PTABWatch Blog

http://www.ptabwatch.com/author/hkissling/

PTABWatch, provided by Marshall, Gerstein & Borun LLP, analyzes and reports recent developments concerning Post-Grant Proceedings at the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office (USPTO), including Inter Partes Review (IPR), Post Grant Review (PGR), and Covered Business Method (CBM) proceedings.

Recent Blog Posts

  • Eli Lilly’s Pemetrexed Therapy Claims Survive Challenge At PTAB The Federal Circuit’s decision in Eli Lilly & Co. v. Teva Parenteral Medicines, Inc., 845 F.3d 1357 (Fed. Cir. 2017) attracted much attention for applying the theory of divided infringement in the context of pharmaceutical therapeutic regimen claims.  Before the Federal Circuit decision, a scrum of petitioners successfully petitioned for IPR of the Lilly patent, alleging that the claims were obvious in view of a combination of references that included prior art considered by the court in the litigation. Our... More
  • Assertion of “Routine Optimization” Without Additional Reasoning Insufficient to Support Obviousness Conclusion Recent Federal Circuit decisions reversing or remanding PTAB holdings of obviousness have faulted the Board for failing to clearly articulate its reasoning.  See our previous posts here and here.  In In re Stepan Co., No. 2016-1811 (Fed. Cir. Aug. 25, 2017), a split CAFC panel vacated a PTAB ex parte appeal decision affirming an obviousness rejection based on “routine optimization” for failing to explain why one of ordinary skill would arrive at the claimed subject matter. The claims of Stepan’s U.S.... More
  • Eli Lilly Successfully Challenges U Penn Erbitux® Claims at PTAB, Derailing Infringement Suit The PTAB recently canceled the University of Pennsylvania’s U.S. Patent No. 7,625,558, a potentially fatal blow to the University’s suit against Eli Lilly and Company alleging its cancer therapeutic Erbitux® (centuximab) infringes the patent.  Eli Lilly and Co. v. Trustees of the Univ. of Penn., Case IPR2016-00458 (July 13, 2017). The PTAB’s decision resolved testimony from the parties’ competing expert witnesses in favor of the Petitioner (Eli Lilly and Company), thus highlighting how the PTAB’s scientific acumen can be leveraged... More
  • PTAB Exercised Discretion to Terminate Ex Parte Reexaminations in Ariosa v. Illumina; CAFC to Review Third parties seeking to challenge pre-AIA patents in the USPTO often choose between IPR and ex parte reexamination.  In some cases, petitioners pursue both proceedings, sequentially or in parallel, taking advantage of different timelines to completion, different standards for institution, and using insights gained in one proceeding in the other.  The PTAB recently exercised its discretion to terminate three reexaminations filed against patents also challenged by IPR in Ariosa Diagnostics, Inc. v. Illumina, Inc., IPR2014-01093, Paper 81 (May 24, 2016). ... More
  • PTAB Grants Hospira Petition to Institute IPR of Genentech Antibody Purification Patent IPRs are an attractive option for biosimilar applicants to clear the patent landscape before delving into litigation under the Biologics Price Competition and Innovation Act of 2009 (BPCIA), which is still in its infancy.  Roche’s Herceptin® (trastuzumab) is a prime target for biosimilar makers, accounting for sales of over $6.5 billion in 2015.  Mylan, Celltrion, and Pfizer, all with competing biosimilar candidates, have filed IPR petitions challenging patents reportedly covering trastuzumab.  Recently, the PTAB granted a petition filed by Hospira... More
  • Another VIMOVO® Patent Survives Challenge by Coalition for Affordable Drugs – Updating the CFAD Scorecard In the spirit of “if at first you don’t succeed, try, try again,” the Coalition for Affordable Drugs (CFAD) challenged a fourth Orange Book-listed patent relating to VIVOMO®, Horizon Pharma’s naproxen/ esomeprazole product.  While denying CFAD’s previous three petitions, the PTAB instituted inter partes review for U.S. Patent No. 8,945,621.  Despite CFAD’s success at the institute phase, the PTAB ultimately determined in its Final Written Decision that the Petitioner did not meet its burden in proving the unpatentability of the... More
  • PTAB Issues First Biotech/Pharma Post-Grant Review Final Written Decision – All Claims Survive The first final written decision in a post-grant review of a patent arising from Art Unit 1600 issued November 14, 2016, in Altaire Pharm. Inc.. v. Paragon Bioteck, Inc., PGR2015-00011.  PGRs allow challenge based on enablement, written description, indefiniteness, and subject matter eligibility, in addition to the novelty and obviousness bases available in IPRs, permitting petitioners to rely on arguments commonly used to invalidate biotechnology and pharmaceutical patents in litigation.  Here, however, the PTAB instituted PGR based only on obviousness... More
  • PTAB Institutes Third Biotech/Pharma Post-Grant Review To date, only 43 petitions for Post-Grant Review have been filed with the PTAB.  Nine PGR petitions (21% of total petitions) have been filed to challenge patents arising from Art Unit 1600, which examines applications directed to biotechnology and organic chemistry subject matter.  The PTAB recently instituted the third ever PGR for a biotech-related patent in B.R.A.H.M.S. Gmbh v. Becton, Dickinson & Co., PGR2016-00018. The petitioner requested PGR of claims 1-12 of U.S. Patent No. 9,091,698, directed to a method for... More
  • PTAB Failed to Properly Apply Incorporation by Reference Standard for Anticipation This blog previously referenced Athena Automation Ltd. v. Husky Injection Molding Systems Ltd., IPR2013-00290 as an example of the Board granting a request for rehearing, but ultimately confirming its original decision.  On appeal, the Federal Circuit vacated the Board’s decision on the particular issues raised by the Petitioner in the request for rehearing, suggesting that if at first you don’t succeed, try again at the Federal Circuit.  Husky Injection Molding Systems Ltd. v. Athena Automation Ltd., 2015-1726, 2015-1727 (Fed. Cir.... More
  • Federal Circuit Refuses to Reweigh Factual Findings, But PTAB’s Conclusory Statements Are Insufficient The Federal Circuit’s precedential decision in In re: Warsaw Orthopedic, Inc., No. 2015-1050, 2015-1058 (Fed. Cir. Aug. 9, 2016), highlights recurring themes in appeals of PTAB IPR decisions.  On one hand, the Federal Circuit is reluctant to overturn a PTAB decision canceling claims for obviousness based on Patent Owner’s assertions that the PTAB failed to properly weigh certain facts found in reaching its decision.  On the other hand, the Federal Circuit will not hesitate to vacate and remand PTAB decisions... More