Patent Term Extension Developments in the U.S. and Europe: Examining the Implications of Biogen v. Banner and Deciphering Europe’s SVC Manufacturing Waiver

July 22, 2021 11:30am

Charlotte Jacobsen
Ropes & Gray LLP

Rachel Mumby
Bristows LLP (London, UK)

  • Understanding how the Federal Circuit’s decision in Biogen Int’l GmbH v. Banner Life Scis. LLC (Fe. Cir. 2020) may influence the future application of patent term extensions in the U.S.
  • Taking a closer look at Europe’s Supplementary Protection Certificate Waiver: this legislation provides a patent term extension during which European generic and biosimilar manufacturers can continue to produce protected medicines for export or stockpiling.  Examining pressing questions including:
    • How is the waiver going to be used and what will the response to using the waiver be?
    • What requirements and qualifications need to be met to use the waiver?
    • What is the scope of the waiver?  What acts are specifically excepted from patent infringement?
    • Who can use the waiver?
    • What partner activities are exempt from infringement?
    • What will the points of attack be?