As we previously reported, last September a District of Delaware jury issued a verdict that Hospira’s manufacture of 14 batches of drug substance in connection with its proposed biosimilar of Amgen’s Epogen® (epoetin alfa) was not protected activity under the § 271(e)(1) safe harbor and infringed Amgen’s ’298 patent, and awarded Amgen $70 million as a reasonable royalty for such infringement.  In October, Hospira filed post-trial motions for judgment as a matter of law of no infringement and invalidity, and in the alternative, requested a new trial or recalculation of damages.  Amgen also filed its own post-trial motions regarding a second asserted patent, the ’349 patent, which the jury found not to be infringed.  The parties completed briefing late last year and have been awaiting a decision on the motions ever since.

The trial judge, Judge Andrews, just issued a Memorandum Opinion, denying all of Hospira’s motions.  The district court ruled in Amgen’s favor as to infringement of the ’298 patent and awarded Amgen $70 million, plus certain pre- and post-judgment interest.  In addition, the court denied Hospira’s requests for a new trial and recalculation of damages, and denied Amgen’s motion for judgment as a matter of law as to the ’349 patent.  As a consequence of today’s decision, the jury’s award of $70 million in damages stands, pending a potential appeal to the Federal Circuit.

Stay tuned for further developments.