Amgen Suit Shows Limitations Of Biosimilar Safe Harbor

By Julia Kolibachuk, Maria Nunez and Ashley Mays-Williams ( September 7, 2018, 2:47 PM EDT) -- On Aug. 27, 2018, the United States District Court for the District of Delaware denied Hospira Inc.'s motion for judgment as a matter of law and found substantial evidence supported an earlier jury verdict that certain batches of drug product manufactured by Hospira failed to qualify for the safe harbor created by 35 U.S.C. § 271(e)(1). In its decision,[1] the court cited, inter alia, Hospira's communications describing batches for use as "commercial inventory" and evidence demonstrating that testing performed with certain batches was not required for U.S. Food and Drug Administration approval as supporting the jury's verdict....

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