Research locally, diffuse globally? American universities, patents and global public health.

Sampat, Bhaven N.

An important challenge in sustainable development is promoting the creation of new medical technologies and ensuring their diffusion in developing countries. There is growing concern that, with the implementation of the World Trade Organization's agreement on Trade Related Intellectual Property Rights (TRIPs), pharmaceutical patents will restrict access to medicines globally. Profit-oriented companies are now aggressively pursuing intellectual property protections in developing countries, many of which had previously not allowed product patents on drugs. The concern is that absent generic competition, patients will not be able to access life-saving medications. Recent attention has focused on a perhaps unlikely set of actors to help ameliorate the access to medicines problem: American research universities. A decade-old student movement has argued that universities own intellectual property rights on many important drugs, and has pushed for inclusion of "humanitarian licensing" clauses that would compel the pharmaceutical firms that license these technologies to allow generic access in developing countries. In this paper, I discuss the emergence and evolution of this student movement, and the set of patent policy changes that got us here. I also summarize data on the feasibility of these policies: for how many drugs would changes in university policies plausibly affect access? Next, I discuss the desirability of changing university licensing practices and the tradeoffs universities face when considering humanitarian licensing approaches. I conclude with a discussion of the limits of campus-level initiatives alone, and the potentially important role for research funding agencies, such as the National Institutes of Health, in promoting humanitarian licensing and access to medicines.

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Over the past decade, global public health has been identified as a crucial driver of sustainable human development. Yet marshaling collective action toward global health goals is difficult, since the developing world lacks the resources to do so and taxpayers in developed countries traditionally have been anemic in providing financial support for this purpose.

In the face of these difficulties, recent attention has focused on a potentially useful role for U.S. universities in promoting global public health. For example, Professor Jeffrey D. Sachs, director of Columbia University's Earth Institute, has argued that, relative to private sector actors, universities are less myopic, less motivated by commercial interest, more cosmopolitan and, therefore, better suited to play a central role in the advancement of global public health. (1) Optimism that universities can help promote global health finds support in history: U.S. universities have a long and storied record of rising to address important social and economic challenges. They were integral in promoting agricultural development in the 19th century; in developing indigenous American chemical and engineering industries in the early 20th century; and most famously perhaps, in advancing U.S. research efforts during the Second World War. (2) In the postwar era, universities have had an important role in biomedical research, including in the war on cancer and in drug development. Sachs suggests that "the challenge today is to extend such local actions to global problems, with universities taking on the challenges in other parts of the world." (3) U.S. universities appear to be rising to this challenge; university activity in the global health arena has grown dramatically over the past decade. Dr. Michael Merson, director of the Duke Global Health Institute based at Duke University, recently suggested that 270 U.S. academic institutions had some sort of global health program, of which seventy had global health centers. (4)

Academic institutions might contribute to global health through numerous channels, including training, research and development (R&D), and program evaluation and delivery. This paper examines the potential for university action in another domain: the diffusion of pharmaceuticals. Specifically, I examine how changes to university patenting and licensing policies can promote broader access to medicines.

Access to medicines is widely viewed as a crucial component of global public health. (5) Recognizing this, and the lack of private sector incentives to promote access, a cross-campus student movement called the Universities Allied for Essential Medicines (UAEM) attempts to shape university licensing policies to ensure that drugs researched and developed at universities, in whole or in part, are licensed at low cost in the developing world. (6) In this paper, I first provide an overview of the potential role that university intellectual property right policies could play in improving the diffusion of biomedical technologies in developing countries. I then set the stage by discussing the problem of access to medicines and new international patent laws that may contribute to it. Next, I examine the rise of academic patenting and licensing. Finally, I discuss the initiatives now underway to use academic technology transfer policies--in particular, so-called humanitarian licensing policies that seek to encourage low prices for university-developed technologies in developing countries--to overcome barriers to diffusion created by patents. In this section, I summarize data on the feasibility of these policies and the tradeoffs universities face when considering humanitarian licensing approaches. I conclude by arguing that campus-level action may need to be reinforced by national policymaking (and/or guidance from U.S. federal funding agencies) for humanitarian licensing policies to be more widely adopted.

PATENTS AND ACCESS TO MEDICINES

Access to drugs is widely recognized as an important component of global health and sustainable development. (7) Many factors affect the extent to which the population in developing countries has access to medicines, including the strength of health systems, the general state of infrastructure, indigenous manufacturing capabilities and national income levels. (8)

Recently, another potential factor has been added to the mix: patents. Patents on new drugs give their owners limited term rights--currently, twenty years from patent filing--to exclude other firms from selling the same technologies. The theory underlying patent policies is that, absent this limited term monopoly, firms would not invest in costly research and development. Patents are more important in pharmaceuticals than in other industries because R&D in the area of new drug development and testing is particularly expensive. Once a compound is discovered, however, imitation is easy. (9) Furthermore, drug patents are difficult to invent around and thus effective at preventing competition. Because they are subject to generic competition, drugs without patents are priced much lower and are more broadly available. This is why Doctors Without Borders has argued that generic competition is "the most significant factor in lowering prices" for drugs. (10) Oxfam similarly notes that it is "the single most important tool to remedy the access gap." (11)

Historically, developing countries have had flexibility in how they designed their patent laws, and many (probably most) chose not to allow patents on pharmaceuticals. (12) This reflected the view among policymakers in the developing world--and among development economists--that the benefits of increased innovation due to patents and other intellectual property incentives were minimal for developing countries; after all, most pharmaceutical R&D is performed on the basis of profit expectations from developed country markets. (13) Additionally, the benefits generated from lower prices and broader access to drugs are potentially large in developing nations. (14)

The World Trade Organization's 1995 agreement on Trade Related Intellectual Property Rights (TRIPS) appears to have changed this. TRIPS led to an upward harmonization of patent standards to match those of the developed world. TRIPS forbids excluding entire fields from patentability. Most developing countries were compelled to introduce TRIPS-compliant patent laws by 1 January 2000. They have been in place now for roughly one decade. Carolyn Deere observes that, as a result, "by the end of 2007 the intellectual property standards of developing country laws were higher than ever before," and most governments now grant pharmaceutical product patents. (15)

There was some enthusiasm that TRIPS would promote research on so-called neglected diseases (those without significant first-world markets) and/or promote innovation by indigenous firms in developing countries; however, the empirical record on both expectations remains mixed (16) There has also been widespread concern that the introduction of drug patents in developing countries will lead to limited generic competition, higher prices and restricted access to medicines. Joseph E. Stiglitz, professor of economics at Columbia University, has, for example, suggested that the TRIPS-mandated changes "were intended to reduce access to generic medicines and they succeeded. As generic medicines cost a fraction of their brand name counterparts, billions could no longer afford the drugs they needed." (17) These concerns about post-TRIPS access to medicines have been most pronounced in the HIV/AIDS arena, perhaps because of the presence of generic suppliers in India and elsewhere that were previously the dominant sources of low-cost drugs to much of the developing world, but whose activities could be foreclosed by TRIPS.

As a result of these concerns, Stiglitz, among others, has advocated replacing our current system of financing drug innovation via patents with other models, including prize-type systems)" In these systems, firms are offered financial or other rewards based on the size of the benefit conferred by a given innovation. While they differ considerably in their detailed recommendations, each of these new proposals stems from the argument that reliance on patents to finance innovation requires putting broad access to potentially life-saving medicines in the hands of private sector pharmaceutical firms. Since these firms are profit-maximizing, they generally do not--and perhaps cannot, given their responsibilities to shareholders--diffuse drug technologies broadly in developing countries.

However, private sector firms are not the only important actors in drug development. A large share of U.S. biomedical research is funded by the public sector and conducted by research universities. Given the characteristics that make universities potentially important actors in global health and sustainable development and their growing engagement in global health, might they also play an important role in drug development and access to medicines?

To answer this question, I begin with a discussion of an important change in U.S. patent policy that led American research universities to become more aggressive claimants of intellectual property rights to campus-based research, known as the Bayh-Dole Act of 1980.

BAYH-DOLE AND ACADEMIC PATENTING

Throughout the 20th century, university patenting was rare. This was especially true of biomedical technologies. Even universities that allowed for patenting generally tended to restrict faculty patenting of medical inventions. Columbia University's patenting policy, up until 1975, allowed patenting generally, while also asserting that "no member of the faculty or staff of the College shall take out a patent on any medicinal, therapeutic, or health substance or process." (19) Similar policies were in place at most other major U.S. universities, reflecting a belief that medical patents were particularly difficult to reconcile with the academic mission to advance and diffuse knowledge. (20)

These restrictions began to be relaxed in the 1970s. The sources of these changes are complex and included academic institutions seeking other revenue sources in the wake of reduced federal funding, and the growth of biotechnology, a field where university research was directly valuable to industry. Federal funding agencies, including the National Science Foundation (NSF) and National Institutes of Health (NIH), also initiated a series of reforms allowing universities to patent through case-by-case petitions or blanket Institutional Patent Agreements (IPAs). Historically, funding agencies had been ambivalent about allowing grantees to patent. This ambivalence reflected a long-standing policy presumption that publicly-funded research should be placed in the public domain, and that taxpayers should not be compelled to pay for research twice: first by funding it and again through monopoly pricing. (21)

What changed? Following the competitiveness crisis of the 1970s and fears about global economic competition, policymakers sought in the 1970s and 1980s to make changes to patent U.S. policies to promote innovation. (22) A range of interest groups highlighted that the lack of patent protection on university research was one reason the United States was getting relatively little return on academic R&D investments. (23) Specifically, they argued that university inventions were typically embryonic technologies. Absent patents, the argument continued, firms would lack incentive to develop academic technologies to the point where they would be commercially viable and useful. In pharmaceuticals, for example, the argument was made that, even when potential therapies were discovered in the laboratory, private firms would not advance them through expensive clinical trials without exclusive market rights. Compounds placed in the public domain would, as a result, simply "languish on the shelf." (24)

This argument, which also applied more broadly to non-pharmaceuticals, was the basis of the Bayh-Dole Act of 1980. The agency-by-agency reforms advanced before Bayh-Dole and discussed above stood on questionable legal footing, and vacillation by individual agencies created considerable uncertainty for university grantees and their potential commercial licensees.

The Bayh-Dole Act was centrally motivated by concerns about lagging U.S. competitiveness and the belief that, in a global economy in which scientific and technological knowledge moves across national boundaries far more rapidly and can be exploited far more easily by non-U.S, enterprises, the U.S. economy (and U.S. taxpayers) would benefit from federal support of academic R&D only if the results of this research were patented. (25) As such, the congressional passage of the Bayh-Dole Act was part of a broader wave of so-called techno-nationalistic technology policies enacted in the 1970s and 1980s aimed at promoting high-technology industry in the United States in an era of increased global competition. (26)

At its most basic level, Bayh-Dole created a uniform government patent policy, clarifying procedures for obtaining academic patents and making them uniform across funding agencies. (27) Bayh-Dole also had an important normative impact, allowing and encouraging universities to patent and exclusively license their inventions, something they had previously avoided and considered somewhat contrary to their academic missions. (28)

Over the past quarter century, academic patenting and licensing activities have grown dramatically. While only a handful of universities had formal technology transfer offices before Bayh-Dole, nearly every major research university now houses a dedicated patenting and licensing office. University patenting has increased sharply. This growth has been most pronounced in the biomedical arena, where the share of university-owned patents in all patents has increased from about 5 percent to about 20 percent between the late 1970s and today. (29)

How does university patenting and licensing work? Consider the case of Xalatan[R], a glaucoma drug developed at Columbia University in the early 1980s by chemistry professor Laszlo Bito. Xalatan[R] was funded by a series of grants from the National Eye Institute, part of the NIH.(30) Though Bito had originally planned to publish only his research--consistent with the practices of the time--he learned that, under Columbia University's post-Bayh-Dole patent policy, he had to report his creation to the university technology transfer office. He did so, and the university acquired a patent on the invention. Because the scientific theory behind Bito's discovery was not well-accepted when the drug was being developed, it was difficult for Columbia to secure a licensee to develop the drug. Eventually, it was licensed exclusively to Pharmacia (later, Pharmacia-Upjohn), which financed the drug through human clinical trials. In time, Xalatan[R] became a blockbuster drug, generating major profits for Pfizer (which eventually acquired Pharmacia-Upjohn). Like most licensing contracts between universities and industry, Columbia's contract included a sales-based royalty. The drug generated significant revenues for Columbia University, much of which was plowed back into research.

Most policy discussions about Bayh-Dole have focused on whether it really fulfills its mandate to promote technology transfer. This remains an open and important empirical question. (31)

Scholars and policymakers have also expressed concerns about whether the Bayh-Dole act has had unintended effects. Has the growth of academic patenting been accompanied by a shift from basic to more applied, commercially attractive research? Does academic medical patenting create conflicts of interest among those conducting research on patients? Can patenting of the inputs into research (gene sequences, reagents, research tools, proprietary data, etc.) hinder the progress of science?

While these arguments focus on the unintended costs of academic patenting, there have also been recent discussions about its unintended benefits; namely, the potential control over dissemination, and possibly pricing, conferred by academic ownership of the basic technology. (32) This is particularly important since drug firms, once they develop a useful product, will generally charge the highest price the market will bear.

The Bayh-Dole Act was about creating incentives for innovation, but since the early days of debates about Bayh-Dole, there have been concerns about the dissemination and fair pricing of taxpayer-funded drugs. These included provisions for "recouping" profits from drugs developed through public funding. Such provisions were dropped from the final legislation at the last hour, though they have occasionally re-emerged in policy discussions since then. (33) There have also been initiatives to use the so-called march-in provisions of the Bayh-Dole Act to promote lower pricing of drugs in the United States, though none have been successful yet. (34) In the next section, I discuss proposals aimed at harnessing the role of American universities in drug development to affect prices and broaden access to medicines in developing countries.

ACADEMIC PATENTS AND ACCESS TO MEDICINES

Ironically, given the techno-nationalistic motivations behind Bayh-Dole described above, initiatives to use university ownership of drugs to promote access to medicines appear to have been more successful in the context of developing countries than in the United States. These initiatives were triggered by the case of Stavudine, an important HIV treatment that was exorbitantly priced in South Africa and therefore unobtainable for many of the country's dying patients in need of this life-saving drug. Student activists and civil society groups learned that the drug was developed at Yale University via NIH funding. These groups successfully pressured Yale to compel Bristol-Myers Squibb, the firm that had licensed the drug from the university, to allow generic competition in South Africa. As a result, according to one source, the price of the drug dropped dramatically, from $1,600 per year to $55 per year. (35) This drop in price instantly meant that many more HIV patients in South Africa were able to afford the drug and proved that a change in university licensing practices could, in fact, save lives.

This remarkable incident spawned a broad student movement called Universities Allied for Essential Medicines (UAEM). UAEM currently has nearly fifty university chapters. Its members are comprised of undergraduates, law students, medical students and those working in various areas of public health. Its slogan, "Our Drugs. Our Labs. Our Responsibility," is based on UAEM's position that

"many important medicines and public health technologies are developed in academic laboratories. Their accessibility in poor nations is profoundly affected by the research, patenting and licensing decisions made by universities." (36)

The main goal of UAEM has been to convince universities to build humanitarian licensing language into their licensing policies. This language would compel licensees of university patents to allow generic competition in the production of these compounds in developing countries. Importantly, this would not prevent pharmaceutical companies from enjoying their monopoly rights in developed countries, where they earn the vast majority of their profits. UAEM's flagship proposal to concretize these principles into a model licensing policy--the Equitable Access License (EAL)--also has a viral component: preventing the enforcement of any follow-on patents associated with a university technology against generic competition in developing countries. (37)

Assuming that profit-oriented firms are unlikely to promote broad access to medicines on their own, the potential role of universities is an intriguing solution to the problem of global access to medicines. How impactful could these interventions be if they were widely adopted? In an earlier work, I assessed the scope for these policies, using data on ownership of all drugs launched between 1988 and 2005. (38) I found that universities owned patents on about 10 percent of new molecular entities and about 20 percent of the most innovative, priority drugs. About a quarter of HIV/ AIDS drugs had academic patents. These figures are likely to understate the potential role of universities for several important types of drugs. For example, the dataset used for the analyses above does not include many biotechnology drugs, a fast-growing segment of the market and one where university research is likely to be particularly prominent. Recent work on the human papillomavirus (HPV) vaccine--a biotechnology drug with large potential markets in the developing world--demonstrates that universities played acritical role in enabling research on this technology. (39) Overall, I read these data as suggesting that the scope for university action is significant and likely to be even more important in the future.

The student movement has had other notable successes beyond the Yale University case. UAEM's members helped to shape the language in the licensing policies for several universities, including Emory University and the University of North Carolina. While the EAL per se has not been adopted by any major university yet, the movement has raised awareness of the relationship between intellectual property and access to medicines on campuses nationwide. As just one example of this, the Philadelphia Consensus Statement outlining the group's main goals has numerous eminent academics among its signatories, including four Nobel Laureates. (40) Last year, the Association of University Technology Managers and six universities--Boston University, Brown University, Harvard University, Oregon Health and Science University, the University of Pennsylvania and Yale University--announced a Statement of Principles and Strategies for the Equitable Dissemination of Medical Technologies, in which the universities pledged a general commitment to global access goals, stating: "In our negotiations with potential licensees we will make vigorous efforts to develop creative and effective licensing strategies that help to promote global access to health-related technologies." (41)

This statement has since been endorsed by other U.S. universities: the University of Illinois, the University of Vermont, Duke University, New York University (NYU) and Florida State University.

Most universities, however, including the most active ones on patenting and licensing, have not signed on yet, though it is true that the statement is still less than one year old. Moreover, at least based on my own impressions, even those that have endorsed this statement or humanitarian licensing principles more generally, have yet to make major changes to their licensing terms or practices. (42)

Given the potential for academic institutions to facilitate access to medicines, and their growing commitment to global public health, why has the responsiveness of academic institutions' licensing policies and practices been so limited?

On the one hand, universities may be concerned that these intellectual property provisions to protect global health will thwart the overall goal of the Bayh-Dole regime, i.e., technology transfer. The specific concern is that potential commercial licensees will balk at humanitarian licensing clauses. Previous empirical research suggests some justification for this concern. Technology transfer is generally thought to be a buyers' market: the modal number of potential suitors for academic technologies is zero. (43) In this context, imposing additional demands on licensees may cause them to walk away from developing academic drugs, which is not the goal anyone intends.

Moreover, while one reason for general optimism about the role of universities in global health is predicated on the fact that they are not profit-motivated institutions (see Sachs's argument in this paper's introduction), in this arena of university licensing and intellectual property they are more so. Previous work by Richard Jensen and Marie Thursby reveals that generating licensing income is, in fact, a main goal of university technology transfer managers. (44)

That said, with pharmaceutical firms increasingly reliant upon academic technologies for their new drug pipeline, it is unclear whether these firms would rationally walk away from promising technologies just because they cannot prevent generic competition in developing countries. After all, the bulk of profits from most drugs comes from developed country markets, which are unlikely to be affected by these proposals. If Xalatan[R] for example, was viewed as worthy of commercial development, surely it likely remained so without the Brazilian or Ghanaian markets. The situation may be different for drugs that address neglected tropical diseases because the bulk of the market for that class of drugs is indeed in the developing world. There is relatively little academic or commercial research on these diseases anyhow, so that is an entirely different problem.(45)

In bargaining negotiations, however, pharmaceutical and other firms may threaten to walk away. In this context, individual universities may be reluctant to push their luck, even for the important cause of global health. Universities tend to be risk-averse and cautious, especially in the context of technology transfer. Professor Louis Menand, in his recent book on U.S. universities, notes an old observation by the classicist F. M. Cornford that at universities, "nothing should ever be done for the first time." (46)

CONCLUDING THOUGHTS

Whether real or perceived, limits to bottom-up action by universities on these issues suggest that more top-down approaches may also be necessary. After all, research universities are not entirely autonomous, but rather are heavily influenced by their funders. For example, in biomedical research, a strong statement of support for humanitarian licensing principles from the NIH could shape university grantees' practices in a profound way. It may even provide cover for individual universities in their negotiations with their commercial licensees: "the NIH made us do it." However, though the NIH has endorsed the statement on broad access principles discussed above, it has not formally conveyed what actions it expects from its research grantees.

And there are some limits to what we might expect a U.S. taxpayer agency to do in order to promote global health. This relates to familiar problems already raised in the introduction about how to persuade U.S. taxpayers to evince more concern for the promotion of global public health.

How might Congress and/or funding agencies be convinced to take action? One argument is quite straightforward: the United States should care about access to medicines in the developing world simply because it is the right thing to do. This might be particularly persuasive if the costs of humanitarian licensing policies--i.e., effects on incentives to develop and test drugs emanating from academic labs--were, in fact, small. Another set of arguments for why rich nations should care about global health might appeal to self-interest rather than ethics: infectious diseases know no boundaries and sick countries make poor trading partners, while also creating security risks. (47)

This highlights another potential role for members of U.S. research universities. University researchers, students and administrators have historically been important advocates in foreign policy and research policy deliberations. They could have a central role in shaping these dialogues and perspectives. Starting a conversation about the costs and benefits of national-level policy changes regarding humanitarian licensing is a critical new task for the movement to harness university patent ownership to promote global public health.

NOTES

(1) Jeffrey D. Sachs, Common Wealth: Economics for a Crowded Planet (New York: Penguin Press, 2008), 328.

(2) Nathan Rosenberg and Richard Nelson, "American Universities and Technical Advance in Industry," Research Policy 23, no. 3 (May 1994), 323-48; also reprinted in Richard Nelson, Sources of Economic Growth (Cambridge: Harvard University Press, 1996).

(3) Sachs, 329.

(4) Michael Merson, "Global Health: How U.S. Universities Are Responding to A Global Priority," (Grand Rounds speech, Maihnan School of Public Health, Columbia University, New York, NY: 15 September 2010).

(5) Jonathan D. Quick, "Essential Medicines Twenty-Five Years On: Closing the Access Gap," Health Policy and Planning 18, no. 1 (2003), 1-3.

(6) "About Us," Universities Allied for Essential Medicines, 2010, http://essentialmedicine.org/ about-us.

(7) Quick, 1-3.

(8) Amir Attaran and Lee Gillespie-White, "Do Patents for Antiretroviral Drugs Constrain Access to AIDS Treatment in Africa?" Journal of the American Medical Association 286, no. 15 (17 October 2001), 1886-92.

(9) Frederic M. Scherer, "The Pharmaceutical Industry," in Handbook of Health Economics, eds. Anthony J. Culver and Joseph R Newhouse, 1:25 (Amsterdam, The Netherlands: Elsevier, 2000), 1298-1322.

(10) As quoted by Amy Kapczynski, Samantha Chaifetz, Zachary Katz, and Yochai Benkler in "Addressing Global Health Inequities: An Open Licensing Approach for University Innovations," Berkeley Technology Law Journal 20, no. 2 (2005), 1048.

(11) ibid., 1049.

(12) Carolyn Deere, The Implementation Game: The TRIPS Agreement and the Global Politics of Intellectual Property Reform in Developing Countries (New York: Oxford University Press USA, 2009), Chapter 2.

(13) Ricki Lewis, "Fighting the 10/90 Gap," Scientist 16, no. 10 (13 May 2002), http://www.fl000scientist.com/article/ display/13038.

(14) Jean O. Lanjouw, "A Patent Policy for Global Diseases" (Washington, DC: The Brookings Institution, 11 June 2001), 26, http://www.brookings.edu/papers/2001/0611development_lanjouw. aspx.

(15) Deere, 12.

(16) Arora Ashish, Lee Branstetter, and Chirantan Chaterjee, "Strong Medicine: Patent Reform and the Transformation of the Indian Pharmaceutical Industry," (working paper, National Bureau of Economic Research (NBER) draft paper for Conference on Location of Biopharmaceutical Activity, 6-8 March 2008), http://chirantanc.weebly.com/ uploads/3/7/4/9/3749410/branstetter.pdf.

(17) Joseph E. Stiglitz, "Scrooge and Intellectual Property Rights," BMJ: British Medical Journal 333 (21 December 2006), 1279.

(18) Prominent proposals include Alden Hollis and Thomas Pogge, The Health Impact Fund: Making New Medicines Accessible for All (New Haven, CT: Incentives for Global Health, Yale University, 2008), http://www.yale.edu/macmillan/igh/hif.html; Michael Kremer and Rachel Glennerster, Strong Medicine: Creating Incentives for Pharmaceutical Research on Neglected Diseases (Princeton, NJ: Princeton University Press, 2004), http://press.princeton.edu/titles/7830.html.

(19) Archie M. Palmer, "Medical Patents," Journal of the American Medical Association 137, no. 6 (5 June 1948), 497-508.

(20) David C. Mowery and Bhaven N. Sampat, "University Patents and Patent Policy Debates in the USA, 1925-1980," Industrial and Corporate Change 10, no. 3 (Oxford, UK: Oxford University Press, 2001), 781-814.

(21) David Mowery et al., Ivory Tower and Industrial Innovation: University-Industry Technology Transfer Before and After the Bayh-Dole Act (Stanford, CA: Stanford Business Books, 2004), Chapter 3, 35-57, and, in particular, 36-38, 42-45.

(22) Sylvia Ostry and Richard R. Nelson, Techno-Nationalism and Techno-Globalism (Washington, DC: The Brookings Institution, 1995), 49-61.

(23) Mowery and Sampat, 781-814; See also Mowery et al., 89-91.

(24) Yudhijit Bhattacharjee, "Indian Government Hopes Bill Will Stimulate Innovation," Science 319 (1 February 2008), 556a.

(25) The Bayh-Dole Act or "University and Small Business Patent Procedures Act" is codified in 35 U.S.C. [section] 200-212, and implemented by 37 C.F.R. 401, http://www.access.gpo.gov/nara/cfr/ waisidx_02/37cfr401_02.html; Mowery et al., (2004), Chapter 5, "A Political History of the Bayh-Dole Act of 1980," 85-98.

(26) Ostry and Nelson.

(27) David Mowery et al., "The Growth of Patenting and Licensing by U.S. Universities: An Assessment of the Effects of the Bayh-Dole Act of 1980," Research Policy 30 (2001), 99-119; Mowery et al., (2004), 90-92.

(28) Bhaven N. Sampat, "Patenting and US Academic Research in the 20th Century: The World Before and After Bayh-Dole," Research Policy 35, no. 6 (July 2006), 776-77.

(29) Pierre Azoulay, Ryan Michigan, and Bhaven N. Sampat, "The Anatomy of Medical School Patenting," New England Journal of Medicine 357, no. 20 (Waltham, MA: Massachusetts Medical Society, 2007), 2049-26.

(30) Mowery et al., (2004), 166-69.

(31) This section draws on the discussion in Mowery et al., (2004).

(32) Peter Arno and Michael Davis, "Why Don't We Enforce Existing Price Controls? The Unrecognized and Unenforced Reasonable Pricing Requirements Imposed Upon Patents Deriving In Whole or In Part From Federally-Funded Research," Tulane Law Review 75, (January 2001).

(33) Matthew Herder, "Asking for Money Back: Chilling Commercialization of Recouping Public Trust in the Context of Stem Cell Research?" Columbia Science and Technology Law Review 203 (14 May 2008), 211.

(34) Essential Medicines, a public interest group, filed a "March In" petition under the Bayh-Dole Act seeking to lower consumer prices for Xalatan, http://www.ott.nih.gov/policy/March-in-xalatan.pdf. In a separate case, CellPro asked the Clinton Administration for a compulsory license to four patents held by Johns Hopkins University, also under the "March In" provisions of the Bayh-Dole Act, http:// www.cptech.org/ip/health/bd/cellpro.html.

(35) Amy Kapczynski et al., "Addressing Global Health Inequities: An Open Licensing Approach for University Innovations," Berkeley Technology Law Journal 20, no. 2 (2005), 1048.

(36) "Homepage," Universities Allied for Essential Medicines, 2010, http://essentialmedicine.org/.

(37) Follow-on patents are additional patents filed on an invention that is already patent-protected, for the purpose of extending the original patent term. This is often referred to as 'evergreening.'

(38) Bhaven N. Sampat, "Academic Patents and Access to Medicines in Developing Countries," American Journal of Public Health 99, no. 1 (January 2009), 9-17.

(39) Swathi Padmanabhan et al., "Intellectual Property, Technology Transfer and Manufacture of LowCost HPV Vaccines in India," Nature Biotechnology 7 (28 July 2010), 671-678.

(40) "Notable Signatories," Universities Allied for Essential Medicines, 2010, http://essentialmedicine. org/cs/notable-signatories.

(41) "Statement of Principles and Strategies for the Equitable Dissemination of Medical Technologies," signed by Association of University Technology Managers (AUTM), Boston University, Brown University, Harvard University, Oregon Health & Science University, University of Pennsylvania and Yale University, http://www.autm.net/Content/NavigationMenu/TechTransfer/GlobalHealth/ statementofprincliples.pdf.

(42) UAEM's activities have recently broadened, in addition to continuing to push for changes in university licensing policy, the group now advocates for neglected disease research; is involved in development of metrics to assess the social impact of university research; and evaluates a range of patent policies affecting access to medicines, e.g., the international emulation of the Bayh-Dole Act, www.essentialmedicines.org.

(43) Richard A. Jensen, Jerry G. Thursby, and Marie C. Thursbv, "Disclosure and Licensing of University inventions: The Best We Can Do With the Sh*t We Get to Work With," International Journal of Industrial Organization 21, no. 9 (2003), 1271-1300.

(44) Richard Jensen and Marie Thursby, "Proofs and Prototypes for Sale: The Licensing of University Inventions," American Economic Review 91, no. 1 (1 March 2001), 240-59.

(45) Jenny Lanouw and Margaret MacLeod, "Statistical Trends in Pharmaceutical Research for Poor Countries," (20 April 2005), http://www.who.int/intellectualproperty/studies/Lanjouw_Statistical%20 Trends.pdf.

(46) Louis Menand, Marketplace of Ideas: Reform and Resistance in the American University (New York, NY: W. W. Norton &Company, Inc., 2010), 15.

(47) Lawrence O. Gostin, "Why Rich Countries Should Care About the World's Least Healthy People," Journal of the American Medical Association 298, no. 1 (4 July 2007), 89-92.

Bhaven N. Sampat, PhD, is an assistant professor in the Department of Health Policy and Management at the Mailman School of Public Health and (by courtesy) in the School of International and Public Affairs at Columbia University.