Biopharma Patent Litigation Updates: Hatch-Waxman, BPCIA, and Beyond *

Biopharma Patent Litigation Updates: Hatch-Waxman, BPCIA, and Beyond *

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The pharmaceutical patent litigation landscape continues to evolve, with court decisions and regulatory actions shaping strategies for both brand and generic companies. This panel will provide an up-to-the-minute review of critical developments, including Orange Book disputes and Hatch-Waxman litigation for small molecules—highlighting cases including Teva v. Amneal and recent FTC enforcement trends. The panel will also compare and contrast Purple Book litigation under the BPCIA for biologics, with Orange Book litigation under Hatch-Waxman. The discussion will also address the scope of the safe harbor for generics to avoid infringement liability, including examination of the decision in Jazz v. Avadel, ongoing debates over “skinny labels.” The panel will also explore the available remedies, including economic damages and the availability (and consequences of) injunctive relief. Attendees will leave with a clear understanding of the latest legal and policy shifts—and what they mean for pharma IP litigation strategies going forward.

Materials:

Heather’s Slides

SCOTUS Asks SG for Input on Petition Seeking to Clarify Inducement Under Hatch-Waxman

Hatch-Waxman Safe Harbor: Lessons from Recent Court Precedent

FTC Renews Campaign to Remove ‘Junk’ Inhaler and Device Patents from Orange Book Listings

Beyond Curiosity: Practical Guidance on the Research Exemption and Hatch-Waxman Safe Harbor

Federal Circuit Reverses Injunction Against Avadel Due to Hatch-Waxman Safe Harbor

The Sky is Not Falling for Skinny Labeling After GSK v. Teva

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https://www.surveymonkey.com/r/Biopharma-Patent-Litigation-Updates