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

  • Play the Claim Monsanto Technology LLC v. E.I. DuPont de Nemours & Co. Appeal 2017-1032 (Fed. Cir. Jan. 5, 2018), illustrates “[t]he life of a patent solicitor has always been a hard one.” [1] The case concerns an inter partes reexamination of a Monsanto patent in which the Patent Office concluded the claimed subject matter was inherently described in an earlier DuPont patent. The Patent Office reached this conclusion because DuPont presented during the reexamination its unpublished data regarding experiments described in its earlier patent.... 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
  • Petitioner Failed to Show That Patent Owner’s Drug Product Package Insert Was a Printed Publication On February 9, 2018, the PTAB denied Sandoz Inc.’s petition for inter partes review of U.S. Patent No. 9,512,216, a patent owned by AbbVie Biotechnology Ltd. The patent recites methods for treating moderate-to-severe chronic plaque psoriasis with adalimumab, a human anti-tumor necrosis factor α (TNFα) antibody.  The methods of the claimed invention involve subcutaneously administering to a patient an initial dose of 80 mg of adalimumab, followed by 40 mg of adalimumab every other week starting one week after the... More
  • CAFC Hears IPR Appeal From Parties That Were Time-Barred From Filing Petition Research Corporation Technologies, Inc. (RCT) sued Mylan Pharmaceuticals, Inc. (Mylan), Breckenridge Pharmaceutical, Inc. (Breckinridge), and Alembic Pharmaceuticals Ltd. (Alembic), in federal district court, accusing them of infringing United States Reissued Patent No. RE38,551. The patent claims pharmaceutical compositions useful in the treatment of epilepsy and other central nervous system disorders. Within one year of being served with the infringement complaint, Breckenridge alone petitioned the PTAB to institute inter partes review of the patent, but the PTAB denied the petition on... More
  • 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