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Do Patent Claims to Methods of Treatment Cover In Vivo Transformations?

Where an alleged infringer administers a substance A to a subject, and the substance is subsequently transformed to a therapeutic agent X inside the subject’s body, does the administration of the substance A constitute an act...more

Supreme Court Unanimously Affirms Amgen Repatha® Antibody Patents Invalid for Lack of Enablement

On May 19, 2023, the Supreme Court in Amgen v. Sanofi, No. 21-757, unanimously held that the claims of two Amgen patents, both directed to a genus of potentially millions of antibodies, are invalid because the patents failed...more

Genus Claims: Foiled again by Written Description

In late August of 2021, the Federal Circuit reversed a jury verdict of $1.2 billion in favor of Juno Therapeutics and Sloan Kettering Institute because the jury’s finding that four of the asserted patent claims did not lack...more

Federal Circuit Upholds Application of Dedication-Disclosure Doctrine at the Pleading Stage

On May 8, 2020, the Court of Appeals for the Federal Circuit affirmed the District of Delaware’s application of the disclosure-dedication doctrine in granting a motion for judgment on the pleadings in Eagle Pharmaceuticals...more

Federal Circuit affirms Safe Harbor ruling and $70 million award in Amgen Inc. v. Hospira, Inc.

On December 16, 2019, the Court of Appeals for the Federal Circuit issued an opinion that fully upheld the District of Delaware’s denial of Hospira, Inc.’s motion for judgment as a matter of law (JMOL), or alternative motion...more

Assertion of Patents Results in Loss of Sovereign Immunity for Public Universities

On December 19, 2017, an expanded panel of the Patent Trial and Appeal Board (PTAB) ruled that the state of Minnesota waived its Eleventh Amendment immunity to challenges to patent validity by inter partes review (IPR) by...more

Federal Circuit Evaluates Import of Factual Statements Made During BPCIA Pre-litigation Patent Dance

In a nonprecedential opinion issued on November 13, 2017, the United States Court of Appeals for the Federal Circuit affirmed a district court finding that Apotex’s aBLAs for biosimilar versions of Neulasta® and Neupogen® did...more

Amgen Sues Coherus Under BPCIA After Completing Patent Dance

On May 10, 2017, Amgen filed a complaint in the District of Delaware asserting that, under section 35 U.S.C. § 271(e)(2)(C)(i) of the Biologics Price Competition and Innovation Act (“BPCIA”), Coherus infringed Amgen’s U.S....more

Apotex to Supreme Court: Review BPCIA 180-Day Notice Requirement

On September 9, 2016, Apotex Inc. filed a petition for writ of certiorari in the U.S. Supreme Court seeking review of the Federal Circuit’s decision in Amgen Inc. v. Apotex Inc., Case No. 2016-1308. This case involves...more

Biosimilars, the BPCIA, and Amgen v. Sandoz: The Federal Circuit’s First Attempt To Make Sense of “A Riddle Wrapped in a Mystery...

On July 21, 2015, the Federal Circuit issued a key decision regarding the meaning of various provisions of the Biologics Price Competition and Innovation Act (BPCIA). See Amgen Inc. v. Sandoz Inc., Fed. Cir. Case No....more

District Court Rules Against Amgen’s Motion for Preliminary Injunction to Prevent Marketing of Sandoz’s Biosimilar Zarxio

In an order released on March 19, 2015, U.S. District Court Judge Richard Seeborg of the Northern District of California denied Amgen’s motion for judgment on the pleadings as well as its request for a preliminary injunction...more

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