In Classen Immunotherapies v. King Pharmaceuticals, et al., No. 04-cv-3521 WDQ (D. Md 2013) (J. Quarles), the U.S. District Court for the District of Maryland denied Classen's motion to reconsider the Court's previous (2006) grant of summary judgment that defendant Elan Pharmaceuticals did not infringe Classen's patents under the patent statute's safe harbor provision, 35 U.S.C 271(e)(1). In doing so, the Court found that Elan's use of Classen's patents as part of fed and fast studies submitted to the FDA in Elan's supplemental New Drug Application and Citizen Petition was "reasonably related to the submission of information under the [Federal Food, Drug, and Cosmetics Act]" and thus immune from infringement.
The safe harbor provision provides that it is not an act of patent 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." In 2011, in Classen Immunotherapies v. Biogen IDEC, 659 F.3d 1057 (Fed. Cir. 2011), the Federal Circuit held that the safe harbor "does not apply to information that may be routinely reported to the FDA, long after marketing approval has been obtained." In 2012, in Momenta Pharm., Inc. v. Amphastar Pharm., Inc., 686 F.3d 1348 (Fed. Cir. 2012), the Federal Circuit held that Amphastar's method of testing batches of its product was covered by the safe harbor provision in that it was not routine but necessary for the continued approval of its ANDA and ability to market its generic product.
In the present case, Elan learned, in 2001, of a study indicating that the absorption and bioavailability of Skelaxin, a muscle relaxant, may be affected by the consumption of food. It subsequently conducted its own fed and fast studies to assess the affects of food on Skelaxin. Notably, Elan did not know at the time it began those studies whether food would in fact have any affect sufficient to warrant submission of any information to the U.S. Food and Drug Administration. Based on its studies, however, Elan ultimately submitted a Citizen's Petition to the FDA requesting that all subsequent Abbreviated New Drug Applications (ANDAs) include fed and fast studies, which the FDA granted. Elan also submitted to the FDA a supplemental label for its Skelaxin New Drug Application (NDA), which the FDA approved. Notably, Elan was not required under any law to conduct fed and fast studies nor was it required to submit any of its fed and fast study information to the FDA as part of its post-approval marketing of Skelaxin in the U.S.
The U.S. District Court found Elan's activities to be within the safe harbor, noting that Elan's studies were ultimately submitted to the FDA in a Citizen's Petition that affected pre-FDA approval of other companies' ANDAs, and affected post-approval labelling requirements for Skelaxin. In distinguishing the case from Classen and Momenta, the Court found that Momenta emphasized that the safe harbor should be interpreted expansively. It also noted that Elan's studies expedited development of information for regulatory approval of generic Skelaxin, which the Court found was an activity that the Federal Circuit in Classen "suggested was directly related to the purpose of the safe harbor" and thus not routine.