News & Analysis as of

CAFC Amgen

Haug Partners LLP

Federal Circuit Affirms Presumption of Separateness in Regeneron Pharmaceuticals, Inc. v. Mylan Pharmaceuticals Inc. et al., C.A....

Haug Partners LLP on

In a formulation claim, if elements are listed separately, does this necessarily entail that those elements are “separate and distinct components”?  This was the question before the district court in Regeneron...more

Proskauer - The Patent Playbook

The Supreme Court Kept the Door Open to Genus Claims

The U.S. Supreme Court on May 18, 2023 delivered its decision on the scope of the patent enablement requirement, set forth in 35 U.S.C. § 112, in the antibody dispute Amgen, Inc. v. Sanofi. While the parties obtained...more

Foley & Lardner LLP

Can FDA Implement The BPCIA As The CAFC Suggested?

Foley & Lardner LLP on

In Amgen v. Apotex, the Federal Circuit held that under the Biologics Price Competition and Innovation Act (“BPCIA”), “an applicant must provide a reference product sponsor with 180 days’ post-licensure notice before...more

Goodwin

Breaking News: CAFC Affirms in Amgen v. Apotex

Goodwin on

The Federal Circuit issued its decision in Amgen v. Apotex (re: Apotex’s Neulasta biosimilar) this morning. The Court affirmed the district court, holding that the commercial-marketing provision in 42 U.S.C. § 262(l)(8)(A)...more

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