Current IP Legal Issues to Watch

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Biotech/ PhRMA: Congressional Patent Hearing

The U.S. House Judiciary IP Subcommittee to hold a hearing on patents, drug prices, and affordability, the week of June 2, 2026.

Watch the hearing and download witness testimony here:

https://judiciary.house.gov/schedule

Biotech/ PhRMA: Supreme Court to review "Skinny Labels"

Hikma Pharmaceuticals USA v. Amarin Pharma, Inc. et al.

SCOTUSBlog coverage

https://www.scotusblog.com/2026/04/justices-poised-to-protect-generics-manufacturers-from-liability-for-decisions-of-pharmacists-ab/

Supreme Court Oral Argument Transcript

https://www.supremecourt.gov/oral_arguments/argument_transcripts/2025/24-889_2024.pdf

Biotech/ PhRMA: Actelion Pharmaceuticals Ltd. v. Mylan Pharmaceuticals Inc

Actelion Pharmaceuticals Ltd. v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2026)

https://www.cafc.uscourts.gov/opinions-orders/24-1641.OPINION.5-13-2026_2693032.pdf "

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Other Washington, D.C. Legal Resources

GAO Report on Nonprofit Drug Companies

Nonprofit Drug Companies: Information on Funding, Drug Types, Challenges, and Reported Effect
GAO-25-107153
Published: May 01, 2025. Publicly Released: May 01, 2025.

https://www.gao.gov/products/gao-25-107153

U.S. Senate Patent Eligibility Hearing

The Senate Subcommittee on Intellectual Property held a key hearing regarding the Patent Eligibility Restoration Act (PERA) on October 8, 2025.

The bipartisan legislation seeks to reform 35 U.S.C. § 101 to effectively overturn Supreme Court decisions that restricted patent eligibility for abstract ideas, isolated genetic materials, and diagnostic methods.

AI/ Digital Replicas

The U.S. Congress is pursuing legislation to fight unauthorized Gen AI digital replicas. It's called the "NO FAKES Act." More below.

U.S. Senate Press release

https://www.google.com/search?client=safari&rls=en&q=blackburn+no+fakes&ie=UTF-8&oe=UTF-8

Updated Bill Text

https://www.blackburn.senate.gov/services/files/7B628752-82C4-4FC6-89DC-94345BC06540