Lawsuit charges that these patents are unconstitutional and restrict healthcare options as well as research.

The long-standing debate over patenting genes is back in the limelight. The American Civil Liberties Union (ACLU) has filed a case charging that patents on BRCA1 and BRCA2, genes associated with breast and ovarian cancer, are unconstitutional and invalid. Myriad Genetics currently holds the patents to these genes and provides a diagnostic test that reportedly costs over $3,000.

The controversy began when researchers and companies first started isolating genes. Patents have traditionally not been granted for products or laws of nature. Companies successfully argued, however, that the fact that they had isolated and purified the DNA made the gene patentable.

Besides calling into question the legality of patenting genes, the plaintiffs state that such a practice impedes everything from basic research to final utility in the clinic. Myriad Genetics’ stance will likely be that the patent promotes innovation by giving firms like them a temporary monopoly to make a return on their R&D investment.

William Warren partner at the law firm Sutherland agrees with this idea. He also notes that genetic patents certainly do not delay or limit research because there are safe-harbor protections against infringement cases being filed on products under research that require FDA approval.

ACLU and the others claim that these gene patents interfere with diagnostic testing, limit women’s healthcare options, stifle research, and restrict training of the next generation of genetics laboratory professionals.

The monopoly that Myriad Genetics now enjoys due to these patents reduces consumer choice and removes the competitive incentives regarding price, quality assurance, or improvement of the tests, states the American College of Medical Genetics (ACMG), one of the plaintiffs. 

They go on to note that it is a major hurdle to harvesting the vast potential of the sequencing of the human genome, which increasingly is making it possible to simultaneously study large collections of genes instead of individual genes one at a time.

“Gene patenting creates an obstacle course that will make true genomic analysis not only cost-prohibitive but impossible, given that no single laboratory will ever own the rights to offer comprehensive testing,” remarks Bruce R. Korf, M.D., Ph.D., president of ACMG.

The lawsuit, Association for Molecular Pathology, et al. v. United States Patent and Trademark Office, et al., was filed in the United States District Court for the Southern District of New York in Manhattan against the PTO, Myriad Genetics, and the University of Utah Research Foundation, which hold the patents on the BRCA genes. The plaintiffs include Breast Cancer Action, The American College of Medical Genetics, the Association for Molecular Pathology, the College of American Pathologists, the American Society for Clinical Pathology, individual researchers, patient advocacy groups, genetic counselors, and individual women.

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