PTAB Quashes Compound Patent After Rethinking Lead Compound Analysis

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® […]

PTAB DENIES INTER PARTES REVIEW IN VIEW OF PETITIONER’S INCONSISTENT CLAIM CONSTRUCTION POSITIONS

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, […]

Athena Diagnostics v. Mayo – Federal Circuit Rejects Subject Matter Eligibility of Diagnostic Method Claims Requiring Man-Made Molecules

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).  […]

Federal Circuit Confirms that Blocking-Patents Can Kill Secondary Considerations

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 […]

Takeaways from Carlson Caspers’ Presentation at the 2018 Midwest IP Institute

Last week, Carlson Caspers’ attorneys Caroline Marsili and Todd Werner 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 […]

Meeting Notes Linked to Notice in Federal Register Qualify as Prior Art

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 […]

Biosimilars Action Plan – FDA Seeks to Create a Dynamic Biologics Market

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 […]

Intention to File an ANDA may be Sufficient to Establish Standing for a PGR Appeal

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 […]

Federal Circuit Holds That a Customer Does Not Have Standing For a Declaratory Judgment

The Federal Circuit recently held that a healthcare provider did not have standing to bring a declaratory judgment action where its only interest was as a purchaser of potential generic versions of the patented drug. AIDS Healthcare Foundation v. Gilead Sciences, Inc., No. 2016-2475 (Fed. Cir. May 11, 2018).  The court held that absent direct […]