Managing IP is part of the Delinian Group, Delinian Limited, 8 Bouverie Street, London, EC4Y 8AX, Registered in England & Wales, Company number 00954730
Copyright © Delinian Limited and its affiliated companies 2023

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

Myriad quizzed by Supreme Court justices

In a landmark case with sweeping repercussions for medical research that's being closely watched around the globe, the US Supreme Court on Monday heard oral arguments on the patent eligibility of human genes

Association for Molecular Pathology v Myriad Genetics hinges on whether the building blocks of life that form the human genome are also intellectual property.

A coalition of plaintiffs that includes researchers, patients, and breast cancer and women's health groups argue that genetic material is a "product of nature" that is ineligible for patents.

Utah-based Myriad, whose supporters include the Biotechnology Industry Organization (BIO) and the Coalition for 21st Century Medicine, maintains that genetic material removed from the body through "invented" methods can be patented because it is no longer naturally occurring.

The lawsuit was brought by the ACLU and the Public Patent Foundation, a non-profit legal group affiliated with the Benjamin N Cardozo School of Law.

A District Court ruled in 2010 that Myriad’s patents related to the isolation of breast and ovarian cancer genes BRCA 1 and BRCA 2 were invalid. But the Federal Circuit reversed the decision in 2011 in a 2-1 decision.

During Monday's arguments, Gregory A Castanias, the attorney representing Myriad Genetics and head of Jones Day’s Federal Circuit practice, quickly found himself on the defensive. Justice Sonia Sotomayor immediately interrupted his opening remarks to express that it's "very, very difficult to see how you can patent a sequential numbering system (created) by nature."

Sotomayor has always been under the impression that to obtain a patent one must "add to what nature does”, she noted. "There was invention," Castanias responded, "in the decision of where to begin the gene and where to end the gene."

Justice Stephen Breyer lectured that if someone discovers a "satisfying new process to extract sap" from a tree or plant in the Amazon or discovers how to treat cancer with the sap, they can patent those things.

"What you can't patent is the sap itself," he said, underscoring the importance of keeping products of nature free from patents. "That's the framework that I'm bringing to the case," he added.

Drawing a comparison with a baseball bat that was "invented”, Chief Justice John Roberts suggested that Myriad didn't have to invent any DNA strands – it just snipped them. "You wouldn't even know where to snip without the Myriad invention," Castanias countered. Elena Kagan, the newest justice, asked whether another major scientific breakthrough, the first isolation of a chromosome, could have been patented. Castanias said “yes” with a caveat – if the chromosome “had a specific utility”.

Earlier in the proceedings, Justice Ruth Bader Ginsburg asked Christopher A Hansen, the attorney for the Association for Molecular Pathology, to explain the difference between a patent on aspirin or whooping cough medication and Myriad's patents.

"This court has used the example of gold," said Hansen, senior national staff counsel for the ACLU. "You can't patent gold because it's a product of nature." He later warned: "When you lock up a product of nature, it prevents industry from innovating and making new discoveries."

During an exchange with Hansen, Justice Antonin Scalia suggested that companies such as Myriad might lack the incentive to make significant financial investments in genetic research if they can't patent DNA. When Hansen surmised that companies would still invest to compete for Nobel prizes and recognition, Justice Kagan said she was hoping for a different answer: that companies would still conclude that such investments were worthwhile business decisions.

The Court is expected to issue its judgment in the case in the next few months. More information on the dispute is available on Managing IP's dedicated topic page.

more from across site and ros bottom lb

More from across our site

Counsel from BMW and Finnegan explain how they got an NPE to sign a covenant agreeing not to sue the automaker ever again
The blue checkmark could be a good tool, but it’s unclear how widespread its adoption will be, say in-house sources
Sarah Harris, partner at Williams & Connolly, reveals how her team secured a copyright victory at SCOTUS and reflects on why the case matters
We provide a rundown of Managing IP’s news and analysis coverage from the week, and review what’s been happening elsewhere in IP
A Court of Appeal judge demanded respect for solicitor-judges after reprimanding a barrister for his 'unwise' words
Speeches at the UPC inauguration highlighted the gap between the unitary patent dream and the reality today
Sources with experience on both sides of the Atlantic believe hugely profitable US law firms may still take some convincing before agreeing to partner with a UK outfit
IP counsel urge the government to restrict safe harbour exceptions available to intermediaries and clear up doubts with the existing law
A New York lawyer could face sanctions after citing fake judgments generated by ChatGPT, but that doesn’t mean practitioners should shy away from AI
Klaus Grabinski told delegates at a UPC inauguration event that the proposed SEP regulation would limit access to justice