24Jan 2020

The Safe Harbor Provision of 35 U.S.C. § 271(e)(1) states that:

“It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention (other than a new animal drug or veterinary biological product which is primarily manufactured using recombinant DNA, recombinant RNA, hybridoma technology, or other processes involving site-specific genetic manipulation techniques) solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.”

In a recent infringement case, Amgen v. Hospira, the allegedly infringed patents related to cells that stimulate the creation of red blood cells in anemia patients and a method of preparing erythropoietin (EPO). 

The district court held for the plaintiff and the defendant appealed on the basis that the Jury had been instructed to determine whether “the manufacture” of the accused infringing article (biosimilar erythropoietin, bEPO) fell under the Safe Harbor when the only burden Hospira rightfully was obliged to meet was whether “use” of the allegedly infringing bEPO was “reasonably related to obtaining FDA approval.” 

The Federal Circuit disagreed with Hospira and held that each accused activity must be evaluated separately to determine whether the Safe Harbor applies. Hospira argued that the instructions to the Jury had focused on the reasons why each batch of EPO was prepared and whether each batch was reasonably related to the development and submission of information to the FDA. 

But the Federal Circuit held that Section 271(e)(1)’s exemption “extends to all uses of patented inventions that are reasonably related to the development and submission of any information under the FDCA.'” The relevant question was whether each of Hospira’s acts for the preparation of EPO was for uses related to submitting information to the FDA”

According to the Federal Circuit, some batches were not protected by the Safe Harbor while others were. There was evidence that Hospira planned to use some batches for commercial purposes once it received the FDA approval, and those batches were thus not covered by the Safe Harbor provision.

Thus, “intent” for how a certain product is used is relevant in order to determine whether some activities (and some products) are shielded by the Safe Harbor provision.

Please contact me at silvia@salvadorilaw.com with questions or comments.

Silvia Salvadori, PhD

Silvia Salvadori, PhD