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October 29, 2021

Drug Companies and Post-Grant Review

Drug companies are taking advantage of a rarely used US Patent and Trademark Office (PTO) trial proceeding in an attempt to challenge their competitors' intellectual property by turning to Post-Grant Review (PGR). PGR is a trial proceeding where the patentability of the claims in a patent are reviewed. Under the PGR process, a third party that is not the patent holder files a petition with the Patent Trial and Appeal Board (PTAB) of USPTO within nine months of a patent being granted or reissued. PGR is a faster way to challenge the patentability of a patent's claims and avoids  waiting to raise invalidity of the patent as a defense once the drug company is sued. Additionally, PGR avoids juries, which usually lack the technical expertise needed to understand drug patents.

PGR can only be used to challenge patents issued after March 16, 2013, and they require drug companies to closely monitor their competitors’ patent applications to be able to file a PGR within nine months of the patent issuing. Nevertheless, the use of PGR is on the rise. ”The number of post-grant reviews to challenge standard drug and biologic patents climbed from one in 2014 to 10 in just the first half of 2021.