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Would I FIE to You? FDA’s First Interchangeable Exclusivity Determination Results in Expiration

FDA Law Blog

In other words, FDA needed to determine whether the initial biosimilar litigation—pre-interchangeable supplemental approval—counts towards the FIE expiration date calculation. Notably, the purpose of the statute seemed to govern much of FDA’s interpretation.

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SCOTUS Clarifies Reach of FAA Exemption for Transportation Workers

Constitutional Law Reporter

LLC , 601 U.S. _ (2024), the U.S. Supreme Court held that the Federal Arbitration Act’s (FAA) exemption for transportation workers in interstate commerce applies to transportation workers regardless of whether they work in the transportation industry. In Bissonnette v. LePage Bakeries Park St.,

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Supreme Court Lowers the Bar for Title VII Suits Alleging Discriminatory Transfers

Constitutional Law Reporter

Louis, Missouri , 601 U.S. _ (2024), the U.S. Supreme Court unanimously held that an employee challenging a job transfer under Title VII of the Civil Rights Act of 1964 must show that the transfer brought about some harm with respect to an identifiable term or condition of employment, but that harm need not be significant. City of St.

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December 2020 Updates to the Climate Case Charts

ClimateChange-ClimateLaw

Each month, Arnold & Porter and the Sabin Center for Climate Change Law collect and summarize developments in climate-related litigation, which we also add to our U.S. climate litigation charts. On November 23, GM announced that it was withdrawing from the litigation. By Margaret Barry and Korey Silverman-Roati.

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The First Precedential Patent Decision of 2023: Dexcom v. Abbott Diabetes Care

Patently O

Court of Appeals for the Federal Circuit has begun 2023 with its first precedential patent decision in DexCom, Inc. January 3, 2024). In an opinion by Judge Stoll, the court affirmed a district court decision denying DexCom’s motion for a preliminary injunction. Abbott Diabetes Care, Inc., 2023-1795 (Fed.

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Six cases to look out for

SCOTUSBlog

Coverage of federal fraud statutes Porat v. The district court held that the allegations were inadequate under the heightened pleading standards of the Private Securities Litigation Reform Act , which Congress adopted to curb perceived abuses of securities litigation. Court of Appeals for the 9th Circuit reversed.

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Supreme Court takes Clean Water Act case

SCOTUSBlog

The case was the only addition to the justices’ docket for their 2024-25 term. The justices should also weigh in, Avenatti contended, on whether an attorney can be held liable for extortion for his conduct during litigation. A Florida state court upheld Cunningham’s conviction. But the justices declined to do so.

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