Safe Harbor Provision of 35 U.S.C. § 271(e)(1) – Implications of Intent and Continued Use

By: Alyson L. Wooten, Pharm.D.

The safe harbor defense has been of issue in two recent cases in which the bounds of the protection has been analyzed. Section 271(e)(1) carves out an exception to patent infringement liability when otherwise-infringing activities are solely for uses reasonably related to obtaining FDA approval. 35 U.S.C. § 271(e)(1) (“It shall not be an act of infringement to make, use, offer for sell, or sell within the United States a patented invention . . . 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.”). The two recent decisions found that (1) intent is relevant to determine if the activity is protected, and (2) continued use of a protected material after conclusion of a clinical trial does not impact the safe harbor protection.

Intent is Relevant to the Safe Harbor Provision

The Federal Circuit has held that “[a]s long as the activity is reasonably related to FDA approval, [a party’s] intent or alternative uses are irrelevant to its qualifications to invoke the Section 271(e)(1) shield.” Abtox, Inc. v. Exiron Corp., 122 F.3d 1019, 1027 (Fed. Cir. 1997). However, despite a party’s recent argument that intent should be entirely irrelevant to the determination of whether the safe harbor protections are applicable, Judge Andrews of U.S. District Court for the District of Delaware held in Amgen Inc., et al. v. Hospira, Inc., Case No. 15-cv-839-RGA (Order, August 27, 2018), that the proposition in Abtox is not that broad. “[E]vidence of intent can be a relevant factor in determining whether an activity is reasonably related to obtaining FDA approval, and that [Abtox and similar cases] stand for the proposition that evidence of commercial intent is not determinative of the safe harbor inquiry.” Judge Andrews held that ignoring intent could lead to a result where “a party could manufacture 200 drug substance batches and earmark them for future use as commercial inventory without infringing, so long as the party used each of those batches for at least one test to generate data of the type used by the FDA in determining whether to approve the drug.” This result would not be within the spirit of safe harbor provision. The proper test is to determine if the use is reasonably related to FDA approval. However, the court emphasized that “once it is determined that the activity is reasonably related to obtaining FDA approval, [] intent or alternative uses are irrelevant to its qualification to invoke the section 271(e) shield.” (internal quotations omitted). Thus, while there may be some commercial attendant consequence to the activity, the ultimate query is focused on whether an activity is reasonably related to obtaining FDA approval.

Continued Use After Conclusion of a Clinical Trial Can Fall Within the Safe Harbor Provision

A recent case in the U.S. District Court for the Northern District of California considered whether the continued use of accused systems after the completion of a clinical trial would still be protected by the safe harbor provision of section 271(e)(1). Nevro Corp. v. Boston Scientific Corp. et al., Case No. 16-cv-6830-VC (Order, July 24, 2018). The case involved patented systems that were used in clinical trials to generate data necessary for FDA approval of the systems. The clinical trial protocol, which was approved by the FDA, allowed study participants to continue to use the systems after the trial concluded and the results necessary for FDA approval were collected. Noting that the FDA specifically approved the trial plan that allowed participants to continue to receive treatment after results were collected, Judge Chhabria found that the clinical trial use and continued use were “reasonably related to the development and submission of information to the FDA for device approval.” (internal quotations omitted). As such, the use did fall within the safe harbor provision.

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