News & Analysis as of

Medical Devices Teva Pharmaceuticals

A&O Shearman

New Jersey District Court Orders Delisting Of Teva Inhaler Patents From The Orange Book

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On June 10, 2024, Judge Stanley R. Chesler of the United States District Court for the District of New Jersey granted the Amneal defendants’ motion for partial judgment on their counterclaims in a Hatch-Waxman dispute, and...more

Jones Day

FTC Weighs In on Orange Book Listing of Drug-Device Patents

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On March 22, 2024, the Federal Trade Commission ("FTC") filed an amicus brief in Teva Branded Pharmaceutical Products R&D, et al. v. Amneal Pharmaceuticals of New York, LLC, et al., 2:23-cv-20964, U.S. District Court for the...more

WilmerHale

The Interplay: Key Decisions at the Intersection of Antitrust & Life Sciences - March 2024

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Calls for Removal of Device Patents Listed in the Orange Book Continue. FTC and Congressional action scrutinizing allegedly “improper” Orange Book listings continued apace in the first few months of 2024. ...more

Harris Beach PLLC

New York Medical and Life Sciences: Year in Review 2020

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From contraceptives to mesh implants, shampoos to pasta, New York state and federal courts issued decisions in 2020 which further shaped the landscape in the medical and life sciences legal world. To prepare the best product...more

Smart & Biggar

Rx IP Update - February 2019

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Orders of prohibition relating to polymorphic form patent for PRISTIQ upheld on appeal - As previously reported, the Federal Court, in a pair of decisions, granted orders prohibiting Apotex and Teva from marketing their...more

Knobbe Martens

FDA Approves First Generic Epinephrine Autoinjectors

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The United States Food and Drug Administration recently announced approval for Teva Pharmaceuticals to market generic epinephrine autoinjectors. According to the press release, Teva’s autoinjectors are the first generic...more

Morrison & Foerster LLP

Hatch-Waxman and BPCIA Developments in June 2018

This month, we highlight significant developments in June 2018, including a Supreme Court decision regarding the PTAB, a federal court affirmation in Impax Laboratories Inc. v. Lannett Holdings Inc., and new legislation...more

Faegre Drinker Biddle & Reath LLP

Seventh Circuit Clarifies Expert Evidence Requirements for Medical Device Cases in Indiana

On June 4, 2018, the Seventh Circuit affirmed an Indiana federal judge’s determination that a woman’s product liability suit for a broken intrauterine contraceptive device (IUD) required expert evidence under the Indiana...more

Morrison & Foerster LLP

Top Developments in Hatch-Waxman Litigation for April 2018

This month, we highlight several significant cases including Celgene Corp. v. Hetero Labs Ltd. and Regeneron Pharmaceuticals, Inc. v. Merus N.V. as well as new legislation proposed in both houses of Congress with respect to...more

Smart & Biggar

Rx IP Update - March 2018

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No Section 8 Liability for Valid and Infringed Patent in NEXIUM Proceeding - What happens when a patentee is unsuccessful in a prohibition application under the Patented Medicines (Notice of Compliance) (PMNOC)...more

Smart & Biggar

Rx IP Update - February 2018

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Federal Court of Appeal dismisses Teva’s levofloxacin damages appeal - On February 8, 2018, the Federal Court of Appeal issued public reasons for its decision dismissing Teva’s appeal relating to the damages and costs...more

The Volkov Law Group

Anti-Corruption Risks and Drug and Device Companies

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For years, the Justice Department and the Securities and Exchange Commission touted the FCPA “sweep” of the pharmaceutical and medical device industries. With good reason, DOJ and the SEC turned the drug and medical device...more

Baker Donelson

Update on Regulatory Compliance in the Global Health Care Industry

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A comprehensive understanding of the constantly evolving layers that make up federal anti-corruption statutes, sanctions regulations and export control restrictions is imperative for both the pharmaceutical and health care...more

Smart & Biggar

Rx IP Update - May 2017

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Federal Court of Appeal finds that Apotex did not fail to mitigate its damages in relation to Apo-Trazodone drug submission - On April 6, 2017, the Federal Court of Appeal overturned the Federal Court’s finding that...more

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