In a nonprecedential opinion issued on June 25, 2021, the Federal Circuit upheld the PTAB’s rule against incorporation of evidence by reference. 3M Company v. Evergreen Adhesives, Inc., No. 2020-1738 (Fed. Cir. June 25, 2021). 3M filed an IPR against Evergreen Adhesives Inc. (formerly Westech Aerosol Corp.), asserting that its aerosol adhesive patent was invalid…
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…
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…
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…
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…
Last week Judge Casper of the District of Massachusetts joined the District of Delaware in holding that IPR estoppel under 35 U.S.C. § 315(e)(2) does not apply to grounds that a petitioner failed to raise in its petition. Koninklijke Philips N.V. et al. v. Wang Alliance Corp. This decision adds to a growing district court…
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…
Last week, the Federal Circuit held in Phigenix, Inc. v. Immunogen, Inc. that a party must be able to prove injury in fact in order to challenge an inter partes review decision in Federal Court. (Fed. Cir. Jan. 9, 2017). Specifically, while any party may challenge a patent via IPR regardless of Article III standing,…
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…
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,…