News & Analysis as of

AstraZeneca

Cadwalader, Wickersham & Taft LLP

Delaware Chancery Court Finds a ~27% Founding Stockholder Is Not a Controller

On July 2, 2024, the Delaware Chancery Court in Sciannella v. AstraZeneca dismissed stockholder claims in connection with the $3 billion merger of Viela Bio and Horizon Therapeutics in 2021. The merger was approved by Viela’s...more

Venable LLP

FDA Approves Second Soliris® (eculizumab) Interchangeable Biosimilar - Samsung Bioepis’s Epysqli® (eculizumab-aagh)

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On July 19, 2024, the FDA approved the second biosimilar of Alexion / AstraZeneca’s Soliris® (eculizumab), Samsung Bioepis’s Epysqli® (eculizumab-aagh), approximately one year after Samsung Bioepis announced the FDA...more

Mintz - Health Care Viewpoints

Mintz IRA Update — IRA Litigation Update: Courts Begin to Address Legal Challenges to the Medicare Drug Price Negotiation Program

The IRA’s Medicare Drug Price Negotiation Program (the “Negotiation Program” or “Program”), which enables the federal government to negotiate prices for some of the costliest Medicare Part D drugs, has been subject to several...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

WilmerHale

The Interplay: Key Decisions at the Intersection of Antitrust & Life Sciences - March 2024

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Calls for Removal of Device Patents Listed in the Orange Book Continue. FTC and Congressional action scrutinizing allegedly “improper” Orange Book listings continued apace in the first few months of 2024. ...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

Goodwin

Court Grants Summary Judgment Ending AstraZeneca’s Lawsuit Challenging the IRA

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Today, the district court for the District of Delaware (Judge Connolly) granted the government’s motion for summary judgment on all claims brought by AstraZeneca in its Complaint challenging the Drug Price Negotiation Program...more

Goodwin

Court Dismisses PhRMA Lawsuit Challenging IRA

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Today, the district court for the Western District of Texas granted the government’s motion to dismiss the lawsuit brought by PhRMA and other organizations challenging the Drug Price Negotiation Program of the Inflation...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

Hogan Lovells

Dutch Supreme Court: Patentee not liable against health insurer for patent enforcement against generic

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On 3 November 2023, the Dutch Supreme Court upheld the decision of the Court of Appeal of The Hague  in which life sciences company AstraZeneca (“AZ”) was held not to be liable towards health insurer Menzis for the...more

Haug Partners LLP

10 Years after Actavis, the Cases that Follow Tell a Story

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I. Introduction - No pharmaceutical antitrust decision has had more impact than the Supreme Court’s 2013 decision in Federal Trade Commission v. Actavis, a decision which officially defined the term “reverse payment...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

Second Circuit Upholds Dismissal of AstraZeneca Investor Suit

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On May 16, 2023, the US Court of Appeals for the Second Circuit affirmed the Southern District of New York’s order dismissing an action brought by investors of AstraZeneca PLC (AstraZeneca) attempting to hold the company...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

BakerHostetler

Discounted Drugs under the 340B Program

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The U.S. Court of Appeals for the Third Circuit is currently hearing arguments from pharmaceutical manufacturers Novo Nordisk, Sanofi and AstraZeneca and the Department of Health and Human Services (HHS) on whether the 340B...more

A&O Shearman

Southern District Of New York Dismisses Putative Class Action Against Pharmaceutical Company For Failure To Adequately Allege...

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On September 12, 2022, Judge J. Paul Oetken of the United States District Court for the Southern District of New York dismissed with prejudice a putative class action asserting claims under the Securities Exchange Act of 1934...more

Robinson+Cole Health Law Diagnosis

Delaware District Court Determines that HRSA Enforcement Letter Targeting 340B Program Restrictions Violates the APA

A federal court in Delaware recently determined that the Health Resources and Services Administration (HRSA) – the federal agency responsible for administering the 340B drug pricing program – did not comply with the...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

WilmerHale

Federal Circuit Patent Watch - December 2021 #2

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Precedential Federal Circuit Opinions - TEVA PHARMACEUTICALS USA v. CORCEPT THERAPEUTICS, INC. [OPINION] (2021-1360, 12/07/2021) (MOORE, NEWMAN, and REYNA) -   Moore, C.J. The Court affirmed the PTAB’s IPR decision...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

Hogan Lovells

Coronavirus: The Hill and the Headlines, June 2021 - Final Issue

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In Washington: Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky urged parents to vaccinate adolescents and teenagers against the coronavirus Friday, adding that COVID-19 can be severe for this age...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

Hogan Lovells

Coronavirus: The Hill and the Headlines, April 2021 # 7

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In Washington: President Biden is expected to announce on Tuesday updated guidance on masking from the Centers for Disease Control and Prevention (CDC). The guidance is still being finalized but is likely to ease...more

Patrick Malone & Associates P.C. | DC Injury...

Will the reluctant and resistant trip up the campaign to quell the pandemic?

Even as the latest coronavirus surge appeared to ease, including in hard-hit areas of the Midwest and Northeast, and as the federal government reported the nation has achieved key milestones in vaccinations, the battle to...more

Hogan Lovells

Coronavirus: The Hill and the Headlines, April 2021 # 5

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In Washington: President Biden said Wednesday that he expects the U.S. will share surplus coronavirus vaccine doses with Canada and Central American countries. “We don’t have enough to be confident to send it abroad now, but...more

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