## Facts

- Upjohn developed and marketed minoxidil products, including 2% topical minoxidil (Rogaine), originally approved for prescription use and later pursued for over-the-counter (OTC) sale.
- Upjohn submitted a supplemental new drug application (sNDA) to switch Rogaine from prescription to OTC status and included new clinical investigations.
- The Federal Food, Drug, and Cosmetic Act provides three-year exclusivity for certain sNDAs that contain new clinical investigations conducted or sponsored by the applicant and “essential to the approval” of the application.
- The FDA approved OTC Rogaine but denied Upjohn a three-year exclusivity period and permitted abbreviated new drug applications (ANDAs) for competing OTC topical minoxidil 2% to become effective.
- Upjohn sued the FDA Commissioner in his official capacity, seeking declaratory and injunctive relief requiring the FDA to grant exclusivity and to block or suspend effective ANDA approvals.
- The court issued an ex parte temporary restraining order preventing approval/effectiveness of ANDAs for OTC topical minoxidil 2% pending further proceedings.
- Competing manufacturers intervened for limited purposes to address the harm they would suffer if a preliminary injunction issued.
- The opinion resolved only Upjohn’s motion for a preliminary injunction.

## Issues

1. Whether Upjohn showed a strong likelihood of success that the FDA acted unlawfully in denying three-year exclusivity by determining Upjohn’s new clinical investigations were not “essential to the approval” of the sNDA.
2. Whether Upjohn established irreparable harm sufficient to justify preliminary injunctive relief.
3. Whether the balance of harms and the public interest favored enjoining FDA action that allowed ANDA competition for OTC topical minoxidil 2%.

## Decision

- The court denied Upjohn’s motion for a preliminary injunction.
- The court found Upjohn did not show a strong or substantial likelihood of success on the merits under the deferential standard applicable to FDA scientific and regulatory determinations.
- The court concluded the record supported FDA’s determination that approval of the OTC switch did not depend on the new studies, so they were not “essential to the approval” for purposes of exclusivity.
- The court determined Upjohn’s claimed economic injury did not justify extraordinary interim relief, particularly given the weak merits showing.
- The court held that an injunction would substantially harm approved ANDA holders and would not serve the public interest in orderly FDA administration and access to lower-cost products.

## Legal Principles

- Preliminary injunctions require balancing: (1) likelihood of success on the merits, (2) irreparable harm, (3) harm to others, and (4) the public interest.
- FDA actions challenged under the Administrative Procedure Act are upheld unless arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law; courts give substantial deference to FDA’s technical and scientific judgments.
- Three-year exclusivity for an sNDA depends on whether submitted new clinical investigations were conducted or sponsored by the applicant and were “essential to the approval,” meaning the approval depended on reliance on those specific investigations.
- Agency review or consideration of additional studies does not, by itself, establish that the studies were “essential” within the meaning of the exclusivity provisions.

## Conclusion

The court refused to preliminarily bar generic competition for OTC topical minoxidil because Upjohn did not show that FDA unlawfully denied three-year exclusivity or that the equitable factors favored interim relief, and the court deferred to FDA’s supported determination that the new clinical investigations were not essential to the OTC approval.


Upjohn Co. v. Kessler, 938 F. Supp. 439 (W.D. Mich. 1996)