Roche Products, Inc. v. Bolar Pharmaceutical Co., Inc.
733 F.2d 858 (1984)
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Rule of Law:
The use of a patented invention for testing and investigation strictly related to obtaining FDA approval for a generic drug is a prohibited use that constitutes patent infringement and does not fall within the narrow experimental use exception.
Facts:
- Roche Products, Inc. (Roche) was the assignee of a patent for the chemical compound flurazepam hydrochloride (flurazepam hcl).
- Flurazepam hcl is the active ingredient in Roche's successful prescription sleeping pill, "Dalmane."
- The patent for flurazepam hcl was set to expire on January 17, 1984.
- In mid-1983, before the patent expired, Bolar Pharmaceutical Co. (Bolar), a generic drug manufacturer, obtained 5 kilograms of flurazepam hcl from a foreign manufacturer.
- Bolar used the patented compound to conduct bioequivalency studies and other tests necessary to prepare a New Drug Application for submission to the U.S. Food and Drug Administration (FDA).
- Bolar's stated purpose was to obtain pre-market approval for a generic version of Dalmane so it could begin marketing its product as soon as Roche's patent expired.
Procedural Posture:
- Roche Products, Inc. filed a complaint against Bolar Pharmaceutical Co. in the U.S. District Court for the District of New Jersey, seeking an injunction.
- The district court granted Roche a Temporary Restraining Order against Bolar.
- The case was transferred on a change of venue to the U.S. District Court for the Eastern District of New York.
- The district court consolidated Roche's motion for a preliminary injunction with the trial on the merits.
- The U.S. District Court for the Eastern District of New York denied Roche’s application for a permanent injunction, holding that Bolar's use was not infringement because it was de minimis and experimental.
- Roche (appellant) appealed the district court's judgment to the U.S. Court of Appeals for the Federal Circuit.
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Issue:
Does a generic drug manufacturer's use of a patented compound, prior to the patent's expiration, solely for testing to gather data required for FDA approval, constitute patent infringement under 35 U.S.C. § 271(a)?
Opinions:
Majority - Nichols, Senior Circuit Judge
Yes. A generic drug manufacturer's use of a patented compound for FDA-required testing constitutes patent infringement. The plain language of 35 U.S.C. § 271(a) prohibits any unauthorized 'use' of a patented invention during the patent's term. Bolar's activities do not fall within the very narrow common law experimental use exception, which is limited to activities performed 'for amusement, to satisfy idle curiosity, or for strictly philosophical inquiry.' Bolar's use was not for philosophical inquiry but for definite, cognizable, and not insubstantial commercial purposes—specifically, to expedite the marketing of its generic drug post-patent expiration. Citing Pitcairn v. United States, the court held that tests and experiments conducted in keeping with the legitimate business of the alleged infringer are infringements, and experimental use is not a defense. The court declined to create a new exception based on public policy arguments regarding the conflict between the Patent Act and the Food, Drug, and Cosmetic Act, stating that resolving such policy conflicts is the role of Congress, not the judiciary.
Analysis:
This decision narrowly construed the experimental use defense, holding that commercially motivated testing for regulatory approval constitutes patent infringement. The ruling created a significant practical barrier for generic drug manufacturers, as it prevented them from starting the lengthy FDA approval process until after the pioneer drug's patent expired, thus creating a de facto extension of the patent holder's market exclusivity. The decision highlighted the tension between patent law and the policy of facilitating generic drug competition, directly prompting Congress to respond. In 1984, Congress passed the Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act), which legislatively overruled this decision by creating a statutory safe harbor, now known as the 'Bolar exemption,' allowing the use of patented inventions for activities reasonably related to developing and submitting information to the FDA.
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