Each fall, leading pharmaceutical patent litigators for brand name and generic drug companies gather at the Paragraph IV Disputes Master Symposium in Chicago to receive up-to-the-minute information on the latest developments affecting Hatch-Waxman litigation and participate in significant peer-to-peer networking opportunities.

As the industry prepares to address the fallout of global pharmaceutical patent losses of billions of dollars and the impact of evolving law, regulation and policy impacting the Hatch-Waxman landscape, the time for this conference has never been more relevant.


Aaron F. Barkoff, Ph.D.

Associate Vice President – General Patent Counsel, IP Litigation
Eli Lilly, and Company


Hon. Tonianne J.Bongiovanni

U.S. M.J.
District of New Jersey


Hon. Christopher J. Burke

U.S. M.J.
District of Delware


Hon. Sherry R. Fallon

U.S. M.J.
District of Delware


Honorable Jacquline Bonilla

Deputy Chief Administrative Patent Judge; Senior Legal Advisor, Under Secretary of Commerce for Intellectual Property and Director


Tim Kamal-Grayson

Attorney, Healthcare Division
Eli Lilly, and Company

Key Program Highlights Include:

  • Chevron Overturned in Loper V. Raimondo
  • 112 Think Tank
  • Examining the Use of Clinical Trials as Prior Art
  • Patent Rights and Supply Chain Dynamics
  • Fireside Chat: Future FDA Activity Affecting Small Molecules

Enhanced Learning with Early Riser Roundtables and Focused Discussions:

  • A Breakfast with ACI’s Hatch Waxman Advisory Board (Closed Door)
  • Discussion on DEI Leadership for Pharmaceutical Patent Practitioners
About the Conference

Small molecule drugs are under attack. The rules of the Hatch-Waxman litigation playbook are changing once again. Both brand and generic pharmaceutical manufacturers will need to assess patent portfolios and formulate strategies through a very different lens. In addition to patent expiration dates and invalidity challenges, they must now take into account the implementation of the Inflation Reduction Act, proposed use of the Bayh Doyle Act, and recent calls for the delisting of Orange Book patents by the FTC and in the District Courts. In short, this trifecta attack on small molecule patents cannot be ignored.

Obviousness Type Double Patenting and the Petition for Cert in In re Cellect

Moreover, the petition for cert in In re Cellect, and continued focus on fine-tuning claim strategies following Amgen v. Sanofi has added new layers of complexity to the offensive plays and defensive moves traditionally associated with the IP litigation landscape and pharmaceutical patent endgame.

…And then in a landmark ruling the Supreme Court overturned Chevron. A move the Biden Administration had previously warned could cause “convulsive shock” to the US legal system.

American Conference Institute (ACI) is pleased to announce that the 10th Anniversary Paragraph IV Disputes – The Masters Edition will return to Chicago on October 15 – 16, 2024 to address these concerns and more, and with consideration for the competing interests of brand and generics.

We invite you to join our esteemed faculty of industry decision-makers and counsel, for analysis of some of the most significant Hatch-Waxman cases and practical insights that will help inform future business decisions and legal strategies in this intense political environment.


Patent attorneys and litigators (in-house & law firms) who represent:

  • Brand name pharmaceutical companies
  • Generic pharmaceutical companies
  • Biopharmaceutical companies
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