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Appeals Pharmaceutical Patents Clinical Trials

Knobbe Martens

Federal Circuit Review | May 2025

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In Jazz Pharmaceuticals, Inc. v. Avadel Cns Pharmaceuticals, LLC, Appeal No. 24-2274, the Federal Circuit held that injunctions prohibiting the initiation of new clinical trials for paper NDA drugs before patent expiration...more

Fish & Richardson

Federal Circuit Reverses Injunction That Barred Clinical Trials in Jazz v. Avadel

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The Federal Circuit recently considered the scope of a permanent injunction that prohibited a drug manufacturer from conducting certain clinical and regulatory activities in Jazz Pharmaceuticals, Inc. v. Avadel CNS...more

McDermott Will & Schulte

Hatch-Waxman or Not, Clinical Trials Aren’t Subject to Injunction

Analyzing the permissible scope of an injunction under the Hatch-Waxman Act, the US Court of Appeals for the Federal Circuit reversed the district court’s prohibitions on an open-label extension (OLE) of a then-running...more

Smart & Biggar

2019 Mid-Year Highlights in Canadian Life Sciences IP

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Below are the major highlights in Canadian life sciences intellectual property and regulatory law that we have reported on in the first half of 2019....more

Knobbe Martens

Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Company

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Federal Circuit Summaries - Before Newman, Dyk, and Chen. Appeal from the Patent Trial and Appeal Board. Summary: An injury-in-fact is required to establish Article III standing for judicial review of agency action,...more

Smart & Biggar

Rx IP Update - May 2018

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An Update on Vanessa’s Law - This is a special update on the Protecting Canadians from Unsafe Drugs Act (Vanessa’s Law) which was approved on November 6, 2014 (as previously reported), amending the Food and Drugs Act...more

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