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 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
  • En Banc Rehearing Petition Denied – PTAB Retains Authority to Institute IPR and Issue Final Decision We previously reported on the Federal Circuit’s decision that neither the AIA nor the Constitution precludes the same PTAB panel from rendering both institution and final decisions in Ethicon Endo-Surgery, Inc. v. Coviden LP, No. 2014-1771 (Fed. Cir. 2016).  Last week, in a 10-1 decision, the Federal Circuit denied Ethicon’s petition for rehearing en banc. The petition was denied without comment by the majority, providing no response to the amici briefs filed by the Biotechnology Industry Organization and Pharmaceutical Research and... More
  • Federal Circuit to PTAB – Explain yourself!! The Federal Circuit recently vacated or reversed-in-part two PTAB final written decisions on the basis that the PTAB did not adequately describe its reasons for concluding the claimed invention is obvious.  In both instances, the court criticized the Board’s “broad, conclusory statements” regarding one of ordinary skill’s motivation to adjust prior art teachings.  These decisions highlight an attractive grounds for appealing a PTAB’s final written decision. In Cutsforth, Inc. v. Motivepower, Inc., No. 2015-1316 (Fed. Cir. Jan. 22, 2016), the Federal... More