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Mar 26, 2012
 |  BioCentury  |  Politics, Policy & Law

Still murky, naturally

Patent specialists dissect Supreme Court ruling in Prometheus diagnostics case

The U.S. Supreme Court's ruling in Mayo Collaborative Services et al. v. Prometheus Laboratories Inc. did little to remove uncertainty about what molecular diagnostic claims are patentable under Section 101 of the Patent Act.

By a 9-0 vote last week, the high court struck down Prometheus' diagnostic patents but gave no guidance on what would have made the claims patentable.

Some intellectual property attorneys expect the ruling will be narrowly construed to affect only tests that analyze a single metabolite, while others worried an extremely broad interpretation might put all biomarker patents and even method of use claims on drugs at risk.

Among patent attorneys contacted by BioCentury, the consensus was that novel detection technologies will be safe, but they have concerns about novel biomarkers and algorithm-based panels.

Even if they were unsure of how broad the effect of the ruling will be, most said rumors of the MDx industry's death are greatly exaggerated, a conclusion echoed by one of the key venture investors in the space.

"I'm concerned about the decision, but I don't think it's going to slow down innovation and development of the personalized medicine industry," Risa Stack told BioCentury. "This decision is one of many challenges that these companies face, but I don't think it's a roadblock."

Stack is a partner at Kleiner, Perkins, Caufield & Byers and has invested in MDx companies and companies developing personalized medicines.

The first signs of clarity are expected to come when the U.S. Patent and Trademark Office publishes detailed guidance for its examiners, which could come within a month.

Creative writing

According to SCOTUS precedents, laws of nature, natural phenomena and abstract ideas are not patent-eligible under Section 101 of the Patent Act, but applications of laws of nature are. The question in Prometheus was whether the company's patents claimed a patentable application of a law of nature.

Prometheus, a unit of Nestle S.A., is the exclusive licensee of two patents that cover a method for optimizing safety and efficacy of a thiopurine drug for autoimmune disease, such as generic azathioprine for Crohn's disease. The claims include the administration of a drug and the measurement of metabolites in the blood.

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