ARTICLE
14 March 2025

ACI's 21st Annual Paragraph IV Disputes

HP
Hyman, Phelps, & McNamara

Contributor

Hyman, Phelps & McNamara, the largest FDA-focused law firm in the U.S., specializes in comprehensive legal solutions for companies regulated by the FDA and related agencies like the DEA, CMS, and USDA. The firm assists with regulatory compliance, product lifecycle management, marketing compliance, and due diligence, offering practical, responsive, and client-focused legal strategies. With extensive experience across the food, drug, and medical device sectors, their team supports businesses throughout the supply chain, providing tailored guidance to management, scientists, and compliance officers.

The American Conference Institute's 21st Annual Paragraph IV Disputes is scheduled to take place from April 29-30, 2025 at The Altman Building in New York, NY.
United States Food, Drugs, Healthcare, Life Sciences

The American Conference Institute's 21st Annual Paragraph IV Disputes is scheduled to take place from April 29-30, 2025 at The Altman Building in New York, NY. Widely recognized as the industry gold standard, the conference unites leaders from brand-name and generic drug companies, alongside federal judges, the U.S. PTO's PTAB, the FTC, and the FDA, to tackle the critical legal, regulatory, and business issues shaping pharmaceutical patent litigation. Those of us in the Hatch-Waxman community look forward to attending this premier conference. It's always a kind of "family reunion" – a "Cheers"-type atmosphere where everyone knows your name.

Focusing on pre-suit strategies, case filings, final adjudications, and everything in between, this conference provides unparalleled insights and actionable takeaways for navigating the complex and high-stakes world of Paragraph IV disputes. Key topics to be addressed this year include:

  • Status of the Inflation Reduction Act and Future Drug Price Negotiations
  • AI's Impact on Drug Discovery and Patent Law
  • Focus on Litigation and Agency Decisions Following the Demise of the Chevron Doctrine in Loper V. Raimondo
  • Exploring the On-Sale Bar and Applicability of Prior Art
  • Orange Book Delisting Attempts
  • Navigating ODP and Patent Family Dynamics

Hyman, Phelps & McNamara, P.C.'s Kurt R. Karst will speak at a two-part session: Part I – Chevron Overturned: Examining Challenges Against the FDA and How the Death of the Doctrine Could Impact Drug Approvals and Exclusivities; and Part II – Anticipating the New Administration's Impact on FDA Policies and Regulations.

FDA Law Blog is a conference media partner. As such, we can offer our readers a special 10% discount. The discount code is: D10-999-FDA25. You can access the conference brochure and sign up for the event here. We look forward to seeing you at the conference!

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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