Jim Hurst, a partner in Winston & Strawn's Chicago office, spoke at ACI's 6th Annual Paragraph IV Disputes conference in New York on April 24-25, 2012. The firm was also a sponsor of this conference which focused on expert insights on Hatch-Waxman litigation strategies for brand names and generics.
Mr. Hurst spoke on a panel titled, "Of Labels, Patents, and Use Codes: The Significant and Possible Repercussions of Novo Nordisk v. Caraco to Hatch-Waxman Challenges" on April 25. Specifically, the panel focused on:
- Exploring the relationship between a drug’s label, patents, use codes and Orange Book listings relative to Hatch-Waxman litigation
- Deciphering therapeutic equivalence evaluation codes
- Defining Section viii carve–outs and understanding their significance to Orange Book listings and Paragraph IV challenges
- Examining how the Supreme Court’s pending ruling in Novo Nordisk A/S v. Caraco Pharmaceutical Laboratories, Ltd. may alter the landscape in this area
- Understanding the significance of Solicitor General’s /U.S. government’s position and arguments in this matter
Joining Mr. Hurst on this panel were Aaron F. Barkoff from McAndrews, Held & Malloy Ltd., Michael A. Sitzman from Gibson, Dunn & Crutcher LLP, Anthony J. Viola from Edwards Wildman Palmer LLP, and moderating the panel was Terry G. Mahn from Fish & Richardson P.C.
Additional speakers at the event included the keynote speaker, Markus Meier, the assistant director of the Health Care Division Bureau of Competition with the Federal Trade Commission who spoke on pay-for-delay settlements. Judicial insights were provided by judges from the District Court of New Jersey, Hon. Garrett E. Brown, Hon. Joel A. Pisano, and Hon. Tonianne Bongiovanni.