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

  • 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
  • Been There, Done That: Petitioners Should Find Art and Arguments Not Previously Considered During Prosecution This blog has previously explained on July 23, 2015, December 10, 2015, and December 16, 2015 why it is important for parties to AIA trials to carefully consider the patent prosecution history.  Under 35 U.S.C. § 325(d), the Board has discretion to deny an AIA trial if “the same or substantially the same prior art or arguments previously were presented to the Office.”  The Board recently exercised that discretion in denying an inter partes review petition and, in doing so, provided... More
  • Status Report on IPR Statistics for the Biotech/Pharma Technology Center On June 30, 2016, lead APJ Jacqueline Wright Bonilla provided a status report on Inter Partes Review/Post Grant Review in the Biotechnology and Chemical Technology Center 1600 during the Biotechnology/Chemical/Pharmaceutical Customer Partnership (BCP) Conference.  The statistics discussed during this BCP Conference are current as of May 31, 2016.  Since the first AIA petition filed in September 16, 2012, 5026 total AIA petitions have been filed, with 90% of these petitions being IPRs, 9% being CBMs and the rest being PGRs and... More
  • Squeezing the ‘Antibody Exception’ to Written Description into a Corner The PTAB has continued the trend of pushing the -“antibody exception” to written description into an ever-smaller corner. Claims to methods of using antibodies that bind Siglec-15 to impair osteoclast differentiation and inhibit bone resorption were deprived of priority because the parent application failed to disclose the “antigenic regions useful for generating antibodies having the desired functional properties.” Consequently, the claims were anticipated by the cited reference under 35 U.S.C. §102(a), and Patentee’s other evidence of prior conception, diligence and... More
  • Rare Grant of Rehearing of Denial of Petition for Inter Partes Review The Board initially denied institution of Mylan Pharmaceuticals’ petition for inter partes review of U.S. Patent No. RE44,186, owned by AstraZeneca.  After a rare grant of Mylan’s request for rehearing, the Board reconsidered the record and decided to institute the IPR.  The decision to institute focused on the content of Mylan’s expert testimony; and although not mentioned in the decision, the replacement of one APJ in the PTAB panel for the decision on rehearing might have played a role in... More
  • Federal Circuit Confirms PTAB Can Cite Prior Art in IPR Final Decision That Was Not In Grounds Of Institution In a recent appeal from a PTAB final written decision, the Federal Circuit determined that a patentee was not denied notice or an opportunity to respond to references cited in the final written decision as representing the state of the art,  but that were not the basis for a grounds for institution.  (Genzyme Therapeutic Prods. Ltd. v BioMarin Pharm. Inc., Appeal Nos. 2015-1720, -1721 (Fed. Circ., June 14, 2016)).  The court concluded that there is no requirement, either in the... More