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Certain post-approval activities to support submissions to the FDA are now subject to claims of patent infringement
  • Jones Day
  • USA
  • September 20 2011

On August 31, the Federal Circuit significantly restricted the scope of the "safe harbor" provision of 35 U.S.C. 271(e)(1), which immunizes the use of patented inventions in connection with regulatory submissions to the Food and Drug Administration ("FDA").