Companies attempting to obtain FDA approval for a pharmaceutical product must satisfy certain FDA requirements to gain approval to market their product. Obtaining the data required by the FDA for market approval may require performance of certain methods that would infringe a claim of a valid patent issued to another party. However, 35 U.S.C. § 271(e)(1) provides a “safe harbor” for activities that would otherwise be considered to infringe such patents. Although the safe harbor provision has been recognized to extend to pre-market approval activities, the scope of the safe harbor has recently been extended to cover activities performed post-market approval when such activities are done to satisfy requirements of a Federal law.

The safe harbor provision provides an exception for activities that would otherwise be considered to infringe valid patent under 35 U.S.C. § 271. The safe harbor provision recites a following:

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 . . . 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.1

In Classen Immunotherapies, Inc. v. Biogen IDEC,2 the Federal Circuit held that the safe harbor provision is directed to activities necessary to obtain regulatory approval, but does not apply to information that may be routinely reported to the FDA, long after marketing approval has been obtained.

In Classen, Classen asserted several patents directed to methods of evaluating and improving safety of immunization schedules, and alleged that Defendants directly infringed the patents through their participation in post-approval studies to evaluate associations between childhood vaccinations and risk of developing type 1 diabetes, and to determine whether timing of vaccination influences risk. Defendants asserted that their post-approval activities of providing vaccines, advising on immunization schedules, and reporting any adverse vaccine effects in conformity with FDA regulations were within the scope of the safe harbor provision. The court disagreed with Defendants, and held that post-approval activities did not fall within the safe harbor because the safe harbor does not apply to information that may be routinely reported to the FDA, long after marketing approval has been obtained, and further, such activities were not related to producing information for an IND,3 NDA4 or marketing approval. According to the court, the legislative history relating to the safe harbor, as well as subsequent case law,5 emphasized that § 271(e)(1) is directed to activities necessary to obtain regulatory approval and exempted preclinical research and other similar activities, whether or not ultimately submitted to the FDA. Furthermore, such activities would fall under § 271(e)(1) as long as it was reasonable that they would produce information relevant to an IND or NDA. However, because Defendant’s post-approval activities did not fit within any of the necessary conditions, the Federal Circuit ruled that § 271(e)(1) did not apply to their activities. Defendants petitioned for certiorari, but were denied by the Supreme Court.

The scope of the safe harbor provision was extended by the Federal Circuit to include post-market approval testing in Momenta Pharmaceuticals, Inc. v. Amphastar Pharmaceuticals, Inc.6 In Momenta, Momenta asserted a patent against Amphastar directed to methods for analyzing heterogeneous populations of sulfated polysaccharides, and alleged that Amphastar included such methods in its manufacturing process for quality control batch testing of its generic enoxaparin product. Amphastar argued that its testing fell within the scope of the safe harbor provision. In response, although Momenta conceded that Amphastar’s batch testing was required by the FDA, it argued that the safe harbor did not apply because the data collected was retained and not submitted to the FDA, the activities were carried out post-approval, and further, non-infringing alternatives were available. The district court granted a preliminary injunction for the alleged infringement.

Upon appeal of the preliminary injunction, the Federal Circuit held that the safe harbor provision included unambiguously broad language that applies to submissions under any Federal law, so long as the law regulates the manufacture, use, or sale of drugs. According to the court, “[P]ost-approval studies that are ‘reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs’ fall within the scope of the § 271(e)(1) safe harbor.”7 The court held that the “reasonably related” language in § 271(e)(1) does not require submissions to the FDA, or activities relevant to filing an ANDA for approval of a generic drug. “As long as the accused infringer ‘has a reasonable basis for believing’ that use of the patented invention might yield information that ‘would be appropriate to include in a submission to the FDA, that use is reasonably related to the development and submission of information under Federal law.’”8 Further, the court held that the safe harbor does not mandate the use of a noninfringing alternative when one exists. Thus, post-market approval testing falls within the safe harbor provision if such testing is used to obtain information to satisfy FDA requirements. As such, even though Amphastar’s testing was not submitted, FDA regulations requiring records associated with produced batches to be retained for at least a year and readily available for FDA inspection demonstrate that the testing was “reasonably related” to the development and submission of information to the FDA.

The court argued that the decision in Classen did not create an artificial distinction between pre- and post-approval activities for safe harbor qualification. Rather, the court stated that the activities inClassen related to information that can be routinely reported to the FDA. However, the studies conducted by Defendants in Classen were non-mandated studies, and thus not within the scope of the safe harbor. Accordingly, in view of Momenta, post-approval testing that is not routine, but instead required by the FDA, would fall within the scope of the safe harbor, even if the data resulting from such activities is not actually submitted to the FDA.

In view of the Momenta decision, it may be more challenging to successfully assert patent claims whose use are limited to obtaining information required by a Federal law. Therefore, patents regarding testing methods may have limited value. Extending claim scope beyond the context of obtaining data required by the FDA (or any other Federal law) may be a necessary consideration in view of Momenta.