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

  • PTAB Issues First Biotech/Pharma PGR Final Written Decision Based On Written Description Challenge The Patent Trial and Appeal Board has received 37 petitions for post grant review of patents issuing from examination conducted by the Patent Office’s Group Art Unit 1600. The Board has issued four final written decisions thus far.  We discussed the first final written decision here, where all claims were upheld in the face of a challenge based on obviousness grounds only.  Three of the four final written decisions issued so far on biotech/pharma subject matter dealt only with art-based... More
  • Rituxan Patent Spared by Failure to Establish Product Label as “Printed Publication” A patent relating to a method of treating rheumatoid arthritis using rituximab recently survived its fourth IPR challenge. Celltrion, Inc. v. Biogen, Inc., IPR2016-01614 (PTAB Feb. 21, 2018). The PTAB determined that the Petitioners failed to establish that the challenged claims of the patent were obvious over prior art, in part, because of the Petitioners’ failure to establish the prior art status of the product label for RITUXIN®, which contains rituximab. Petitioners bears the burden of establishing that a printed... More
  • First Derivation Proceeding Instituted by PTAB March 13, 2018, marked the fifth anniversary of the transition from the previous “first to invent” system to the AIA’s “first to file” regime.  The PTAB seemingly marked the occasion by instituting the first ever derivation proceeding one week later in Anderson Corporation v. GED Integrated Solutions, Inc., Case DER2017-00007, Paper 32 (March 21, 2018). The concept of “derivation” was not created by the AIA.  Pre-AIA 35 U.S.C. § 102(f) dictated that a person shall not be entitled to a patent... More
  • PTAB Defines Further Limitation to Sovereign Immunity Defense PTABWatch Takeaway: Sovereign immunity is not available to dismiss an IPR challenge where the Patent Owner has filed an infringement action against the Petitioner. Ericsson v. Regents of the University of Minnesota, IPR2017-01186, -01197, -01200, -01213, -01214, and -01219 (Dec. 19, 2017). The Eleventh Amendment was rarely mentioned in the same breath as patent law until last year, which began with the Board’s decision in Covidien LP v. University of Florida Research Foundation Inc., IPR2016-01274, -01275, -01276 (Jan. 25, 2017), discussed... More
  • 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