial Research Commons: Strategies for Accessing, Managing and Using Essential Public Knowledge, unpublished presentation to the Turin Communia Conference of June 26, 2009 (in connection with microbial collections). Except to the extent required by confidentiality agreements; in connection with publications see the balancing suggested by #. Indeed, the notion of "contracting into liability" advocated by R.P. MERGES, Contracting Into Liability Rules: Intellectual Property Rights and Collective Rights Organisations, in 84 Cal. L. Rev., 1996, 1293 ff. seems to emerge in several crucial points of the proposals concerning contractually reconstructed commons. I have not yet read the work by B. Demil & X. Lecoq, Neither market nor hierarchy nor network: the emergence of bazaar governance, in 27 Organization studies 2006, 1447-1466 and by Janet Hope, Biobazaar. The Open Source Revolution and Biotechnology, Harvard University Press, 2008, which might contain replies to the questions indicated below. On which see I.V. HEFFAN, Copyleft: Licensing Collaborative Works in the Digital Age, in 49 Stanford Law Rev. 1997, 1487 ss. C. PATTERSON, Copyright Misuse and Modified Copyleft: New Solutions to the Challenges of Internet Standardization, in 98 Michigan Law Review, 2000, 1351 ff. See Wikipedia, item Synthetic biology, last visited August 21, 2009. A similar view is expressed by A. RAI & J. BOYLE, Synthetic Biology: Caught between Property Rights, the Public Domain and the Commons, in Plos Biology March 2007, Vol. 5, Issue 3, 389-393, at 391. Which would seem a dubious proposition to begin with because no component does have utility or, in European parlance, industrial application and therefore it also is very difficult to speak of originality. The point is made, in a slightly different context (astronomy) by L. LESSIG, Remix. Making Art and Commerce Thrive in the Hybrid Economy, The Penguin Press, 2008, 170. As related by A.K. RAI-J.H. REICHMAN-P.F. UHLIR-C. CROSSMAN, Pathways Across the Valley of Death, above at note #, 3, "an average of only three drugs that act on novel targets", i.e. proteins implicated in disease pathways, "have reached the market in recent years". On the features of high throughput screening of molecule libraries against assays containing target proteins to identify promising compounds which may lead to patentable drugs see A.K. RAI-J.H. REICHMAN-P.F. UHLIR-C. CROSSMAN, Pathways Across the Valley of Death, above at note #, 7. For a thoughtful comment on this possibility see A. JACK, Remedy for a malady, Financial Times August 15-16, 2009, page 8.
Marco Ricolfi Torino Law School
-----Messaggio originale----- Da: meo [mailto:meo@polito.it] Inviato: mercoledì 13 gennaio 2010 12.25 A: Marco Ricolfi Cc: nexa@server-nexa.polito.it Oggetto: Re: R: [nexa] proprietà intellettuale sul prodotto industriale
Caro Marco, non entro nel merito della prima parte del tuo mail perchè proprio di questo vorrei parlare in Nexa. Peraltro, tu sai benissimo cosa pensano i fanatici estremisti come me di WIPO e delle sue iniziative, per non parlare di quella che consideriamo la grande truffa dell' "allargamento delle regole sui farmaci salva vita". Entro invece sul merito della "competenza dell'argomento". Perchè il prodotto artistico rientra e quello industriale no? Solo perchè sembra più facile diffondere il primo via Rete? Ma la Rete è ormai lo strumento principale per la diffusione del sapere scientifico che poi diventa brevetto. Per non parlare delle molte migliaia di brevetti su Internet (c'è una causa legale nella quale si sostiene che tutta l'attività della Rete è una violazione di brevetti precedenti) e dei prodotti proprietari che la Rete ospita, in contrapposizione con i suoi standard aperti. Comunque, se i due direttori concordano, ritiro la mia richiesta, senza far perdere tempo ad altri. Scusa ancora la mia assenza alla riunione di oggi che mi pare molto importante. Raf
On Tue, 12 Jan 2010 19:20:43 +0100, "Marco Ricolfi" <marco.ricolfi@studiotosetto.it> wrote:
Caro Raffaele, peccato non averti con noi. Rispetto al tema. Condivido - come,
penso,
anche Juan Carlos - la tua affermazione che "la proprietà intellettuale industriale è un freno allo sviluppo, fattore di disuguaglianze fra imprese grandi e piccole, fra paesi forti e deboli, e ragione della morte di
decine
di milioni di uomini, ogni anno, come illustrato da Medici senza Frontiere". Penso che si possa dire che pochi come noi, a Torino, abbiano dato
un
contributo sul tema. Pensa che in 8 anni di Master sulla proprietà intellettuale abbiamo lavorato su questo tema; che ci abbiamo formato
più
di 200 candidati, più della metà dei quali proviene dai paesi in via di sviluppo; e che, siccome moltissimi - decine - di questi sono delegati
dei
loro governi nelle istituzioni internazionali, abbiamo contribuito agli sviluppi in questo settore. La nostra Vanessa Lowenstein è stata tra le prima a lavorare alla Development Agenda del WIPO (una serie di
iniziative
richieste dai paesi in via di sviluppo per contrastare la deriva iper-protezionista della proprietà intellettuale); e l'allargamento
delle
regole sui farmaci salva vita ci ha visto particolarmente attivi. Occorre però anche rispettare un principio di competenza e di specializzazione delle competenze. Da questo punto di vista, quello che
non
è facile capire è come questo tema - prioritario - trovi collocazione in un centro che si occupa della rete internet, salvo che per il profilo del brevetto di software, sul quale abbiamo posizioni chiare e costanti (nel senso che va, in linea generale, evitato e combattuto). Possiamo ritornare quando vuoi sul tema. Sulla base però di un'argomentazione almeno ipotetica della rilevanza ai fini di una riflessione sistematica specificamente riferita alla rete. Dico bene,
Juan
Carlos? m.
-----Messaggio originale----- Da: nexa-bounces@server-nexa.polito.it [mailto:nexa-bounces@server-nexa.polito.it] Per conto di Angelo Raffaele Meo Inviato: lunedì 11 gennaio 2010 16.37 A: nexa@server-nexa.polito.it Oggetto: [nexa] proprietà intellettuale sul prodotto industriale
Carissimi, desidero scusare la mia assenza all'incontro Nexa
previsto
per mercoledì 13. Come nel caso dei precedenti mercoledì, debbo partecipare alla seduta mensile dell'Accademia delle Scienze, ove, tra l'altro, dobbiamo discutere di un convegno sulla ricerca industriale che
intendiamo
organizzare. Avanzo comunque una richiesta relativa alla roadmap 2010. Mi piacerebbe, come anticipai in un incontro lontano, che Nexa
affrontasse
anche la questione della proprietà intellettuale sui prodotti
industriali
e dei brevetti in particolare. Quel giorno Marco (Ricolfi, non Ciurcina)
mi
rispose che quella questione non rientrava negli obiettivi di Nexa e
oggi,
in un incontro privato, Juan Carlos mi ha ribadito la posizione di
Marco.
Se questa è la posizione di tutti, accetto disciplinatamente la decisione collegiale. Tuttavia, mi sia consentito ricordare l'opinione
di
un numero rapidamente crescente di studiosi, secondo la quale la questione della proprietà intellettuale sul prodotto industriale è molto più importante della questione della proprietà sul prodotto artistico,
perchè
la proprietà intellettuale industriale è un freno allo sviluppo, fattore di disuguaglianze fra imprese grandi e piccole, fra paesi forti e deboli, e ragione della morte di decine di milioni di uomini, ogni anno, come illustrato da Medici senza Frontiere. Grazie per l'attenzione. Colgo l'occasione per associarmi alle congratulazioni di Marco R. a Marco C. Raf
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Caro Marco, scusami, ma non ho ancora trovato il tempo di leggere il tuo articolo, che leggerò sicuramente con attenzione. Infatti, sto lavorando come un matto per lavori organizzativi vari e non trovo il tempo per le cose che mi interessano di più. E neppure ho trovato il tempo necessario per documentarmi e rispondere al tuo quesito sui farmaci salva-vita. Spero di trovare il tempo per farlo presto. Per ora, ricordo, a memoria, quel che si disse allora: "Non serve a nulla concedere a un paese povero il diritto di produrre farmaci coperti da brevetto, poichè i paesi più poveri non posseggono le risorse industriali per farlo. Occorre invece abolire l'istituto del brevetto liberalizzando completamente il mercato". WIPO sostiene che i brevetti sono lo strumento necessario per trovare le risorse necessarie per la ricerca, ma molti studi mettono in evidenza che solo 20% o meno degli utili delle multinazionali del farmaco vanno in ricerca. Stigliz ribatte a WIPO: "..the current system results in limited funds being spent in the wrong way..", per cui propone una ricetta elementare: gli stati ricchi paghino i ricercatori e i frutti del loro lavoro vadano tutti nel pubblico dominio, in modo che tutti, in ogni parte del mondo, possano produrre i farmaci necessari per la sopravvivenza di milioni di persone. E' la considerazione per la quale chiedevo che si parlasse del pubblico dominio in termini più generali, ma non intendo sollevare nuovamente la questione. Ne riparleremo privatamente. Un caro saluto!!!! Raf
Caro Angelo, ieri sono stato un po' cortino anch'io. Quel che volevo dire è che anche il tema dei farmaci è più complesso: ci sono proposte, come quelle della Lanyeuw, che mi paiono meno semplicistiche di quel che dice il grande Stiglitz.J. LANJOUW, A Patent Policy Proposal for Global Diseases, <http://www.brookings.edu/> www.brookings.edu June 11, 2001. Io l'avevo ripresa in una conferenzas a New Delhi dieci anni fa ("Here I will confine myself to saying that the proposal which seems most satisfactory to me is the one under which patenting of drugs should be admitted either for developed countries or for developed ones, but not for both": in The Interface between Intellectual Property and International Trade: the TRIPs Agreement, in Italian Intellectual Property, 2002, 29 ss.); negli attuali assetti di potere, però, il passaggio dall'art. 31 TRIPs al 31-bis mi è sembrato un passo in avanti, perché prima il Sud Africa che non ha un'industria farmaceutica poteva imporre una licenza obbligatoria ma non poteva servirsene, perché mancavano case locali che potessero produtte; oggi con il 31 bis la produzione può anche avvenire in India, se il mercato in cui il farmaco è usato è il Sud Africa. Comunque, hai ragione che sono temi di cui potremo parlare alla prima occasione, anche extra-Nexa. Per l'intanto fa piacere a me - come so che fa piacere a JC - avere potuto raccogliere i tuoi stimoli. m. _____ Da: Angelo Raffaele Meo [mailto:meo@polito.it] Inviato: venerdì 29 gennaio 2010 18.57 A: Marco Ricolfi Cc: nexa@server-nexa.polito.it Oggetto: Re: R: R: [nexa] proprietà intellettuale sul prodotto industriale Marco Ricolfi ha scritto: Caro Angelo, grazie del tuo e-mail. Quanto al master che dirigo, e di cui ho la responsabilità scientifica, potrà interessarti venire ad assistere alle lezioni, specie quelle sui brevetti che ti interessano; e sono sicuro che avrai sorprese se parti dallassunto che meritino il giudizio che riservi alle iniziative WIPO. A me invece interessa sapere se hai evidenze empiriche su quella che tu consideri la grande truffa dellallargamento delle regole sui farmaci salva vita, che è stata fortemente voluta dai paesi in via di sviluppo. E infatti venuto il momento non per Nexa, peraltro per fare un bilancio su questo argomento. Hai invece ragione di insistere sulla rilevanza del tema dei brevetti per la rete; e precisamente sotto i due profili che ti indichi. Di uno mi sono occupato anchio, forse un po incidentalmente, come mostra il testo della conferenza che ho tenuto ad Ottobre a Ginevra nellambito del Master e che riproduco qui sotto. Il brevetto è stato pensato per leconomia classica; oggi la rete apre possibilità di cooperazione per le quali il brevetto rischia di divenire un ostacolo invece che un incentivo. Dellaltro che definirei più che i brevetti su internet i brevetti sugli strumenti di comunicazione e condivisione del sapere in forma digitale, ivi incluso lo strumento di internet, già ci occupiamo, occupandoci di brevetti di software; e lattenzione potrebbe (e forse dovrebbe, risorse permettendo) estendersi a brevetti su protocolli e formati, come già segnalato da Juan Carlos. Condivido anche lidea di JC secondo cui il tema dellinteroperabilità merita di essere particolarmente sviluppato, essendo del resto al centro della tesi di dottorato del nostro managing director Federico Morando. Mettendo insieme questi due pezzi, risulta un quadro non diverso da quello cui dirigono le tue osservazioni. Grazie dunque per lo stimolo, che insieme con Juan Carlos non lasceremo cadere, nei limiti delle risorse e del tempo a disposizione. Ma comunque tenendo conto dellesigenza di rifocalizzare lattenzione anche su temi importanti come quelli che tu segnali. m. 20/01/2010 Genevatex Genetic Engineering: Where is the Innovation?* Summary: § 1. Which Innovation? § 2. Patent law and genetic engineering. § 3. The tragedy of the commons and the tragedy of the anticommons. § 4. Two emerging paradigms: contractually reconstructed commons and open source biotechnology. § 5. Concluding remarks. § 1. Which Innovation? There is a certain ambiguity in the title of the presentation which was allotted to me. One possible way to read the question Where is the Innovation? is to ask whether the requirement for patentability which in the US legal system is referred as non obviousness and in Europe as inventive step is in some way different in the field of genetic engineering as opposed to general patent law. This would certainly be an interesting issue to research. Indeed, it is arguable that in this regard genetic engineering is a pretty special case: just to mention the first differences which occur to me, the standard used in this area is lower than the one used in more traditional fields, such as mechanics, chemistry and pharmaceuticals; when it comes to the field of biotech, the notion of person skilled in the art, against which the inventiveness of each invention is tested, is a specialized one; and so on. There are even more interesting ways to read the question in the title, however. The title might refer either to the identification of the genetic engineering areas in which innovation would appear most promising; or even to the issue whether the legal rules governing the protection of genetic engineering research and investment should they themselves be innovated, that is adapted or changed. I find this perspective even more challenging than the one I mentioned at the outset, so that I chose to explore it rather than elaborating on the notion of inventive step. I must also add that, being a lawyer rather than a scientist or a technologist, I will mainly look at the second strand of the second issue, asking what is the legal innovation to be expected in this field, rather than trying to fathom what the technological innovation will be. I am afraid, however, that as a lawyer I cannot totally avoid the necessity of also dealing, if only to a certain extent, with the first strand of the same question. The nature of the legal profession is such that lawyers cannot stand totally separate from the non-legal issues to which they apply their analytical skills; and I am sure that the participants in this eight edition of the Turin-WIPO LL. M. program will by now have become acutely aware that in IP law the interpenetration of technical aspect and legal rules is even more advanced than in other areas of the law. Taking this to account, in the final part of my presentation (at § 5) I will ask whether there is any relationship between proposed changes concerning the legal rules and changes underway in the actual technological reality of genetic engineering research and development. § 2. Patent law and genetic engineering. Now, concerning the question whether changes are required in the legal protection of genetic engineering innovation, it would appear that the question really has two sides to it. The first one is to ask whether we do have empirical evidence confirming the hypothesis, sometimes described with reference to the notion of the tragedy of the anticommons, that protection of genetic engineering innovation via patent law does in fact entail an increase in transaction costs and encourages opportunistic and strategic behaviour. The second one is to ask whether there are mechanisms which conceivably could be adopted to foster research and innovation in the field of genetic engineering which are promising enough and sufficiently tested to warrant consideration as alternatives to patent protection or possibly as complements to it. A few words may be in place to elucidate the first question. At some point in the late Seventies or in the early Eighties of last century biotechnology emerged as a revolutionary technological approach based on i. the identification of the DNA sequences responsible for certain traits of living organism, e.g. coding for a protein making the plant resistant to salinity; and ii. the cutting and pasting of the relevant sequence from an original living organism to the receiving cell of a different target organism. (That the cutting of the DNA sequence usually took place through so called restriction enzymes and that its splicing on the receiving cell usually was effected by means of a virus are details which even today may sound extraordinary to the non-specialist but in the present context do not seem to have particular implications). In many ways, this kind of innovation was very different from the innovation we had been accustomed to through the previous centuries and decades, in areas such as mechanics first, chemistry and pharmaceuticals later. This discontinuity between prior forms of innovation and biotechnology called in question the advisability of pouring new wine in old bottles by protecting biotech innovation through patent laws; nevertheless the various legal systems of advanced economies came more or less in unison to the conclusion that patent protection was the most appropriate tool to provide an incentive for the creation and dissemination of a technological innovation in general and that this applied also to biotech innovation. In fact, some jurisdictions incorporated biotech into patent laws by means of case law; others went all the way and changed patent rules to specifically accommodate biotechnological innovation. In the end the outcome was the same: currently the job of providing the appropriate incentive to originate, disclose, and disseminate biotech innovation lays with patent laws in most of the advanced economies. § 3. The tragedy of the commons and the tragedy of the anticommons. When the adoption of the EU Directive on the legal protection of biotechnological inventions was discussed, I was in the camp of the sceptics. Today, I might recollect some of the doubts I then harboured; for the present purposes I find it more relevant, however, to look at the kind of critique to patent protection of biotech innovation which currently is described as the anticommons argument. We may begin to understand what the anticommons argument means by considering it turns on its head the theory of the tragedy of the commons, originally advocated by an important article written in the early Sixties by a scientist, Garrett Hardin. In the Middle Ages, he had remarked, stretches of land held in common by the local population were gradually depleted, as they were overgrazed (too much cattle over the same fields) and deforested (too much wood extraction from the communal woods). In his account, an optimal allocation was restored by enclosures such as the ones which took place in Sixteenth Century England: as soon as individual owners obtained undivided title over the land, depletion stopped. An individual owner would not disregard the long term implications of depletion, as he himself would bear all the future costs of inefficient use; while, as long as short term benefits were reaped by the commoners individually while the corresponding costs were born by the whole community, the same long term costs were disregarded. A similar situation applied to fisheries, which were running and indeed still are running, in spite of quotas the risk of depletion of stock as each fishing fleet ignores the long term implications of overfishing. In this perspective, the commons, appealing as they may sound to the romantics and to the left leaning, in reality are a tragedy; their opposite number, property rights, are efficient. You may wonder what this all has to do with biotech patents. The connection may become a bit clearer when I mention that about in the same years one of the most powerful minds behind the Law and Economics movement, professor Ronald Coase, was bent on proving that, by protecting the resource with a property right, the law combines the static efficiency Garret Hardin was talking about with dynamic efficiency, as it enables market transactions whereby the resource may move to its highest valued use. From there the argument migrated to intellectual property rights: also protection of IPRs by means of property rights contributes to the optimal allocation of resources; therefore biotechnological innovation too should be protected by means of patent rights. Fundamental research concerning the double helix may well have originated within the commons of the public, academic research; but when it came to reaping the fruits of the tree of knowledge, property rights, not the commons, would be the most appropriate regime. Now, this line of argument is, as I was saying, literally turned on its head by those scholars who have argued that protecting innovation by means of property rights may lead to a tragedy opposite and symmetrical to the one elucidated by Garrett Hardin, the tragedy of the anticommons; and that this may specially be the case in novel fields like digital technology and indeed genetic engineering. According to this viewpoint, while traditionally basic scientific research in agriculture and medicine had for a long time been open and the information resources widely shared by the scientific community, propertization of research outcomes by the grant of patents on agricultural and medical innovation as initiated in the late Seventies or early Eighties must be seen as apt to build up barriers to the access ad reuse of information and of information-carrying assets and is thus liable to endanger the enormous benefits which scientific cooperation entails. Let us examine more closely the reasons which usually are given to account for the emergence of the phenomenon described as the tragedy of the anticommons and for the outcomes which are said to derive from it. The first reason resides in the nature of technological innovation in genetic engineering: the originally extended trajectory which leads from the scientific enterprise to its commercial application has in the last decades to a large extent collapsed and shrunk. The second reason resides in the fact that this novel type of technical innovation exactly as it is the case in connection with digital technology tends to bear the know-how which makes it valuable on its face. Both aspects can be simultaneously illustrated by an example drawn from the here relevant field of genetic engineering. The difficult thing in devising an emergency treatment for a heart attack based on tissue plasminogen activator (TPA), a known substance produced by the body to help the heart to revascularize in the first hours after the event, was to identify the DNA sequence which codes for this protein with a view to synthetically producing the protein itself and administering it to early stage patients. Once the TPA sequence is identified, it becomes quite easy to synthesize the desired amount of this protein for treatment of heart attacks; in turn the scientific knowledge obtained in the sequencing is immediately available to other entities which may wish to manufacture and sell the protein. Thus, theoretical knowledge of the sequence entails as a matter of course ease of manufacture of the protein for which it codes; and this activity may be replicated by any entity possessing the knowledge of the sequence, without the efforts, such as the costs of reverse engineering, usually associated with imitation of products available on the market. Now, while it is quite predictable that, in such a context, no institution would engage in investment unless it can obtain a legal monopoly on its research outputs, exactly as posited by the supporters of patent protection, several commentators have also noted that an analysis of the costs and benefits of patent protection for genetic engineering should never forget that, as a result of the just illustrated features, propertization may also have severely adverse impact upstream and downstream on the innovation process. Upstream the very possibility of obtaining property rights over research outcomes suggests to all the players that it is advisable for them to avoid organizational arrangements which entail sharing of information with third parties. Therefore, if the grant of a patent is possible, all interim steps, including materials obtained in the preliminary stages of a research trial or information pertaining thereto tend not to cross the door of the laboratory, to avoid making disclosures which may prevent patentability and give leads to potential competitors. Even presentation of ongoing research at academic meetings and publication of research findings before patent filings recede for exactly the same reasons. Exchanges may in to some extent continue, e.g. in terms of material transfer agreements; but then they tend to be governed by restrictive terms, intended to reserve the transferor entitlements over downstream innovation. In turn, the process may trigger domino effects: any initial move by one of the players to obtain exclusive right and to leverage them to secure contractual privileges is bound to trigger defensive reactions by similarly situated players. A similar analysis applies to downstream outcomes. Research outputs tend to be complementary in nature. Marketable end products may incorporate a number of contributions, which may be a method of sequencing, a research tool, a DNA sequence. To the extent complementary items are covered by separate property rights and these belong to different entities, a powerful incentive is given to each player to hold out contributing her asset as a bargaining chip to extract the highest possible share of downstream profits to be derived from marketable end products. An increasing number of commentators have therefore expressed fears that patent protection, when applied to genetic engineering innovation, may entail costs greater than the expected benefits. While in principle property rights are seen as an efficient tool to induce innovation and enhance market based exchanges over it, it is often feared that the specificity of some areas, including biomedical research and biotech, may lead to the adoption of strategic behaviour and to an unacceptable increase of transaction costs. § 4. Two emerging paradigms: contractually reconstructed commons and open source biotechnology. I do not know whether the anticommons argument is true or not. Actually, this is a matter of empirical evidence rather than of pure theory, even though of course theory may help us to make educated guesses and even to build parameters and benchmarks against which to test the hypothesis. I will therefore come back to say something about the empirical evidence as to the failure or success of the current regime in a short while. For the moment, I would rather like to point out that it may be of some significance that in the last decade we witnessed to the emergence of paradigms which in many ways are radically different from patent law and which may be described for the sake of convenience as contractually reconstructed commons and open source biotechnology. Let me say just a few words about each. The first one, i.e. the proposed contractually reconstructed commons paradigm, recognizes the benefits which can accrue if innovators are granted property rights over their research contributions and assets; but advocates contractual arrangements which may ex ante take care of the risk that players in the research community may engage in strategic behavior of the kind described by anticommons theory. A variety of mechanisms is proposed, depending on the specific technological sector to which the arrangements are to apply, which may from case to case be drugs discovery or microbial research. There are recurring features in the design however, among which I should mention the adoption by the different players of standard contractual forms, which contemplate non-exclusive use and access to information resources and research inputs that either are covered by some form of exclusive rights or are de facto in exclusive possession of one of the parties; extensive confidentiality agreements limiting access by third parties to the resource; a dichotomy between non commercial, research uses, for all purposes free and commercial uses, subject to a contractual liability rule whereby the party first bringing to the market a commercially valuable end-product is enabled to do so subject to a duty of compensation of the provider of the different inputs which may go into the end product in accordance with a predetermined scale of royalties. These are complex concepts, which, I submit, we may start to understand better if we think of them by analogy to well known organizational paradigms in IP such as patent pools and even collective management organizations in the field of copyright. I must however confess that I do have even more difficulties in elucidating the open source biotechnology proposal, as I cannot fully understand how this concept can work in the absence of legislative changes. The basic notion derives from open source software or, to be more specific, from the mechanism of copyleft on which open source licenses, including the GPL, are based. Under current copyright laws, software is protected and so are all additions to it which have a minimum of significance. It is well possible for the initiators of a project, which usually form a community, to provide for the initial body of code making it available both in source and object code (hence the designation as open source software) and release it on the condition that the copyright license granted to any subsequent user is subject to compliance with a set of conditions, including the so called copyleft clause, which requires the licensee to make all his additions available under the same open access conditions to all subsequent users. Much has been written about this viral feature in software licenses, whereby the original condition imposed by the first licensor to the first licensees is propagated by the latter downstream, exactly as a virus would do, to cover each and all pieces of software building on the basis of the initial chunks of programming. Therefore for present purposes I do not need to add much, except to highlight that the whole mechanism is built on the solid foundation of copyright protection. If subsequent licensees do not abide by the copyleft clause, they are plain infringers; therefore it is copyright protection which makes sure that downstream innovation is kept open and is not enclosed by downstream innovators. This solution originates in the digital environment, where lawmakers, about three decades ago, saw fit to innovate and to adopt a rule whereby software programs are protected by copyright. I am not yet able to see how this approach can be extended to biotechnology, however. I am aware, of course within the limits accessible to a lawyer and, I should add, to an old timer who has not yet had much time to devote to understanding the technological evolution that there are new fields as the one referred to as synthetic biology; that these are a fertile ground for the emergence of distributed collective cooperation efforts, in which the innovation does not resemble the classical cherry on the pie which was the original genetic engineering innovation and may be analogized to having the different parties constructing the bricks, i.e. the building blocks which go into the larger blueprint agreed among them. What I miss is to see how there the individual building blocks may enjoy some legal protection. Neither patent nor copyright would seem to fit here; the first one because, even if we were to admit that all the requirements for patent protection are met, the costs and time of patenting would be devastating for any project; the latter one, because frankly I do not see any creative work as yet in the bricks, at least until lawmakers do not step in and choose to indicate otherwise, as they did when they legislated on copyright protection of software. But then, if the individual blocks are not IP protected, it would seem to me that the very basis for copyleft licensing is missing. My provisional conclusion therefore is that open source biotechnology still misses a legislative starting point. § 5. Concluding remarks. Is there any relationship between the emergence of the two paradigms I just referred to and the difficulties allegedly faced by traditional patent law in providing an appropriate regime for genetic engineering innovation? Quite frankly, I must say that I do not know and, even more frankly, that I would not be the one to know. What I can do is to make a few guesses, for what they may be worth. The first one is that it would appear to me that one of the most fundamental reasons for the emergence of the two innovative paradigms I dealt with in § 4 is to be found in the changes which the web is undergoing. The web no longer is just a vast library; it has in the meantime become a user driven collaborative workplace. It therefore stands to reason that the possibility of myriad cooperative research enterprises in the field of biotechnology, using the web as an instrument to bring together vast data sets accumulated by the different players, has in the meantime emerged and that this distributed collective intelligence is now looking for sets of rules which may provide a finely balanced mechanism to optimize cooperation and cooperation results. Both contractually reconstructed commons and open source biotechnology would appear to be plausible candidates. Am I therefore saying that what accounts for the emergence of these two paradigms is the success of the web, rather than the putative failure of patent law in governing biotech innovation? Not quite. In fact, it would indeed appear, at least to my naïve eyes, that there are signs which show that indeed the model on which much of the initial successes in genetic engineering was based are no longer functioning. The number of blockbuster drugs is dramatically declining; the number of drugs in the pipelines is decreasing. Just a few years ago the future of bioinformatics was all the rage; today it would appear that the promises of what is referred to as High-Throughput-Screening have not come true if not to a very small extent. Therefore, we cannot rule out that the story according to which in the first years of genetic engineering our patent-driven research has been able to reap the lower hanging fruits of the tree of knowledge is correct after all. It may also well be that, to reach the fruits which hang from the higher branches, the effort of a given, specific laboratory alone is no longer sufficient; and that a cooperative effort, among firms and between firms and public research institutions and possibly even with regulatory authorities. After all it appears that gene expression is not confined to the standard linear model of one gene-one protein; but is a complex non linear process involving not just the coding of genes for individual proteins (the cDNA segments), but also the DNA involved in gene regulation and organization; I do not know whether this the case, for the simple reason that I possess neither the necessary empirical data nor the required skills to assess them. What I know is that, if this is the case, the role of cooperative arrangements will increase; but I also expect that these arrangements will not replace IPRs but will build on patent protection while trying to take care ex ante of several of the problems highlighted by the scholars who have described the dangers associated with the tragedy of the anticommons. * This draft paper is released under a Creative Commons Attribution 3.0 unported license (http://creativecommons.org/licenses/by/3.0/). On the first issue see among others R.P. MERGES, One Hundred Years of Solicitude. Intellectual Property Law, 1900-2000, in 88 Cal. L. Rev., 2000, 2189 ff., 2224 ff.; on the second one S.J.R. BOSTYN, Enabling Biotechnological Inventions in Europe and the United States. A study of the patentability of proteins and DNA sequences with special emphasis on the disclosure requirement, European Patent Office, München, 2001, 72 ff. Throughout this paper I shall use biotechnology and genetic engineering as equivalents. The corresponding notion was originally introduced into the debate by M.A. HELLER, The Tragedy of the Anticommons: Property in the Transition from Marx to Markets, in 111 Harvard Law Review, 1998, 111 ff. and M.A. HELLER-R.S. EISENBERG, Can Patents Deter Innovation? The Anticommons in Biomedical Research, in Science 280, 1998, 698-701 and in F.H. MILLER ed., Rights and Resources, Ashgate, Dartmouth, 2003, 401-404. An excellent treatment is in E. BERTACCHINI, Contractually Constructed Research Commons: a Critical Economic Appraisal, ##. Wonderfully illustrated by J.H. REICHMAN, Legal Hybrids Between the Patent and Copyright Paradigms, in 94 Columbia L. Rev., 1994, 2432 ff. For a thorough discussion of the costs and benefits of patenting, including a discussion of the different incentives (to generate innovation, to disclose it and to disseminate it before and after the term of the patent), also with specific reference to special industries such as biotech see R. MAZZOLENI, R. NELSON, Economic Theories about the Benefits and Costs of Patents, in XXXII Journal of Economic Issues, 1998, 1031 ff. Diamond v. Chakrabarty, in 447 U.S. 303 (1980). Directive No 98/44 of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions, in OJ 2000, L 213, 13 ff. But see Art. 27(3)(b) of the Agreement on Trade Related Aspects of Intellectual Property Rights, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, LEGAL INSTRUMENTSRESULTS OF THE URUGUAY ROUND vol. 3, 1869 U.N.T.S., 33 I.L.M. 81 (1994) [hereinafter TRIPS Agreement]. See my La proposta di direttiva del Consiglio sulla protezione giuridica delle invenzioni biotecnologiche, in Giur. Comm., 1991, I, 918 ff. and Bioethics Markets and Morals: The Case of Biotechnological Patents, in a cura di C.M. Mazzoni A Legal Framework for Bioethics, Kluwer, Dordrecht, 1998, 131 ff. and for commentary after the enactment of Directive 98/44 Biotechnology, Patents and Epistemic Approaches, in The journal of Biolaw and Business, Special Supplement, 2002, 77-90. For a classical account of this position see H. DEMSETZ, Toward a Theory of Property Rights, in American Economic Review, 1967, 347 ff. See R. COASE, The Problem of Social Cost, in 3 Journal of Law & Economics, 1960, 1 ff. For a brilliant treatment see R.P. MERGES, Of Property Rules, Coase and Intellectual Property Law, in 94 Colum. L. Rev., 1994, 2655 ff. An offspring of this conception was the adoption of rules providing incentives to patenting by Universities, such as the U.S. Bayh-Dole Act of 1980, Publ. L. No. 96-517, 94 Stat. 3015 (codified as amended at 35 U.S.A. §§ 200-212 (2000)), for an assessment of which see A. K. RAI & R.S. EISENBERG, Bayh-Dole Reform and the Progress of Biomedicine, in 66 Law & Contemp. Probs., 2003, 289 ff. and R.R. NELSON, Observations on the Post-Bayh-Dole Rise of Patenting at American Universities, in IPQ 2001, 1 ff. G.B. DINWOODIE & R. COOPER DREYFUSS, International Intellectual Property Law and the Public Domain of Science, in 7 Journal of Int. Ec. Law 2004, 431 ff., 433 and, in specific connection with the process of extension of protectable subject matter to disembodied knowledge, H. ULLRICH, Expansionist Intellectual Property and Reductionist Competition Rules, in 7 Journal of Int. Ec. Law 2004, 401 ff. As shown in the case not only of genetic engineering but also of plant varieties, semiconductor chips and data bases. For a full treatment of this line of thought see the abundant work of Jerome H. Reichman, from Legal Hybrids Between the Patent and Copyright Paradigms, above at note # to The Globalization of Private Knowledge Goods and the Privatization of Global Public Goods, in 7 Journal of Int. Ec. Law, 2004, 279 (written with Keith E. Maskus). E. BERTACCHINI, Contractually Constructed Research Commons: a Critical Economic Appraisal, quoted above at note #, E. BERTACCHINI, Contractually Constructed Research Commons: a Critical Economic Appraisal, quoted above at note #, § 2. M.A. HELLER-R.S. EISENBERG, Can Patents Deter Innovation? The Anticommons in Biomedical Research, above at note #. In this connection see E. BERTACCHINI, Contractually Constructed Research Commons: a Critical Economic Appraisal, quoted above at note #, § 3.1. The approach originally advocated by J. H. REICHMAN & P. UHLIR, A Contractually Reconstructed Research Commons for Scientific Data in a Highly Protectionist Intellectual Property Environment, in 66 Law & Contemp. Probs. 2003, 315 ff. has been refined and adapted to a number of specific contexts by A.K. RAI-J.H. REICHMAN-P.F. UHLIR-C. CROSSMAN, Pathways Across the Valley of Death: Novel Intellectual Property Strategies for Accelerated Drug Discovery, in VIII Yale Journal of Health Policy, Law, and Ethics, 2008, 1 ff. (in connection with drug discovery) and J.H. REICHMAN-T. DEDEURWAERDERE-P.F. UHLIR, Designing the Microbial Research Commons: Strategies for Accessing, Managing and Using Essential Public Knowledge, unpublished presentation to the Turin Communia Conference of June 26, 2009 (in connection with microbial collections). Except to the extent required by confidentiality agreements; in connection with publications see the balancing suggested by #. Indeed, the notion of contracting into liability advocated by R.P. MERGES, Contracting Into Liability Rules: Intellectual Property Rights and Collective Rights Organisations, in 84 Cal. L. Rev., 1996, 1293 ff. seems to emerge in several crucial points of the proposals concerning contractually reconstructed commons. I have not yet read the work by B. Demil & X. Lecoq, Neither market nor hierarchy nor network: the emergence of bazaar governance, in 27 Organization studies 2006, 1447-1466 and by Janet Hope, Biobazaar. The Open Source Revolution and Biotechnology, Harvard University Press, 2008, which might contain replies to the questions indicated below. On which see I.V. HEFFAN, Copyleft: Licensing Collaborative Works in the Digital Age, in 49 Stanford Law Rev. 1997, 1487 ss. C. PATTERSON, Copyright Misuse and Modified Copyleft: New Solutions to the Challenges of Internet Standardization, in 98 Michigan Law Review, 2000, 1351 ff. See Wikipedia, item Synthetic biology, last visited August 21, 2009. A similar view is expressed by A. RAI & J. BOYLE, Synthetic Biology: Caught between Property Rights, the Public Domain and the Commons, in Plos Biology March 2007, Vol. 5, Issue 3, 389-393, at 391. Which would seem a dubious proposition to begin with because no component does have utility or, in European parlance, industrial application and therefore it also is very difficult to speak of originality. The point is made, in a slightly different context (astronomy) by L. LESSIG, Remix. Making Art and Commerce Thrive in the Hybrid Economy, The Penguin Press, 2008, 170. As related by A.K. RAI-J.H. REICHMAN-P.F. UHLIR-C. CROSSMAN, Pathways Across the Valley of Death, above at note #, 3, an average of only three drugs that act on novel targets, i.e. proteins implicated in disease pathways, have reached the market in recent years. On the features of high throughput screening of molecule libraries against assays containing target proteins to identify promising compounds which may lead to patentable drugs see A.K. RAI-J.H. REICHMAN-P.F. UHLIR-C. CROSSMAN, Pathways Across the Valley of Death, above at note #, 7. For a thoughtful comment on this possibility see A. JACK, Remedy for a malady, Financial Times August 15-16, 2009, page 8. Marco Ricolfi Torino Law School -----Messaggio originale----- Da: meo [mailto:meo@polito.it] Inviato: mercoledì 13 gennaio 2010 12.25 A: Marco Ricolfi Cc: nexa@server-nexa.polito.it Oggetto: Re: R: [nexa] proprietà intellettuale sul prodotto industriale Caro Marco, non entro nel merito della prima parte del tuo mail perchè proprio di questo vorrei parlare in Nexa. Peraltro, tu sai benissimo cosa pensano i fanatici estremisti come me di WIPO e delle sue iniziative, per non parlare di quella che consideriamo la grande truffa dell' "allargamento delle regole sui farmaci salva vita". Entro invece sul merito della "competenza dell'argomento". Perchè il prodotto artistico rientra e quello industriale no? Solo perchè sembra più facile diffondere il primo via Rete? Ma la Rete è ormai lo strumento principale per la diffusione del sapere scientifico che poi diventa brevetto. Per non parlare delle molte migliaia di brevetti su Internet (c'è una causa legale nella quale si sostiene che tutta l'attività della Rete è una violazione di brevetti precedenti) e dei prodotti proprietari che la Rete ospita, in contrapposizione con i suoi standard aperti. Comunque, se i due direttori concordano, ritiro la mia richiesta, senza far perdere tempo ad altri. Scusa ancora la mia assenza alla riunione di oggi che mi pare molto importante. Raf On Tue, 12 Jan 2010 19:20:43 +0100, "Marco Ricolfi" <mailto:marco.ricolfi@studiotosetto.it> <marco.ricolfi@studiotosetto.it> wrote: Caro Raffaele, peccato non averti con noi. Rispetto al tema. Condivido - come, penso, anche Juan Carlos - la tua affermazione che "la proprietà intellettuale industriale è un freno allo sviluppo, fattore di disuguaglianze fra imprese grandi e piccole, fra paesi forti e deboli, e ragione della morte di decine di milioni di uomini, ogni anno, come illustrato da Medici senza Frontiere". Penso che si possa dire che pochi come noi, a Torino, abbiano dato un contributo sul tema. Pensa che in 8 anni di Master sulla proprietà intellettuale abbiamo lavorato su questo tema; che ci abbiamo formato più di 200 candidati, più della metà dei quali proviene dai paesi in via di sviluppo; e che, siccome moltissimi - decine - di questi sono delegati dei loro governi nelle istituzioni internazionali, abbiamo contribuito agli sviluppi in questo settore. La nostra Vanessa Lowenstein è stata tra le prima a lavorare alla Development Agenda del WIPO (una serie di iniziative richieste dai paesi in via di sviluppo per contrastare la deriva iper-protezionista della proprietà intellettuale); e l'allargamento delle regole sui farmaci salva vita ci ha visto particolarmente attivi. Occorre però anche rispettare un principio di competenza e di specializzazione delle competenze. Da questo punto di vista, quello che non è facile capire è come questo tema - prioritario - trovi collocazione in un centro che si occupa della rete internet, salvo che per il profilo del brevetto di software, sul quale abbiamo posizioni chiare e costanti (nel senso che va, in linea generale, evitato e combattuto). Possiamo ritornare quando vuoi sul tema. Sulla base però di un'argomentazione almeno ipotetica della rilevanza ai fini di una riflessione sistematica specificamente riferita alla rete. Dico bene, Juan Carlos? m. -----Messaggio originale----- Da: nexa-bounces@server-nexa.polito.it [mailto:nexa-bounces@server-nexa.polito.it] Per conto di Angelo Raffaele Meo Inviato: lunedì 11 gennaio 2010 16.37 A: nexa@server-nexa.polito.it Oggetto: [nexa] proprietà intellettuale sul prodotto industriale Carissimi, desidero scusare la mia assenza all'incontro Nexa previsto per mercoledì 13. Come nel caso dei precedenti mercoledì, debbo partecipare alla seduta mensile dell'Accademia delle Scienze, ove, tra l'altro, dobbiamo discutere di un convegno sulla ricerca industriale che intendiamo organizzare. Avanzo comunque una richiesta relativa alla roadmap 2010. Mi piacerebbe, come anticipai in un incontro lontano, che Nexa affrontasse anche la questione della proprietà intellettuale sui prodotti industriali e dei brevetti in particolare. Quel giorno Marco (Ricolfi, non Ciurcina) mi rispose che quella questione non rientrava negli obiettivi di Nexa e oggi, in un incontro privato, Juan Carlos mi ha ribadito la posizione di Marco. Se questa è la posizione di tutti, accetto disciplinatamente la decisione collegiale. Tuttavia, mi sia consentito ricordare l'opinione di un numero rapidamente crescente di studiosi, secondo la quale la questione della proprietà intellettuale sul prodotto industriale è molto più importante della questione della proprietà sul prodotto artistico, perchè la proprietà intellettuale industriale è un freno allo sviluppo, fattore di disuguaglianze fra imprese grandi e piccole, fra paesi forti e deboli, e ragione della morte di decine di milioni di uomini, ogni anno, come illustrato da Medici senza Frontiere. Grazie per l'attenzione. Colgo l'occasione per associarmi alle congratulazioni di Marco R. a Marco C. Raf _______________________________________________ nexa mailing list nexa@server-nexa.polito.it https://server-nexa.polito.it/cgi-bin/mailman/listinfo/nexa Caro Marco, scusami, ma non ho ancora trovato il tempo di leggere il tuo articolo, che leggerò sicuramente con attenzione. Infatti, sto lavorando come un matto per lavori organizzativi vari e non trovo il tempo per le cose che mi interessano di più. E neppure ho trovato il tempo necessario per documentarmi e rispondere al tuo quesito sui farmaci salva-vita. Spero di trovare il tempo per farlo presto. Per ora, ricordo, a memoria, quel che si disse allora: "Non serve a nulla concedere a un paese povero il diritto di produrre farmaci coperti da brevetto, poichè i paesi più poveri non posseggono le risorse industriali per farlo. Occorre invece abolire l'istituto del brevetto liberalizzando completamente il mercato". WIPO sostiene che i brevetti sono lo strumento necessario per trovare le risorse necessarie per la ricerca, ma molti studi mettono in evidenza che solo 20% o meno degli utili delle multinazionali del farmaco vanno in ricerca. Stigliz ribatte a WIPO: "..the current system results in limited funds being spent in the wrong way..", per cui propone una ricetta elementare: gli stati ricchi paghino i ricercatori e i frutti del loro lavoro vadano tutti nel pubblico dominio, in modo che tutti, in ogni parte del mondo, possano produrre i farmaci necessari per la sopravvivenza di milioni di persone. E' la considerazione per la quale chiedevo che si parlasse del pubblico dominio in termini più generali, ma non intendo sollevare nuovamente la questione. Ne riparleremo privatamente. Un caro saluto!!!! Raf
Se posso permettermi di introdurre la prospettiva di un grande saggio, su patent e farmaci: Scherer, F.M. "Markets and Uncertainty in Pharmaceutical Development." KSG Faculty Research Working Paper Series RWP07-039, September 2007. http://web.hks.harvard.edu/publications/workingpapers/citation.aspx?PubId=49... Giovanni ----- Messaggio originale ----- Da: "Marco Ricolfi" <marco.ricolfi@studiotosetto.it> A: "Angelo Raffaele Meo" <meo@polito.it> Cc: nexa@server-nexa.polito.it Inviato: Sabato, 30 gennaio 2010 10:35:27 Oggetto: [nexa] R: R: R: proprietà intellettuale sul prodotto industriale Caro Angelo, ieri sono stato un po' cortino anch'io. Quel che volevo dire è che anche il tema dei farmaci è più complesso: ci sono proposte, come quelle della Lanyeuw, che mi paiono meno semplicistiche di quel che dice il grande Stiglitz.J. LANJOUW, A Patent Policy Proposal for Global Diseases , www.brookings.edu June 11, 2001. Io l'avevo ripresa in una conferenzas a New Delhi dieci anni fa (" Here I will confine myself to saying that the proposal which seems most satisfactory to me is the one under which patenting of drugs should be admitted either for developed countries or for developed ones, but not for both": in The Interface between Intellectual Property and International Trade: the TRIPs Agreement, in Italian Intellectual Property , 2002, 29 ss.); negli attuali assetti di potere, però, il passaggio dall'art. 31 TRIPs al 31-bis mi è sembrato un passo in avanti, perché prima il Sud Africa che non ha un'industria farmaceutica poteva imporre una licenza obbligatoria ma non poteva servirsene, perché mancavano case locali che potessero produtte; oggi con il 31 bis la produzione può anche avvenire in India, se il mercato in cui il farmaco è usato è il Sud Africa. Comunque, hai ragione che sono temi di cui potremo parlare alla prima occasione, anche extra-Nexa. Per l'intanto fa piacere a me - come so che fa piacere a JC - avere potuto raccogliere i tuoi stimoli. m. Da: Angelo Raffaele Meo [mailto:meo@polito.it] Inviato: venerdì 29 gennaio 2010 18.57 A: Marco Ricolfi Cc: nexa@server-nexa.polito.it Oggetto: Re: R: R: [nexa] proprietà intellettuale sul prodotto industriale Marco Ricolfi ha scritto: Caro Angelo, grazie del tuo e-mail. Quanto al master che dirigo, e di cui ho la responsabilità scientifica, potrà interessarti venire ad assistere alle lezioni, specie quelle sui brevetti che ti interessano; e sono sicuro che avrai sorprese se parti dall’assunto che meritino il giudizio che riservi alle ‘iniziative WIPO’. A me invece interessa sapere se hai evidenze empiriche su quella che tu consideri la grande truffa dell’”allargamento delle regole sui farmaci salva vita”, che è stata fortemente voluta dai paesi in via di sviluppo. E’ infatti venuto il momento – non per Nexa, peraltro – per fare un bilancio su questo argomento. Hai invece ragione di insistere sulla rilevanza del tema dei brevetti per la rete; e precisamente sotto i due profili che ti indichi. Di uno mi sono occupato anch’io, forse un po’ incidentalmente, come mostra il testo della conferenza che ho tenuto ad Ottobre a Ginevra nell’ambito del Master e che riproduco qui sotto. Il brevetto è stato pensato per l’economia classica; oggi la rete apre possibilità di cooperazione per le quali il brevetto rischia di divenire un ostacolo invece che un incentivo. Dell’altro – che definirei più che i brevetti su internet – i brevetti sugli strumenti di comunicazione e condivisione del sapere in forma digitale, ivi incluso lo strumento di internet, già ci occupiamo, occupandoci di brevetti di software; e l’attenzione potrebbe (e forse dovrebbe, risorse permettendo) estendersi a brevetti su protocolli e formati, come già segnalato da Juan Carlos. Condivido anche l’idea di JC secondo cui il tema dell’interoperabilità merita di essere particolarmente sviluppato, essendo del resto al centro della tesi di dottorato del nostro managing director Federico Morando. Mettendo insieme questi due pezzi, risulta un quadro non diverso da quello cui dirigono le tue osservazioni. Grazie dunque per lo stimolo, che insieme con Juan Carlos non lasceremo cadere, nei limiti delle risorse e del tempo a disposizione. Ma comunque tenendo conto dell’esigenza di rifocalizzare l’attenzione anche su temi importanti come quelli che tu segnali. m. 20/01/2010 Genevatex Genetic Engineering: Where is the Innovation?* Summary: § 1. Which Innovation? – § 2. Patent law and genetic engineering. – § 3. The tragedy of the commons and the tragedy of the anticommons. – § 4. Two emerging paradigms: contractually reconstructed commons and open source biotechnology. – § 5. Concluding remarks. – § 1. Which Innovation? There is a certain ambiguity in the title of the presentation which was allotted to me. One possible way to read the question “Where is the Innovation?” is to ask whether the requirement for patentability which in the US legal system is referred as non obviousness and in Europe as inventive step is in some way different in the field of genetic engineering as opposed to general patent law. This would certainly be an interesting issue to research. Indeed, it is arguable that in this regard genetic engineering is a pretty special case: just to mention the first differences which occur to me, the standard used in this area is lower than the one used in more traditional fields, such as mechanics, chemistry and pharmaceuticals; when it comes to the field of biotech, the notion of person skilled in the art, against which the inventiveness of each invention is tested, is a specialized one; and so on. There are even more interesting ways to read the question in the title, however. The title might refer either to the identification of the genetic engineering areas in which innovation would appear most promising; or even to the issue whether the legal rules governing the protection of genetic engineering research and investment should they themselves be innovated, that is adapted or changed. I find this perspective even more challenging than the one I mentioned at the outset, so that I chose to explore it rather than elaborating on the notion of inventive step. I must also add that, being a lawyer rather than a scientist or a technologist, I will mainly look at the second strand of the sec ond issue, asking what is the legal innovation to be expected in this field, rather than trying to fathom what the technological innovation will be. I am afraid, however, that as a lawyer I cannot totally avoid the necessity of also dealing, if only to a certain extent, with the first strand of the same question. The nature of the legal profession is such that lawyers cannot stand totally separate from the non-legal issues to which they apply their analytical skills; and I am sure that the participants in this eight edition of the Turin-WIPO LL. M. program will by now have become acutely aware that in IP law the interpenetration of technical aspect and legal rules is even more advanced than in other areas of the law. Taking this to account, in the final part of my presentation (at § 5) I will ask whether there is any relationship between proposed changes concerning the legal rules and changes underway in the actual technological reality of genetic engineering research and development. § 2. Patent law and genetic engineering. – Now, concerning the question whether changes are required in the legal protection of genetic engineering innovation, it would appear that the question really has two sides to it. The first one is to ask whether we do have empirical evidence confirming the hypothesis, sometimes described with reference to the notion of the tragedy of the anticommons, that protection of genetic engineering innovation via patent law does in fact entail an increase in transaction costs and encourages opportunistic and strategic behaviour. The second one is to ask whether there are mechanisms which conceivably could be adopted to foster research and innovation in the field of genetic engineering which are promising enough and sufficiently tested to warrant consideration as alternatives to patent protection or possibly as complements to it. A few words may be in place to elucidate the first question. At some point in the late Seventies or in the early Eighties of last century biotechnology emerged as a revolutionary technological approach based on i. the identification of the DNA sequences responsible for certain traits of living organism, e.g. coding for a protein making the plant resistant to salinity; and ii. the cutting and pasting of the relevant sequence from an original living organism to the receiving cell of a different target organism. (That the cutting of the DNA sequence usually took place through so called restriction enzymes and that its splicing on the receiving cell usually was effected by means of a virus are details which even today may sound extraordinary to the non-specialist but in the present context do not seem to have particular implications). In many ways, this kind of innovation was very different from the innovation we had been accustomed to through the previous centuries and decades, in areas such as mechanics first, chemistry and pharmaceuticals later. This discontinuity between prior forms of innovation and biotechnology called in question the advisability of pouring new wine in old bottles by protecting biotech innovation through patent laws; nevertheless the various legal systems of advanced economies came more or less in unison to the conclusion that patent protection was the most appropriate tool to provide an incentive for the creation and dissemination of a technological innovation in general and that this applied also to biotech innovation. In fact, some jurisdictions incorporated biotech into patent laws by means of case law; others went all the way and changed patent rules to specifically accommodate biotechnological innovation. In the end the outcome was the same: currently the job of providing the appropriate incentive to originate, disclose, and disseminate biotech innovation lays with patent laws in most of the advanced economies. § 3. The tragedy of the commons and the tragedy of the anticommons. – When the adoption of the EU Directive on the legal protection of biotechnological inventions was discussed, I was in the camp of the sceptics. Today, I might recollect some of the doubts I then harboured; for the present purposes I find it more relevant, however, to look at the kind of critique to patent protection of biotech innovation which currently is described as the anticommons argument. We may begin to understand what the anticommons argument means by considering it turns on its head the theory of the tragedy of the commons, originally advocated by an important article written in the early Sixties by a scientist, Garrett Hardin. In the Middle Ages, he had remarked, stretches of land held in common by the local population were gradually depleted, as they were overgrazed (too much cattle over the same fields) and deforested (too much wood extraction from the communal woods). In his account, an optimal allocation was restored by enclosures such as the ones which took place in Sixteenth Century England: as soon as individual owners obtained undivided title over the land, depletion stopped. An individual owner would not disregard the long term implications of depletion, as he himself would bear all the future costs of inefficient use; while, as long as short term benefits were reaped by the commoners individually while the corresponding costs were born by the whole community, the same long term costs were disregarded. A similar situation applied to fisheries, which were running – and indeed still are running, in spite of quotas – the risk of depletion of stock as each fishing fleet ignores the long term implications of overfishing. In this perspective, the commons, appealing as they may sound to the romantics and to the left leaning, in reality are a tragedy; their opposite number, property rights, are efficient. You may wonder what this all has to do with biotech patents. The connection may become a bit clearer when I mention that about in the same years one of the most powerful minds behind the Law and Economics movement, professor Ronald Coase, was bent on proving that, by protecting the resource with a property right, the law combines the static efficiency Garret Hardin was talking about with dynamic efficiency, as it enables market transactions whereby the resource may move to its highest valued use. From there the argument migrated to intellectual property rights: also protection of IPRs by means of property rights contributes to the optimal allocation of resources; therefore biotechnological innovation too should be protected by means of patent rights. Fundamental research concerning the double helix may well have originated within the commons of the public, academic research; but when it came to reaping the fruits of the tree of knowledge, property rights, not the commons, would be the most appropriate regime. Now, this line of argument is, as I was saying, literally turned on its head by those scholars who have argued that protecting innovation by means of property rights may lead to a tragedy opposite and symmetrical to the one elucidated by Garrett Hardin, the tragedy of the anticommons; and that this may specially be the case in novel fields like digital technology and – indeed – genetic engineering. According to this viewpoint, while traditionally basic scientific research in agriculture and medicine had for a long time been open and the information resources widely shared by the scientific community, propertization of research outcomes by the grant of patents on agricultural and medical innovation as initiated in the late Seventies or early Eighties must be seen as apt to build up barriers to the access ad reuse of information and of information-carrying assets and is thus liable to endanger the enormous benefits which scientific cooperation entails. Let us examine more closely the reasons which usually are given to account for the emergence of the phenomenon described as the tragedy of the anticommons and for the outcomes which are said to derive from it. The first reason resides in the nature of technological innovation in genetic engineering: the originally extended trajectory which leads from the scientific enterprise to its commercial application has in t he last decades to a large extent collapsed and shrunk. The second reason resides in the fact that this novel type of technical innovation – exactly as it is the case in connection with digital technology – tends to bear the know-how which makes it valuable “on its face”. Both aspects can be simultaneously illustrated by an example drawn from the here relevant field of genetic engineering. The difficult thing in devising an emergency treatment for a heart attack based on tissue plasminogen activator (TPA), a known substance produced by the body to help the heart to revascularize in the first hours after the event, was to identify the DNA sequence which codes for this protein with a view to synthetically producing the protein itself and administering it to early stage patients. Once the TPA sequence is identified, it becomes quite easy to synthesize the desired amount of this protein for treatment of heart attacks; in turn the scientific knowledge obtained in the sequencing is immediately available to other entities which may wish to manufacture and sell the protein. Thus, theoretical knowledge of the sequence entails as a matter of course ease of manufacture of the protein for which it codes; and this activity may be replicated by any entity possessing the knowledge of the sequence, without the efforts, such as the costs of reverse engineering, usually associated with imitation of products available on the market. Now, while it is quite predictable that, in such a context, no institution would engage in investment unless it can obtain a legal monopoly on its research outputs, exactly as posited by the supporters of patent protection, several commentators have also noted that an analysis of the costs and benefits of patent protection for genetic engineering should never forget that, as a result of the just illustrated features, propertization may also have severely adverse impact upstream and downstream on the innovation process. Upstream the very possibility of obtaining property rights over research outcomes suggests to all the players that it is advisable for them to avoid organizational arrangements which entail sharing of information with third parties. Therefore, if the grant of a patent is possible, all interim steps, including materials obtained in the preliminary stages of a research trial or information pertaining thereto tend not to cross the door of the laboratory, to avoid making disclosures which may prevent patentability and give leads to potential competitors. Even presentation of ongoing research at academic meetings and publication of research findings before patent filings recede for exactly the same reasons. Exchanges may in to some extent continue, e.g. in terms of material transfer agreements; but then they tend to be governed by restrictive terms, intended to reserve the transferor entitlements over downstream innovation. In turn, the process may trigger domino effects: any initial move by one of the players to obtain exclusive right and to leverage them to secure contractual privileges is bound to trigger defensive reactions by similarly situated players. A similar analysis applies to downstream outcomes. Research outputs tend to be complementary in nature. Marketable end products may incorporate a number of contributions, which may be a method of sequencing, a research tool, a DNA sequence. To the extent complementary items are covered by separate property rights and these belong to different entities, a powerful incentive is given to each player to hold out contributing her asset as a bargaining chip to extract the highest possible share of downstream profits to be derived from marketable end products. An increasing number of commentators have therefore expressed fears that patent protection, when applied to genetic engineering innovation, may entail costs greater than the expected benefits. While in principle property rights are seen as an efficient tool to induce innovation and enhance market based exchanges over it, it is often feared that the specificity of some areas, including biome dical research and biotech, may lead to the adoption of strategic behaviour and to an unacceptable increase of transaction costs. § 4. Two emerging paradigms: contractually reconstructed commons and open source biotechnology. – I do not know whether the anticommons argument is true or not. Actually, this is a matter of empirical evidence rather than of pure theory, even though of course theory may help us to make educated guesses and even to build parameters and benchmarks against which to test the hypothesis. I will therefore come back to say something about the empirical evidence as to the failure or success of the current regime in a short while. For the moment, I would rather like to point out that it may be of some significance that in the last decade we witnessed to the emergence of paradigms which in many ways are radically different from patent law and which may be described – for the sake of convenience – as “contractually reconstructed commons” and “open source biotechnology”. Let me say just a few words about each. The first one, i.e. the proposed “contractually reconstructed commons” paradigm, recognizes the benefits which can accrue if innovators are granted property rights over their research contributions and assets; but advocates contractual arrangements which may ex ante take care of the risk that players in the research community may engage in strategic behavior of the kind described by anticommons theory. A variety of mechanisms is proposed, depending on the specific technological sector to which the arrangements are to apply, which may from case to case be drugs discovery or microbial research. There are recurring features in the design however, among which I should mention the adoption by the different players of standard contractual forms, which contemplate non-exclusive use and access to information resources and research inputs that either are covered by some form of exclusive rights or are de facto in exclusive possession of one of the parties; extensive confidentiality agreements limiting access by third parties to the resource; a dichotomy between non commercial, research uses, for all purposes free and commercial uses, subject to a contractual liability rule whereby the party first bringing to the market a commercially valuable end-product is enabled to do so subject to a duty of compensation of the provider of the different inputs which may go into the end product in accordance with a predetermined scale of royalties. These are complex concepts, which, I submit, we may start to understand better if we think of them by analogy to well known organizational paradigms in IP such as patent pools and even collective management organizations in the field of copyright. I must however confess that I do have even more difficulties in elucidating the “open source biotechnology proposal”, as I cannot fully understand how this concept can work in the absence of legislative changes. The basic notion derives from open source software or, to be more specific, from the mechanism of “copyleft” on which open source licenses, including the GPL, are based. Under current copyright laws, software is protected and so are all additions to it which have a minimum of significance. It is well possible for the initiators of a project, which usually form a community, to provide for the initial body of code making it available both in source and object code (hence the designation as ‘open source’ software) and release it on the condition that the copyright license granted to any subsequent user is subject to compliance with a set of conditions, including the so called “copyleft clause”, which requires the licensee to make all his additions available under the same open access conditions to all subsequent users. Much has been written about this ‘viral’ feature in software licenses, whereby the original condition imposed by the first licensor to the first licensees is propagated by the latter downstream, exactly as a virus would do, to cover each and all pieces of software building on the basis of the initial chunks o f programming. Therefore for present purposes I do not need to add much, except to highlight that the whole mechanism is built on the solid foundation of copyright protection. If subsequent licensees do not abide by the copyleft clause, they are plain infringers; therefore it is copyright protection which makes sure that downstream innovation is kept open and is not enclosed by downstream innovators. This solution originates in the digital environment, where lawmakers, about three decades ago, saw fit to innovate and to adopt a rule whereby software programs are protected by copyright. I am not yet able to see how this approach can be extended to biotechnology, however. I am aware, of course within the limits accessible to a lawyer – and, I should add, to an old timer who has not yet had much time to devote to understanding the technological evolution – that there are new fields as the one referred to as synthetic biology; that these are a fertile ground for the emergence of distributed collective cooperation efforts, in which the innovation does not resemble the classical cherry on the pie which was the original genetic engineering innovation and may be analogized to having the different parties constructing the bricks, i.e. the building blocks which go into the larger blueprint agreed among them. What I miss is to see how there the individual building blocks may enjoy some legal protection. Neither patent nor copyright would seem to fit here; the first one because, even if we were to admit that all the requirements for patent protection are met, the costs and time of patenting would be devastating for any project; the latter one, because frankly I do not see any ‘creative work’ as yet in the bricks, at least until lawmakers do not step in and choose to indicate otherwise, as they did when they legislated on copyright protection of software. But then, if the individual blocks are not IP protected, it would seem to me that the very basis for copyleft licensing is missing. My provisional conclusion therefore is that open source biotechnology still misses a legislative starting point. § 5. Concluding remarks. – Is there any relationship between the emergence of the two paradigms I just referred to and the difficulties allegedly faced by traditional patent law in providing an appropriate regime for genetic engineering innovation? Quite frankly, I must say that I do not know and, even more frankly, that I would not be the one to know. What I can do is to make a few guesses, for what they may be worth. The first one is that it would appear to me that one of the most fundamental reasons for the emergence of the two innovative paradigms I dealt with in § 4 is to be found in the changes which the web is undergoing. The web no longer is just a vast library; it has in the meantime become a user driven collaborative workplace. It therefore stands to reason that the possibility of myriad cooperative research enterprises in the field of biotechnology, using the web as an instrument to bring together vast data sets accumulated by the different players, has in the meantime emerged and that this distributed collective intelligence is now looking for sets of rules which may provide a finely balanced mechanism to optimize cooperation and cooperation results. Both contractually reconstructed commons and open source biotechnology would appear to be plausible candidates. Am I therefore saying that what accounts for the emergence of these two paradigms is the success of the web, rather than the putative failure of patent law in governing biotech innovation? Not quite. In fact, it would indeed appear, at least to my naïve eyes, that there are signs which show that indeed the model on which much of the initial successes in genetic engineering was based are no longer functioning. The number of blockbuster drugs is dramatically declining; the number of drugs in the pipelines is decreasing. Just a few years ago the future of bioinformatics was all the rage; today it would appear that the promises of what is referred to as High-Throughput- Screening have not come true if not to a very small extent. Therefore, we cannot rule out that the story according to which in the first years of genetic engineering our patent-driven research has been able to reap the lower hanging fruits of the tree of knowledge is correct after all. It may also well be that, to reach the fruits which hang from the higher branches, the effort of a given, specific laboratory alone is no longer sufficient; and that a cooperative effort, among firms and between firms and public research institutions and possibly even with regulatory authorities. After all it appears that gene expression is not confined to the standard linear model of one gene-one protein; but is a complex non linear process involving not just the coding of genes for individual proteins (the cDNA segments), but also the DNA involved in gene regulation and organization; I do not know whether this the case, for the simple reason that I possess neither the necessary empirical data nor the required skills to assess them. What I know is that, if this is the case, the role of cooperative arrangements will increase; but I also expect that these arrangements will not replace IPRs but will build on patent protection while trying to take care ex ante of several of the problems highlighted by the scholars who have described the dangers associated with the tragedy of the anticommons. * This draft paper is released under a Creative Commons Attribution 3.0 unported license ( http://creativecommons.org/licenses/by/3.0/ ). On the first issue see among others R.P. MERGES, One Hundred Years of Solicitude. Intellectual Property Law, 1900-2000, in 88 Cal. L. Rev., 2000, 2189 ff., 2224 ff.; on the second one S.J.R. BOSTYN, Enabling Biotechnological Inventions in Europe and the United States. A study of the patentability of proteins and DNA sequences with special emphasis on the disclosure requirement, European Patent Office, München, 2001, 72 ff. Throughout this paper I shall use biotechnology and genetic engineering as equivalents. The corresponding notion was originally introduced into the debate by M.A. HELLER, The Tragedy of the Anticommons: Property in the Transition from Marx to Markets, in 111 Harvard Law Review, 1998, 111 ff. and M.A. HELLER-R.S. EISENBERG, Can Patents Deter Innovation? The Anticommons in Biomedical Research, in Science 280, 1998, 698-701 and in F.H. MILLER ed., Rights and Resources, Ashgate, Dartmouth, 2003, 401-404. An excellent treatment is in E. BERTACCHINI, Contractually Constructed Research Commons: a Critical Economic Appraisal, ##. Wonderfully illustrated by J.H. REICHMAN, Legal Hybrids Between the Patent and Copyright Paradigms, in 94 Columbia L. Rev., 1994, 2432 ff. For a thorough discussion of the costs and benefits of patenting, including a discussion of the different incentives (to generate innovation, to disclose it and to disseminate it before and after the term of the patent), also with specific reference to special industries such as biotech see R. MAZZOLENI, R. NELSON, Economic Theories about the Benefits and Costs of Patents, in XXXII Journal of Economic Issues, 1998, 1031 ff. Diamond v. Chakrabarty, in 447 U.S. 303 (1980). Directive No 98/44 of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions, in OJ 2000, L 213, 13 ff. But see Art. 27(3)(b) of the Agreement on Trade Related Aspects of Intellectual Property Rights, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1C, LEGAL INSTRUMENTS—RESULTS OF THE URUGUAY ROUND vol. 3, 1869 U.N.T.S., 33 I.L.M. 81 (1994) [hereinafter TRIPS Agreement]. See my La proposta di direttiva del Consiglio sulla protezione giuridica delle invenzioni biotecnologiche, in Giur. Comm., 1991, I, 918 ff. and Bioethics Markets and Morals: The Case of Biotechnological Patents, in – a cura di C.M. Mazzoni – A Legal Framework for Bioethics, Kluwer, Dordrecht, 1998, 131 ff. and for commentary after the enactment of Directive 98/44 Biotechnology, Patents and Epistemic Approaches, in The journal of Biolaw and Business, Special Supplement, 2002, 77-90. For a classical account of this position see H. DEMSETZ, Toward a Theory of Property Rights, in American Economic Review, 1967, 347 ff. See R. COASE, The Problem of Social Cost, in 3 Journal of Law & Economics, 1960, 1 ff. For a brilliant treatment see R.P. MERGES, Of Property Rules, Coase and Intellectual Property Law, in 94 Colum. L. Rev., 1994, 2655 ff. An offspring of this conception was the adoption of rules providing incentives to patenting by Universities, such as the U.S. Bayh-Dole Act of 1980, Publ. L. No. 96-517, 94 Stat. 3015 (codified as amended at 35 U.S.A. §§ 200-212 (2000)), for an assessment of which see A. K. RAI & R.S. EISENBERG, Bayh-Dole Reform and the Progress of Biomedicine, in 66 Law & Contemp. Probs., 2003, 289 ff. and R.R. NELSON, Observations on the Post-Bayh-Dole Rise of Patenting at American Universities, in IPQ 2001, 1 ff. G.B. DINWOODIE & R. COOPER DREYFUSS, International Intellectual Property Law and the Public Domain of Science, in 7 Journal of Int. Ec. Law 2004, 431 ff., 433 and, in specific connection with the process of extension of protectable subject matter to disembodied knowledge, H. ULLRICH, Expansionist Intellectual Property and Reductionist Competition Rules, in 7 Journal of Int. Ec. Law 2004, 401 ff. As shown in the case not only of genetic engineering but also of plant varieties, semiconductor chips and data bases. For a full treatment of this line of thought see the abundant work of Jerome H. Reichman, from Legal Hybrids Between the Patent and Copyright Paradigms, above at note # to The Globalization of Private Knowledge Goods and the Privatization of Global Public Goods, in 7 Journal of Int. Ec. Law, 2004, 279 (written with Keith E. Maskus). E. BERTACCHINI, Contractually Constructed Research Commons: a Critical Economic Appraisal, quoted above at note #, E. BERTACCHINI, Contractually Constructed Research Commons: a Critical Economic Appraisal, quoted above at note #, § 2. M.A. HELLER-R.S. EISENBERG, Can Patents Deter Innovation? The Anticommons in Biomedical Research, above at note #. In this connection see E. BERTACCHINI, Contractually Constructed Research Commons: a Critical Economic Appraisal, quoted above at note #, § 3.1. The approach originally advocated by J. H. REICHMAN & P. UHLIR, A Contractually Reconstructed Research Commons for Scientific Data in a Highly Protectionist Intellectual Property Environment, in 66 Law & Contemp. Probs. 2003, 315 ff. has been refined and adapted to a number of specific contexts by A.K. RAI-J.H. REICHMAN-P.F. UHLIR-C. CROSSMAN, Pathways Across the Valley of Death: Novel Intellectual Property Strategies for Accelerated Drug Discovery, in VIII Yale Journal of Health Policy, Law, and Ethics, 2008, 1 ff. (in connection with drug discovery) and J.H. REICHMAN-T. DEDEURWAERDERE-P.F. UHLIR, Designing the Microbial Research Commons: Strategies for Accessing, Managing and Using Essential Public Knowledge, unpublished presentation to the Turin Communia Conference of June 26, 2009 (in connection with microbial collections). Except to the extent required by confidentiality agreements; in connection with publications see the balancing suggested by #. Indeed, the notion of “contracting into liability” advocated by R.P. MERGES, Contracting Into Liability Rules: Intellectual Property Rights and Collective Rights Organisations, in 84 Cal. L. Rev., 1996, 1293 ff. seems to emerge in several crucial points of the proposals concerning contractually reconstructed commons. I have not yet read the work by B. Demil & X. Lecoq, Neither market nor hierarchy nor network: the emergence of bazaar governance, in 27 Organization studies 2006, 1447-1466 and by Janet Hope, Biobazaar. The Open Source Revolution and Biotechnology, Harvard University Press, 2008, which might contain replies to the questions indicated below. On which see I.V. HEFFAN, Copyleft: Licensing Collaborative Works in the Digital Age, in 49 Stanford Law Rev. 1997, 1487 ss. C. PATTERSON, Copyright Misuse and Modified Copyleft: New Solutions to the Challenges of Internet Standardization, in 98 Michigan Law Review, 2000, 1351 ff. See Wikipedia, item Synthetic biology, last visited August 21, 2009. A similar view is expressed by A. RAI & J. BOYLE, Synthetic Biology: Caught between Property Rights, the Public Domain and the Commons, in Plos Biology March 2007, Vol. 5, Issue 3, 389-393, at 391. Which would seem a dubious proposition to begin with because no component does have utility or, in European parlance, industrial application and therefore it also is very difficult to speak of originality. The point is made, in a slightly different context (astronomy) by L. LESSIG, Remix. Making Art and Commerce Thrive in the Hybrid Economy, The Penguin Press, 2008, 170. As related by A.K. RAI-J.H. REICHMAN-P.F. UHLIR-C. CROSSMAN, Pathways Across the Valley of Death, above at note #, 3, “an average of only three drugs that act on novel targets”, i.e. proteins implicated in disease pathways, “have reached the market in recent years”. On the features of high throughput screening of molecule libraries against assays containing target proteins to identify promising compounds which may lead to patentable drugs see A.K. RAI-J.H. REICHMAN-P.F. UHLIR-C. CROSSMAN, Pathways Across the Valley of Death, above at note #, 7. For a thoughtful comment on this possibility see A. JACK, Remedy for a malady, Financial Times August 15-16, 2009, page 8. Marco Ricolfi Torino Law School -----Messaggi o originale----- Da: meo [ mailto:meo@polito.it ] Inviato: mercoledì 13 gennaio 2010 12.25 A: Marco Ricolfi Cc: nexa@server-nexa.polito.it Oggetto: Re: R: [nexa] proprietà intellettuale sul prodotto industriale Caro Marco, non entro nel merito della prima parte del tuo mail perchè proprio di questo vorrei parlare in Nexa. Peraltro, tu sai benissimo cosa pensano i fanatici estremisti come me di WIPO e delle sue iniziative, per non parlare di quella che consideriamo la grande truffa dell' "allargamento delle regole sui farmaci salva vita". Entro invece sul merito della "competenza dell'argomento". Perchè il prodotto artistico rientra e quello industriale no? Solo perchè sembra più facile diffondere il primo via Rete? Ma la Rete è ormai lo strumento principale per la diffusione del sapere scientifico che poi diventa brevetto. Per non parlare delle molte migliaia di brevetti su Internet (c'è una causa legale nella quale si sostiene che tutta l'attività della Rete è una violazione di brevetti precedenti) e dei prodotti proprietari che la Rete ospita, in contrapposizione con i suoi standard aperti. Comunque, se i due direttori concordano, ritiro la mia richiesta, senza far perdere tempo ad altri. Scusa ancora la mia assenza alla riunione di oggi che mi pare molto importante. Raf On Tue, 12 Jan 2010 19:20:43 +0100, "Marco Ricolfi" <marco.ricolfi@studiotosetto.it> wrote: Caro Raffaele, peccato non averti con noi. Rispetto al tema. Condivido - come, penso, anche Juan Carlos - la tua affermazione che "la proprietà intellettuale industriale è un freno allo sviluppo, fattore di disuguaglianze fra imprese grandi e piccole, fra paesi forti e deboli, e ragione della morte di decine di milioni di uomini, ogni anno, come illustrato da Medici senza Frontiere". Penso che si possa dire che pochi come noi, a Torino, abbiano dato un contributo sul tema. Pensa che in 8 anni di Master sulla proprietà intellettuale abbiamo lavorato su questo tema; che ci abbiamo formato più di 200 candidati, più della metà dei quali proviene dai paesi in via di sviluppo; e che, siccome moltissimi - decine - di questi sono delegati dei loro governi nelle istituzioni internazionali, abbiamo contribuito agli sviluppi in questo settore. La nostra Vanessa Lowenstein è stata tra le prima a lavorare alla Development Agenda del WIPO (una serie di iniziative richieste dai paesi in via di sviluppo per contrastare la deriva iper-protezionista della proprietà intellettuale); e l'allargamento delle regole sui farmaci salva vita ci ha visto particolarmente attivi. Occorre però anche rispettare un principio di competenza e di specializzazione delle competenze. Da questo punto di vista, quello che non è facile capire è come questo tema - prioritario - trovi collocazione in un centro che si occupa della rete internet, salvo che per il profilo del brevetto di software, sul quale abbiamo posizioni chiare e costanti (nel senso che va, in linea generale, evitato e combattuto). Possiamo ritornare quando vuoi sul tema. Sulla base però di un'argomentazione almeno ipotetica della rilevanza ai fini di una riflessione sistematica specificamente riferita alla rete. Dico bene, Juan Carlos? m. -----Messaggio originale----- Da: nexa-bounces@server-nexa.polito.it [ mailto:nexa-bounces@server-nexa.polito.it ] Per conto di Angelo Raffaele Meo Inviato: lunedì 11 gennaio 2010 16.37 A: nexa@server-nexa.polito.it Oggetto: [nexa] proprietà intellettuale sul prodotto industriale Carissimi, desidero scusare la mia assenza all'incontro Nexa previsto per mercoledì 13. Come nel caso dei precedenti mercoledì, debbo partecipare alla seduta mensile dell'Accademia delle Scienze, ove, tra l'altro, dobbiamo discutere di un convegno sulla ricerca industriale che intendiamo organizzare. Avanzo comunque una richiesta relativa alla roadmap 2010. Mi piacerebbe, come anticipai in un incontro lontano, che Nexa affrontasse anche la questione della proprietà intellettuale sui prodotti industriali e dei brevetti in particolare. Quel giorno Marco (Ricolfi, non Ciurcina) mi rispose che quella questione non rientrava negli obiettivi di Nexa e oggi, in un incontro privato, Juan Carlos mi ha ribadito la posizione di Marco. Se questa è la posizione di tutti, accetto disciplinatamente la decisione collegiale. Tuttavia, mi sia consentito ricordare l'opinione di un numero rapidamente crescente di studiosi, secondo la quale la questione della proprietà intellettuale sul prodotto industriale è molto più importante della questione della proprietà sul prodotto artistico, perchè la proprietà intellettuale industriale è un freno allo sviluppo, fattore di disuguaglianze fra imprese grandi e piccole, fra paesi forti e deboli, e ragione della morte di decine di milioni di uomini, ogni anno, come illustrato da Medici senza Frontiere. Grazie per l'attenzione. Colgo l'occasione per associarmi alle congratulazioni di Marco R. a Marco C. Raf _______________________________________________ nexa mailing list nexa@server-nexa.polito.it https://server-nexa.polito.it/cgi-bin/mailman/listinfo/nexa Caro Marco, scusami, ma non ho ancora trovato il tempo di leggere il tuo articolo, che leggerò sicuramente con attenzione. Infatti, sto lavorando come un matto per lavori organizzativi vari e non trovo il tempo per le cose che mi interessano di più. E neppure ho trovato il tempo necessario per documentarmi e rispondere al tuo quesito sui farmaci salva-vita. Spero di trovare il tempo per farlo presto. Per ora, ricordo, a memoria, quel che si disse allora: "Non serve a nulla concedere a un paese povero il diritto di produrre farmaci coperti da brevetto, poichè i paesi più poveri non posseggono le risorse industriali per farlo. Occorre invece abolire l'istituto del brevetto liberalizzando completamente il mercato". WIPO sostiene che i brevetti sono lo strumento necessario per trovare le risorse necessarie per la ricerca, ma molti studi mettono in evidenza che solo 20% o meno degli utili delle multinazionali del farmaco vanno in ricerca. Stigliz ribatte a WIPO: "..the current system results in limited funds being spent in the wrong way..", per cui propone una ricetta elementare: gli stati ricchi paghino i ricercatori e i frutti del loro lavoro vadano tutti nel pubblico dominio, in modo che tutti, in ogni parte del mondo, possano produrre i farmaci necessari per la sopravvivenza di milioni di persone. E' la considerazione per la quale chiedevo che si parlasse del pubblico dominio in termini più generali, ma non intendo sollevare nuovamente la questione. Ne riparleremo privatamente. Un caro saluto!!!! Raf _______________________________________________ nexa mailing list nexa@server-nexa.polito.it https://server-nexa.polito.it/cgi-bin/mailman/listinfo/nexa
participants (4)
-
Angelo Raffaele Meo -
Giovanni Battista Ramello -
Marco Ricolfi -
meo