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

June 6, 20142:30 pm - 3:15 pm

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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