## Facts

- Roche owned U.S. Patent No. 3,299,053 covering certain benzodiazepine compounds, including flurazepam hydrochloride, the active ingredient in Roche’s sleeping pill Dalmane.
- The patent issued in 1967 and was set to expire on January 17, 1984.
- In early 1983, Bolar planned to market a generic equivalent of Dalmane immediately upon patent expiration.
- To prepare an FDA submission before expiration, Bolar obtained about 5 kilograms of flurazepam hydrochloride and conducted stability, dissolution, bioequivalence, and blood serum studies required for regulatory approval.
- Roche sued in the Eastern District of New York, alleging Bolar’s pre-expiration testing infringed under 35 U.S.C. § 271(a) and seeking injunctive relief.
- The district court found no infringement, treating Bolar’s conduct as de minimis and experimental, and entered judgment for Bolar.
- Roche appealed to the Federal Circuit.

## Issues

1. Whether Bolar’s unlicensed use of a patented drug during the patent term for federally required pre-marketing tests constitutes infringement under 35 U.S.C. § 271(a).
2. Whether the judge-made experimental use doctrine exempts commercially directed regulatory testing intended to enable market entry immediately after patent expiration.
3. Whether courts may recognize a policy-based implied exception to patent infringement to account for FDA approval timing.

## Decision

- The Federal Circuit reversed the judgment of noninfringement and remanded.
- Bolar’s activities were an infringing “use” under § 271(a) even without manufacturing for sale or actual sales during the patent term.
- The experimental use doctrine did not apply because Bolar’s testing served definite, cognizable, and not insubstantial commercial objectives—securing regulatory approval for prompt post-expiration competition.
- The court declined to create a regulatory-testing exception based on drug-access policy concerns, treating any accommodation as a matter for Congress.
- On remand, the district court was directed to consider appropriate equitable relief under traditional equity principles.

## Legal Principles

- Under 35 U.S.C. § 271(a), unauthorized “use” of a patented invention during the patent term is independently actionable; infringement does not require proof of sales or measurable damages.
- The experimental use doctrine is narrow and generally limited to uses for scientific curiosity or other noncommercial purposes that do not materially implicate the patentee’s economic interests.
- Testing performed to obtain regulatory approval for a competing commercial product is not exempt experimental use when it is directed toward the user’s business and planned market entry.
- Courts will not create implied statutory exceptions to infringement to reconcile patent exclusivity with regulatory review timing; such policy adjustments are for legislative action.

## Conclusion

The Federal Circuit held that a generic manufacturer infringes by using a patented drug during the patent term to conduct FDA-required tests aimed at enabling immediate post-expiration marketing, and that the experimental use doctrine does not shield commercially motivated regulatory testing; any safe harbor for such conduct must come from legislation.


Roche Prods., Inc. v. Bolar Pharm. Co., 733 F.2d 858 (Fed. Cir. 1984)