IS THE A IN ANDA BEGINNING TO MEAN ANTITRUST?
Case Name: Amgen Inc. v. Sandoz Inc., Nos. 2022-1147, 2022-1149, 2022-1150, 2022-1151, 2023 WL 2994166 (Fed. Cir. Apr. 19, 2023) (Circuit Judges Lourie, Cunningham, and Stark presiding; Opinion by Lourie, J.) (Appeal from...more
Case Name: Amgen Inc. v. Amneal Pharms. LLC, 2018-2414, 2019-1086, 2020 U.S. App. LEXIS (Fed. Cir. Jan. 7, 2020) (Circuit Judges Newman, Lourie, and Taranto presiding; Opinion by Lourie, J.) (Appeal from D. Del., Goldberg,...more
The Federal Circuit’s recent decision in Amgen Inc. v. Amneal Pharms. LLC, 945 F.3d 1368 (Fed. Cir. 2020) provides guidance on construing claims that recite Markush groups, particularly in combination with the open and closed...more
About Life Sciences Court Report: We will periodically report on recently filed biotech and pharma litigation. ...more
PATENT CASE OF THE WEEK - Amgen Inc. v. Amneal Pharmaceuticals LLC, et al., Appeal Nos. 2018-2414, et al. (Fed. Cir. Jan. 7, 2020) - In this appeal from Markman and summary judgment opinions by the district court in a...more
Transitional terms in patent law (conventionally, "comprising," "consisting of," and the more arcane "consisting essentially of") have their own provenance and meaning, denoting limitations that are "open" (comprising) or...more
THE COURT DENIED DEFENDANT’S MOTION TO ENFORCE ITS SETTLEMENT AGREEMENT WITH PLAINTIFF AFTER THE AT-RISK LAUNCH AND SUBSEQUENT SETTLEMENT OF ANOTHER DEFENDANT. Case Name: Amgen Inc. v. Amneal Pharms. LLC, No. 16-853-MSG...more
The Court Denied Defendant’s Motion To Enforce Its Settlement Agreement With Plaintiff After The At-risk Launch And Subsequent Settlement Of Another Defendant. ...more
Case Name: Cipla Ltd. v. Amgen Inc., No. 19-44-LPS, 2019 U.S. Dist. LEXIS 74970 (D. Del. May 2, 2019) (Stark, J.) - Drug Product and Patent(s)-in-Suit: Sensipar® (cinacalcet HCl); U.S. Patent No. 9,375,405 (“the ’405...more
Case Name: Amgen Inc. v. Amneal Pharms. LLC, Civ. No. 16-0853 (MSG), 2018 U.S. Dist. LEXIS 125631 (D. Del. July 27, 2018) (Goldberg, J.)....more
Case Name: Amgen Inc. v. Alkem Labs. Ltd., Civ. No. 17-cv-815-GMS, -817-GMS, 2017 U.S. Dist. LEXIS 208124 (D. Del. Dec. 19, 2017) (Sleet, J.). Drug Product and Patent(s)-in-Suit: Sensipar® (cinacalcet HCl); U.S. Patent...more
By Memorandum Order entered by The Honorable Gregory M. Sleet in Amgen Inc. v. Macleods Pharmaceuticals, Ltd., Civil Action No. 17-817-GMS (D.Del. December 19, 2017) (consolidated), the Court denied the Motion for Judgment on...more
On August 4, 2016, Abbvie Inc. filed a complaint against Amgen, Inc. under the Biologics Price Competition and Innovation Act (BPCIA), asserting that Amgen’s application for approval of a biosimilar version of HUMIRA®...more
In Amgen v. Apotex, the Federal Circuit held that under the Biologics Price Competition and Innovation Act (“BPCIA”), “an applicant must provide a reference product sponsor with 180 days’ post-licensure notice before...more
180-Day Notice Period for Biosimilar Approval Is Always Mandatory and Enforceable by Injunction - Amgen Inc., v. Apotex Inc., (Fed. Cir. July 5, 2016) - A year after analyzing the patent dance and notice...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Astellas Pharma Inc. et al. v. Apotex Inc. et al. 1:15-cv-00857; filed September 22, 2015 in the District Court of...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Amgen Inc. et al. v. Apotex Inc. et al. 0:15-cv-61631; filed August 6, 2015 in the Southern District of Florida. •...more
Near the end of last month, the U.S. Food and Drug Administration ("FDA") denied a citizen petition filed by Amgen in which it requested that action be taken to ensure that biosimilar applicants comply with the disclosure and...more
As we have discussed before, the first generation of biosimilar litigation under the Biologics Price Control and Innovation Act (BPCIA) addresses whether the BPCIA’s patent dispute resolution procedures – the “patent dance” –...more
About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Par Pharmaceutical, Inc. v. Glaxosmithkline LLC et al. 2:14-cv-06627; filed November 19, 2014 in the Eastern District of...more