News & Analysis as of

Patent Infringement Generic Drugs Product Labels

Polsinelli

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

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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

Proskauer - Life Sciences

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

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

Jones Day

Federal Circuit Vacates Judgment, Reinstates Jury's Verdict of Induced Infringement

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Background - On August 5, 2021, the Federal Circuit issued an opinion in GlaxoSmithKline v. Teva Pharmaceuticals, Case No. 18-1976, in favor of GSK, finding that Teva was liable for inducing infringement of GSK's patent....more

Proskauer - Life Sciences

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

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

Knobbe Martens

Ineffective Skinny Label Leaves Generic Liable Despite Effort to Carve-Out the Patented Indication

Knobbe Martens on

GLAXOSMITHKLINE LLC v. TEVA PHARMACEUTICALS USA, INC. [OPINION] – PRECEDENTIAL - Before Moore, Newman, Prost (dissent). Panel rehearing of an appeal from the U.S. District Court for the District of Delaware - Summary:...more

Dechert LLP

Federal Circuit Tailors its Decision on Skinny Labels

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As we sensed when we last wrote about the Federal Circuit’s handling of the infringement dispute over GlaxoSmithKline’s ("GSK") Coreg® product in GlaxoSmithKline LLC, v. Teva Pharm. USA, Inc., the Judges have dug into their...more

Dechert LLP

Chief Judge Leads Federal Circuit in Reconsidering its Appetite for Skinny Labels

Dechert LLP on

The Chief Judge of the U.S. Court of Appeals for the Federal Circuit Sharon Prost, has quipped that, with her experience in both the legislative and judicial branches of government, she is a “walking separation of powers.”...more

Sheppard Mullin Richter & Hampton LLP

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

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

Hogan Lovells

Labeling carve-out does not shield generic drug makers from induced infringement claims, CAFC rules

Hogan Lovells on

The U.S. Court of Appeals for the Federal Circuit (CAFC) recently decided (2-1) in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc. that a labeling carve-out by a generic drug sponsor did not preclude a finding of...more

Fish & Richardson

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

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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

McDermott Will & Emery

Polymorphic Patent Survives Obviousness Challenge

McDermott Will & Emery on

In a Hatch-Waxman case involving patents directed to a polymorphic compound for a treatment for polyneuropathic pain, the US Court of Appeals for the Federal Circuit affirmed a district court finding that a patent was not...more

Smart & Biggar

Rx IP Update - July 2017

Smart & Biggar on

Supreme Court of Canada strikes down "promise doctrine", upholds AstraZeneca’s NEXIUM patent as useful - As previously reported, on June 30, 2017, the Supreme Court of Canada granted AstraZeneca’s appeal in the NEXIUM...more

Foley & Lardner LLP

Divided Infringement Between Doctor and Patient

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Recent jurisprudence on the issue of divided infringement has arisen in the context of computer-related technologies, where a user or customer performs one or more steps of a patented method. Now the issue has arisen in the...more

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