Genes: Produced in Nature, Monopolized Through Patents

Vol. 43 No. 1

By

Lovely Carter received her LLM in international and business law in 2010 and is an attorney specializing in employment immigration issues.

Advancements in cancer screening gained worldwide attention this year when actress Angelina Jolie announced she had had a double mastectomy after undergoing BRCA1 and BRCA2 genetic testing. The test results indicated she had an extremely high risk of developing breast cancer and ovarian cancer. Patients with BRCA1 and BRCA2 mutations face up to an 85 percent cumulative risk of breast cancer, as well as up to a 50 percent cumulative risk of ovarian cancer. Association for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013). The existence of BRCA1 and BRCA2 mutations is, therefore, an important consideration in the provision of clinical care for cancer. Upon learning the results of the test for these mutations, any patient will not only understand more about risks for hereditary breast and ovarian cancer, but, like Angelina Jolie, the patient will also be able make more informed medical decisions when considering prevention and treatment options.

Soon after the BRCA1 and BRCA2 genes gained worldwide attention in the media, the U.S. Supreme Court issued its decision in Myriad and invalidated the company’s patents on the BRCA1 and BRCA2 genes, which it obtained after it discovered the precise location and sequence of the genes. The respondents in this case included both Myriad Genetics and the Trustees of the University of Utah. The plaintiffs were the Association for Molecular Pathology; the University of Pennsylvania; researchers at Columbia, NYU, Emory, and Yale; several patient advocacy groups; and several individual patients. The plaintiffs challenged Myriad’s patents covering the BRCA1 and BRCA2 genes, isolated DNA sequences, methods to diagnose propensity to cancer by looking for mutated DNA sequences, and methods to identify drugs using isolated DNA sequences. The plaintiffs argued that the patents on the genes restricted research for clinicians and limited scientific progress. They further argued that, from a patient’s perspective, Myriad’s use of the patents not only made it impossible to obtain a second opinion on a patient’s genetic predisposition to breast and ovarian cancer, but also kept the cost of BRCA1 and BRCA2 testing high by preventing competition.

In Myriad, the Court addressed the issue of whether “products of nature” can be treated the same as “human-made” inventions, thereby allowing them to be held as the exclusive intellectual property of individuals and companies. Id. at 2116. The plaintiffs argued in part that, although Myriad discovered the location of the genes, the location and order of the nucleotides existed in nature before Myriad found them and that Myriad did not create or alter any of the genetic information encoded in the BRCA1 and BRCA2 genes. The Court held that a naturally occurring DNA segment such as BRCA1 and BRCA2 is a product of nature and not patent eligible merely because it has been isolated.

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