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 […]

Proposed Amendment to Hatch-Waxman Act May Prohibit Use of Post-Grant Procedures

U.S. Senator Orrin Hatch, co-author of the Hatch-Waxman Act, recently proposed an amendment to the Act that would prevent generic drug companies from using any AIA post-grant procedure (IPR or PGR) on an Orange Book patent identified in their PIV certifications.  The proposed amendment would require that the patent certification required under 21 USC § […]

USPTO Begins Effort to Abandon Broadest Reasonable Construction Standard in Contested PTO Proceedings

Less than two months after Andrei Iancu was confirmed as the new Director of the USPTO, the Office issued a Notice of Proposed Rulemaking concerning the claim construction standards employed in contested USPTO proceedings, including IRPs, PGRs, and CBMs.  The proposed change would abandon the broadest reasonable construction standard currently used for unexpired patents in […]

Federal Circuit Skips the Mayo in Upholding Vanda’s Fanapt® Patent

A divided Federal Circuit panel upheld Vanda’s patent covering its iloperidone schizophrenia treatment (Fanapt®), holding the method of treatment claims were directed to patent-eligible subject matter.  Vanda Pharms. Inc., et al. v. West-Ward Pharms. Int’l Ltd., et al., Nos. 2016-2707, 2016-2708 (Fed. Cir. Apr. 13, 2018).  In meticulously evading the Supreme Court’s Mayo decision, Vanda […]