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Pharmaceutical Industry › Food and Drug Administration (FDA) › En Banc Review

Fenwick & West LLP

Federal Circuit Reaffirms Scope of Safe Harbor Defense to Patent Infringement

Fenwick & West LLP on

In 2019, Edwards Lifesciences Corporation sued Meril Life Sciences Pvt. Ltd. for patent infringement in the Northern District of California, with Fenwick representing Meril in the district court case and the recent appellate...more

Proskauer - Minding Your Business

The Broad Impact of Edwards v. Meril on the Safe Harbor Provision

Proskauer - Minding Your Business on

The Federal Circuit’s decision in Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., has garnered significant attention, especially concerning the application of the “safe harbor” provision under 35 U.S.C. §...more

McDonnell Boehnen Hulbert & Berghoff LLP

Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. (Fed. Cir. 2024)

McDonnell Boehnen Hulbert & Berghoff LLP on

A fractured affirmance of a district court decision to dismiss an infringement action under 35 U.S.C. § 271(e)(1) was the occasion for the Federal Circuit to illustrate the continued debate over the scope of the safe harbor...more

King & Spalding

Genus Medical Technologies LLC v. FDA: D.C. Circuit Holds FDA Cannot Regulate Devices as Drugs

King & Spalding on

FDA regulation of biomedical products can be like a very complex game theory decision tree. Choices made at each intersection impact the ultimate regulatory framework under which any given product is developed, seeks...more

Patterson Belknap Webb & Tyler LLP

Sovereign Immunity for State Plaintiffs in Antitrust Class Actions?

Patterson Belknap Webb & Tyler LLP on

The Third Circuit recently denied a petition for rehearing en banc a panel’s earlier decision in the In re Flonase Antitrust Litigation. In that case, the panel decision addressed the degree to which class settlements can...more

K&L Gates LLP

BPCIA Statute: Has the Music Stopped or Will the Patent Dance Continue?

K&L Gates LLP on

In July, a divided Federal Circuit issued a ruling in the Amgen Inc. et al. v. Sandoz Inc., Case No. 2015-1499 appeal and held: (1) the Biologics Price Competition and Innovation Act’s (“BPCIA’s”) “patent dance” provisions...more

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