Paragraph IV Disputes

Each fall in Chicago, top pharmaceutical patent litigators for brand name and generic drug companies gather to receive the latest updates on Hatch-Waxman litigation and engage in valuable peer networking. As the industry grapples with significant patent losses and evolving laws and regulations, this conference has never been more essential or timely.

Co-Chairs

Aaron F. Barkoff, Ph.D.

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

April E. Weisbruch

Partner
McDermott Will & Emery LLP

Kevin Zive

Vice President, General Counsel, and Head of Global Intellectual Property
Apotex Inc.

SPECIAL PRESENTATION BY U.S. MAGISTRATE JUDGES

Honorable Tonianne J.Bongiovanni

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

Honorable Christopher J. Burke

U.S. M.J.
District of Delaware

Honorable Sherry R. Fallon

U.S. M.J.
District of Delaware

USPTO PTAB

Honorable Jacqueline Bonilla

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

FTC

Tim Kamal-Grayson

Attorney
Federal Trade Commission (FTC)

Key Program Highlights Include:

Spotlight on Chevron Overturned in Loper V. Raimondo
§112 Think Tank
Drill down on the Use of Clinical Trials as Prior Art
Focus on Patent Rights and Supply Chain Dynamics
Fireside Chat Future FDA Activity Affecting Small Molecules

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 Hatch-Waxman Practitioners Think Tank on 10th Anniversary Paragraph IV Disputes – The ANDA Litigation Strategy Symposium for Brand Name and Generics will return.

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.