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…show that following a…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…
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[I]n 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.…
Ultimately, it will be difficult to unravel what impact the patent decline is having on the personalized-medicine industry, cautions [legal scholar] Arti Rai…The sector is facing challenges from several sides: the US Food and Drug Administration has proposed tougher regulations…and insurance companies have been reluctant to pay for new diagnostic tests.
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