摘要：There is a widespread and growing concern that patents hinder access to life-saving drugs in developing countries. Recent student movements and legislative initiatives emphasize the potential role that research universities in developed countries could have in ameliorating this “access gap.” These efforts are based on the assumption that universities own patents on a substantial number of drugs and that patents on these drugs are currently filed in developing countries. I provide empirical evidence regarding these issues and explore the feasibility and desirability of proposals to change university patenting and licensing practices to promote access to medicines in the developing world. THE PHARMACEUTICAL REVO lution contributed to dramatic reductions in morbidity and mortality from disease in developed countries during the last century. Today, however, as many as 2 billion people in the world—most of them in developing countries—lack access to life-saving drugs. 1 Righting this imbalance is among the most important challenges in global public health in this century. One source of the access gap in developing countries is a lack of research on specific diseases within developing countries. Both the public and private sectors devote relatively little research to diseases without markets in developed countries. As a result, relatively few new drugs target diseases specific to developing countries. 2 Analysts have also argued that poor health infrastructure, cumbersome drug regulatory procedures, and high tariffs and taxes in developing countries are important obstacles to access. 3 A third potential obstacle—my focus—is pharmaceutical patenting in developing countries, which (by restricting generic competition) can raise the prices of drugs and thus hinder access to medicines. One proposed solution to this last problem targets a perhaps surprising set of actors: research universities and public sector research institutes in developed countries. One of the main advocates of this approach, Universities Allied for Essential Medicines, a student group with over 40 campus chapters (with the slogan “Our Labs, Our Drugs, Our Responsibility”) argues on its Web site: Many of the world's most important medicines and public health devices are wholly or partly developed in academic laboratories. Their accessibility to those living in poor nations is profoundly affected by the research, licensing and patenting decisions made by universities… . As members of these institutions of higher learning, we believe that universities have an opportunity and a responsibility to improve global access to public health goods—particularly those they have helped develop. 4 I explore the feasibility and desirability of proposals to use the power of universities—conferred by ownership of key patents—to help reduce drug prices and promote access in developing countries. I provide and discuss new data, university ownership of key patents, and their propensity to file these patents in developing countries. However, before doing so, it is useful to reflect on the broader institutional and historical context for the current proposals. Drug patents allow their owners to exclude others from using or producing the drug until patent expiration (typically 20 years from the date the patent is filed). By excluding generic competition, patents keep prices high. The typical justification for patent protection is that these temporary high prices are needed to create incentives for firms to invest in research and development. In other words, patents involve tradeoffs: although they create incentives to innovate, they can raise prices and reduce access. Until the mid-1990s, many developing countries did not allow product patents in pharmaceuticals. 5 This generally reflected a conscious policy decision that the benefits from low-cost access to drugs were greater than any potential negative impact that lack of domestic patents would have on the research and development decisions of multinational companies. However, following the World Trade Organization's 1995 Trade-Related Intellectual Property Rights (TRIPs) agreement, all countries were compelled to allow product patents in pharmaceuticals. In the post-TRIPs era, there is widespread concern that, by raising prices, drug patents will reduce access to medicines in developing countries. 6 University patenting, too, is a relatively recent development. Throughout much of the 20th century, research universities did not file patents in the biomedical arena, reflecting an ambivalence about limiting access to health research and discoveries. 7 This ambivalence faded during the 1970s, and the Bayh–Dole Act of 1980 both removed bureaucratic obstacles to patenting publicly funded research and gave congressional endorsement to the notion that academic patenting and licensing facilitated commercialization of university discoveries. The logic of the Bayh–Dole Act was that, without patents on academic discoveries—often “embryonic” in form and requiring additional development, including clinical trials—firms would lack incentives to develop them to the point where they were commercially useful. Under this theory, patents on academic research—which are then licensed to firms that develop and market the academic technologies—would promote “technology transfer.” 8 In the decades following Bayh–Dole, academic patenting and licensing grew dramatically, with the bulk of this growth concentrated in the biomedical arena. 9 Academic institutions collect income on licensed patents, including sales-based royalties on products commercialized based on their patents. In the most recent year for which data are available, academic licensing income exceeded 1 billion US dollars. 10 These activities have been surrounded by controversies, including debate about whether academic patents in fact are necessary for new product development; whether the presence of patent incentives distorts academic research agendas away from “basic” and toward “applied” research; whether they create conflict of interest in clinical research; and whether academic patents on “research tools” can hinder the progress of scientific research. 11 , 12 The proposals just noted attempt to harness an unintended benefit from academic patenting of biomedical discoveries. By giving universities ownership rights over upstream discoveries, academic patents can give universities the power to compel licensees to not enforce these patents, or any follow-on patents, in developing countries, thus helping to promote access. This movement began in 2001, when, in response to demands from student and health activists, Yale University, the owner of the key patent on an important HIV treatment (stavudine), pressured Bristol-Myers Squibb, the licensee of this patent, to agree not to enforce the patent in South Africa. 13 This intervention reportedly led to a 30-fold reduction in the drug's price and a dramatic expansion of HIV treatment programs in South Africa. 14 These developments were catalysts for the formation of Universities Allied for Essential Medicines, the campus chapters of which aim to persuade their parent universities to develop patent licensing policies that limit the ability of licensees to enforce academic patents (or related patents held by firms) in developing countries. These proposed licensing terms are generally modeled on the equitable access license developed by legal scholars. 15 The movement also led to the introduction of legislation in the US Senate: S. 4040, The Public Research in the Public Interest Act, sponsored by Senator Patrick Leahy (D, VT), which requires that, as a condition for receipt of federal funds, universities include in their licensing agreements clauses limiting the licensees' abilities to enforce academic patents—and the licensees' own patents on drugs with academic patents—against developing-country generic producers. Similar proposals have been endorsed by a range of international bodies, including the Association of American Medical Colleges, the World Health Organization, and the American Association of Arts and Sciences. 16 Although this movement is intensifying, there is little empirical information on how large an impact such a strategy would have. Is the Yale case unique, or do academic institutions have ownership rights in a large number of drugs, making this strategy more generally feasible? In addition to citing specific cases in which universities owned key patents, the proposals discussed above are motivated by research showing that academic institutions play an important role in pharmaceutical innovation, drawing on bibliometric data, 17 case studies, 18 , 19 and survey evidence. 20 However, this previous research on the academic role in pharmaceutical innovation does not explicitly examine the extent to which academic institutions hold patents on the drugs, which is the relevant consideration for proposals to use university ownership of patents to attempt to affect prices and access. Academic research can affect industrial innovation through a range of channels: firms benefit from knowledge obtained through published academic articles and conference presentations, through collaborations with academic scientists, and through hiring trained graduate students. These channels of knowledge and technology transfer are generally not accompanied by patents held by universities. Accordingly, even if universities did significantly contribute to pharmaceutical innovation through these channels, because there are no patents, academic institutions can have little control over the pricing or dissemination of resulting drugs. That is, the broad research on the academic influence on drug development is not directly relevant for considerations of whether universities can help affect access; the salient consideration is whether universities hold patents on their contributions. For proposals to use university ownership of drug patents to affect drug prices (and access) in developing countries to be feasible, two things would need to be true for such proposals to be reasonable. First, universities would have to own patents on a substantial number of drugs, and second, universities or firms licensing university technologies would have to currently be filing patents in developing countries. If the first statement were false, the proposed interventions would have little effect. If the second were false, the interventions would not be needed. I provide data on these issues.
