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20/06/2024 21/06/2024 America/Toronto Biosimilars & Innovator Biologics Biosimilars & Innovator Biologics
June 20 – 21, 2024
New York City Bar Association, New York, NY
Please visit https://www.americanconference.com/biosimilars/ for more information and updates. New York City Bar Association, New York, NY true DD/MM/YYYY 1440 use-title -
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20/06/2024 21/06/2024 America/Toronto Biosimilars & Innovator Biologics Biosimilars & Innovator Biologics
June 20 – 21, 2024
New York City Bar Association, New York, NY
Please visit https://www.americanconference.com/biosimilars/ for more information and updates. New York City Bar Association, New York, NY true DD/MM/YYYY 1440 use-title -
Reference Drug Patent Challenges: Unpacking Recent IPR Decisions and Insights
Mira A. Mulvaney
Associate VP – Assistant General Patent Counsel, IP Litigation
Eli Lilly and Company
Kurt Mathas
Partner
Winston & Strawn LLP
- Reviewing recent cases that impact the patentability of biologics
- e.g., Amgen v. Sanofi, Kite v. Juno, and recent subject matter eligibility case law
- Understanding the advantages for applicants to resolve prior art invalidity disputes via IPRs
- Establishing standing to appeal in an IPR in connection with BPCIA and the FDA approval process for biosimilars
- Appreciating the timing for applicants to file petitions for IPRs relative to filing BLAs and BPCIA litigation
- Analyzing biosimilars IPR filings and recent PTAB decisions, e.g., the PTAB challenges relating to SOLIRIS and STELARA