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