Amgen v. Hospira: Litigation Update

With the September 18, 2017 trial date fast approaching, the district court in Amgen v. Hospira last week denied Hospira’s motion for summary judgment of non-infringement of its proposed biosimilar of Epogen®/Procrit® (epoetin alfa) and granted-in-part and denied-in-part the parties’ respective motions for exclusion of expert testimony.

As we previously reported, Hospira filed a motion in May 2017 for summary judgment of non-infringement on grounds that the accused EPO batches are (1) protected by the safe harbor provision of 35 U.S.C. § 271(e)(1), and therefore did not infringe the ‘349 and ‘298 patents, and (2) that they did not infringe the ‘298 asserted claims directed to EPO isoforms and methods of preparing such isoforms.  The court denied summary judgment on both grounds.  On the safe harbor issue, the court found a genuine dispute as to whether Hospira’s manufacture of 21 lots of commercial inventory of EPO, with a commercial value “in the hundreds of millions,” was “solely for uses reasonably related to the development and submission of information” to the FDA.  The district court also found a genuine dispute as to whether Hospira practiced the isoform claims, rejecting its argument that it merely practiced the prior art purification process.  The district court also construed the term “preparing a mixture of two or more” as “allowing for simultaneous preparation of a mixture of the isoforms,” thus rejecting Hospira’s defense that it made the isoforms separately prior to making the mixture.

The district court also rejected-in-part and granted-in-part each parties’ motion to exclude expert testimony.  Notably, in response to Hospira’s motion, the district court precluded Amgen’s expert from presenting his opinion on a $415.3 million lump sum royalty payment, instead limiting him to a maximum figure of $153.9 million.

We will continue to monitor this litigation.  Stay tuned to Big Molecule Watch for further updates.