News & Analysis as of

Patent Infringement Appeals Prescription Drugs

Robins Kaplan LLP

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

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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

McDermott Will & Emery

Hatch-Waxman Litigation Expenses Are Deductible Under Internal Revenue Code § 162(a)

The US Court of Appeals for the Federal Circuit upheld a US Court of Federal Claims ruling that Hatch-Waxman Act litigation expenses are ordinary and necessary business expenses under § 162(a) of the Internal Revenue Code,...more

McDermott Will & Emery

The Devil Is in the Details: Bioequivalence, In Vitro Testing Not Enough to Establish Infringement

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Addressing for the first time the issue of whether bioequivalence data and in vitro testing can show that an abbreviated new drug application (ANDA) product with different immediate and delayed release portions infringed on a...more

Wilson Sonsini Goodrich & Rosati

The PTAB Review - August 2024

This issue of The PTAB Review begins by providing an analysis of how institution decisions consider declaration testimony submitted by a patent owner. Next, it summarizes proposed rulemaking from the United States Patent and...more

A&O Shearman

Federal Circuit affirms district court finding of no induced or contributory infringement of generic depression drug

A&O Shearman on

In H. Lundbeck A-S v. Lupin Ltd., Case No. 2022-1194 (Fed. Circ. December 7, 2023), Plaintiffs, H. Lundbeck A/S (“Lundbeck”) and Takeda Pharmaceutical Company Ltd., Takeda Pharmaceuticals U.S.A., Inc., Takeda Pharmaceuticals...more

Knobbe Martens

Silence May Support Negative Claim Limitation

Knobbe Martens on

NOVARTIS PHARMACEUTICALS v. ACCORD HEALTHCARE INC. Before Moore, Linn, and O’Malley. Appeal from the United States District Court for the District of Delaware. Summary: A patent application that was silent about a...more

Smart & Biggar

PM(NOC) Regulations: Fourth year following major amendments

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September 21, 2021 marked the fourth anniversary of the significant amendments to the Patented Medicines (Notice of Compliance) Regulations (Regulations). This article provides an update on activities in the fourth year...more

McDermott Will & Emery

Federal Circuit Restores Induced Infringement Verdict Against Teva

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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

Wilson Sonsini Goodrich & Rosati

Federal Circuit Holds That Claims of a Patent Asserted During a Patent Term Extension Are Not Infringed by the Carboxylic Acid...

Recently, the Federal Circuit issued its holding in a case dealing with asserting claims of an extended patent covering administration of dimethyl fumarate formulations to treat multiple sclerosis (MS). Dimethyl fumarate...more

McDermott Will & Emery

Court’s Drug Patent Prescription: Unclaimed Disclosure is Dedicated

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Addressing the disclosure-dedication doctrine, the US Court of Appeals for the Federal Circuit concluded that the disclosure-dedication doctrine barred a patent owner’s claim of infringement under the doctrine of equivalents...more

WilmerHale

Unprecedented State Law on Pharmaceutical “Reverse Payments” Goes Into Effect

WilmerHale on

A new California law, Preserving Access to Affordable Drugs, AB-824 (the Act), which is aimed at curbing reverse-payment patent settlements, took effect on January 1. The Act codifies a presumption that any transfer of value...more

McDermott Will & Emery

Definiteness, Drug Labels and Diclofenac, Oh My

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The US Court of Appeals for the Federal Circuit affirmed a district court’s invalidity and infringement judgments for patents directed to a topical nonsteroidal anti-inflammatory drug, finding that a patent claim reciting a...more

Robins Kaplan LLP

INO Therapeutics LLC v. Praxair Distribution Inc.

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BUT FOR A CLERICAL ERROR TO BE ADDRESSED ON REMAND, THE FEDERAL CIRCUIT AFFIRMS FINDINGS OF INELIGIBLE SUBJECT MATTER AND NON-INFRINGEMENT. Case Name: INO Therapeutics LLC v. Praxair Distribution Inc., 2019 U.S. App. LEXIS...more

Smart & Biggar

Rx IP Update - May 2019

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IN THIS ISSUE: - Federal Court dismisses Servier's application for order of prohibition regarding salt patent for perindopril arginine - FCA upholds issuance of NON-W letter and cancellation of reconsideration process...more

Akin Gump Strauss Hauer & Feld LLP

Federal Circuit Decision Clarifies When an ANDA Filer May Appeal an Adverse IPR Ruling

In Amerigen Pharmaceuticals Limited v. UCB Pharma GmbH, generic drug manufacturer Amerigen appealed a decision of the Patent Trial & Appeal Board finding UCB’s patent to certain chemical derivatives of diphenylpropylamines...more

Smart & Biggar

Rx IP Update - April 2018

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Standing Committee on Health proposes National Pharmacare program, modifications to prescription and generic drug pricing - While common among member countries of the Organisation for Economic Co-operation and Development...more

Ladas & Parry LLP

UK Supreme Court Decision In Actavis V. Eli Lilly – Doctrine Of Equivalents Recognized

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In its decision of July 12, 2017 in Actavis v. Eli Lilly, the Supreme Court of the United Kingdom for the first time formally adopted the concept of a doctrine of equivalents when considering what constituted an infringement...more

Robins Kaplan LLP

Merck Sharp & Dohme Corp. v. Hospira, Inc.

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Case Name: Merck Sharp & Dohme Corp. v. Hospira, Inc. 874 F.3d 724, No. 17-1115, 2017 U.S. App. LEXIS 21201 (Fed. Cir. Oct. 26, 2017) (Circuit Judges Newman, Lourie, and Hughes presiding; Opinion by Lourie, J.; Dissent by...more

Proskauer - New England IP Blog

Jury Verdict Overturned in Pepcid® Dispute After Court Finds Insufficient Evidence of Infringement

Last year, a jury awarded Brigham and Women’s Hospital (“BWH”) approximately $10 million after it found that defendant Perrigo Company’s (“Perrigo”) generic version of Pepcid® Complete® willfully infringed BWH’s patent. After...more

Smart & Biggar

Rx IP Update - June 2017

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Supreme Court of Canada News - SCC denies Apotex leave to appeal omeprazole infringement decision. On June 1, 2017, the Supreme Court dismissed Apotex’s application for leave to appeal (docket no. 37478) the Federal Court...more

Smart & Biggar

Rx IP Update - February 2017

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Federal Court of Appeal rules on non-infringing alternatives and apportionment as defences to an accounting of profits from patent infringement - On February 2, 2017, the Federal Court of Appeal released a...more

Foley & Lardner LLP

Federal Circuit Finds Infringement Under Akamai Of Two-Step Method Of Treatment

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In Eli Lilly & Co. v. Teva Parenteral Medicines, Inc., the Federal Circuit affirmed the district court decision finding infringement under Akamai of a two-step method of treatment when the prescribing information for the...more

Patterson Belknap Webb & Tyler LLP

Biosimilar Litigation Update

With the U.S. biosimilar pathway created by the Biologics Price Competition and Innovation Act (BPCIA) now fully up and running, there are now seven ongoing biosimilar litigations in the U.S. Here are brief updates on recent...more

Troutman Pepper Locke

Third Circuit Decertifies Class on Numerosity Grounds, Listing Relevant Factors for the First Time

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The Modafinil decision bodes well for defendants and represents another step toward increased scrutiny of the class action device in the Third Circuit. On September 13, a divided panel of the U.S. Court of Appeals for...more

McDermott Will & Emery

Contract Manufacturing Is a Commercial Transaction for Purpose of “On-Sale” Bar - The Medicines Company v. Hospira, Inc.

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Addressing the application of the on-sale bar under § 102(b), the U.S. Court of Appeals for the Federal Circuit found that the claims of an asserted patent were invalid based on an agreement, dated more than one year prior to...more

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