Recently, the U.S. Supreme Court heard oral arguments in Association for Molecular Pathology v. Myriad Genetics, Case No. 11-725, on the eligibility of patenting the BRCA1 and BRCA2 genes, which identify hereditary breast and ovarian cancers. The Court granted certiorari to hear this case after a split developed among the United States circuit court of appeals in which some courts held that identifying a gene is novel and therefore subject to U.S. patent laws, while others held that identifying a gene is merely a “law of nature” and therefore cannot be patented. While we wait for the Court to finish deliberating, we must consider the implications of its decision.
Arguments on each side of the Myriad case center on protecting innovation. The U.S. patent system boasts a successful history of protecting large investments in research, which result in innovative products. In the case at hand, Myriad Genetics has invested almost two decades and hundreds of millions of dollars into its research. Supporters of Myriad and the right to patent genes more broadly argue that without these protections locked in place, a company has no incentive to invest in discovery.
Conversely, proponents of more open data sharing maintain that traditional intellectual property protections are outdated and will stifle future innovation. For instance, Harvard geneticist Heidi Rehm noted in response to the Myriad case, “having one company control the data for genes is contrary to the way medicine is developing.” According to this line of thought, the paradigm for drug discovery has changed. Scientific discovery supporting research for new therapies is premised on access to quantities of data too large for any single researcher, company or university to efficiently generate on its own. Today, the success of drug development is dependent upon “collaborating and sharing intellectual property at the very outset,” explained former FDA Commissioner Andrew von Eschenbach in a 2013 seminar at the Lahey Hospital and Medical Center on combination products. “No company… can ever get as big as it needs to be to do everything on this,” he observed.
This debate over whether the law should allow for institutions to patent genetic discoveries raises the more general policy question of what good a patent will do for its holder and for the public health in light of advances in technology and basic understanding of science, biology, and disease? If scientific achievement is now predicated on access to large amounts of data, do those invested in drug development, including the government, academia, and industry, need to retool an incentive system to support the knowledge sharing needed to progress?
Data sharing at various stages of scientific discovery is already well underway. In January 2013, the British Medical Journal pledged to only publish results of clinical trials where the sponsoring company or researcher agrees to provide detailed study data upon request. Beginning in 2014, the European Medicines Agency, pledged access to all complete clinical trial data sets submitted to outside investigators. Private companies like GlaxoSmithKline have made similar promises.
While intellectual property law does and will continue to play an important role in medical innovation and entrepreneurship, its application to each stage of development needs to adapt to the realities of modern science. If scientific advancement depends on access to large amounts of data, including access to identified genes, so do the profits on the therapies these discoveries will deliver down the line. “Do we have the right legal framework [in the U.S.] that allows for sharing of IP? I don’t know,” surmised von Eschenbach. “There’s going to be winners and losers here. Those countries that create the right legal systems to encourage that are going to be the winners. The game has begun.”
The views reflected in this expert column are those of the individual authors and do not necessarily represent those of the O’Neill Institute for National and Global Health Law or Georgetown University. This blog is solely informational in nature, and not intended as a substitute for competent legal advice from a licensed and retained attorney in your state or country.