On May 7, 2019, Chris Loh published “Navigating the 35 U.S.C. § 271(e)(1) Safe Harbor” in The Patent Lawyer. The following is an excerpt:
The Biologics Price Competition and Innovation Act of 2009 (BPCIA) gives a biologics maker (“reference product sponsor” or RPS) the ability to sue a biosimilar maker (“applicant”) for patent infringement following the applicant’s submission to the FDA of its abbreviated biologics license application (aBLA), and before the actual commercial marketing of the biosimilar. This ability of RPSs to sue applicants early, however, is not unlimited. One limitation can be found at 35 U.S.C. § 271(e)(1), which provides a “safe harbor” to applicants who use patented inventions in a manner reasonably related to the submission of their aBLAs.