The Future of Gene Patents
by Angela M. Buchanan
In 1980, the Supreme Court broadened the availability of gene patents in Diamond v. Chakrabarty, 447 U.S. 303 (1980). Since that time, gene patenting has grown so that in 2005 it was estimated that 20 percent of the human genome was protected by patents. Stefan Lovgren, One-Fifth of Human Genes Have Been Patented, Study Reveals, Nat’l Geographic News, Oct. 13, 2005, http://news.nationalgeographic.com/news/2005/10/1013_051013_gene_patent.....
Recently, Judge Sweet in Association for Molecular Pathology v. United States PTO, 2010 702 F.Supp.2d 181 (S.D.N.Y. 2010) (Myriad), ruled on the limitations of gene patents when he held that patents for isolated gene sequences were invalid under Chakrabarty because they were naturally occurring. Currently, there are thousands of other Myriad-type gene patents that would be invalidated under Judge Sweet’s holding. Though that judgment is on appeal, opponents of gene patents seek to capitalize on Myriad, while patent holders rush to protect their rights. Myriad provides fodder to the longstanding debate regarding the morality of patenting genes as many are left to question where the future of gene patents lie.
Gene patents are a hotbed for moral debate. Gene patents both promote the progress of medical science, as well as restrict access to health technologies. The restricted access to medicines, diagnostic tests and other innovations is detrimental to human well-being and disproportionately impacts America’s poor. However, without patents, many argue that medical innovation would slow due to lack of economic incentive.
Much of the animosity towards gene patents originates from the impact that the patents have on access to medicines and medical tests. Patents elevate prices because they restrict competition by giving patent holders exclusive rights to use patented material. History illustrates that patents adversely affect the affordability and access to health technologies.
For example, in 2005, the average worldwide price for anti-retroviral combination therapies (ARVs) that treat HIV/AIDS cost was about $10,000 per patient. However, when critical patents for those therapies expired, the cost decreased to $168 per patient. Amy Kapczynski et al., Addressing Global Health Inequities: An Open Licensing Approach for University Innovations, 20 Berkeley Tech. L.J. 1031, 1033 (2005).
The expiration of ARV patents provided access to vital medicines for those who had great need but limited resources to acquire them. The access to generic drugs caused by the expiration of the ARV patents saved lives. Before the patents expired, nearly 8,000 people died of AIDS in developing nations every day. Ellen F.M. ‘t Hoen, The Responsibility of Research Universities to Promote Access to Essential Medicines, 3 Yale J. Health Pol’y L. & Ethics 293, 294 (2003). Opponents of gene patenting feel that prices should be manageable for medicines, especially when the medicines are essential for survival.
Proponents of gene patents focus on scientific and medical progress and postulate that progress would languish without the economic incentive that patents offer through exclusivity rights. See e.g., F. Scott Kieff, Property Rights and Property Rules for Commercializing Inventions, 85 Minn. L. Rev. 697, 703 (2001). Patents give time-constrained exclusive rights to inventors of new and useful creations. U.S. Const. art. I § 8, cl. 8. Proponents argue that without these exclusive rights two things would happen: a reduction in invention and an increase in privacy for inventions. This is because development of gene technology is expensive and time consuming.
Development costs are exceptionally expensive in the biopharmaceutical field where it is estimated that the cost of developing a new FDA-approved drug is $802 million dollars. See Joseph A. DiMasi et. al., The Price of Innovation: New Estimates of Drug Development Costs, 22 J. Health Econ. 151, 166 (2003).
Without patents, many inventors and researchers would have to rely on trade secret law if they wanted to make a profit from their labors. This, proponents argue, would limit access to knowledge, further reducing progress. Patents allow for economic rewards and the sharing of knowledge.
This economic theory champions consequentialism, the idea that the ends justify the means. Expansive gene patentability may limit access and cost lives, but without them, the technologies might not have been invented in the first place. Opponents champion the deontological argument that moral means are necessary for a just result and the death of thousands for hastened progress is unacceptable.
This debate is not likely to end in the foreseeable future, and human life will continue to be the benefactor and victim of both sides of this debate. As the courts debate the law and scope of gene patentability, society debates the morality of gene patents.
Angela M. Buchanan, an associate at Greenberg Traurig, LLP, handles complex commercial litigation. She can be reached at firstname.lastname@example.org.