On March 27, 2014, speakers from McCarter & English, LLP, the Gallatin School of New York University (NYU), and the Biotechnology Industry Organization (BIO) addressed the social, legal, and fiscal implications of gene patenting during a panel discussion at the German Center for Research and Innovation in New York. This topic has been highly debated as the arguments surrounding patenting and intellectual property in the health sciences are both nuanced and complex.
One of the most fervent arguments against the patentability of genes stems from the notion that facts and products of nature are not patentable and a private company should not own or control information about human bodies. When the U.S. Supreme Court heard a case in 2013 that challenged the validity of gene patents in the U.S., several attempts were made to define where natural processes end and human ingenuity begins.
Moderator Maneesh Gulati, Partner of the Intellectual Property/Information Technology Group at McCarter & English, LLP, kicked off the evening by citing where in the U.S. Constitution the legal foundations for the patent system are located, making clear that no indication actually exists about what exactly is patentable or how this information can be applied to the general debate on gene patenting. Gulati also illustrated how important patentable subject matter has become in the life sciences over the past three years. “It’s a new beast now,” he said, noting the “significant degree of confusion” that has arisen since the AMP vs. Myriad Genetics case.
Prof. Myles W. Jackson, Dibner Family Professor of the History and Philosophy of Science and Technology at the Polytechnic Institute of New York University (NYU) and Professor of the History of Science and Technology at the Gallatin School of NYU, recounted the establishment of the “product of nature” doctrine, explaining how it led up to the Myriad case. He described the early stages of U.S. patent law and how by the beginning of the 20th century isolated natural substances were considered patent eligible if the substance was rendered more useful than its natural homolog. Prof. Jackson then provided a historical overview of Germany’s leading role in pharmaceutical production during the turn of the 20th century. His talk described how the “product of nature” doctrine developed in the U.S. over the decades that followed and also explained the most important case that led to Myriad: Funk Brothers Seed Co. vs. Kalo Inoculant Co. Prof. Jackson then took a closer look at the 2013 AMP vs. Myriad Genetics case, describing his own involvement while at the American Civil Liberties Union (ACLU). This case was groundbreaking as it was the first time a U.S. court declared a gene patent invalid. With this in mind, Prof. Jackson considers the Court’s ruling against patenting natural products not as a categorical statement against patents, but rather as a decision with limitations. Prof. Jackson concluded his presentation by examining European patent law with regards to gene patenting. In terms of sequence homology in particular, Germany has stricter requirements for patentability, according to Prof. Jackson. Nonetheless, TRIPS, an international agreement administered by the World Trade Organization (WTO) that establishes minimum standards for IP regulation, attempts “to harmonize all branches of law among the major patent offices” (EPO, JPO, USPTO).
Dr. Hans Sauer, Deputy General Counsel for Intellectual Property for the Biotechnology Industry Organization (BIO), continued the discussion by introducing the versatile work of BIO, the world’s largest trade association representing biotechnology companies, academic institutions, state biotechnology centers, and related organizations. After citing the implications of the Myriad case, Dr. Sauer then examined patent claims as well as the complexity and importance of patents. He also discussed the misperceptions about what patents cover, stressing that the claim in this case was an isolated preparation of the DNA molecule, which coded for the BRCA1 protein. As Dr. Sauer explained, “patents were never permitted to claim things that are in our bodies – those are ours alone.” He then outlined the impact on the biotechnology industry following the Supreme Court’s decision, which ruled “genes are not patentable” and made at least 8,700 pre-existing U.S. patents invalid. About 60% of these patents were owned by industrial microbiology, bioenergy, and agricultural, food, and beverage manufacturing companies; diagnostic companies were not generally involved. He then raised the question about how other compounds purified from nature, such as anticancer compounds or antibiotics, could still be isolated in the future if DNA is no longer considered patentable. Likewise, Dr. Sauer talked about the fear of commercial competitors no longer entering the market as a result of the Court’s ruling.
A lively discussion with the audience then ensued about the importance of patents in science, how patents in Europe compare to those in the U.S., and the economic and philosophical motivation behind patent law as a “contribution to public knowledge.”