Eric Marandett Speaks on Hatch-Waxman and the Patenting Process

Eric Marandett Speaks on Hatch-Waxman and the Patenting Process

Choate Speaking Engagement

 | September 15, 2009

 | Eric Marandett

FDA Boot Camp

Organization:  American Conference Institute
Location:  Boston


Eric Marandett, chair of Intellectual Property Litigation, spoke at the American Conference Institute’s FDA Boot Camp.  The conference gave patent attorneys and products litigators background on relevant regulatory law for life sciences cases.  Mr. Marandett presented, “Patent & IP Spotlight: Hatch-Waxman, the Patenting Process and More,” which covered the following issues:

  • Seeking and obtaining patent protection during the pre-approval process
  • Making up for lost time in the patent life cycle during the pre-approval process
  • Distinguishing the patenting process for drugs from that of biologics: which biologics are treated as drugs and why?
  • Identifying the respective roles of the FDA and the PTO in the patenting of drugs and biological products
  • NDA vs. ANDA (Abbreviated New Drug Application)
  • What does an ANDA require?
  • Listings and De-listings
  • Hatch Waxman and reforms under MMA

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