European Supplementary Protection Certificates: What Every Regulatory and IP Attorney Needs to Know About the Evolving Framework Governing SPCs

December 1, 2022 11:15am

The introduction of the SPC manufacturing waiver which went into effect on 2 July 2022 addressed a significant disadvantage that European producers of biosimilars had compared to non- European rivals. Under the new system, the UPC will have jurisdiction over SPCs unless the opt-out provision is invoked or if they originate from an already opted out European patent. This session will detail the rights conferred by the SPC.

Topics of discussion will include:

  • Whether an SPC under the current national SPC laws can be based on a unitary patent
  • Outlining the implications of the rules of origin on the biopharmaceutical industry
  • Detailing the scope, relevant marketing authorization, and which patents can be used to obtain an SPC
  • Considering areas where clarification from CJEU may still be required
  • Preparing for the EU Commission’s prospect of introducing a unitary SPC