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Pharmaceutical Patents Enforcement Actions

Knobbe Martens

Antitrust Lawsuit Brought Against Drug Manufacturer Based on Its Allegedly Improper Listing of Device Patents in the FDA’s Orange...

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As we recently discussed, the Federal Trade Commission (“FTC”) sent warning letters to certain drug manufacturers regarding their purportedly improper listing of device patents in the Food and Drug Administration’s (“FDA”)...more

Fish & Richardson

FTC Challenges More Than 100 Patents as Improperly Listed in Orange Book

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On November 7, the Federal Trade Commission announced that it is challenging more than 100 patents held by 10 branded drug companies as improperly or inaccurately listed in the Food and Drug Administration’s Orange Book. The...more

American Conference Institute (ACI)

[Event] 41st FDA Boot Camp - September 20th - 21st, Boston, MA

ACI’s FDA Boot Camp is back in Boston! This essential training course – now in its 41st iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under...more

McDermott Will & Emery

Early Adoption of the Unified Patent Court

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The Unified Patent Court (UPC) opened its doors on June 1, 2023. Nineteen actions were initiated during the first six weeks, across a range of subject areas and case values. It had been widely assumed that large companies...more

Jones Day

Vital Signs: Digital Health Law Update Winter 2022

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Note From the Editors With 2022 well underway, the rapid pace of statutory, regulatory, policy, and industry activities in digital health continues in force. We bring you Vital Signs, a curated, one-stop resource on the most...more

Jones Day

Supreme Court Denies Cert On Tribal Sovereign Immunity Question

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On April 15, the Supreme Court denied a petition for certiorari filed by Saint Regis Mohawk Tribe, leaving intact the Federal Circuit’s ruling that tribal sovereign immunity does not apply in inter partes reviews. See Saint...more

Knobbe Martens

The Federal Circuit Finds Tribal Sovereign Immunity does not Apply in IPR

Knobbe Martens on

On July 20, 2018, the Federal Circuit held that tribal sovereign immunity is not available as a defense in IPR. Allergan Pharmaceuticals owned patents that it had asserted in litigation against various generic...more

Knobbe Martens

Saint Regis Mohawk Tribe v. Mylan Pharmaceuticals Inc.

Knobbe Martens on

Federal Circuit Summary - Before Dyk, Moore, and Reyna. Appeal from the Patent Trial and Appeal Board. Summary: Tribal sovereign immunity does not shield Indian Tribe owned patents from IPR. ...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Federal Circuit Declares Tribal Sovereign Immunity Cannot Be Asserted In Inter Partes Review Proceedings

U.S. Court of Appeals for the Federal Circuit affirmed a U.S. Patent Trial and Appeal Board (PTAB) decision finding that tribal sovereign immunity does not apply to Inter Partes Review (IPR) proceedings. In so holding, the...more

Jones Day

European Commission Sets its Sights on Allegedly Excessive Drug Prices

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In the European Union, Big Pharma has been operating with a target on its back for the best part of the last decade. Following its 2008 sector inquiry into the pharmaceutical sector, the Commission vowed to clamp down on...more

Robins Kaplan LLP

After Actavis: Crafting Pharmaceutical Settlements that Avoid Antitrust Scrutiny

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Last year’s Supreme Court decision in FTC v. Actavis cleared the way for more antitrust challenges to settlements between generic and branded pharmaceutical companies resolving Hatch-Waxman patent litigation. As a result,...more

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