Guidelines for Gene Patent Ruling

The USPTO offers guidance to its patent examiners on how to interpret the Supreme Court’s rulings in the recent Myriad and Prometheus cases.

By | March 7, 2014

WIKIMEDIA COMMONS, GALLO & SPERO LLPLast summer, the US Supreme Court invalidated patents held by Salt Lake City, Utah-based Myriad Genetics on the BRCA1 and BRCA2 genes. A year earlier, the high court ruled that two diagnostic patents held by San Diego-based Prometheus were also not patent eligible. In both cases, the justices cited laws against patenting products or laws of nature or natural phenomena.

This week (March 4), the US Patent and Trademark Office (USPTO), whose role is to interpret court decisions on patentability into procedures for patent examiners to follow, issued guidelines on how to apply these new rulings. It all comes down to “whether a claim reflects a significant difference from what exists in nature and thus is [patent] eligible,” the USPTO described. Alternatively, if “a claim is effectively drawn to something that is naturally occurring,” then it is not patent eligible, according to the guidelines.

“In a new set of training materials, the USPTO has attempted to provide some concrete guidance to its examiners on determining whether claims improperly encompass laws of nature, natural principles, natural phenomena, or products of nature,” Dennis Crouch, an associate professor at the University of Missouri School of Law, wrote at his blog, Patently-O. “Although these guidelines do not have force of law, they are important because of their de facto power for the several hundred thousand pending patent applications.”

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