May 22, 2022

Volume XII, Number 142

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May 20, 2022

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May 19, 2022

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Supreme Court Issues Split Decision on Myriad Genetics' DNA Claims

On June 13, 2013, the Supreme Court affirmed in part and reversed in part the Federal Circuit decision in Association for Molecular Pathology v. Myriad Genetics, Inc. The Court held that isolated DNA is not patent eligible under Section 101, but cDNA, which is not a product of nature, is. The majority dismissed the argument that cDNA is dictated by nature but did note a possible exception to patent eligibility of cDNA where "very short series [sic] of DNA may have no intervening introns to remove when creating cDNA."

The majority also emphasized the narrow holding of the decision. It specifically noted that the claims-at-issue were not method claims. Had Myriad claimed an innovative method of manipulating genes or new applications of knowledge of the genes, or had Myriad claimed DNA with an alteration of the naturally occurring nucleotides, such claims might have been patent eligible.

Justice Scalia concurred in the judgment, and wrote a short concurrence basing his opinion on the understanding that isolated DNA is identical to DNA in its natural state and cDNA is a synthetic creation not normally present in nature. He stated mysteriously, "I am unable to affirm those [molecular biology] details on my own knowledge or even my own belief."

This decision does not have a strong effect for a large portion of the biotech community. Many companies that have therapeutic products do not necessarily use isolated sequences, but many of the companies that do use isolated nucleic acid sequences, do not want these sequences patentable. Myriad, because it is a diagnostics company, will be affected more than a biotech company which makes actual drugs. Although the Court held that natural isolated DNA is not patentable but synthetic DNA is patentable, it is still an important decision philosophically as to the patentability of naturally-occurring molecules. It is interesting to see how the court views this issue, specifically how it draws the line between cDNA and isolated DNA. The practical results of the decision are that (1) companies like Myriad marketing genetic diagnostics will seek other approaches to maintain exclusivity of their diagnostics and (2) the $3000 BRCA test (a test for genetic susceptibility for breast cancer) will likely be much less expensive.

© 2022 ArentFox Schiff LLPNational Law Review, Volume III, Number 171
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Schiff Hardin offers substantial experience and strength in handling intellectual property litigation, among other major areas of the law. More than 50 Schiff Hardin attorneys practice in the field of intellectual property law, in offices across the country. We provide a broad range of litigation, counseling, and transactional services involving patents, trademarks, trade dress, trade secrets, copyrights, franchising, licensing and electronic commerce of all types.

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