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

Leveraging Successful IPR Arguments, Strengthening Patent Applications to Survive PGR Petitions

Recording of a 90-minute CLE webinar with Q&A


Conducted on Thursday, January 19, 2017
Recorded event now available


This CLE webinar will provide guidance to prepare patent counsel for pharma-related America Invents Act (AIA) post-grant reviews (PGRs). The panel will provide theories for surviving a declared PGR with instituted claims intact, or, even better, achieving denial of institution. Two of the panelists were recently involved in assisting a patent owner obtain the first two substantive denials in pharma-related PGRs—PGR2016-00007 and PGR2016-00008.

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.

Outline

  1. Analysis of PGR petitions denied in PGR2016-00007 and PGR2016-00008
  2. Analysis of PGR final written decisions: Lessons for patent owners in PGRs
  3. Lessons from IPR practice for PGRs

Benefits

The panel will review these and other key issues:

  • How can practitioners help patent owners prepare for PGRs?
  • What can patent owners do during prosecution to strengthen their patents against PGR challenges?
  • What can patent counsel learn from successful IPRs in order to succeed in PGRs?

Faculty

Thomas L. Irving, Partner
Finnegan Henderson Farabow Garrett & Dunner, Washington, D.C.

Mr. Irving has 35 years of experience in the field of IP law. His practice includes due diligence, patent prosecution, reissue and reexamination, patent interferences, and counseling, including prelitigation, Orange Book listings of patents covering FDA-approved drugs, and infringement and validity analysis in the chemical fields, as well as litigation. He has served as lead counsel in many patent interferences.

Amanda K. Murphy, Ph.D.
Finnegan Henderson Farabow Garrett & Dunner, Washington, D.C.

Dr. Murphy focuses her practice on client counseling and patent prosecution for a range of clients. She prepares new patent applications, prosecutes U.S. and foreign applications, and represents applicants at appeals and oral hearings before the PTAB. She has experience in prosecuting inter partes and ex partes reexamination applications, reissue applications, and patent term extension applications for approved pharmaceuticals, including obtaining supplemental protection certificates in Europe.

Kerry Flynn, Vice President, Chief IP Counsel
Vertex Pharmaceuticals, Boston

Ms. Flynn is a highly experienced licensing and intellectual property attorney with over 30 years of experience in both large law firm and in house pharmaceutical practice. She has significant experience in all areas of U.S. and international patent law, including strategic filing and prosecution of patents, multi-jurisdictional litigation, Oppositions and post grant proceedings. Prior to Vertex, she was Vice President Intellectual Property at Shire Pharmaceuticals. She has previously held leadership positions at Transkaryotic Therapies, Biogen, and Finnegan, Henderson, Farabow, Garrett & Dunner. She also holds a CLP certification from the Licensing Executives Society.


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