Hatch Waxman Boot Camp Chicago: Assessing Patent Protections Afforded Under the Safe Harbor

The ACI-sponsored two-day Hatch Waxman Boot Camp Chicago takes place June 9-10.


With the precedential regulatory changes in the IP regulatory arena there will clearly be impacts to Hatch-Waxman. Attend this essential event to understand the interplay of IP and FDA regulation relative to pharma/biotech patents vis-à-vis Hatch-Waxman and recently released biosimilars guidance and ensure that you are aware of the intersection of the newly promulgated America Invents Act with Hatch-Waxman. It is vital to understand how all these components work together and that both will influence the Hatch-Waxman rubric.

A thorough understanding of Hatch-Waxman is absolutely essential to anyone working in the biopharmaceutical area. This knowledge sets the foundation for the protection of small molecules and small proteins and provides the tools to ponder an IP and regulatory framework for what lies beyond the realm of traditional pharmaceuticals. The highly regulated nature of the products which the pharmaceutical and biotechnology industries manufacture dictates that the patenting of these products be closely tied to regulatory approval by the FDA. Anyone who works in the life sciences industry — and who even remotely deals with its IP — must be well versed in the regulatory components and IP subtleties that play such an integral role in the patenting of its products. You cannot afford to be left in the dark regarding the interconnection of IP and FDA regulation in these industries.

MBHB partner Dr. Paul Tully is a featured presenter for the following program.

    Tues., June 10 – 1:45-2:45 p.m. CT

    Assessing Patent Protections Afforded Under the Safe Harbor

    • Exploring the safe harbor of the Hatch-Waxman Act 35 USC § 271(e)(1)
    • Understanding the safe harbor’s scope of protection for otherwise infringing activities
    • Examining the impact of Proveris, Classen and Momenta on safe harbor protections
    • Identifying safe harbor protections relative to:

      • basic R&D
      • new product screening
      • optimization
      • pre-clinical testing
      • post-approval testing


Sponsored by: American Conference Institute (“ACI”)

View complete details including registration