October 20, 2021

Volume XI, Number 293

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Is an Isolated DNA Patentable?

Is DNA patentable? Are isolated genes representative of what the Supreme Court characterizes as patent-ineligible “products of nature”? In a much anticipated decision, the Federal Circuit recently reversed a District Court’s decision that Myriad Genetics’ composition claims to “isolated DNA” are unpatentable under 35 USC § 101.

The disputed patent claims were directed to DNA compositions associated with breast cancer and methods for using these isolated DNAs for diagnosing breast cancer and screening for potential cancer therapeutics targeting breast cancer. More than 20 plaintiffs, including researchers, professional societies, and women affected by cancer brought the lawsuit against Myriad Genetics and the United States Patent & Trademark Office. Myriad Genetics, which owns the patents, carries out commercial testing for mutations in the breast cancer susceptibility genes, BRCA1 and BRCA2. Much of the controversy and debate centered on whether gene patents incite or hinder innovation. Many believe that they drive up costs and squelch competition.

In a 2-1 ruling reflecting the controversy surrounding the validity of gene patents, Judges Lourie and Moore agreed that isolated DNAs are patentable, “human-made inventions” exhibiting “markedly different characteristics” from what is found in nature. Writing for the majority, Judge Lourie held that “isolated DNAs, not just cDNAs have a markedly different chemical structure compared to native DNAs” and constitute a “distinct chemical entity” distinguished from their corresponding DNAs in nature by cleavage from native DNAs through removal of covalent bonds. Judge Moore agreed that the DNAs in question are not products of nature, but emphasized that such products are not automatically patentable subject matter per se, except in this case they are, since “the isolated DNA sequences have markedly different properties which are directly responsible for their new and significant utility.” In his dissenting opinion, Judge Bryson agreed that cDNAs are patent eligible, but held that the disputed intron-containing DNAs are patent-ineligible because they fail the Supreme Court’s Chakrabarty standard insofar as the genetic coding material is the same, structurally and functionally, in both the native gene and the isolated form of the gene. Judge Bryson further opined that “a contrary ruling is likely to have substantial adverse effects on research and treatment in this important field.”

The Court further affirmed the District Court’s decision that Myriad’s method claims for “analyzing” or “comparing” gene sequences were invalid, since “they claim only abstract mental processes (e.g., ‘…wherein a difference in sequence indicates an alteration in sequence.’)” and reversed the District Court’s decision that Myriad’s cancer therapeutic screening claims were invalid, since the claims do not merely recite abstract method steps, but rather “transformative steps…present[ing] ‘functional and palpable applications’ in the field of biotechnology.”

The decision was reassuring to many in the biotech industry whose 40,000+ DNA-related patents and 2,645 patents claiming “isolated DNA” issued over the past 29 years could have been rendered invalid. Nevertheless, the decision is unlikely to end the debate, given the strong sentiments surrounding the case and the unresolved issues under 35 USC §101 that remain open to debate. It is likely that requests for en banc rehearing or petitions to the Supreme Court will follow.

Copyright © 2021, Hunton Andrews Kurth LLP. All Rights Reserved.National Law Review, Volume I, Number 300
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About this Author

Ping Wang, M.D., Intellectual Property Attorney, Andrews Kurth, Law firm
Partner

Dr. Wang’s practice focuses on all aspects of intellectual property law, including patent prosecution, patent interference and patent litigation. Dr. Wang has drafted, filed and prosecuted several thousand patent applications in the fields of pharmaceuticals, biotechnology, chemical/organic chemistry and medical devices.

She is also experienced in counseling clients on issues of patentability, noninfringement, freedom-to-operate, validity and design around. Dr. Wang has extensive experience in due diligence work in connection with mergers and acquisitions in the biotechnology...

202-662-3042
Peter Brunovskis, Ph.D., Patent Agent, Andrews Kurth Law firm
Patent Agent

Peter has over 13 years experience in patent law together with 14 years molecular biology research experience. He has prepared and prosecuted U.S. and foreign patent applications in a variety of fields including biotechnology (e.g., therapeutics, diagnostics, genomics, vaccines, nucleic acid and protein compositions, liposomal formulations, plant sciences, animal testing systems); medical devices (e.g., closure devices, drug-eluting devices, catheters, stents, guidewires, graft materials); chemical compositions; personal care and hygiene products; anti-aging and cosmetic compositions;...

202-662-2782
Michael Xuehai Ye Ph.D., Intellectual Property Attorney, Andrews Kurth, Law Firm
Partner

Michael’s practice area is intellectual property, especially in the fields of biotechnology, chemistry, bioinformatics, pharmaceuticals and medical devices. He works directly with inventors and in-house counsel to draft and prosecute patent applications and engages in the preparation of patentability, validity and related opinions. He handles product clearance searches, product evaluations, inventorship analysis, non-disclosure agreements and licensing agreements. Michael also performs due diligence in connection with mergers and acquisitions in the biotechnology and pharmaceutical...

202-662-3008
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