For Claimed Methods of Manufacture, the Relevant Safe Harbor Inquiry Is Whether an Act of Manufacture Was for Uses Reasonably Related to Submitting Information to the FDA

In Amgen Inc. v. Hospira, Inc., Nos. 2019-1067 and 2019-1102 (Fed. Cir. Dec. 16, 2019), the Federal Circuit affirmed the district court’s denial of the parties’ motions for JMOL or alternative motions for new trial, regarding infringement, invalidity, § 271(e)(1) Safe Harbor, and damages.

Regarding Safe Harbor, Hospira challenged the jury instructions, which indicated that manufacturing a batch of a particular drug was protected by the Safe Harbor provision if it was “reasonably related” to submitting information to the FDA to obtain approval.  The Federal Circuit, however, found no legal error.  It reasoned that because the accused activity is Hospira’s use of Amgen’s claimed methods of manufacture, the relevant inquiry is not how Hospira used each batch it manufactured, but whether each act of manufacture was for uses reasonably related to submitting information to the FDA.

Hospira also contended that no reasonable jury could have found that some, but not all, of Hospira’s batches were protected by the Safe Harbor.  But the Federal Circuit upheld the jury’s finding based on substantial evidence.