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Around half of pharmaceutical patents survive a patent board validity challenge, which is better than other fields, a new analysis released June 14 said.
Inter partes review (IPR) was created by the America Invents Act to allow third-party challenges to the validity of patents before the Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB). Across all fields, 91 percent of the IPR challenges that go to PTAB trial result in all or some of the claims being invalidated. This caused Randall Ray Rader, former chief judge of the U.S. Court of Appeals for the Federal Circuit, to call the PTAB “a death squad” for patents.
A new analysis by law firm Fitzpatrick, Cella, Harper & Scinto continued the pattern of reports finding that IPRs’ impact on biopharma patents isn’t as severe as for other technologies. “In short, PTAB is not a ‘death squad’ for” pharmaceutical and biologic patents, the analysis concluded. Biopharma attorneys, however, have told Bloomberg BNA that even an invalidation rate of 50 percent for some or all claims of patents that were painstakingly reviewed by the PTO continues to be a concern.
The Fitzpatrick analysis of petitions filed from Sept. 16, 2012, through March 31, 2017, found that across all technologies, after an IPR petition was filed, IPRs were instituted at a rate of 53 percent. For pharmaceutical patents, the rate was 44 percent, and for biologic drugs, it was 41 percent.
For pharmaceutical patents, the Fitzpatrick analysis found all claims survived an IPR in 50 percent of final written decisions, and for biologic drugs, all claims survived in 37.5 percent, both better than the average across all sectors of 19 percent for the survival of some or all of the claims.
A 2016 Bloomberg BNA report also concluded that biopharma patents fare better in IPRs than patents for other technologies. It concluded IPR challengers stand about a 50-50 chance of having the PTAB grant an IPR petition. If it does, there’s a 40 percent chance the challenger will succeed in canceling some or all of the patent’s claims.
A 2017 Bloomberg BNA/American Intellectual Property Law Association study found a softening in the negative attitude held against IPRs by attorneys across all sectors.
The Fitzpatrick analysis found that based on March 2017 PTAB statistics:
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