The American Convention Institute’s twenty first Annual Paragraph IV Disputes is scheduled to happen from April 29-30, 2025 at The Altman Constructing in New York, NY. Well known because the trade gold commonplace, the convention unites leaders from brand-name and generic drug firms, alongside federal judges, the U.S. PTO’s PTAB, the FTC, and the FDA, to sort out the crucial authorized, regulatory, and enterprise points shaping pharmaceutical patent litigation. These of us within the Hatch-Waxman group stay up for attending this premier convention. It’s all the time a type of “household reunion” – a “Cheers”-type environment the place everybody is aware of your title.
Specializing in pre-suit methods, case filings, last adjudications, and every part in between, this convention gives unparalleled insights and actionable takeaways for navigating the complicated and high-stakes world of Paragraph IV disputes. Key matters to be addressed this yr embody:
- Standing of the Inflation Discount Act and Future Drug Value Negotiations
- AI’s Affect on Drug Discovery and Patent Regulation
- Concentrate on Litigation and Company Choices Following the Demise of the Chevron Doctrine in Loper V. Raimondo
- Exploring the On-Sale Bar and Applicability of Prior Artwork
- Orange E-book Delisting Makes an attempt
- Navigating ODP and Patent Household Dynamics
Hyman, Phelps & McNamara, P.C.’s Kurt R. Karst will communicate at a two-part session: Half I – Chevron Overturned: Inspecting Challenges Towards the FDA and How the Demise of the Doctrine May Affect Drug Approvals and Exclusivities; and Half II – Anticipating the New Administration’s Affect on FDA Insurance policies and Rules.
FDA Regulation Weblog is a convention media companion. As such, we are able to provide our readers a particular 10% low cost. The low cost code is: D10-999-FDA25. You may entry the convention brochure and join the occasion right here. We stay up for seeing you on the convention!
