Medical Uses of Known Biological Products and Drug Repurposing: Reconciling Infringement and Enforcement

December 1, 2022 12:15pm

As originators become more active in the business of biosimilars, and biosimilar manufacturers have entered the arena of creating their own new biologics, the importance of second medical uses for individual companies as well as the global industry is of growing importance.

Topics of discussion will include:

  • Understanding second medical use patents & carve out strategies
    • Clarifying the patentability of further medical use inventions
  • Whether eliminating an indication claimed by a second medical use patent from the product label does or does not alone save the generic from a finding of infringement and a consequent injunction
  • Assessing the implications of second use patents for:
    • Regulatory
    • Market Access
    • Legal
  • Outlining the implications
  • What form can second medical use claims take?
  • What must be established for a second medical use patent to be infringed?
  • How do you enforce a second medical use patent?
  • Can you prevent off-label use?