Myriad decision could be a drag on personalized medicine R&D

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After a skeptical Supreme Court hearing, diagnostics and biopharma patent lawyers are sweating the outcome of Association for Molecular Pathology vs. Myriad Genetics, in which the Court could decide whether or not swatches of genes are patentable.  

At issue is a Myriad test for two genes – BRCA1 and BRCA2 – that serve as markers for breast cancer susceptibility. A coalition of medical societies and patient advocacy groups have challenged the patents, saying they're laughably overbroad, thwart patient options and discourage further research in the area. Myriad, backed by industry trade groups, says the patents are necessary to reward its $500 million investment in developing the test and to incentivize further diagnostic innovations. Lower courts have clashed on the case.

The stakes are high for diagnostics firms that do genetic testing, and the decision, expected in the summer, will have a knock-on effect on pharmaceutical manufacturers looking to capitalize on the promise of personalized medicine through companion diagnostics or targeted drugs.

Trade group BIO said in a statement: "The Supreme Court is being asked to categorically strike down a large class of patents based on the purported marketplace behavior of a single genetic diagnostic testing company. We are concerned that this case could potentially affect many biotech companies whose activities have nothing to do with the clinical testing services that are at issue in this litigation ... The term 'gene patent' is misleading, because patents cannot cover the genes that exist in humans, plants, animals or microbes. Contrary to what has been said, patents confer no ownership over genes. Nor have the patents which are allowed stifled research, harmed patients, or interfered with medical care."

The judges, accounts say, tried on a number of analogies, seemingly trying to bring a high-science subject down to earth. Tim Worrall, a partner at Dorsey & Whitney who represents pharmas and biotechs, offers this one: “What if I have a natural product – say, a tobacco leaf – and I chew this and something happens. I can isolate nicotine from a tobacco leaf. In every single case of discovery, you are isolating something from nature, and a lot of times, those things have been patented.” Gila monster spit, anyone?

But genetic material is personal, and central to the Myriad case is the question of where the patenting of the process ends and the patenting of a person begins.

Writes ScotusBlog's Lyle Denniston:

No one on the Court was in doubt that Myriad would have been entitled to a patent if it found some unique way to make use of the genes it has isolated, but the Justices drew a sharp distinction between creative applications and the core natural item, the gene itself. But that is a legal distinction, between a natural product and its uses, and the Myriad case in some ways involves a patent that sort of straddles the two.

Court-watchers said a narrow decision is likely. It's also possible that the court could deny the plaintiffs standing altogether and throw the case out without a decision on its merits.

But patent lawyers remember well the Court's shocker decision in Mayo Collaborative Services vs. Prometheus, in which the court unanimously held a Prometheus Labs patent on a dosing procedure invalid because, as a decision authored by Justice Breyer put it, “One must do more than simply state the law of nature while adding the words `apply it.'”

“That surprised a lot of people in the patent community,” says Dorsey & Whitney's Worrall, “not just the decision itself by that it was unanimous. It's been a heavily criticized case, though I don't think the court cares. They've certainly not shied away from surprising people.”

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