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

  • Purdue Not Estopped From Raising Invalidity Contentions at Trial That Were Submitted But Not Instituted During IPR Recently, the Federal District Court for the District of New Jersey allowed Purdue Pharma to assert invalidity arguments in the litigation that were previously submitted in an IPR petition, but upon which IPR review was not instituted. See Depomed Inc. v Purdue Pharma LP, Civil Action 13-571, Order (D.N.J. Nov. 4, 2016). The Court rejected the patent owner’s arguments that Section 315(e) of Title 35 estopped Purdue from raising these argument. Patent Owner Depomed holds multiple patents directed to compositions... More
  • Federal Circuit to PTAB (Again) – Explain Yourself!! The Federal Circuit has once again vacated and remanded a PTAB final written decision on the basis that the PTAB did not adequately explain its reasons for finding a claimed invention obvious.  In In re Nuvasive, Appeal No. 15-1670 (Fed. Cir. Dec. 7, 2016), the Federal Circuit reviewed the PTAB’s final written decision in IPR2013-00506 that concluded various claims of  NuVasive, Inc’s U.S. Patent No. 8,361,156 were invalid as obvious over a combination of prior art references.  The patent claims... 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 Cancels Gattax® Patent Claims in Coalition for Affordable Drugs IPRs In two final written decisions (IPR2015-01093 and IPR2015-00990), the PTAB found that challenged claims in Shire’s U.S. Patent No. 7,056,886 (the ’886 patent) were invalid as obvious.  The decisions highlight potential issues related to patents directed to pharmaceutical formulations that petitioners and patent owners alike may want to consider if confronted with an IPR related to such subject matter. The Coalition for Affordable Drugs filed two petitions for IPR, one challenging claims 1−45 of U.S. Patent No. 7,056,886 (IPR2015-01093) and one... More
  • Ignore Occam’s Razor at your Peril In IPR 2015-01127, PAR Pharmaceuticals, challenged claims 1-11 of USPN 8,404,215 owned by Horizon Therapeutics, LLC on grounds of obviousness over various combinations of six references.  Lupin Ltd. and Lupin Pharmaceuticals, Inc. filed another challenge to the claims of the ‘215 patent on the same grounds using the same arguments and evidence as used by PAR.  The Board joined the two proceedings and construed the claims-at-issue in accordance with the plain meaning of the recited terms, crediting the unrebutted testimony... More
  • 3 Is a Magic Number for Mylan: 3 Teva Copaxone Patents Struck Down in IPRs In a series of unfortunate events for Teva Pharmaceuticals, three patents covering methods for administering the blockbuster multiple sclerosis (MS) drug Copaxone® (glatiramer acetate) (owned by Yeda Research and Development Co.) were struck down by the PTAB in recent IPR decisions (IPR2015-00830, IPR2015-00643, and IPR2015-00644).  These patents are directed to methods for administering Copaxone in a 40 mg dosage form, 3 times per week to treat relapsing-remitting MS:  U.S. Patent Nos. 8,232,250, 8,399,413 and 8,969,302.  Illustrative claim 1 of the... More
  • IPR Institution Denied Because Petitioner Used Hindsight Bias to Formulate Arguments On August 23, 2016, the PTAB denied Mylan Laboratories Limited’s (Mylan) petition for IPR (IPR2016-00627) against a patent owned by Aventis Pharma S.A. (Aventis). In doing so, the PTAB offered guidance regarding what is required to successfully make out a claim of obviousness regarding a new chemical compound. In particular, the PTAB’s decision offers insight into the threshold a petitioner will need to meet in order to establish that a person of ordinary skill in the art would have recognized... More
  • PTAB Accords Little Weight to Evidence without Analysis or Explanation The PTAB recently issued a final written decision in an inter partes review (IPR), refusing to cancel claims in Verinata Health, Inc.’s U.S. Patent No. 8,318,430.  Ariosa Diagnostics v. Verinata Health, Inc., Cases IPR2013-00276 and -00277 (P.T.A.B. Aug. 15, 2016). The claims are directed to methods for determining the presence or absence of fetal aneuploidy in a fetus.  This is the second such decision from the PTAB.  The first decision was the subject of an appeal to the Federal Circuit.... More
  • Federal Circuit Affirms PTAB Upholding Patent Claims In what has been a rare outcome to date, the Federal Circuit in Apotex v. Wyeth, dkt. no. 2015-1871 (Fed. Cir. Aug. 16, 2016) affirmed in a non-precedential decision the PTAB’s final written decision in IPR2014-00115 that the challenged claims were not unpatentably obvious over three references.  At trial, the PTAB found that Apotex did not sustain its burden of showing by a preponderance of the evidence that there was a reason to substitute the claim-recited antibiotic for a prior... More
  • Priority Claims Unchallenged In Prosecution Can Be Weak Links IPR2015-00291 decided a petition filed by Daiichi Sankyo Co. Ltd. against USPN 8,168,181 owned by Alethia Biotherapeutics, Inc.  The ‘181 patent issued from a continuation-in-part of the U.S. national phase of a PCT application and contains claims drawn to methods of impairing osteoclast differentiation, useful in treating various bone diseases.  The Board denied the Patent Owner’s priority claim and found an attempt to antedate intervening art inadequate, leading to a holding that the ‘181 claims were unpatentable under 35 U.S.C.... More