Biogen Idec

News & Analysis as of

Momenta Pharmaceuticals, Inc. v. Teva Pharmaceuticals USA Inc. (Fed. Cir. 2015)

The question of the extent to which the "safe harbor" against infringement as part of the Hatch-Waxman Act (set forth in 35 U.S.C § 271(e)(1)) extends to activities post-generic drug approval is unresolved, as evidenced by...more

PTAB Says: Abuse of Process and Improper Use Discovery is Moot in Denial of IPR Petition

In a recent decision on yet another inter parties review petition brought by billionaire hedge-fund manager Kyle Bass through one of his Coalition for Affordable Drugs entities, the PTAB denied institution of an IPR against...more

Federal Circuit Finds Prosecution History Disclaimer in Enablement Arguments

In Biogen Idec, Inc. v. GlaxoSmithKline LLC, the Federal Circuit upheld a narrow claim interpretation based on prosecution history disclaimer. The court held that the applicants’ arguments against an enablement rejection...more

Biogen Idec, Inc. v. GlaxoSmithKline LLC (Fed. Cir. 2013)

Yesterday, in Biogen Idec, Inc. v. GlaxoSmithKline LLC, the Federal Circuit affirmed the determination by the District Court for the Southern District of California that the claim term "anti-CD20 antibody" as used in U.S....more

Intellectual Property Bulletin Winter 2013: Murky Waters: Post-Approval Regulatory Activities and the § 271(e)(1) Safe Harbor

On January 14, 2013, the U.S. Supreme Court refused to consider the U.S. Court of Appeals for the Federal Circuit's exclusion in Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057 (Fed. Cir. 2011), of post-approval...more

Supreme Court Declines Opportunity to Clarify Scope of Hatch-Waxman Safe Harbor

The U.S. Supreme Court on Jan. 14, 2013, denied GlaxoSmithKline’s petition for certiorari seeking review of the Federal Circuit’s interpretation of the Hatch-Waxman safe-harbor provision at 35 USC 271(e)(1) in Classen...more

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