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 the Patent Trial and Appeal Board invalidated Concert Pharmaceuticals’ patent covering modified ruxolitinib compounds in a final inter partes review decision, despite having initially denied institution of the underlying petition. The Board found all claims of U.S. Patent No. 9,249,149 obvious over the prior art. Ruxolitinib is the active ingredient in Concert’s Jakafi® […]
Last week, the Federal Circuit reversed a decision from the District of Delaware that held that a method of treatment patent invalid under 35 U.S.C. § 101. Endo Pharms. Inc. et al. v. Teva Pharms. USA et al. The claim at issue recited: A method of treating pain in a renally impaired patient, comprising the steps […]
The PTAB recently denied a petitioner’s request for inter partes review of a competitor’s surgical device patent, stating that the petitioner failed to provide a claim construction necessary to meet its burden to show a reasonable likelihood that at least one claim is unpatentable. OrthoPediatrics Corp. v. K2M, Inc., IPR2018-01548, Paper 9 (P.T.A.B. March 1, […]
Recently, the Federal Circuit affirmed the decision of the U.S. District Court for the District of Massachusetts holding claims directed to methods for diagnosing neurological disorders invalid for lack of subject matter eligibility under 35 U.S.C. § 101. Athena Diagnostics, Inc. v. Mayo Collaborative Servs , LLC, 2019 U.S. App. LEXIS 3645 (Fed. Cir. 2019). […]
The Federal Circuit recently refused to rehear a panel decision that affirmed a district court’s finding that the existence of a blocking patent negated the patent owner’s argument that commercial success, failure of others, and long-felt but unmet need showed the patents-in-suit were non-obvious. Acorda Therapeutics, Inc. et al. v. Roxane Labs., Inc. et al. (original […]
Last week, Carlson Caspers’ attorneys Caroline Marsili presented a CLE at the 2018 Midwest IP Institute addressing (1) subject matter eligibility under 35 U.S.C. § 101, (2) biosimilar applicants’ use of IPR proceedings and their standing to appeal PTAB decisions, and (3) the CRISPR patent battles. Slides from this presentation summarizing the state of the […]
The Federal Circuit upheld a PTAB decision in which meeting materials published on the FDA website and linked to in a notice in the Federal Register (“Notice”) were sufficiently accessible to constitute “printed publication” prior art in Jazz Pharm. Inc. v Amneal Pharm. LLC, No. 2017-1671, 2018 WL 3400764 (Fed. Cir. July 13, 2018). The […]
Last week, the U.S. Food & Drug Administration (“FDA”) released a Biosimilars Action Plan (“BAP”) with the objective of promoting innovation, competition and affordability of biologics and biosimilar products. Characterizing the BAP as “an important piece of the Administration’s bold Blueprint to Lower Drug Prices,” the FDA underscored the need for a competitive market for […]
Around the same time the Federal Circuit decided that a prospective ANDA customer lacked declaratory judgment standing in AIDS Healthcare, reported on here, it held that a prospective ANDA filer has standing to appeal a PTAB decision. In Altaire Pharmaceuticals, Inc. v. Paragon Bioteck, Inc., No. 2017-1487 (Fed. Cir. May 2, 2018), a sharply-divided panel found […]