Global Health and University Patents

Abstract

U niversities have long been important in the development of life-saving medicines and technologies, and they once considered patenting to be antithetical to academic science and public health. Now a fierce debate rages about whether and when patents promote innovation, but in practice, the patenting worm has turned: Seeking revenues and ways to commercialize their inventions, U.S. universities are taking out patents in unprecedented numbers. In 2001, they were granted more than 3000 of them. But patents bring more than revenues. They also bring controversy, when they ensure power over commodities that are the very currency of life itself. Today, universities hold important patents on many life-saving drugs, including the antiretroviral drugs stavudine (Yale University), abacavir (University of Minnesota), lamivudine (Emory University), and enfuvirtide (Duke University). As the AIDS pandemic has demonstrated, patents and exclusive licenses typically drive prices up and thereby impede access to lifesaving medications. Low prices alone cannot solve the global crisis in access to medicines, but they are necessary, particularly for those in lowand middle-income (LMI) countries, where governments have limited resources and people often pay for part or all of their health care. We have seen firsthand the effects of university patenting and licensing decisions. In February 2001, Doctors Without Borders sought Yale's permission to use a generic version of stavudine in South Africa. This prompted global attention and intense discussions between the university and Bristol-Myers Squibb (to whom it had exclusively licensed the drug). The result was the first patent concession on an AIDS drug and a 30-fold reduction in the price of the patented drug in South Africa. This action was taken without negative consequences to the university, financial or otherwise. Recently, a local company began selling generic stavudine in South Africa at up to 40% less than the reduced patented price. A group of experts recently convened at Yale concluded that universities can improve and save lives by working collectively to adopt access-friendly intellectual property (IP) policies (see Access to Essential Medicines and University Research: Building Best Practices at http://cira.med.yale.edu). This will require developing specific licensing and patenting strategies that are applicable to LMI countries. Such strategies must be tailored to the technology and partner, but broadly speaking, they fall into two categories. First, universities could not patent their discoveries in LMI countries. This will promote generic competition as long as all the IP necessary to produce a generic version of a product stays in the public domain and no patent barriers exist in important source countries for generics (such as Brazil, India, and Thailand). Today, universities rarely patent in most developing countries because of the expense, but some will do so if a licensee requests it or if there is a market or potential generic competitor in the country. If univer...

Are Patents Impeding Medical Care and Innovation?

“…The initiative finances R&D up front and offers the outcome of its research on a nonexclusive basis to generic producers, allowing for technology transfer and competition among multiple producers [51]. Furthermore, universities currently hold important patents on many life-saving drugs, including the antiretroviral drugs stavudine (Yale University), abacavir (University of Minnesota), lamivudine (Emory University), and enfuvirtide (Duke University) [52]. In recognition of these university patents, Universities Allied for Essential Medicines (http://www.essentialmedicine.org) proposes that “when a university licenses a promising new drug candidate to a pharmaceutical company, it should require that the company allow the drug to be made available in poor countries at the lowest possible cost” [53].…”

Patenting the sun: Enclosing the scientific commons and transforming the university—ethical concerns

“…First, the knowledge is restricted and may be unaffordable. Second, the tools and technologies necessary to use and exploit such knowledge are unavailable, or less available and typically far more expensive, hence the poor world falls further behind in the knowledge-based economy [Burton and Strauss, 2000;Kapczynski et al, 2003;Phillips et al, 2004;Wagner and Lee, 2004]; this situation is exacerbated by the TRIPS agreement (and other instruments of the rich world including the IMF and the WTO). This issue has been recognized by the Commission on Intellectual Property Rights that advocated policies that were far more responsive and sensitive to the needs of the poor world [CIPR, 2002;Triggle, 2003].…”

The Silent Epidemic of Exclusive University Licensing Policies on Compounds for Neglected Diseases and Beyond

“…In 2001, Yale University and Bristol-Myers Squibb agreed to that situation for its widely used HIV drug stavudine (d4T, Zerit), triggering a 96% price reduction of the drug in South Africa. Simply by permitting the manufacture and sale of generic stavudine in South Africa, market forces drove down the price of the small molecule [5]. Importantly, Yale's action came at no cost to the university in terms of licensing revenues.…”