Rejections for US patents related to personalized medicine have spiked after recent Supreme Court decisions tightened the rules for such claims, an analysis of more than 39,000 patent applications reveals.
The data, presented on 11 August at the Intellectual Property Scholars Conference in Stanford, California, address patent applications in eight categories that commonly include personalized-medicine patents. They show that following a key Supreme Court decision in 2012, the US Patent and Trademark Office (USPTO) was nearly four times more likely to deem subjects of such applications unpatentable — and applicants were less than half as likely to overcome those rejections.
“The change in office actions was absolutely striking,” says Nicholson Price, who studies intellectual property at the University of Michigan Law School in Ann Arbor. “The data are very clear that the patent office has changed its behaviour.”
Over the past decade, the Supreme Court has used a series of patent cases to clarify what the USPTO should consider patentable. Natural phenomena and abstract ideas, for example, are not patentable, according to section 101 of the US patent code, and the court has attempted to distinguish between these categories and true inventions.
Two of those Supreme Court cases touched directly on the biomedical industry. In 2012, the Mayo Collaborative Services v. Prometheus Laboratories, Inc. decision struck down two patents on medical diagnostics, and in the 2013 Association for Molecular Pathology v. Myriad Genetics ruling, the court threw out patents on gene sequences used to assess cancer risk. In the wake of those decisions, many lawyers predicted that patents on inventions that are important to personalized medicine — particularly, diagnostic tests that could match individuals to a particular therapy — would be hard to come by, potentially driving away investors.
Legal scholar Bernard Chao of the University of Denver in Colorado …