Eye on Biotech

http://www.ptabwatch.com/category/biotechnology/

Through the rise of biosimilars, the evolution of patent eligibility (Section 101), and the advent of hedge-fund challenges to pharma patents, Marshall Gerstein keeps a watchful eye on PTAB developments in the world of biotechnology and life sciences. Follow this industry-focused section of our blog to stay informed on post-grant proceedings and the related issues that matter most to your business.

Recent Blog Posts

  • PTAB Not Always Bound By Previous Court Decisions Regarding Patent Validity In Novartis AG v. Noven Pharm. Inc., Appeal 2016-1678-1679 (April 2017), Novartis appealed two PTAB decisions holding claims of two patents obvious over cited prior art (IPR2014-00549 and IPR2014-00550), arguing that previous judicial holdings of non-obviousness should control the PTAB’s factual findings and that the claims should have been held non-obvious. The two Novartis patents at issue (U.S. Patent Nos. 6,316,023 and 6,335,031) were from the same patent family and are directed to a pharmaceutical composition comprising rivastigmine (Exelon®) and an... 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
  • 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
  • One-Year Time Bar Does Not Apply to a Request for Joinder of IPR Proceedings Teva Pharmaceuticals USA, Inc. (“Teva”) filed a Petition, seeking an IPR of claims 1–20 of Allergan’s U.S. Patent No. 8,642,556. [IPR2017-00579, Paper No. 9]  Along with the Petition, Teva filed a Motion for Joinder to join Mylan Pharmaceuticals Inc. v. Allergan, Inc., IPR2016-01129.  This blog has previously reported on the topic of joinder in IPR Petitions here and here. Teva’s Petition was not timely, having been filed more than one year after Allergan filed a complaint alleging infringement of the ‘556... More
  • Claim Construction Sends Duke’s Patent Back to PTAB for Reconsideration, In Part In a recent appeal from a PTAB final written decision, the Federal Circuit reversed the Board’s determination that all claims of a Duke patent were unpatentable (Duke Univ. v. BioMarin Pharm. Inc., Appeal No. 2016-1106 (Fed. Cir., April 25, 2017). The court concluded that certain of the Board’s claim constructions were incorrect, and that others, while appropriate, were mis-applied and reversed the Board’s decision on anticipation, as well as obviousness of some claims. This case is the third in a series of IPRs... More
  • Presentation Not Qualified as a Printed Publication Because Audience Lacked Expertise In a recent final written decision (Trustees of the University of Pennsylvania v. Coalition for Affordable Drugs VIII, LLC, IPR2015-01835, Paper No. 56 (PTAB Mar. 6, 2017)), the Board determined that the Coalition for Affordable Drugs (“Petitioner”) failed to demonstrate that claims 1-10 of U.S. Patent No. 8,618,135 (“the ’135 patent) were obvious. The claims recite methods of treating a subject suffering from a disorder associated with hyperlipidemia and/or hypercholesterolemia. Petitioner asserted these claims were obvious because the alleged prior... 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
  • CFAD Fails to Knock Out 4 Acorda Patents to Multiple Sclerosis Drug A recent set of final written decisions in four IPRs against Acorda Therapeutics puts more marks in the loss column for Kyle Bass and the Coalition for Affordable Drugs.  In IPRs 2015-01850, -01853, -01857 and -01858 (Coalition for Affordable Drugs v. Acorda Therepuatics Inc.), the Coalition for Affordable Drugs (CFAD) requested review of Acorda Therapeutics U.S. patents U.S. 8,440,703, U.S. 8,007,826, U.S. 8,663,865, and U.S. 8,354,437, respectively, directed to sustained release formulations of fampridine (4-AP) and methods for administering the... More
  • Don’t Switch Horses Midstream In IPR2015-01157, 10X Genomics, Inc. challenged claims 1-31 of USPN 8,889,083 owned by the University of Chicago.  PTAB instituted trial on grounds of obviousness over two references.  Each party relied on the testimony of one or more experts, and the Patent Owner challenged expert testimony as exceeding the proper scope of Petitioner’s Reply. The technology at issue involved a device and method for pressurized transport of fluidic plugs, or droplets, in microfluidic systems used in chemical and biochemical reactions.  The plug... More