News & Analysis as of

Patent Infringement Induced Infringement Abbreviated New Drug Application (ANDA)

A&O Shearman

Federal Circuit Affirms Findings Of Non-Obviousness And Infringement Of Method Of Treatment Patent Claiming Dosing Regimen For...

A&O Shearman on

On March 28, 2025, the United States Court of Appeals for the Federal Circuit issued an opinion affirming the United States District Court for the District of New Jersey decision that Mylan Laboratories Ltd. (“Mylan”) induced...more

Robins Kaplan LLP

Janssen Pharms., Inc. v. Mylan Labs. Ltd.

Robins Kaplan LLP on

Invega Trinza® (paliperidone palmitate) - Case Name: Janssen Pharms., Inc. v. Mylan Labs. Ltd., No. 2023-2042, 2025 WL 946390 (Fed. Cir. Mar. 28, 2025) (Circuit Judges Dyk, Prost, and District Judge Goldberg presiding;...more

Robins Kaplan LLP

Salix Pharms., Ltd. v. Norwich Pharms., Inc. Xifaxan® (Rifaximin)

Robins Kaplan LLP on

Case Name: Salix Pharms., Ltd. v. Norwich Pharms., Inc., C.A. No. 20-cv-430-RGA, 2022 WL 3225381 (D. Del. Aug. 10, 2022) (Andrews, J.) Drug Product and Patent(s)-in-Suit: Xifaxan® (rifaximin); U.S. Patents Nos. 7,612,199...more

Hogan Lovells

Federal Circuit affirms GSK labeling carve-out ruling in favor of innovator

Hogan Lovells on

Earlier this month, in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., a panel of the U.S. Court of Appeals for the Federal Circuit (CAFC) affirmed (2-1) upon rehearing its October 2020 decision that a labeling...more

Proskauer - The Patent Playbook

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

Kilpatrick

GSK v. Teva: The Skinny On Induced Infringement And Label Carve-Outs

Kilpatrick on

Statutory Basis For Label Carve-Outs - Section viii of the Hatch-Waxman Act permits an Abbreviated New Drug Application (ANDA) applicant to obtain FDA approval to market a generic version of a drug for a non-patented use...more

Troutman Pepper Locke

Federal Circuit Places “Skinny Labels” in Danger

Troutman Pepper Locke on

Section viii of the Hatch-Waxman Act, 21 U.S.C. § 355(j)(2)(A)(viii), allows a generic applicant to “carve out” indications and other use information from its labeling that are protected by patents listed in FDA’s Orange Book...more

McDermott Will & Emery

Federal Circuit Restores Induced Infringement Verdict Against Teva

McDermott Will & Emery on

Addressing the issue of whether a generic pharmaceutical company can be found to induce infringement even when all patented uses have been “carved out” of the label (resulting in a so-called “skinny label”), the US Court of...more

Haug Partners LLP

Induced Infringement: The Federal Circuit Addresses the Role of Skinny Labels in the Determination of Induced Infringement for...

Haug Partners LLP on

On October 2, 2020, the Federal Circuit issued a decision in GlaxoSmithKline LLC v. Teva Pharm. USA, Inc.1 that addressed whether a generic drug manufacturer induced infringement of a method of use patent when its product...more

McDonnell Boehnen Hulbert & Berghoff LLP

GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc. (Fed. Cir. 2020)

What Quantum of Culpable Conduct Is Required for an ANDA Applicant to Induce Infringement? The back-and-forth, (almost) cat-and-mouse-like competition between branded innovator and generic drug makers sanctioned under the...more

Knobbe Martens

Federal Circuit Review - October 2019

Knobbe Martens on

The PTAB Cannot Approve or Deny Certificates of Correction - In Honeywell International, Inc. v. Arkema Inc., Arkema France, Appeal Nos. 2018-1151, -1153, the Patent Trial and Appeal Board (“Board”) does not have the...more

Foley & Lardner LLP

How The Fanapt Product Label Established Infringement Of Personalized Treatment Claims

Foley & Lardner LLP on

Our first article on Vanda Pharmaceuticals, Inc. v. Aventisub, LLC focused on the Federal Circuit’s decision upholding the subject matter eligibility of the personalized method of treatment claims under 35 USC § 101. Here, we...more

Schwabe, Williamson & Wyatt PC

Fresh From the Bench: Latest Federal Circuit Court Cases

In an ANDA applicant’s appeal from a bench trial judgment of validity and infringement, the Court affirmed the district court’s judgment on all counts. The case presented unusual procedural circumstances in a Hatch-Waxman...more

Foley & Lardner LLP

CAFC Finds ANDA Infringement Despite Differences Between FDA Labeling And Claim Language

Foley & Lardner LLP on

In a non-precedential decision issued in Braintree Labs., Inc. v. Breckenridge Pharmaceutical, Inc., the Federal Circuit reversed the district court’s grant of summary judgment of noninfringement in favor of Breckenridge, and...more

Morris James LLP

Closed Case Is Reopened To Amend Induced Infringement Claims In ANDA Litigation Relating To Mitigare

Morris James LLP on

Robinson, J. Plaintiff’s motion to reopen judgment and amend the complaint is granted. Plaintiff’s request for a preliminary injunction was denied and the denial was affirmed on appeal. On September 10, 2015, Takeda...more

Morris James LLP

Iloperidone trial results in finding of infringement of valid patents

Morris James LLP on

In this ANDA trial, the disputed technology relates to the treating a patient suffering from schizophrenia with iloperidone. The court finds that all asserted claims in the patents-in-suit are valid. The ‘610 patent is not...more

McDermott Will & Emery

Supplier to ANDA Filer Is Not Liable for Induced Infringement Until After ANDA Approval - Shire LLC v. Amneal Pharms., LLC

McDermott Will & Emery on

Addressing the scope of the safe harbor provision of § 271(e)(1), the U.S. Court of Appeals for the Federal Circuit reversed the district court, holding that supplying an active pharmaceutical ingredient (API) to the filer of...more

Foley & Lardner LLP

Divided Infringement Between Doctor and Patient

Foley & Lardner LLP on

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

McDonnell Boehnen Hulbert & Berghoff LLP

Eli Lilly and Company v. Teva Parenteral Medicines, Inc. (S.D. Ind. 2015) - District Court Finds Lilly Patent Infringed Based on...

Last week, in Eli Lilly and Company v. Teva Parenteral Medicines, Inc., Judge Tanya Walton Pratt of the U.S. District Court for the Southern District of Indiana determined that Eli Lilly and Company had shown by a...more

McDermott Will & Emery

ANDA Update - July 2015

McDermott Will & Emery on

Supreme Court Holds Good Faith Belief of Patent Invalidity Is Not a Defense to Induced Infringement - Commil USA, LLC v. Cisco Systems, Inc. (Supr. Ct. May 26, 2015): Pharmaceutical patents commonly include...more

Morris James LLP

Magistrate Recommends Dismissing Certain Induced Infringement Claims

Morris James LLP on

The disputed technology relates to carvedilol, initially patented 20 years ago for the treatment of hypertension, and now for the treatment of chronic heart failure. Defendants filed ANDAs for generic versions of the drug...more

Robins Kaplan LLP

United Therapeutics Corp. v. Sandoz, Inc.

Robins Kaplan LLP on

Nature of the Case and Issue(s) Presented: UTC claimed that Sandoz induced infringement of the ’007 patent by instructing physicians to dilute its product for use intravenously. The asserted claim required a particular...more

McDermott Will & Emery

IP Update, Vol. 16, No. 7, July 2013

McDermott Will & Emery on

“Reverse Payment” Settlements Face Greater Antitrust Scrutiny Following U.S. Supreme Court Ruling in FTC v. Actavis: Federal Trade Commission v. Actavis, Inc. - Resolving a split among the U.S. Courts of Appeals, the...more

23 Results
 / 
View per page
Page: of 1

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
- hide
- hide