PTAB not a ‘death squad’ for drug patents: report

The Patent Trial and Appeal Board (PTAB) is not a “death squad” for drug patents, according to a study conducted by Fitzpatrick, Cella, Harper & Scinto.

Drug patents survive inter partes review (IPR) proceedings at a higher rate than patents for other technologies, offering a “welcome rebuke” to the prediction that the PTAB would be a patent “death squad”.

In October 2013, Randall Rader, who was chief judge of the US Court of Appeals for the Federal Circuit at the time, blasted the PTAB as a “death squad” for patents, predicting that many would be invalidated under the board.

As of March 31, 2017, statistics show that a total of 4,563 IPR petitions were resolved, including 1,577 final written decisions.

Across all technologies, all patent claims survived IPR in 19% of final written decisions.

But for Orange Book-listed drug patents, all claims survived IPR in 50% of final written decisions, while for Center for Drug Evaluation and Research (CDER)-listed biologic drugs, all claims survived IPR in 37.5% of final written decisions.

The CDER, part of the Food and Drug Administration, regulates over-the-counter and prescription drugs.

IPRs were instituted at a rate of 53% across all technologies, at a rate of 44% for Orange Book drug patents, and of 41% for CDER-listed biologics.

Fitzpatrick’s findings are based on a review of more than 200 IPRs concerning Orange Book-listed drugs and more than 25 IPRs concerning biologics.

Did you enjoy reading this story?  Sign up to our free newsletters and get stories like this sent straight to your inbox.