Safe Harbor Defense Under 35 U.S.C. §271(e)(1) Requires That the Accused Activity Is Solely for Uses Reasonably Related to Submitting Information to the FDA

| Mark Kachner


Before Moore, Bryson, and Chen. Appeal from the United States District Court for the District of Delaware.

Summary: Biological engineering activity that would otherwise constitute patent infringement is protected under a safe harbor, if the activity is solely for uses reasonably related to submitting information to the FDA. Where the patent covers a method of manufacture, the relevant safe harbor inquiry is whether the act of manufacture is solely for submitting information to the FDA. The relevant inquiry is not whether the products of the manufacture are for uses related to submitting information to the FDA.

Amgen accused Hospira of infringing a patent covering a method to manufacture EPO—a protein that regulates red blood cells, based on Hospira preparing twenty-one batches of EPO. A jury determined that seven batches were subject to a safe harbor, but the remaining fourteen batches were not. The protected batches included two used to qualify Hospira’s process and equipment, and five batches used for mandatory pre-approval inspection by the FDA. The remaining batches were for various types of testing, revisions to release specifications, stability testing, and continued process verification.

On appeal, the Federal Circuit found that substantial evidence supported the jury’s finding that fourteen batches were not manufactured “solely for uses reasonably related to the development and submission of information” to the FDA. The court rejected Hospira’s argument that the safe harbor always applies in the pre-approval context. The court also rejected Hospira’s argument that simply submitting information about a drug substance lot to the FDA brings the manufacture of that lot within the safe harbor. Evidence showed that preparing the additional batches was not an activity required for FDA approval, but was to meet post-approval stability requirements or to prepare for commercialization. The Federal Circuit also affirmed the $70 million damages verdict that was based on the profit Hospira could earn if it were in place to launch its EPO as soon as the patents expired.

Editor: Paul Stewart