Classen Immunotherapies

News & Analysis as of

Patent Safe Harbor Applies to Supplemental New Drug Applications

On May 13, 2015, the Federal Circuit confirmed in Classen Immunotherapies, Inc. v. Elan Pharmaceuticals, Inc. that the safe harbor provisions of 35 U.S.C. § 271(e)(1) can shield post-FDA approval activities from liability for...more

Classen Immunotherapies, Inc. v. Elan Pharmaceuticals, Inc. (Fed. Cir. 2015)

The Hatch Waxman statute created a safe-harbor provision, found at 35 U.S.C. § 271(e)(1), that allows ANDA filers and others to practice patented inventions without fear of infringement liability, provided the acts are...more

Classen Immunotherapies, Inc. v. Shionogi, Inc.

Case Name: Classen Immunotherapies, Inc. v. Shionogi, Inc., Civ. No. 13-921-RWT, 2014 U.S. Dist. LEXIS 10642 (D. Md. Jan. 29, 2014) (Titus, J.) - Drug Product and Patent(s)-in-Suit: Computer algorithm and method of...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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