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The debate about the patentability of human genes is being reopened. On February 2, 2010, the United States District Court for the Southern District of New York heard arguments on summary judgment motions in Association for Molecular Pathology, et al. v. U.S. Patent and Trademark Office, et. al., a case challenging the patentability of human gene sequences and methods using those sequences.
At issue is a family of patents related to BRCA1 and BRCA2 genes. Arguments against the patents raised in a complaint filed by a group of plaintiffs that includes the American Civil Liberties Union (ACLU) assert that human genes and methods of looking at or comparing genes represent unpatentable subject matter because unmodified genes are "products of nature, laws of nature and/or natural phenomena, and abstract ideas or basic human knowledge or thought." In a more unusual constitutional challenge, the plaintiffs argued that genes represent information, that the comparison of gene sequences requires human thought and that, by issuing a patent, the U.S. government, through the U.S. Patent & Trademark Office, is impermissibly limiting thought and knowledge by giving control over that knowledge to a private entity.
Since the United States Supreme Court's decision in Diamond v. Chakrabarty, 447 U.S. 303 (1980), which established the patentability of genetic material where the claimed bacterium was genetically engineered by inventor Chakrabarty, the USPTO has issued thousands of patents covering isolated genetic sequences. The defendants in Association for Molecular Pathology, which include Myriad Genetics, Inc., co-assignee of the patents in suit and provider of diagnostic tests for detecting mutations in the BRCA1 and BRCA2 genes, emphasize in their arguments that, because the claims are directed to isolated nucleic acids, they do not cover a product of nature. In their Motion for Summary Judgment they also state that the diagnostic method claims "do not prevent anyone from thinking, speaking, or disseminating information," because "the diagnostic method claims cover physical laboratory testing."
Given that the district court opinion may not be rendered for several months and the possibility of subsequent appeals, this case may still have a long way to go before a final decision is reached on this issue. In the meantime, this question leaves some uncertainty regarding the future of patent protection for technologies and products that involve diagnostic tests and methods that are becoming increasingly important in the emerging field of personalized medicine. For patents applications that are filed in the interim, claims could be drafted to take into consideration the issues raised in Association for Molecular Pathology. But will this be enough?
Gene patents may be facing attacks on another front: namely, in the form of recommendations in the "Revised Draft Report on Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests," approved by the Secretary's Advisory Committee on Genetics, Health, and Society on February 5, 2010, and to be forwarded to the Secretary of Health and Human Services. Also, the decision in Bilski v. Kappos (No. 08-964), expected from the U.S. Supreme Court in the next few months, could change the way that diagnostic method claims are evaluated for patentability. One thing is certain: 2010 could be an important year for determining the fate of the gene patent.
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