Upjohn Co. v. Kessler

The Upjohn Company (Upjohn) (plaintiff) brought an action for declaratory judgment and injunctive relief after the Food and Drug Administration (FDA) approved Upjohn’s supplemental new drug application (NDA) for its prescription-to-over-the-counter (OTC) sales of its hair-growth drug Rogaine but denied Upjohn’s application for a three-year period of market exclusivity and approved abbreviated new drug applications (ANDAs) for three competitors. Under federal law, a three-year exclusivity period will not be granted unless a supplemental NDA includes reports of a new clinical test conducted by the applicant. Upjohn’s supplemental NDA included reports of a new clinical test, but Upjohn and the FDA disagreed whether the FDA determined that its approval was conditional on the additional testing. Upjohn argued that because the new testing addressed concerns raised by the FDA when Upjohn and the FDA initially met to discuss the prescription-to-OTC proposal and that the testing was reviewed by and questioned by the FDA before it denied Upjohn’s request for an exclusivity period, the new testing was essential to approval by the FDA. The FDA argued that it did not require Upjohn to conduct the additional testing as a condition to approving its request for an exclusivity period and that the FDA’s review of the additional testing did not significantly add to its ultimate decision.