News & Analysis as of

Life Sciences Article III Standing

Akerman LLP - Health Law Rx

What’s it to You? Justice Scalia’s 41-Year-Old Gatekeeping Question on “Standing” Influences Court to Uphold FDA’s Regulation of...

Mifepristone is safe for now. On June 13, 2024, the Supreme Court unanimously held that the plaintiffs — doctors and medical associations alike — lacked standing to challenge 2000 and 2019 FDA approvals of mifepristone (brand...more

Manatt, Phelps & Phillips, LLP

Supreme Court Will Hear Medication Abortion Case; Three States Ask to Intervene in District Court

The Big Picture - On December 13, 2023, the Supreme Court announced its intention to review the August 16 ruling by the Fifth Circuit in Alliance for Hippocratic Medicine (AHM) v. U.S. Food and Drug Administration, et al....more

Knobbe Martens

Federal Circuit Review - November 2023

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Federal Circuit Orders District Court to Consider Extrinsic Evidence in Claim Construction - In Actelion Pharmaceuticals Ltd. v. Mylan Pharmaceuticals Inc., Appeal No. 22-1889, the Federal Circuit held that where a...more

Knobbe Martens

No Standing in IPR Appeal for Sublicensee’s Speculative Royalty-Based Injuries

Knobbe Martens on

MODERNATX, INC. v. ARBUTUS BIOPHARMA CORPORATION - Before Lourie, O’Malley, and Stoll.  Appeal from the Patent Trial and Appeal Board. Summary: Sublicensee’s theory of royalty-based injury was too speculative to...more

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - June 2021 #2

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Supreme Court Upholds Affordable Care Act: On June 17, 2021, the Supreme Court ruled 7 to 2 to dismiss for lack of standing a challenge to the Affordable Care Act (ACA) brought by Texas and other states. The states had...more

Troutman Pepper

Article III Standing Strikes Again

Troutman Pepper on

Argentum Pharmaceuticals LLC v. Novartis Pharmaceuticals Corp., Appeal No. 2018-2273 (Fed. Cir., April 23, 2020). Argentum and other petitioners filed IPRs against Novartis’ patent related to methods of treating...more

Seyfarth Shaw LLP

Fifth Circuit Affirms Striking Down Individual Mandate of Affordable Care Act and Remands on Issue of Severability

Seyfarth Shaw LLP on

In a bold but conservative 2-1 decision Wednesday, The United States Court of Appeals for the Fifth Circuit affirmed the ruling of a federal district judge in Texas striking down the individual mandate of the Affordable Care...more

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