No Standing for ANDA Partner to Appeal Unfavorable IPR Ruling

The Federal Circuit recently dismissed an appeal of an adverse IPR decision by a generic pharmaceutical company for lack of Article III standing, finding that the company—which had yet to file an ANDA—had not suffered an injury-in-fact. The underlying IPR, originally filed by Apotex, involved U.S. Patent No. 9,187,405 (directed to methods of treating multiple […]

PETITIONERS SHOULD ADDRESS OBJECTIVE INDICIA OF NONOBVIOUSNESS IN PETITIONS FILED WITH THE PTO

Recently, the PTAB denied Gilead Sciences, Inc.’s (Gilead) request to institute an inter partes review of two patents relating to HIV-prevention, U.S. Patent No. 9,044,509 (the ’509 patent) and U.S. Patent No. 9,579,333 (the ’333 patent). One key reason for the denial was because Gilead failed to adequately address unexpected results in its Petition. The […]

Success in an IPR Does Not Necessarily Ensure Success in Court

In a recent opinion, the District Court of New Jersey held that a decision in a parallel proceeding at the Patent and Trademark Appeal Board (PTAB) does not give rise to collateral estoppel in the court proceeding. The case concerns Sanofi Aventis’s (“Sanofi”) LANTUS® injectable insulin drug, indicated for the treatment of diabetes mellitus. After […]

District of Delaware Applies IPR Estoppel Even Though the Final Written Decision Did Not Issue Until After Trial

The District of Delaware recently weighed in on the scope of IPR estoppel in Novartis Pharmaceuticals Corp. v. Par Pharmaceutical, Inc., 14-cv-01289 (D. Del. Apr. 11, 2019).  Describing the issue before it as a matter of first impression, the Court held that “IPR estoppel will still apply post-trial where the Court has not entered a […]

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 […]

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 […]