Supreme Court rules naturally occurring DNA is patent ineligible
Managing IP is part of the Delinian Group, Delinian Limited, 4 Bouverie Street, London, EC4Y 8AX, Registered in England & Wales, Company number 00954730
Copyright © Delinian Limited and its affiliated companies 2024

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 ros bottom lb

More from across our site

External counsel for automotive companies explain how trends such as AI and vehicle connectivity are affecting their practices and reveal what their clients are prioritising
We provide a rundown of Managing IP’s news and analysis coverage from the week, and review what’s been happening elsewhere in IP
The winners of the awards will be revealed at a gala dinner in New York City on April 25
Counsel debate the potential outcome of SCOTUS’s latest copyright case after justices questioned whether they should dismiss it
Each week Managing IP speaks to a different IP lawyer about their life and career
The small Düsseldorf firm is making a big impact in the UPC. Founding partner Christof Augenstein explains why
The court criticised Oppo’s attempts to delay proceedings and imposed a penalty, adding that the Chinese company may need to pay more if the trial isn’t concluded this year
Miguel Hernandez explains how he secured victory for baby care company Naterra in his first oral argument before the Federal Circuit
The UPC judges are wrong – restricting access to court documents, and making parties appoint a lawyer only to have a chance of seeing them, is madness
The group, which includes the Volkswagen, Seat and Audi brands, is now licensed to use SEPs owned by more than 60 patent owners
Gift this article