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