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FDA Approval Appeals Orange Book

Fish & Richardson

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

Fish & Richardson on

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 & Emery

ANDA Applicant Has Standing to Appeal IPR Decision, Even with Only Paragraph III Certification

The US Court of Appeals for the Federal Circuit found that a failed inter partes review (IPR) petitioner that maintained a Paragraph III certification had sufficient standing to appeal an adverse decision, but affirmed the...more

Knobbe Martens

Endo Pharmaceuticals Solutions v. Custopharm Inc.

Knobbe Martens on

Federal Circuit Summary - Before Moore, Linn, and Chen. Appeal from the United States District Court for the District of Delaware. Summary: A prior art reference does not inherently disclose the elements of a claim...more

Jones Day

Federal Circuit Holds Objective Indicia Must Be Linked to Novel Features

Jones Day on

In Novartis AG v. Torrent Pharms. Ltd. (2016-1352), the Federal Circuit affirmed the PTAB’s decision in consolidated IPR proceedings (IPR2014-00784, IPR2015-00518) invalidating all claims of U.S. Patent 8,324,283. In doing...more

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