Tag Archives: Supreme Court

Congress Enacts CLOUD Act within Omnibus Spending Bill to Address Overseas Storage of Electronic Data, Potentially Mooting Supreme Court’s Pending Microsoft Case

On March 23, 2018, the President signed into law the Consolidated Appropriations Act of 2018 (H.R. 1625), an omnibus spending bill that includes the Clarifying Lawful Overseas Use of Data Act (the CLOUD Act). Among other provisions, the CLOUD Act amends the Stored Communications Act of 1986 (18 U.S.C. §§ 2701-2712, hereinafter the SCA) by adding a new § 2713 which states as follows:…

Third Circuit Recognizes Escobar “Heightened Materiality Standard” in Dismissal of False Claims Act Case Tied to Avastin

In May 2017, the U.S. Court of Appeals for the Third Circuit relied on the “heightened materiality standard” endorsed by the U.S. Supreme Court in its 2016 Escobar decision in dismissing a False Claims Act (FCA) whistleblower suit filed against pharmaceutical giant Genentech related to its billion dollar cancer drug Avastin. In Escobar, the Supreme Court upheld the validity—“at least in some circumstances”—of the “implied false certification” theory of FCA liability, and provided that this theory can attach where at least two conditions are met: a defendant must (1) …

Supreme Court Decision Allows Faster Marketing of Biosimilars

On Monday, June 12, 2017, the United States Supreme Court in a unanimous decision held that manufacturers making biosimilars of biologic drugs did not have to wait until after gaining federal approval of the biosimilar to notify the manufacturer of biologic reference products (Sponsor) that they intend to commercially market a biosimilar drug. The Court’s decision addresses two cases in the same opinion: Sandoz v. Amgen and Amgen v. Sandoz. …

Anthem Terminates Cigna Merger Following D.C. Circuit Setback

On May 12, 2017, Anthem Inc. announced that it had terminated its merger agreement with Cigna Corporation, a deal that would have united the second and third largest sellers of health insurance to large companies in the country. Anthem’s termination of the merger came two weeks to the day after the U.S. Court of Appeals for the D.C. Circuit rejected Anthem’s appeal of an injunction blocking the merger issued by a U.S. District Court earlier this year. Anthem terminated the merger one week after filing a petition for a writ …

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