Challenging Patents on Reference Drugs: Litigation Strategies in the IPR Forum

June 28, 2022 2:00pm

Whitney Meier Howard
Venable LLP

Siegmund Y. Gutman
Proskauer Rose LLP

Gregory A. Morris
Honigman LLP

Maureen L. Rurka
Winston & Strawn LLP


John J. Molenda
Co-Chair, Healthcare & Life Sciences Practice

Steptoe & Johnson LLP

IPRs offer biosimilar and generic drug manufactures the benefit of challenging innovator patents with comparative haste and efficiency. While IPRs continue to provide an alternative forum for biosimilar manufactures who seek a faster alternative to BPCIA litigation, successful IPRs of biologics patents remains a challenge. During this interactive session, points of discussion will include:

  • Reducing risk by challenging patents in advance of launching biosimilars at risk
  • 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
  • Anticipating an answer to the unresolved question as to how much investment is required in the biosimilar context under Article III to establish standing
  • Appreciating the timing for applicants to file petitions for IPRs relative to filing BLAs and BPCIA litigation
    • Assessing concerns surrounding multiple filer petitions and relevant timing considerations
  • Analyzing biosimilars IPR filings and recent PTAB decisions