American Conference Institute will be holding a "Hatch-Waxman Boot Camp" conference in San Diego on June 25-26. McAndrews partner Herb Hart will be speaking at the conference on post-grant proceedings under the America Invents Act, and particularly how such proceedings might impact ANDA litigation.
The full agenda is as follows:
- Key Agencies Overview: Understanding the Jurisdication and Interplay of the FDA and PTO in the Patenting of Drugs and Biologics
- Identifing and Comprehending Pre-Commercialization Concerns Relative to Small Molecules and Biologics
- Exploring the Link Between the FDA Approval Process and the Patenting of Drugs and Biologics
- IP Overview for Drugs and Biologics: Hatch-Waxman, BPCIA, Trade Dress, and More
- Paragraph IV Disputes and Litigation: Federal Court, PTO Proceedings and ITC Actions
- How the Dynamics of Biosimilars are Changing the Hatch-Waxman Landscape
- Orange Book Listings, De-Listings and Related Challenges
- Bioequivalence and the "Same Active Ingredient" vis-a-vis Patentability
- An In-Depth Look at 180-Day Exclusivity
- Comprehending the Intracacies of Non-Patent/Regulatory Exclusivity
- Assessing Patent Protections Afforded Under the Safe Harbor of Section 271(e)(1)
- Examining Pharmaceutical Patent Extensions: Patent Term Adjustment and Patent Term Restoration
In addition, ACI is offering two post-conference workshops on June 27th: "Biosimilars: An In-Depth Look at the Law, Interpreting Guidance, and Anticipated Litigation" and "Patent Reform 101: Overview of the Fundamental Provisions in the America Invents Act and the Impact on Hatch-Waxman Litigation."
For more information or to register, please visit the conference website. Use registration code OBB 200 to save $200 on fees.
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