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