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 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
  • Your Supplemental Evidence is Timely, but is it Relevant to a Claim at Issue? PTAB Will Decide. Once a trial has been instituted at the PTAB, a party seeking consideration of supplemental evidence may file a motion in accordance with the following requirements: (1) the request for the authorization to file a motion to submit supplemental information must be made within one month of the date the trial was instituted; and (2) the supplemental information must be relevant to a claim for which the trial was instituted.  37 C.F.R. § 42.123(a). Mere satisfaction of these requirements for... More
  • 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