Preparing for Pharma PGRs: Lessons for Patent Owners From PGR Denials

Description

The high institution rate and claim cancellation rate of the Patent Trial and Appeal Board (PTAB) in inter partes reviews (IPRs) are well known. Patent owners are now seeing the other new post-grant proceeding established under the AIA: PGRs. The filing numbers are still small compared to IPRs, but PGRs are only available to challengers in the first nine months after a patent issues, and may only be filed on patents containing at least one claim with an effective filing date after Mar. 15, 2013, so the impact of PGRs is only just now starting to hit. Of great interest to practitioners in the pharmaceutical area, biotech, pharma and chemical patent challenges account for about half of all PGRs filed so far. In fact, the first PGR Final Written Decision with all claims surviving relates to a pharmaceutical patent, Altaire Pharms., Inc. v. Paragon Bioteck, Inc., PGR2015-00011, Paper 48 (P.T.A.B. Nov. 14, 2016).

PGRs are a very real threat to those patent owners deliberately setting up a “Jedi Master Mixer” (JMM) application to achieve goals such as eliminating pre-AIA §102 art. Careful consideration must be given to proactive measures patent owners can take to strengthen their JMM for surviving PGR petitions.

The pharma patent owner has only three months from a PGR petition filing date to file a patent owner preliminary response (POPR). If a PGR is instituted, the on-year to final written decision time frame applies like in IPRs. However, the grounds of possible attacks in PGRs are broader than in IPRs. PGRs may be brought on “any ground that could be raised under paragraph (2) or (3) of Section 282(b) (relating to invalidity of the patent or any claim).” 35 U.S.C. §321(b). This puts a very high premium on establishing a strong record during patent application drafting and prosecution to support patentability arguments in the POPR and POR.

Objective evidence of non-obviousness, as is often noted in litigation, may be the “most probative” evidence of nonobviousness available, but it has not been a total success for patent owners in IPR proceedings to date. However there have been a few recent successes that the panel will discuss for teaching points to take forward in defending against PGR petitions.

Listen as our authoritative panel of patent practitioners, with pioneering expertise in PTAB PGR practice, analyzes and discusses the recent PGR PTAB denials and successful IPR arguments for take-home lessons applicable in defending patent owners in PGRs.