Biopharma Patents Survive Patent Board Challenges Better Than Others

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By John T. Aquino

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.

Matches Other Analyses

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.

Pharmaceuticals Top Biologics

The Fitzpatrick analysis found that based on March 2017 PTAB statistics:

  •   53 percent of filed petitions across all technologies resulted in inter partes review, 35 percent reached a final written decision, and in 19 percent of the decisions, no instituted claim was found unpatentable;
  •   for pharmaceutical patents, 44 percent of petitions resulted in an IPR; 38 percent reached a final written decision, and, of those, no claim was then found unpatentable in 50 percent of final written decisions;
  •  for biologic claims, 41 percent of petitions filed went to an IPR, 28 percent reached a final written decision, and no claim was then found unpatentable in 37.5 percent of final written decisions; and
  •  a higher percentage of biologic drug claims—21 percent compared to 12 percent for pharmaceutical claims and 17 percent for claims across all sectors—resulted in a settlement prior to the decision on whether to institute an IPR.
Robert Schwartz, a partner at Fitzpatrick and chairman of the firm’s biotechnology and biologics industry group, said in a statement, “Over recent years, a number of assumptions have been made about how patent disputes will be resolved by the PTAB—and some have turned out to be wrong. This research is encouraging to the pharmaceutical industry.”

To contact the reporter on this story: John T. Aquino in Washington at jaquino@bna.com

To contact the editor responsible for this story: Randy Kubetin at RKubetin@bna.com

For More Information

The analysis is at http://src.bna.com/pTQ. The PTO's statistics are at http://src.bna.com/pUC.

Copyright © 2017 The Bureau of National Affairs, Inc. All Rights Reserved.

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