Hatch-Waxman Safe Harbors Patents

News & Analysis as of

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

Hatch-Waxman Watch: Safe Harbor Edition

Last week, two district courts dispensed with lawsuits based on the protections afforded by the safe harbor provision of the Hatch-Waxman statute. Both of the cases relied heavily on the Federal Circuit case Momenta Pharm....more

MBHB Snippets: Review of Developments in Intellectual Property Law - Winter 2013 - Volume 11, Issue 1

In This Issue: Federal Courts Debate Safe Harbor Exemption for Patent Infringement Under 35 U.S.C. § 271(e) Following Merck v. Integra; If I Prioritize Examination of My Application, Should the Patent Office?;...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

Intellectual Property Newsletter - December 2012

In This Issue: ..News From the Bench: - Clarification of the “Vitiation Test” when applying the Doctrine of Equivalents. - The “Success More Likely Than Not” and “Ordinary Observer” Standards for a...more

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