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Life Sciences › Generic Drugs › Product Labels

Polsinelli

Federal Circuit Clarifies Rules for Skinny Labeling for Generics and Biosimilar Companies

Polsinelli on

Last week, the Federal Circuit decided Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc., 23-1169 (Fed. Cir. June 25, 2024), a case that spotlighted the issues of skinny labeling and induced infringement for generic...more

American Conference Institute (ACI)

[Virtual Conference] FDA Boot Camp - September 14th - 15th, 8:15 am - 1:30 pm EST

American Conference Institute (ACI) on

Through nearly 19 years, ACI’s FDA Boot Camp has been the training grounds for life sciences attorneys and executives to master the fundamentals of FDA regulation. Don’t miss your opportunity to join their ranks....more

Proskauer - Life Sciences

Skinny Labels May Not Be Dead: Delaware District Court Distinguishes GSK, Dismisses Induced Infringement Claim

Proskauer - Life Sciences on

In one of the first district court opinions applying the Federal Circuit’s recent GSK decision on induced infringement in the context of label carve-outs, Judge Richard Andrews in the District of Delaware held that plaintiff...more

Proskauer - Life Sciences

GSK v. Teva: Federal Circuit Issues New Opinion Analyzing Induced Infringement

Proskauer - Life Sciences on

On August 5, 2021, the Federal Circuit withdrew its October 2020 opinion in GSK v. Teva, summarized in this post on induced infringement of method-of-treatment claims, and issued an opinion that reiterated the prior holding...more

Sheppard Mullin Richter & Hampton LLP

Federal Circuit Agrees to Reconsider Ruling in GSK v. Teva Drug Patent Case

Sheppard Mullin Richter & Hampton LLP on

A Federal Circuit panel on Tuesday vacated its earlier finding that Teva induced infringement of U.S. Patent No. RE40,000, GSK’s patent covering its drug, Coreg®, and set a new round of oral argument for February 23. Back in...more

Fish & Richardson

Attorneys for Branded Companies Should Carefully Review ANDAs for Admissions Regarding Generic Infringement

Fish & Richardson on

Previously, it was recommended that regulatory attorneys consult patent attorneys when preparing labels covering branded pharmaceuticals. In so doing, the label would closely reflect limitations in the asserted patent claims...more

Robins Kaplan LLP

HZNP Medicines LLC v. Actavis Labs. UT, Inc.

Robins Kaplan LLP on

THE DISTRICT COURT’S FINDINGS REGARDING INDEFINITENESS, NON-INFRINGEMENT, AND NON-OBVIOUSNESS WERE AFFIRMED BY THE APPELLATE COURT. Case Name: HZNP Medicines LLC v. Actavis Labs. UT, Inc., No. 2017-2149, -2152, -2153,...more

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