Responsibilities come with rights while handling patents

L By Daniela Morales and Greta Bauer

last year there was a push from students at the University to pressure the administration to address the ethical dilemmas produced by its contractual relationship to the pharmaceutical giant GlaxoSmithKline. The University holds three patents on the AIDS drug abacavir that are licensed to Glaxo under an exclusive contract. Though Glaxo has reduced the price at which it offers its AIDS drugs to developing countries, it maintains a patent-based monopoly that does not allow for generic competition. Its drugs are still priced out of reach of the majority of HIV-infected people in the world. This issue drew a lot of support from faculty, students and the community. However, our administration failed to proactively address the situation with regard to abacavir or future essential medicines produced through University-based research.

The roots of this issue go back more than 20 years. The federal Bayh-Dole Act, also known at the Government Patent Policy Act of 1980, allowed universities to hold patents for inventions they produced through federally funded research. In addition, universities were given the right to exclusively license those patents to commercial companies. Previously, the federal government held all such patents and allowed nonexclusive licensing for product development. At the time Bayh-Dole was passed, legislative debate centered on the ethical implications of exclusive licensure. Nevertheless, the act was allowed to go forward because the benefits of promoting product development were perceived to outweigh the ethical risks.

While the changes enacted have undoubtedly increased commercial development of viable inventions, serious ethical problems have arisen where those products are essential medicines. Patents grant a legal, temporary monopoly within each country where they are held. In strong markets this provides an incentive for product development, as profitability is nearly guaranteed. In weak markets, products are rarel actively marketed although the patent may be enforced to prevent generic competition or even to prevent the reimportation of drugs to wealthier countries where they may undermine established markets. Pharmaceutical companies claim a major financial loss at lowering the cost, or even letting go of the patent, in developing countries. This statement does not hold much validity, since there was not much of a market to begin with.

Ethically, life-saving medications are in a different category than non-life-saving products. If the patented Ronco salad shooter is not made available worldwide, the implications are nil; if patented life-saving, anti-HIV medications are not made available in countries where up to 30 percent of the population is HIV-infected, the implications can be measured in millions of dead or orphaned children. This distinction should be reflected within patent policy. Here is where the University can make a difference. Like most research universities, our technology transfer office has seen rapid growth since the Bayh-Dole Act was passed. Our intellectual property policy is a relatively new one. Undoubtedly, our university perceived the licensing of the abacavir patents to Glaxo as a good thing; we were bringing more potential solutions to a severe health crisis. Unfortunately, there were unforeseen secondary consequences to the exclusivity of that license.

One possible solution is the incorporation of an ethics clause within our intellectual property policy. For example, a clause specific to essential medicines could be included that would require corporations to whom we grant patent licenses to meet some measurable level of product delivery within countries that are experiencing a high rate of a disease. If they fail to meet this requirement within a specified time, the patent would become unenforceable within that country. The logic is simple: With rights come responsibilities.

Such a policy change is feasible. Universities outside of our own are attempting to grapple with similar issues. Columbia University has a policy allowing a faculty inventor to stop or modify the licensing of their invention based on ethical considerations. Yale University has attempted to get out of a similar but well-publicized conflict surrounding its AIDS drug d4T by monetizing, or selling off, its patent rights. Pharmaceutical companies should not be averse to such contractual language; it would allow them to assume an ethical posture. Even the royalties generated for the University by such patents would not be significantly reduced; by definition, an undeveloped market is not one that is generating much revenue.

Beyond being feasible, such a policy change would be timely. Given current moves to hold corporations accountable for unethical moves designed to maximize profitability, it seems only reasonable that maximizing profitability in a way that costs lives could be addressed. In addition, a current lawsuit between AIDS Healthcare Foundation, the largest U.S. provider of HIV-related health care services, and GlaxoSmithKline over the pricing of several AIDS drugs including abacavir may have the potential to nullify the University’s contract with Glaxo. Whether in a possible renegotiation with Glaxo or in the negotiation of future patent licenses, the University must address the ethical issues relevant to patents involving essential medicines.

Daniela Morales is a senior majoring in global studies. Greta Bauer is a doctoral candidate in epidemiology. Send letters to the editor to [email protected]