Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
The US Court of Appeals for the Federal Circuit invalidated yet another set of antibody genus claims, finding the case “materially indistinguishable” from those in the 2023 Supreme Court of the United States case, Amgen v....more
In Amgen Inc. v. Sanofi, the Federal Circuit held that the use of broad functional claim language raises the bar for enablement. Specifically, the court held that defining an antibody based on binding to a certain protein...more
On June 16, 2021, the District Court for the District of Delaware issued a claim construction order construing a key term in the ongoing patent dispute between Amgen and Hospira over Hospira’s proposed biosimilar of Amgen’s...more
PATENT CASE OF THE WEEK - Amgen Inc. v. Amneal Pharmaceuticals LLC, et al., Appeal Nos. 2018-2414, et al. (Fed. Cir. Jan. 7, 2020) - In this appeal from Markman and summary judgment opinions by the district court in a...more
Transitional terms in patent law (conventionally, "comprising," "consisting of," and the more arcane "consisting essentially of") have their own provenance and meaning, denoting limitations that are "open" (comprising) or...more
The US Court of Appeals for the Federal Circuit affirmed a summary judgment non-infringement ruling, finding that where both the claim language and the specification require that the disclosed steps be performed in the order...more
As we previously reported, Mylan recently filed a motion for judgment on the pleadings regarding Amgen’s assertion of the ’707 Patent, which covers methods related to producing the biosimilar pegfilgrastim. Mylan’s motion...more
Last week, the Patent Trial and Appeal Board (“Board”) denied institution of four IPR petitions on biologics-related patents. First, the Board denied institution of IPR2017-01987 and IPR2017-01988, both filed by Sandoz Inc. ...more
The Situation: The Biologics Price Competition and Innovation Act was considered in a November 2017 decision by the United States Court of Appeals for the Federal Circuit. The Result: The court found that the commercial...more
Andrews, J. Claim construction opinion issues regarding two terms from one patent. A Markman hearing took place on September 21, 2016. The disputed technology relates to pharmaceutical compositions containing isoforms...more
A few BPCIA litigation updates to wrap up the week for our readers, looking ahead to next week: ..The Federal Circuit issued its formal mandate in Amgen v. Apotex yesterday. With the issuance of the formal mandate, the...more
WBIP, LLC v. Kohler Co. (No. 2015-1038, -1044, 7/19/16) (Moore, O'Malley, Chen) - Moore, J. Affirming denial of JMOL that patent was invalid as obvious and lacked an adequate written description, affirming finding of...more