MBHB Partner Kevin Noonan a Featured Presenter at ACI’s 5th Annual Summit on Biosimilars

MBHB partner Dr. Kevin Noonan is a featured presenter at the American Conference Institute’s 5th Annual Summit on Biosimilars set for June 4-6, 2014 in New York City.

Details for Dr. Noonan’s presentation are as follows:

Friday, June 6 – 2:30-3:15 p.m. ET

Case Spotlight: Momenta v. Amphastar and Bioequivalence: Understanding the Implications for the Future of Biosimilars

  • Overview of the case and procedural history

    • Examining the significance of FDA’ statement that this case is instructional in how they will handle biosimilars

    • Understanding the ramifications of the Supreme Court’s denial of Cert

    • Figuring in the implications of the Court’s decision in Classen: can the cases be reconciled?

  • Delineating the parameters of the 271(e) safe harbor: when and to what extent does the safe harbor exception apply to pre-approval and post-approval activities?

    • Developing and submitting info under a federal law versus reporting routinely to the FDA after marketing approval

    • Understanding the impact on Roche Bolar

  • Exploring Judge Rader’s dissent and contention that the majority decision essentially renders manufacturing method patents worthless

    • Does this significantly limit the types of patents available for biosimilars?

    • Is this a research disincentive for the first biosimilar applicants?


About American Conference Institute

A unique organization, American Conference Institute is devoted to providing the business intelligence that senior decision-makers need to respond to challenges both here in the US, and around the world. Staffed by industry specialists, lawyers and other professionals, American Conference Institute operates as a think tank, monitoring trends and developments in all major industry sectors, the law, and public policy, with a view to providing information on the leading edge.

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