[Upd-discuss] PLoS article: Is Bayh-Dole Good for Developing Countries? Lessons from the US Experience

robert weissman rob@essential.org
Tue, 28 Oct 2008 17:01:43 -0400


Dear all,

The following article, "Is Bayh-Dole Good for Developing Countries? 
Lessons from the US Experience," appears in the current issue of PLoS 
Biology. Bayh-Dole is the US legislation establishing rules for control 
over government-funded inventions. It gives universities control over 
inventions developed with federal support. Our article is critical of 
the US experience; suggests that Bayh-Dole is not a proper model for 
developing countries; and urges various safeguards for countries which 
feel compelled to adopt Bayh-Dole legislation.

A formatted version with linked footnotes is available on the PLoS 
website. The text of the article is printed below.

Robert Weissman


http://biology.plosjournals.org/perlserv/?request=get-document&doi=10.1371/journal.pbio.0060262&ct=1

Is Bayh-Dole Good for Developing Countries? Lessons from the US Experience

Anthony D. So*, Bhaven N. Sampat, Arti K. Rai, Robert Cook-Deegan, 
Jerome H. Reichman, Robert Weissman, Amy Kapczynski

Recently, countries from China and Brazil to Malaysia and South Africa 
have passed laws promoting the patenting of publicly funded research 
[1,2], and a similar proposal is under legislative consideration in 
India [3]. These initiatives are modeled in part on the United States 
Bayh-Dole Act of 1980 [4]. Bayh-Dole (BD) encouraged American 
universities to acquire patents on inventions resulting from 
government-funded research and to issue exclusive licenses to private 
firms [5,6], on the assumption that exclusive licensing creates 
incentives to commercialize these inventions. A broader hope of BD, and 
the initiatives emulating it, was that patenting and licensing of public 
sector research would spur science-based economic growth as well as 
national competitiveness [6,7]. And while it was not an explicit goal of 
BD, some of the emulation initiatives also aim to generate revenues for 
public sector research institutions [8].

We believe government-supported research should be managed in the public 
interest. We also believe that some of the claims favoring BD-type 
initiatives overstate the Act's contributions to growth in US 
innovation. Important concerns and safeguards—learned from nearly 30 
years of experience in the US—have been largely overlooked. Furthermore, 
both patent law and science have changed considerably since BD was 
adopted in 1980 [9,10]. Other countries seeking to emulate that 
legislation need to consider this new context.
Overstating Claims

On a positive note, the BD Act required different agencies that funded 
US research and development to adopt more consistent policies about 
ownership of patents arising from federal funding [5]. One of BD's 
intended virtues involved transferring default patent ownership from 
government to parties with stronger incentives to license inventions. BD 
assigned ownership to institutions, such as universities, nonprofits, 
and small businesses, although it could just as easily have opted for 
individual grant and contract recipients.

Nevertheless, many advocates of adopting similar initiatives in other 
countries overstate the impact of BD in the US. Proponents note The 
Economist's 2002 claim that the Act was “[p]ossibly the most inspired 
piece of legislation to be enacted in America over the past 
half-century” [11]. They also cite data (originally used by US 
proponents of the Act) on the low licensing rates for the 28,000 patents 
owned by the US government before BD to imply that the pre-BD legal 
regime was not conducive to commercialization [12]. But as Eisenberg [5] 
has argued, that figure is misleading because the sample largely 
comprised patents (funded by the Department of Defense) to which firms 
had already declined the option of acquiring exclusive title. Moreover, 
these figures are of questionable relevance to debates about public 
sector research institutions, because most of the patents in question 
were based on government-funded research conducted by firms, not 
universities or government labs [13]. Finally, and most importantly, the 
narrow focus on licensing of patented inventions ignores the fact that 
most of the economic contributions of public sector research 
institutions have historically occurred without patents—through 
dissemination of knowledge, discoveries, and technologies by means of 
journal publications, presentations at conferences, and training of 
students [6,14,15].

Throughout the 20th century, American universities were the nation's 
most powerful vehicles for the diffusion of basic and applied research 
results [16], which were generally made available in the public domain, 
where industry and other public sector researchers could use them. These 
activities were central to the rise of American technological success 
broadly and to the growth of knowledge-based industries, such as 
biotechnology and information technology, in particular.

Public sector research institutions also relied on generous public 
funding for academic research—from a highly diverse group of federal 
funding agencies—which grew dramatically after the Second World War, and 
on the availability of venture capital to foster the development of 
early-stage ideas [6]. These and other unique features of the US 
research and development system explain much more about innovation in 
the US after BD than the rules about patenting that BD addressed.

In the pre-BD era, discoveries emanating from public research were often 
commercialized without patents, although academic institutions 
occasionally patented and licensed some of their publicly funded 
inventions well before BD, and these practices became increasingly 
common in the 1970s [17]. Since the passage of the Act in 1980, US 
academic patenting, licensing, and associated revenues have steadily 
increased. BD accelerated this growth by clarifying ownership rules, by 
making these activities bureaucratically easier to administer, and by 
changing norms toward patenting and licensing at universities [6]. As a 
result, researchers vested with key patents sometimes took advantage of 
exclusive licenses to start spin-off biotechnology companies. These 
trends, together with anecdotal accounts of “successful” 
commercialization, constitute the primary evidence used to support 
emulating BD in other countries. However, it is a mistake to interpret 
evidence that patents and licenses have increased as evidence that 
technology transfer or commercialization of university technology has 
increased because of BD.

Although universities can and do patent much more in the post-BD era 
than they did previously, neither overall trends in post-BD patenting 
and licensing nor individual case studies of commercialized technologies 
show that BD facilitated technology transfer and commercialization. 
Empirical research suggests that among the few academic patents and 
licenses that resulted in commercial products, a significant share 
(including some of the most prominent revenue generators) could have 
been effectively transferred by being placed in the public domain or 
licensed nonexclusively [6,18].

Another motivation for BD-type legislation is to generate licensing 
revenues for public sector research institutions. In the US, patents are 
indeed a source of revenues for some universities, but aggregate 
revenues are small. In 2006, US universities, hospitals, and research 
institutions derived US$1.85 billion from technology licensing compared 
to US$43.58 billion from federal, state, and industry funders that same 
year [19], which accounts for less than 5% of total academic research 
dollars. Moreover, revenues were highly concentrated at a few successful 
universities that patented “blockbuster” inventions [20].

A recent econometric analysis using data on academic licensing revenues 
from 1998 to 2002 suggests that, after subtracting the costs of patent 
management, net revenues earned by US universities from patent licensing 
were “on average, quite modest” nearly three decades after BD took 
effect. This study concludes that “universities should form a more 
realistic perspective of the possible economic returns from patenting 
and licensing activities” [21]. Similarly, the head of the technology 
licensing office at MIT (and former President of the Association of 
University Technology Managers) notes that “the direct economic impact 
of technology licensing on the universities themselves has been 
relatively small (a surprise to many who believed that royalties could 
compensate for declining federal support of research)… [M]ost university 
licensing offices barely break even” [22].

It is thus misleading to use data about the growth of academic patents, 
licenses, and licensing revenues as evidence that BD facilitated 
commercialization in the US. And it is little more than a leap of faith 
to conclude that similar legislation would automatically promote 
commercialization and technology transfer in other, very different, 
socioeconomic contexts.
Sources of Concern

What have we learned from the US experience with BD? Because the Act 
gives recipients of government research funds almost complete discretion 
to choose what research to patent, universities can patent not only 
those inventions that firms would fail to commercialize or use without 
exclusive rights, but also upstream research tools and platforms that do 
not need patent protection and exclusive licensing to be adopted by 
industry [6,9,10].

For example, while the patented technologies underlying recombinant DNA 
were fundamentally important for biotechnology and generated ample 
revenues for Stanford, the University of California, Columbia 
University, and City of Hope Medical Center [6], the patenting and 
licensing of these research platforms and technologies were not 
necessary for commercialization. Both the Cohen-Boyer patents for 
recombinant DNA and the Axel patents on cotransformation were rapidly 
adopted by industry even though neither invention came with the BD 
“carrot” of an exclusive right. The Cohen-Boyer patents reportedly 
contributed to 2,442 new products and US$35 billion in sales. Its 
licensing revenues to Stanford University and the University of 
California San Francisco were US$255 million [23]. With 34 firms 
licensing the technology, the Axel patents earned US$790 million in 
royalties for Columbia University over the patent period (Colaianni and 
Cook-Deegan, unpublished data). While the patenting and licensing of 
these inventions clearly enriched the universities involved, there is no 
reason to believe that nonexclusive licensing (as opposed to simple 
dedication to the public domain) deterred commercialization of the 
invention(s). In fact, Columbia University justified efforts to extend 
the life of its Axel patents not because such extension would improve 
commercialization, but rather because it protected royalty income that 
would be channeled back into its educational and research mission.

While BD gave those conducting publicly funded research the discretion 
to patent fundamental technologies, changes in US patent law since 1980 
provided the means, by expanding eligibility standards to include basic 
research and research tools. These trends have been notable in the 
biotechnology and information technology sectors [24,25]. A widely 
watched, recent consequence of this shift involves the suite of 
University of Wisconsin patents on embryonic stem cell lines [26–28]. 
Biotechnology firms eager to do research on stem cells have complained 
about the excessive licensing fees that Wisconsin charges (as well as 
about “reach through” provisions that call for royalties on any product 
developed from research on embryonic stem cells, and impose restrictions 
on use) [29]. Rather than promote commercialization, these patents on 
basic research platforms constitute a veritable tax on commercialization 
[30]. Nor were these efforts to tax future innovation unprecedented, as 
the example of recombinant DNA shows. The Wisconsin Alumni Research 
Foundation's extension of licensing terms to academic research 
institutions [31] and its imposition of restrictions on use became 
especially controversial because these measures went beyond the 
Cohen-Boyer precedent. The manager of recombinant DNA licensing at 
Stanford quipped, “[W]hether we licensed it or not, commercialization of 
recombinant DNA was going forward…a nonexclusive licensing program, at 
its heart, is really a tax…But it's always nice to say ‘technology 
transfer’” [32].

The broad discretion given to publicly funded research institutions to 
patent upstream research raises concern about patent thickets, where 
numerous patents on a product lead to bargaining breakdowns and can 
blunt incentives for downstream research and development (R&D) [33,34]. 
Barriers to bundling intellectual property necessary for R&D become 
higher in frontier interdisciplinary research areas, such as synthetic 
biology, microarrays, and nanobiotechnology, because they draw upon 
multiple fields, some of which may be likelier than others to form 
thickets over time [9,10,32,35]. Although there is some evidence that 
biotechnology and pharmaceutical firms may be able to avoid thickets 
through secret infringement or by “off-shoring” research to countries 
with fewer patent restrictions [36], secret infringement and the 
transfer of R&D to other countries are hardly tactics that government 
policy should encourage.

The problems that BD has raised for the biopharmaceutical industry are 
dwarfed by the problems it has raised for information technology. 
Universities may too often take a “one size fits all” approach to 
patenting research results, notwithstanding the evidence that patents 
and exclusive licensing play a much more limited role in the development 
of information technology than they do in the pharmaceutical sector 
[37]. In testimony to the US Congress, a prominent information 
technology firm complained that aggressive university patenting impeded 
both product development and university–industry collaboration, which 
encouraged companies to find other university partners, often outside 
the US [38]. Expressing similar concerns in a proposal to explore 
alternatives to the BD model, officials from the Ewing Marion Kauffman 
Foundation (the leading US foundation supporting entrepreneurship 
research) recently argued that “Technology Transfer Offices (TTOs) were 
envisioned as gateways to facilitate the flow of innovation but have 
instead become gatekeepers that in many cases constrain the flow of 
inventions and frustrate faculty, entrepreneurs, and industry” [39].

These problems have not escaped the attention of funding agencies, most 
notably the US National Institutes of Health (NIH), which has issued 
guidelines stating that patents should be sought, and exclusive licenses 
should be restricted, only when they are necessary for purposes of 
commercialization [40,41]. Beyond such hortatory guidelines, however, US 
funding agencies retain very limited authority to guide the patenting 
and licensing practices of publicly funded research institutions. Under 
BD, agencies can declare particular areas off-limits to patenting only 
when they find “exceptional circumstances.” Moreover, they must present 
this decision to the Department of Commerce, the primary administrator 
of BD. The “exceptional circumstances” authority has only rarely been 
used [30]. However, when exclusive licensing demonstrably impeded 
commercialization, the funding agencies did not intervene by exercising 
their authority to mandate additional licensing. Their reluctance to 
take such action stems in part from the realization that, under the BD 
regime as enacted, any mandate could immediately be challenged (and its 
effect stayed) pending the outcome of protracted litigation [30].

Some of the top US universities have themselves begun to recognize the 
difficulties that overly aggressive proprietary behavior can engender, 
as demonstrated by their March 2007 declaration highlighting “Nine 
Points to Consider in Licensing University Technology” [42]. How this 
declaration will affect university behavior is difficult to predict. 
Moreover, the “Nine Points” declaration focuses almost entirely on 
licensing and fails to address how universities should determine whether 
patents are necessary for commercialization in the first instance.

BD has also led to downstream concerns. The BD framework makes minimal 
reciprocal demands from licensees of government-funded technologies, and 
neither universities nor government agencies have sought to include 
requirements that products derived from these inventions be sold to 
consumers on reasonable terms [43]. Nor do funders require either 
disclosure of follow-on investments, so that prices might reflect the 
private contribution to development or the avoidance of abusive or 
anticompetitive marketing practices [43–47].

Some have raised concerns that the Act contributed to a change in 
academic norms regarding open, swift, and disinterested scientific 
exchange [48,49]. For example, in a survey to which 210 life science 
companies responded, a third of the companies reported disputes with 
their academic collaborators over intellectual property, and 30% noted 
that conflicts of interest had emerged when university researchers 
became involved with another company [50]. Nearly 60% of agreements 
between academic institutions and life science companies required that 
university investigators keep information confidential for more than six 
months—considerably longer than the 30 to 60 days that NIH considered 
reasonable—for the purpose of filing a patent [50]. Similarly, in a 
survey of life science faculties at universities receiving the most NIH 
funding, nearly a third of the respondents receiving a research-related 
gift (e.g., biomaterials, discretionary funds, research equipment, trips 
to meetings, or support for students) reported that the corporate donor 
wanted pre-publication review of any research articles generated from 
the gift; and 19% reported that the companies expected ownership of all 
patentable results from the funded research [51].

Although the surveys discussed above were conducted in the mid to early 
1990s, their findings appear robust over time. In a more recent survey 
of university geneticists and life scientists, one in four reported the 
need to honor the requirements of an industrial sponsor as one of the 
reasons for denying requests for post-publication information, data, or 
materials [52]. This finding is also corroborated by a survey of US 
medical school faculty. In these settings, researchers most likely to 
report being denied research results or biomaterials by others were 
“those who have withheld research results from others” or who had 
patented or licensed their own inventions [53]. So the practices of 
patenting and licensing clearly encumber the openness of scientific 
exchange in universities.

Instituting Safeguards

Countries seeking to enhance the contributions of universities and 
public sector laboratories to social and economic development have 
numerous policy options. Many of these policies do not involve 
intellectual property rights at all, but rather look to provide funds 
for basic and applied research, subsidize scientific and engineering 
education, strengthen firms' ability to assimilate university research, 
and invest in extension, experimentation, and diffusion activities 
[39,54,55]. But even policies focused on intellectual property 
management need not presume that patenting and exclusive licensing are 
the best options. For example, they may instead focus on placing by 
default or by strategy government-funded inventions into the public 
domain, creating a scientific commons, enabling collective management of 
intellectual property, or fostering open-source innovation [56–60]. 
Where greater commercial incentives seem necessary, the benefits of 
nonexclusive licensing should always be weighed against the social cost 
of exclusive licenses.

The appropriate array of policies will vary from country to country: 
there is no “one size fits all” solution. Based on our review above, we 
believe it is doubtful that the benefits of legislation closely modeled 
on BD would outweigh their costs in developing counties. For those 
countries that nonetheless decide to implement similar laws, the US 
experience suggests the crucial importance, at a minimum, of considering 
a variety of safeguards (see Box 1).

Conclusion

While policies supporting technological innovation and diffusion 
contribute to economic growth and development, the appropriate sets of 
policies to harness public sector R&D are highly context-specific. Much 
depends on factors such as the level of publicly funded research, the 
focus of such research on basic versus applied science, the capabilities 
of industry partners, and the nature of university–industry linkages 
[54,55].

Recognizing these difficulties, reasonable minds may disagree about the 
likely impact of BD-type legislation elsewhere. Nevertheless, the 
present impetus for BD-type legislation in developing countries is 
fueled by overstated and misleading claims about the economic impact of 
the Act in the US, which may lead developing countries to expect far 
more than they are likely to receive. Moreover, political capital 
expended on rules of patent ownership may detract from more important 
policies to support science and technology, especially the need for 
public funding of research. Given the low level of public funding for 
research in many developing countries, for example, the focus on royalty 
returns at the expense of public goods may be misplaced [61]. 
Furthermore, it is unclear whether any of the positive impacts of BD in 
the US would arise in developing countries following similar 
legislation, absent the multiagency federal pluralism, the practically 
oriented universities, and other features of the US research system 
discussed above.

In any event, both the patent laws and patterns of scientific 
collaboration have changed substantially since BD was passed in 1980. To 
the extent that legislation governing the patenting and licensing of 
public sector research is needed in developing countries at all, it 
should reflect this new context rather than blindly importing a US model 
that is 30 years old.

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Box 1: Safeguards Serving the Public Interest

Governments adopting laws styled after the US BD Act should be vigilant 
to ensure that the public's interests are served. In commercializing 
publicly funded research, a number of safeguards on patenting and 
licensing practices should be built into any law or its regulatory 
implementation.

No Exclusive Licensing Unless Necessary for Commercialization

Any BD-style legislation should be founded on the principle that 
publicly funded research should not be exclusively licensed unless it is 
clear that doing so is necessary to promote the commercialization of 
that research. Public sector institutions should not, for example, 
exclusively license research tools that were developed with public 
funding if those tools can instead be used off the shelf by others. 
Where exclusive licenses are not required for commercialization, one may 
ask whether universities and public sector labs should be patenting 
research at all. Will encouragement of patenting and nonexclusive 
licensing, as in the Cohen-Boyer model discussed above, help or hurt 
researchers, firms, and the public in developing countries? Even 
nonexclusive licenses will tax downstream users, although presumably 
with lower rents and transaction costs and more procompetitive effects. 
As suggested above, revenues from licensing academic inventions are 
likely to be minuscule for most institutions, and aggressive university 
patenting can have other deleterious effects. A robust research 
exemption can ward off some of the problems potentially associated with 
restrictive licensing of upstream inventions [62].

Transparency

The legislation should ensure transparency in the patenting and 
licensing of publicly funded research. Public accountability should 
follow public funding. Institutions that engage in patenting and 
licensing should be required to report or make public all information 
that is necessary to determine whether they are reasonably serving the 
public interest. Such information may include the number of patents and 
licenses obtained, the funds expended on patenting and licensing 
activities, licensing revenues, and the key terms (e.g., exclusive or 
nonexclusive, humanitarian access, research exemption, definition of 
market segmentation or field of use, performance milestones, and 
march-in rights) of licenses. The lack of a transparency mandate is a 
key flaw of the BD Act that should not be replicated.

Government Authority To Issue Additional Licenses

Where licensing arrangements for publicly funded research do not achieve 
public interest objectives, governmental authorities must have power to 
override such licenses and to grant licenses to additional or 
alternative parties [9,10,43]. In the US, this authority is formally 
embodied in the government's “march-in” rights under BD, but this power 
has never been exercised. Petitions to invoke it have been made a few 
times [46,47,63,64], but they have never been granted, and because of 
the administrative disincentives built into BD, this power is unlikely 
ever to be used [30]. To avoid this result, legislatures must develop 
standards to ensure that march-in rights or comparable authority will be 
exercised when public interest objectives are not otherwise attained.

In evaluating licensing options, those receiving government research 
funding could also be required to consider the option of licensing 
patented inventions to a “technology trust,” that is, a commons that 
would ensure designated inventions remained available to all interested 
parties on predetermined terms. Such a commons could enable the pooling 
of socially useful bundles of technology, particularly research tools 
and health technologies for neglected or rare diseases. Governments 
might also consider reducing or waiving patent application and 
maintenance fees for such inventions when they are made broadly 
available for research and humanitarian application, without royalty, 
for a specific geographical area or field of use.

Government Use Rights

The government should retain an automatic right to use any invention 
arising from its funding. Under BD, the US government has an automatic 
“nonexclusive, nontransferable, irrevocable, paid-up license” [65] to 
use any invention developed with government funds. Typically, however, 
it does not invoke such a license and often pays monopoly prices for 
products that it funded. The US experience shows the importance both of 
establishing that the government should be provided with an automatic 
license in products resulting from its funding and of elaborating 
standards to ensure such licenses are actually exercised in appropriate 
circumstances.

 From a broader perspective, governments retain the right to use any 
invention, whether or not it arises from public funding, under 
international law [66]. Governments may choose to use patented 
inventions to promote public health [67], national security [66], or 
comparable objectives, while public-interest compulsory licenses may 
sometimes be granted to avoid abusive licensing practices or to ensure 
access to patented research products on reasonable terms and conditions 
[43,66]. Where publicly funded grantees fail to commercialize a 
technology appropriately or to foster its availability, the trigger for 
government use—under any enabling provision adopted in domestic law—must 
work better than the march-in right has under BD.

Access to End Products

Besides promoting commercialization, the government must ensure consumer 
access to end products. The public is entitled to expect that the 
inventions it paid for will be priced fairly. The US experience shows 
that a BD system that lacks mandatory rules concerning the affordability 
of end products will not deliver on this reasonable expectation [43–47]. 
As a condition of receiving a license to a government-funded invention, 
parties should be required to ensure that end products are made 
available to the public on reasonable terms and conditions. What 
constitutes “reasonable” will vary by national context, but it is 
important to ensure that the term is defined with enough precision to be 
enforceable.

Licenses to government-funded inventions should presumptively include 
access-oriented licensing provisions that address humanitarian needs in 
other countries [68]. One such provision is an open license for 
production and sale of end products in (or to) developing countries in 
exchange for a fair royalty [69]. At the very least, when inventions 
have foreseeable applications in resource-poor regions, a plan for 
access in those regions should be explicitly incorporated into 
technology licensing.

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------

Anthony D. So is with the Program on Global Health and Technology Access 
and the Center for Strategic Philanthropy and Civil Society, Terry 
Sanford Institute of Public Policy, Duke University and the Duke Global 
Health Institute, Durham, North Carolina, United States of America. 
Bhaven N. Sampat is with the Department of Health Policy and Management 
and the International Center for Health Outcomes and Innovation 
Research, Mailman School of Public Health, Columbia University, New 
York, New York, United States of America. Arti K. Rai and Jerome H. 
Reichman are with the Duke University School of Law, Durham, North 
Carolina, United States of America. Robert Cook-Deegan is with the 
Center for Genome Ethics, Law & Policy, Institute for Genome Sciences & 
Policy, Duke University, Durham, North Carolina, United States of 
America. Robert Weissman is with Essential Action, Washington, D. C., 
United States of America. Amy Kapczynski is with the School of Law, 
University of California, Berkeley, California, United States of America.

* To whom correspondence should be addressed. E-mail: anthony.so@duke.edu

------

Acknowledgments

This work emerged from “Emulating the BD Act: Steps to Ensure Innovation 
and Access for Health in Developing Countries,” a meeting organized on 
May 29, 2008 by the Program on Global Health and Technology Access at 
Duke University's Terry Sanford Institute of Public Policy. All of the 
authors contributed to the writing of the paper. The authors 
particularly appreciate the capable research assistance of Corrina 
Moucheraud Vickery, Chris Manz, and Amy Forrestel.

Funding. The authors gratefully acknowledge the support of the Open 
Society Institute, the Ford Foundation, and the Ewing Marion Kauffman 
Foundation, as well as grants from the National Human Genome Research 
Institute (Grant 5R01HG003763, Building a Technology Trust in Genomics), 
and the National Human Genome Research Institute and the Department of 
Energy (CEER Grant P50 HG003391, Duke University, Center of Excellence 
for ELSI Research).

Competing interests. The authors report the following nonfinancial 
conflicts of interest:

ADS is a Member of the Advisory Board for Universities Allied for 
Essential Medicines and has conducted commissioned research for the 
World Health Organization Commission on Intellectual Property Rights, 
Innovation and Public Health (2005).

BNS is a Member of the Advisory Board for the Initiative for Medicines, 
Access & Knowledge and has testified before the Secretary's Advisory 
Committee on Genetics, Health, and Society, Task Force on Impact of 
Patents and Licensing Practices on Clinical Access to Genetic Testing 
(July 10, 2007).

AKR is a Member of the Scientific Advisory Board for Science Commons and 
the Advisory Board for the Peer-to-Patent Project. She has testified 
before the Senate Committee on the Judiciary hearing on “The Role of 
Federally-Funded University Research in the Patent System” (October 24, 
2007) and has conducted commissioned research for the World Health 
Organization Commission on Intellectual Property Rights, Innovation and 
Public Health (2005).

RC-D is a Member of the National Research Council Committee on 
Management of University Intellectual Property and the Task Force on 
Patent Reform of the Association of American Universities, Council on 
Government Relations, Council on Education, National Association of 
State Universities and Land Grant Colleges, and Association of American 
Medical Colleges (joint committee). He has also conducted commissioned 
research for the Secretary's Advisory Committee on Genetics, Health, and 
Society, Task Force on Impact of Patents and Licensing Practices on 
Clinical Access to Genetic Testing (ongoing) and for the World Health 
Organization Commission on Intellectual Property Rights, Innovation and 
Public Health (2005).

JHR is a Member of the Editorial Board for the Journal of International 
Economic Law. He has testified before the NIH Public Hearing on March-In 
Rights under the Bayh-Dole Act, National Institutes of Health (May 25, 
2004).

RW is the Director of Essential Action. He is also Counsel to, and 
Member of the Board of Directors of, Essential Inventions, which has 
petitioned for the issuance of march-in licenses for two 
government-funded pharmaceutical products, ritonavir and latanoprost. He 
is also a Member of the Board of Directors for Health GAP (Global Access 
Project) and the Board of Directors for Union for the Public Domain. He 
has testified before the Senate Committee on the Judiciary hearing on 
“The Role of Federally-Funded University Research in the Patent System” 
(October 24, 2007).

AK is a Member of the Board of Directors for Universities Allied for 
Essential Medicines.