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Robinson+Cole Health Law Diagnosis

Appellate Court Gives Go-Ahead for 340B Contract Pharmacy Insulin Pricing Suit to Proceed

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On August 6, 2025, the U.S. Court of Appeals for the Second Circuit issued an opinion allowing a case challenging drug pricing changes to proceed. The case, an antitrust action brought by health centers against certain...more

A&O Shearman

Ninth Circuit Affirms Dismissal of Putative Class Action Against Pharmaceutical Company for Failure to Adequately Allege Falsity...

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On August 20, 2025, the United States Court of Appeals for the Ninth Circuit affirmed the dismissal of a putative class action asserting claims under the Securities Exchange Act of 1934 against a pharmaceutical company and...more

A&O Shearman

Court of Appeal upholds invalidity of AstraZeneca's compound patent and clarifies the standard of plausibility

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On July 16 2025, the Court of Appeal dismissed AstraZeneca’s appeal and upheld the first instance decision, finding that AstraZeneca’s compound patent for dapagliflozin, an SGLT2 inhibitor used to treat diabetes, was invalid...more

Greenbaum, Rowe, Smith & Davis LLP

First Circuit Decision Regarding Anti-Kickback Statute Standard Widens Circuit Split and Creates Potential for Supreme Court...

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The U.S. Court of Appeals for the First Circuit, in United States v. Regeneron, has joined the Sixth and Eighth Circuits in adopting the “but-for” standard to find that a violation of the Anti-Kickback Statute (AKS) triggers...more

Hudnell Law Group

Federal Circuit Enforces Gatekeeping Role in Patent Damages Testimony

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On May 21, 2025, the United States Court of Appeals for the Federal Circuit, sitting en banc, reversed a $20 million damages award against Google LLC in a patent infringement dispute with EcoFactor, Inc. EcoFactor, Inc. v....more

Carlton Fields

Fourth Circuit Applies Supreme Court’s Coinbase Decision Outside Context of Arbitration

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The Fourth Circuit Court of Appeals recently concluded that the U.S. Supreme Court’s decision in Coinbase Inc. v. Bielski is not limited to interlocutory appeals involving arbitration....more

Rivkin Radler LLP

April 2025 Insurance Update

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As temperatures in the Northeast have made it feel more like winter than spring, it’s only fitting that we begin our April Insurance Update with a case from Alaska. There, the Alaska Supreme Court decides for the first time...more

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

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

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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

Epstein Becker & Green

First Circuit Joins Sixth and Eighth Circuits in Adopting “But-For” Causation Standard Under the Federal Anti-Kickback Statute for...

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In 2010, as part of the Affordable Care Act, Congress resolved a highly litigated issue about whether a violation of the Anti-Kickback Statute (AKS) can serve as a basis for liability under the federal False Claims Act (FCA)....more

Robinson+Cole Health Law Diagnosis

First Circuit Makes Historic Decision: “But-For” Causation is the Majority Standard in AKS-Based FCA Claims

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In a much-anticipated decision, the First Circuit unanimously ruled the government and relators must prove that a violation of the federal Anti-Kickback Statute (AKS) was the “but-for” cause of a false claim under the False...more

Davis Wright Tremaine LLP

In Key Ruling, 1st Circuit Adopts "But-For" Causation Standard for FCA Claims Arising From Unlawful Kickbacks

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On February 18, 2025, the U.S. Court of Appeals for the 1st Circuit issued a highly anticipated ruling interpreting the relationship between the False Claims Act ("FCA") and the federal Anti-Kickback Statute ("AKS"), holding...more

Polsinelli

A Deepened Divide: Appellate Court Joins False Claims Act Circuit Split in Favor of Health Care Defendants

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On February 18, 2025, the United States Court of Appeals for the First Circuit issued its opinion in United States v. Regeneron Pharmaceuticals Inc., finding that, in Anti-Kickback Statute (AKS) cases, the government must...more

WilmerHale

First Circuit Adopts “But For” Causation Standard under the Anti-Kickback Statute, Paving the Way for Potential Supreme Court...

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Last week, the First Circuit Court of Appeals issued its long-awaited decision in United States v. Regeneron Pharmaceuticals with significant implications for health care companies facing allegations of violations of the...more

Arnall Golden Gregory LLP

Narrowing FCA Cases Based on Kickback Allegations: What Healthcare and Life Sciences Companies Need to Know About the Regeneron...

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On February 18, 2025, in a closely watched decision, the United States Court of Appeals for the First Circuit in United States v. Regeneron Pharmaceuticals Inc., No. 23-2086, 2025 U.S. App. LEXIS 3667 (1st Cir. Feb. 18, 2025)...more

Stevens & Lee

First Circuit Rules Against Government in False Claims Act Case

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On Feb. 18, in U.S. v. Regeneron Pharmaceuticals, the First Circuit Court of Appeals joined the Sixth Circuit and the Eighth Circuit in holding that, for purposes of establishing that a claim for payment of items or services...more

Robins Kaplan LLP

Purdue Pharma L.P. v. Accord Healthcare, Inc.

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OxyContin® (oxycodone HCl) - Case Name: Purdue Pharma L.P. v. Accord Healthcare, Inc., No. 2023-1953, 2024 WL 5244764 (Fed. Cir. Dec. 30, 2024) (Circuit Judges Prost, Reyna, and Taranto presiding; Opinion by Prost, J.)...more

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

Federal Circuit Stays Teva v. Amneal Ruling

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In our previous article, we reported that the Federal Circuit affirmed the district court’s decision requiring Teva to delist certain patents related to its Teva’s ProAir® HFA metered-dose inhaler from the FDA’s Orange...more

Knobbe Martens

A Patent Must Describe What Is Claimed, Not What Infringes

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Before Lourie, Prost, and Reyna. Appeal from the U.S. District Court for the District of Delaware. Summary: A patent was not invalid for lack of written description for failing to describe the specific infringing embodiment...more

Goodwin

2022 Year in Review: Securities Litigation Against Life Sciences Companies

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We are proud to present our seventh annual Securities Litigation Year in Review publication, in which we analyze data for securities class actions filed nationally against publicly traded pharmaceutical, biotechnology,...more

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