Supreme Court rules naturally occurring DNA is patent ineligible

Managing IP is part of Legal Benchmarking Limited, 4 Bouverie Street, London, EC4Y 8AX

Copyright © Legal Benchmarking Limited and its affiliated companies 2025

Accessibility | Terms of Use | Privacy Policy | Modern Slavery Statement

Supreme Court rules naturally occurring DNA is patent ineligible

The Supreme Court delivered a mixed ruling in the Myriad case today, finding that some parts of the biotech company’s patents on genes linked to breast and ovarian cancer can be patented while others cannot

The court unanimously ruled that isolated and purified DNA was a product of nature and therefore not eligible for patent protection under Section 101. But it said that synthetically created complementary DNA (cDNA) can be patented because it is not a naturally occurring substance.

The case, Association for Molecular Pathology v Myriad Genetics, revolved around Myriad’s US patents covering the isolation and detection of the BRCA1 and BRCA2 genes, which can be used to screen for certain types of cancer. Testing, which could only be carried out by Myriad because of the patents, cost around $3,000.

The case sharply divided supporters and opponents of patents on human genetic material. Public interest organisations including the American Civil Liberties Union (ACLU) and the Public Patent Foundation filed amicus briefs in support of AMP, arguing that Myriad’s patents had caused “a proven chilling effect on research” into the genes.

Others, including Biotechnology Industry Organization (BIO) which filed an amicus brief in support of Myriad, argued that a ruling against the biotech company could disincentive investment in research and development in the field.

AIPLA took a neutral position on Myriad's specific claims, but in general supports patent eligibility for genetic material.

In their ruling, the justices said patent protection must strike “a delicate balance” between creating incentives for innovation and impending the flow of information that might spur further inventions.

“Myriad did not create or alter either the genetic information encoded in the BCRA1 andBCRA2 genes or the genetic structure of the DNA. It found an im­portant and useful gene, but groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the §101 inquiry.”

But they said that with regard to complementary DNA, “the lab technician unquestionably creates something new when introns are removed from a DNA sequence to make cDNA.”

The decision affirmed in part and reversed in part a July 2012 decision by the Federal Circuit, which reversed a previous district court ruling that Myriad’s composition claims covered patent-ineligible products of nature.

The Federal Circuit had initially ruled on the case in July 2011, but after an appeal to the Supreme Court was filed the case was returned to the Federal Circuit following the Supreme Court's decision in Mayo v Prometheus in March 2012.

more from across site and SHARED ros bottom lb

More from across our site

Jinwon Chun discusses the need for vigilance, his love for iced coffee, and preparing for INTA
Karl Barnfather’s new patent practice will focus on protecting and enforcing tech innovations in the electronics, AI, and software industries
Partner Ranjini Acharya explains how her Federal Circuit debut resulted in her convincing the court to rule that machine learning technology was not patent-eligible
Paul Hastings and Smart & Biggar also won multiple awards, while Baker McKenzie picked up a significant prize
Burford Capital study finds that in-house lawyers have become more likely to monetise patents, but that their IP portfolios are still underutilised
Robert Reading and Faidon Zisis at Clarivate unpick some of the data surrounding music-related trademarks
China's latest IP litigation statistics and a high-profile hire by O'Melveny were also among the top talking points this week
David Aylen, who spent more than 20 years at Gowling WLG, has joined United Trademark and Patent Services as of counsel in the UAE
Europe is among the most lucrative legal markets for PE firms to bet on, but clients’ reactions will decide whether external investment drives success
Rulings of note covered pre-June 2023 infringements and jurisdiction over non-UPC states, while winners of Managing IP’s EMEA Awards acted in multiple cases
Gift this article