Resources

Global Drug Development Seminar - Strategies for ANDA Litigation and Regulatory Affairs

3/15/2016
Belle Essence Hotel Diamond Ballroom
237 Gangnam-gu, 테헤란로 강남구 서울특별시
Seoul,
South Korea

Partners Sunhee Lee, Michael Dzwonczyk, Chid Iyer and Mark Boland will participate in a Global Drug Development Seminar in South Korea. The seminar, hosted by the Korea Biotech Industry Organization, will cover a number of topics of interest to the pharmaceutical and biotechnology industries. Specifically, Sughrue partners will cover the following matters:

  • Chid Iyer - Obviousness of compound patent and post-filing evidence showing actual differences between a patented invention and the prior art in Bristol-Myers Squibb v. Teva
  • Michael Dzwonczyk - Hatch-Waxman cases you should know for drug developments and ANDA filing
    - Is a use of claimed drug in clinical trial a "sale bar"? - The Medicines Co., v. Hospira, Inc.
    - Jurisdictions over parents, subsidiaries, affiliates in Hatch-Waxman cases - AstraZeneca AB v. Mylan Pharms, Inc.; Acorda Therapeutics v. Mylan Pharms. Inc.
    - Analysis of drug intermediates for impurities so that nonconforming batches can be separated may not infringe claims directed to the analysis method under 271(g) - Momenta v. Teva
    - Is a drug manufacturer providing product labels containing directions for use liable for induced infringement? - Eli Lilly and Company v. Teva Parenteral Medicines
  • Sunhee Lee - Next Big Drug: Biosimilar Litigation Updates, including related IPR: Amgen v. Sandoz, Amgen v. Apotex, Jenssen v. Celtrion, Amgen v. Hospira
  • Mark Boland - Exploring use of USPTO trial proceedings (IPR) in Hatch-Waxman litigation
    - Analysis and statistics of increasing use of IPR in HW litigation
    - IPR on the types of claims (compound, formulation, treatment method)
    - Use of IPR by second, third ANDA filers
    - Relationship of IPR and court proceedings (settlements, final decisions, or discovery)