News & Analysis as of

Orange Book Patent Invalidity FDA Approval

American Conference Institute (ACI)

[Virtual Conference] Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA - October 14th - 30th, 1:00 pm EST

ACI’s virtual Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA equips early-career professionals with the legal and regulatory fluency needed to contribute meaningfully to product strategy and...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

Foley & Lardner LLP

No Nexus For Novartis Gilenya Patent

Foley & Lardner LLP on

In Novartis AG v. Torrent Pharmaceuticals Ltd., the Federal Circuit affirmed the decision of the USPTO Patent Trial and Appeal Board (PTAB) invalidating all claims of U.S. Patent 8,324,283, which is one of four Orange...more

McDermott Will & Emery

ANDA Update - October 2015

McDermott Will & Emery on

Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...more

McDonnell Boehnen Hulbert & Berghoff LLP

Spectrum Pharmaceuticals Inc. v. Sandoz Inc. (Fed. Cir. 2015)

Last week the Federal Circuit affirmed a District Court's finding of invalidity and non-infringement in ANDA litigation between Spectrum Pharmaceuticals and Sandoz. In so doing, the Court deferred to the factual...more

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