News & Analysis as of

Patent Litigation Summary Judgment Food and Drug Administration (FDA)

Rothwell, Figg, Ernst & Manbeck, P.C.

Federal Circuit Denies Teva’s Request for En Banc Rehearing in Orange Book Patent Dispute

In our previous articles, we reported that the Federal Circuit affirmed the district court’s decision on December 20, 2024 ordering Teva Pharmaceuticals (“Teva”) to delist certain patents related to Teva’s ProAir® HFA...more

Fuerst Ittleman David & Joseph

Lilly v. FDA: Two Stories Collide to Make this GLP-1 Case a Tale of Our Time

I recently learned of Eli Lilly & Co.’s (“Lilly”) recent lawsuit against FDA from Nicole DeFeudis, who interviewed me for her Endpoints News story about the case. Lilly’s lawsuit, filed in September 2024 in the Southern...more

Robins Kaplan LLP

ANDA Litigation Settlements - Fall 2019

Robins Kaplan LLP on

Please see full Chart below for more information....more

WilmerHale

Federal Circuit Patent Updates - July 2016

WilmerHale on

Amgen Inc. v. Apotex Inc. (No. 2016-1308, 7/5/16) (Wallach, Bryson, Taranto) - July 5, 2016 12:05 PM - Taranto, J. In a suit under the Biologics Price Competition and Innovation Act, affirming the grant of a...more

McDermott Will & Emery

Supplier to ANDA Filer Is Not Liable for Induced Infringement Until After ANDA Approval - Shire LLC v. Amneal Pharms., LLC

McDermott Will & Emery on

Addressing the scope of the safe harbor provision of § 271(e)(1), the U.S. Court of Appeals for the Federal Circuit reversed the district court, holding that supplying an active pharmaceutical ingredient (API) to the filer of...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

Robins Kaplan LLP

Braintree Labs., Inc. v. Novel Labs., Inc.

Robins Kaplan LLP on

Case Name: Braintree Labs., Inc. v. Novel Labs., Inc., Case No. 3:11-cv-01341-PGS-LHG, 2015 U.S. Dist. LEXIS 70993 (D.N.J. June 2, 2015) (Sheridan, J.) - Drug Product and Patent(s)-in-Suit: Suprep® Bowel Prep Kit (sodium...more

Foley & Lardner LLP

Federal Circuit Find Fractures in Roche Boniva Patents

Foley & Lardner LLP on

In Hoffman-LaRoche, Inc. v. Apotex, Inc., the Federal Circuit affirmed the district court’s summary judgment that two Roche Boniva patents are invalid as obvious. The conclusion of obviousness is not particularly remarkable...more

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