Stanford BioLaw Tackles Property in a Biotech Era

Stanford BioLaw’s first two events of the year proved a rousing success. In the first event, Dr. David Magnus, new co-director of the Stanford University Center for Biomedical Ethics, provided a detailed and immensely useful presentation on the problems that the biotech age poses to some of our most deeply ingrained ideas about property. The second event featured Dr. Amir Attaran, an associate fellow at Royal Institute of International Affairs in London, who discussed the effects of the current intellectual property regime on efforts to combat the AIDS epidemic in Africa.

Dr. David Magnus—“Property in an Age of Biotechnology”

Delving into situations in which the U.S. patent system has inadequately accounted for the wide range of actors and motives involved in the advancement of biotechnology, Dr. Magnus brought some needed complexity to a conversation that many try to paint in reductive terms. He illustrated for a rapt audience the difficulties that arise when we consider the negotiation of the conditions of medical and genetic development as an overly simplified clash between profit-seeking corporations and altruistic individual donors (often represented by patient advocacy groups). At the same time, he gamely pointed out the ways in which the current patent system does indeed favor those whose interest in biotechnology is primarily commercial—for instance, those who seek the licensing of new diagnostic tests. Dr. Magnus pleaded for a reformed system that would recognize the many and complex interests of the individuals who contribute raw materials (literally, blood and plasma) to the development of such tests.

Putting current questions about gene patenting into historical context, Dr. Magnus began his talk by categorizing the various objections and defenses that people over the years have made to the patent system.

One common objection is that the patenting of organisms and their genes represents the commodification of life. Along similar lines, many suggest that it is improper to place a product of nature under artificial scientific control. Still others worry that the patenting of cell lines and tissue impinges upon our common human heritage. Dr. Magnus described these sorts of objections as ‘metaphysical’ in character. He contrasted them with objections of ‘justice’ that suggest that the patenting of organisms will end up being systematically unfair to less developed countries, which may lose control of their natural resources, or to biomedical researchers, who will face new and possibly crippling royalty costs as a result of too many upstream patents.

Swamped with applications for new patents, the U.S. Patent and Trademark Office has decided to allow almost everything to be patentable, according to Magnus. Rather than adjudicating each particular claim, that is, the PTO tends to automatically grant patents to those companies and researchers that seek them. It thus becomes the duty of the courts—and not the PTO itself—to determine if certain patents are unfair or invalid. Consequently, a researcher adversely affected by a patent claim must summon steep court costs and reams of intricate written evidence if she wishes to challenge the claim. In the past, this state of affairs has blocked less developed countries from contesting patent claims that they viewed as environmentally or economically destructive. These days, the PTO’s position on patents also means that genetic researchers—faced with increasing royalty costs and diminished control over patented gene sequences—will find themselves in a similar situation.

After contextualizing the most common objections to organism patenting, Dr. Magnus proceeded to discuss the specific legal problems that arise from the patenting of genes. He pointed out that scientists traditionally patent a gene for its use as a therapeutic agent, just as they patent a protein or any other molecule. But since genes have informational properties and not just structural properties, it becomes possible for a researcher to take out a second kind of “disease gene” patent on the particular association that she uncovers between an allele and a phenotype. Certain allele-phenotype associa-tions, either by themselves or in conjunction with a number of other testable associations, will have an immensely valuable use for the diagnosis of diseases within particular communities.

If we are to conclude that each association between an allele and a phenotype is patentable, as many have done, then the likely business model arising from this conclusion will be to require doctors and researchers to include royalties for all relevant patents when they order a given diagnostic test. Dr. Magnus describes this situation as the “clinician’s dilemma”: the more we learn about genetics, the less we will be able to use what we have learned, as testing becomes prohibitive-ly expensive and the number of “upstream” obstacles to research grows exponentially.

Pointing to a forthcoming clash between patient advocacy groups and commercial interests, Dr. Magnus reiterated the point that there are multiple actors (all acting with multiple motives) involved in the development of new medical technologies. Our current IP system, however, recognizes only a narrow range of contributions to these technologies, and reduces individuals to one of two character types: the profit-seeker or the altruist. Dr. Magnus argued that the U.S. patent system was built for a brick-and-mortar world containing only a limited number of actors and motives. He built a convincing case for the need to design reformations to this system that will enable it to fully and fairly account for what can be done with the informational properties of a gene.

Dr. Amir Attaran—“IP and the AIDS Epidemic”

Dr. Attaran’s talk began with compelling data regarding the spread of AIDS in Africa. He predicted that in less than two years AIDS would surpass the bubonic plague as the worst epidemic humanity has ever faced. Against this dire backdrop, Dr. Attaran explored how politics and law are preventing essential treatments from reaching afflicted Africans. Dr. Attaran presented data from his research, reaching the counterintuitive conclusion that the presence or absence of a patent system in a country has very little effect on whether the citizens of that country will have access to medicines. Poverty and lack of infrastructure, Dr. Attaran argued, are much better indicators of whether life-saving treatments will reach those suffering the devastating effects of HIV.

Dr. Attaran then discussed previous attempts to remedy this lack of access to essential medicines, most notably the compulsory licensing regimes introduced by the Doha Declaration, a declaration of governments’ rights to take steps to safeguard public health by providing access to affordable medicine regardless of the exclusivity imposed by patent restrictions on those medicines. Calling Doha “essentially useless,” Dr. Attaran reasoned that because compulsory licenses only work for patented medicines, they have little effect in countries where few if any of the essential medicines are under patent. Dr. Attaran noted that since 1995 not a single country has issued a compulsory license for a medicine.

Dr. Attaran concluded his talk by focusing on two areas, distinct from intellectual property, where he felt efforts should be focused: funding and “capacitation.” Regarding funding, Dr. Attaran lamented that, of all developed nations, the United States offers the smallest percentage of its GNP as foreign aid. Given that sub-Saharan African nations often spend less than $12 a year on the medical needs of their citizens, Dr. Attaran stated that foreign aid is critical.

“Capacitation,” which means the building and maintenance of infrastructure and expertise needed to deliver treatments, is an equally pressing need according to Dr. Attaran. Using Botswana as an example, Dr. Attaran stressed how even with money available (Botswana is relatively wealthy due to natural resources), “bureaucratic impotence” can prevent the building of hospitals and clinics. Dr. Attaran stressed that there is a need for administrative lawyers in these regions who could help streamline the process of developing the capacity to deliver treatments.

These two events illustrated how progress in medicine and biology must be accompanied by development in legal and political doctrines, both at home and abroad, if the full benefit of that progress is to be realized. The high stakes and moral quandaries surrounding property in a biotechnology era promise to provide lawyers and scientists alike with challenges for years to come. Stanford BioLaw looks forward to providing a continuing forum to discuss those challenges.