Board Holds that Unexpected Results Overcome Claims that Were Prima Facie Obvious

In Coalition for Affordable Drugs V LLC v. Biogen MA Inc., the PTAB denied an obviousness challenge of a patent covering methods of treating multiple sclerosis using a particular dosage of known fumarate drugs.  The patent at issue—U.S. Patent No. 8,399,514—is listed in the Orange Book for Biogen’s Tecfidera® product. The claims of the ’514 […]

Submission of New Evidence After Institution of an IPR is “Perfectly Permissible”

Last week, in Genzyme v. Biomarin, the Court of Appeals for the Federal Circuit held petitioners may introduce new evidence after an institution decision in IPR proceedings as long as the opposing party received notice of the new evidence and an opportunity to respond. In its final written decision, the PTAB relied on references beyond […]

Beware: PTAB Mercilessly Enforces Deadlines

The Patent Trial and Appeal Board (PTAB) recently denied motions by Teva to amend the filing dates of two petitions to institute IPRs related to patents covering Suboxone, a drug used to help patients suffering from opioid addiction.  Teva’s deadline for filing these petitions was December 3, 2016, but due to technical difficulties in filing, […]

Federal Circuit Again Defers to PTO, Granting PTAB Broad Discretion Where Statute Offers Little

Last week we posted about the Federal Circuit’s decision in In re Cuozzo Speed Techs., LLC, deferring to the PTAB’s application of the “broadest reasonable interpretation” standard in IPR proceedings.  The Federal Circuit recently gave deference to the PTAB in another context in Redline Detection LLC v. Star Envirotech Inc., granting the PTAB discretion in […]

Federal Circuit Holds it Cannot Review PTAB Decision to Institute IPR

The Federal Circuit held that the Administrative Patent Trial and Appeal Board’s (“PTAB”) decision to institute an Inter Partes Review Proceeding (“IPR”) is not reviewable by the Federal Circuit on appeal.  See Achates Reference Publishing, Inc. v. Apple Inc.  This decision arose from an appeal by the patentee, Achates, of the PTAB’s decision that several […]

PTAB Narrowly Interprets Estoppel Provisions Governing Successive IPR Petitions

In ruling on a “follow-on” inter partes review (IPR), the PTAB held that estoppel under 35 U.S.C. §315(e)(1) does not extent to grounds set forth in a petition that are denied as being redundant to a previous IPR proceeding.  Apotex Inc. v. Wyeth LLC, IPR2015-00873, Paper 8 (P.T.A.B. Sept. 16, 2015). The Facts.  Apotex filed […]

The USPTO’s Second Set of Proposed Changes to IPR Proceedings

Inter partes review became available on September 16, 2012.  Since then, over 3,400 IPR petitions have been filed.  The USPTO implemented a first set of changes, or “quick fixes,” in March, and now, the USPTO seeks to improve IPR via a host of additional proposed changes.  But will they result in any real change?  Only […]

PTAB Rejects ANDA-Filer’s IPR Challenge to Endo’s Opana ER Patent, Finds Limitations Not Inherently Disclosed in Prior Art

On July 22, 2015, the Patent Trial and Appeal Board rejected Amneal Pharmaceuticals LLC’s America Invents Act (AIA) challenge to Endo Pharmaceuticals’ patent related to Opana ER. The patent at issue (the ‘216 patent) relates to oral controlled-release pharmaceutical formulations comprising oxymorphone and methods of using it for sustained pain relief. In its Final Written […]