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Patent Litigation AstraZeneca Pharmaceutical Industry

Venable LLP

Soliris® (eculizumab) Interchangeable Biosimilar Launches: Bkemv™ and Epysqli®

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On April 7, 2025, Samsung Bioepis and Teva announced the launch of Epysqli® (eculizumab-aagh), a provisionally interchangeable biosimilar of Alexion / AstraZeneca’s Soliris® (eculizumab), at a 30% discount to Soliris®’s...more

Venable LLP

The First Biosimilar Disputes at the Unified Patent Court (UPC)

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As the era of biologics and biosimilar litigations heats up in the United States, Europe’s Unified Patent Court (UPC) is also taking center stage with the first two biosimilar disputes filed in March and April....more

Axinn, Veltrop & Harkrider LLP

Puma and the Pitfalls of the “Narrow” Exclusive License

8 Puma Biotechnology is the latest victim of standing requirements in patent cases that continue to wreak havoc on plaintiffs’ ability to recover a full measure of damages. In Puma Biotechnology, Inc. v. AstraZeneca...more

Venable LLP

PTAB Issues Final Written Decision Finding Seagen’s Adcetris® Patent Claims Unpatentable

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On January 16, 2024, the PTAB issued a Final Written Decision in a post-grant review (“PGR”) of claims in U.S. Patent No. 10,808,039 (the “’039 patent”) owned by Seagen Inc. (“Seagen”). PGR2021-00030 was filed by Daiichi...more

Goodwin

Bristol-Myers Squibb and AstraZeneca Settle Anti-PD-L1 Antibody Product Litigation

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We previously reported on Bristol-Myers Squibb’s (“BMS”) complaint alleging AstraZeneca’s PD-L1 antibody product, IMFINZI (durvalumab), infringed U.S. Patent No. 9,402,899 (“the ’899 patent”). BMS alleged that the ’899 patent...more

Goodwin

Bristol-Myers Squibb Files Patent Infringement Complaint Against AstraZeneca Regarding Anti-PD-L1 Antibody Product

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On April 25, 2023, Bristol-Myers Squibb (“BMS”) filed a complaint in the District of Delaware against AstraZeneca related to AstraZeneca’s anti-PD-L1 antibody product, IMFINZI (durvalumab), alleging willful infringement of...more

Knobbe Martens

Federal Circuit Review - December 2021

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Ranges for Interdependent and Interactive Components Can Be Tricky to Derive - In Modernatx, Inc. v. Arbutus Biopharma Corporation, Appeal No. 20-2329, the Federal Circuit held that a presumption of obviousness based on...more

Knobbe Martens

Intrinsic Evidence Trumps Plain and Ordinary Meaning

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ASTRAZENECA AB v. MYLAN PHARMACEUTICALS INC. Before:  Taranto, Hughes, and Stoll - Summary: For purposes of claim construction, intrinsic evidence can trump the plain and ordinary meaning of scientific conventions such...more

Robins Kaplan LLP

AstraZeneca AB v. Mylan Pharms. Inc.

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Symbicort® (budesonide and formoterol fumarate dihydrate) - Case Name: AstraZeneca AB v. Mylan Pharms. Inc., No. 1:18CV193, 2021 WL 798856 (N.D.W.V. Mar. 2, 2021) (Keeley, J.) - Drug Product and Patent(s)-in-Suit: Symbicort®...more

Robins Kaplan LLP

AstraZeneca AB v. Mylan Pharms. Inc.

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BECAUSE DELAWARE WAS AN IMPROPER VENUE FOR DEFENDANT MYLAN, AND DEFENDANT 3M DEMONSTRATED THAT VARIOUS FACTORS WEIGHED IN FAVOR OF A TRANSFER, THE CASE WAS TRANSFERRED TO THE NORTHERN DISTRICT OF WEST VIRGINIA. Case...more

Smart & Biggar

Rx IP Update - April 2018

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Standing Committee on Health proposes National Pharmacare program, modifications to prescription and generic drug pricing - While common among member countries of the Organisation for Economic Co-operation and Development...more

Robins Kaplan LLP

AstraZeneca AB v. Aurobindo Pharma Ltd.

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Case Name: AstraZeneca AB v. Aurobindo Pharma Ltd., 14-664-GMS, 2017 U.S. Dist. LEXIS 14647 (D. Del. Feb. 2, 2017) (Sleet, J.). Drug Product and Patent(s)-in-Suit: Onglyza® (saxagliptin) and Kombiglyze™ XR (saxaglibtin...more

McDonnell Boehnen Hulbert & Berghoff LLP

PTAB Life Sciences Report -- Part III

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. InnoPharma Licensing, LLC v AstraZeneca AB - PTAB Petition: IPR2017-00900; filed February 17,...more

McDonnell Boehnen Hulbert & Berghoff LLP

PTAB Life Sciences Report -- Part III

About the PTAB Life Sciences Report: Each month we will report on developments at the PTAB involving life sciences patents. Complex Innovations, LLC. v. AstraZeneca AB - PTAB Petition: IPR2017-00631; filed January 9,...more

McDonnell Boehnen Hulbert & Berghoff LLP

PTAB Life Sciences Report - October 2016

About the PTAB Life Sciences Report: Each month we will report on recent developments at the PTAB involving life sciences patents. Argentum Pharmaceuticals LLC. v. Janssen Oncology, Inc. - PTAB Petition: ...more

McDonnell Boehnen Hulbert & Berghoff LLP

Court Report - September 2016

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Horizon Therapeutics, Inc. v. Lupin Ltd. et al. 1:16-cv-04438; filed July 21, 2016 in the District Court of New Jersey -...more

McDonnell Boehnen Hulbert & Berghoff LLP

Court Report - March 2016 #2

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Unimed Pharmaceuticals LLC et al. v. Lupin Atlantis Holdings SA et al. 1:15-cv-00904; filed October 9, 2015 in the...more

McDonnell Boehnen Hulbert & Berghoff LLP

Court Report - January 2016

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Spectrum Pharmaceuticals, Inc. et al. v. Amneal Pharmaceuticals LLC - 2:15-cv-01697; filed September 3, 2015 in the...more

McDonnell Boehnen Hulbert & Berghoff LLP

Court Report - November 2015

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Janssen Biotech Inc. et al. v. Par Pharmaceutical Inc. et al. 1:15-cv-00679; filed August 3, 2015 in the District Court of...more

McDermott Will & Emery

ANDA Update - October 2015

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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

AstraZeneca AB v. Apotex Corp.

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Case Name: AstraZeneca AB v. Apotex Corp., 2014-1221, 2015 U.S. App. LEXIS 5543 (Fed. Cir. Apr. 7, 2015) (Circuit Judges O’Malley, Clevenger, and Bryson presiding; Opinion by Bryson, J.) (Appeal from S.D.N.Y., Cote, J.) - ...more

Robins Kaplan LLP

AstraZeneca LP v. Breath Ltd.

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Case Name: AstraZeneca LP v. Breath Ltd., 2015-1335, 2015 U.S. App. LEXIS 7525 (Fed. Cir. May 7, 2015) - Drug Product and Patent(s)-in-Suit: Pulmicort Respules® (budesonide inhalation suspension); U.S. Patent No....more

WilmerHale

Federal Circuit Patent Updates - April 2015

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Biosig Instruments, Inc. v. Nautilus, Inc. (No. 2012-1289, 4/27/15) (Newman, Schall, Wallach) - April 27, 2015 11:12 AM. Wallach, J. On remand from the Supreme Court, reversing district court summary judgment...more

McDonnell Boehnen Hulbert & Berghoff LLP

AstraZeneca AB v. Apotex Corp. (Fed. Cir. 2015)

Earlier this month, the Federal Circuit rendered a decision on damages in what may be the last of a long-running series of ANDA cases involving AstraZeneca's Prilosec® (omeprazole) franchise. As set forth in the opinion,...more

McDonnell Boehnen Hulbert & Berghoff LLP

Court Report - March 2015 #2

About Court Report: Each week we will report briefly on recently filed biotech and pharma cases. Janssen Biotech, Inc. et al. v. Celltrion Healthcare Co., Ltd. et al. 1:15-cv-10698; filed March 6, 2015 in the District...more

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