Stockpiling Biologics Under Hatch-Waxman Protection

By Paul Dietze, Whitney Remily, Scott Cunning, C. Kyle Musgrove and Yongjin Zhu (October 23, 2017, 11:47 AM EDT) -- A recent biosimilars litigation raises issues regarding the scope of the 35 U.S.C. § 271(e)(1) safe harbor provision and whether it protects commercial stockpiling. Amgen Inc. et al. v. Hospira Inc., No. 1:15-cv-839 (D. Del., Sept. 25, 2017). Hospira is seeking approval to market a biosimilar version of Amgen's erythropoeietin ("EPO") anemia treatment. Hospira had manufactured 21 lots of EPO between 2013 and 2015. These lots numbered in the tens of millions of doses. Prior to trial, Hospira filed a motion for summary judgment arguing that its activities were protected by the safe harbor provisions of 35 U.S.C. § 271(e)(1)....

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