The PTAB May Be Taking a More Balanced Approach in Biotech and Pharmaceutical IPRs

Knobbe Martens
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Patent challengers were first able to file inter partes review (IPR) petitions on September 16, 2012. Since then IPRs have become an increasingly popular way of challenging the validity of patents. In the first three months that IPRs were available 97 petitions were filed with the Patent Trial and Appeal Board (‘‘PTAB’’). That number has now risen by over fourfold, with more than 450 petitions being filed in the last three months of 2014. As the first final decisions were released, many commenters felt that the PTAB was acting as a ‘‘death squad,’’ invalidating almost every challenged patent. Even PTAB Chief Judge James Smith mentioned at a U.S. Patent and Trademark Office Patent Public Advisory Committee that if the PTAB wasn’t doing some ‘‘death squadding’’ they wouldn’t be doing what Congress mandated in developing the IPR process. This naturally led to much concern that the PTAB wasn’t providing the proper balance between the rights of challengers to invalidate patents in view of the prior art, and the rights of patent owners to have certainty in the strength of their intellectual property. doing some ‘‘death squadding’’ they wouldn’t be doing what Congress mandated in developing the IPR process. This naturally led to much concern that the PTAB wasn’t providing the proper balance between the rights of challengers to invalidate patents in view of the prior art, and the rights of patent owners to have certainty in the strength of their intellectual property.

However, as we start to review more decisions by the PTAB, and particularly recent cases, it appears that the pendulum is starting to swing away from invalidity of almost every case and towards more balance to the IPR process. For example, the PTAB is now instituting a noticeably lower percentage of IPRs by finding that the challenger hasn’t met its initial burden of demonstrating there is a reasonable likelihood that the claims are unpatentable over the prior art. In addition to granting fewer institution decisions, the PTAB has also started to find that a greater number of challenged patents are patentable over the prior art cited by the IPR petitioner.

Originally published in Bloomberg BNA's Pharmaceutical Law & Industry Report, 13 PLIR 378, 03/13/2015.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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