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Roche Products, Inc. v. Bolar Pharmaceutical Co., Inc. Case Brief
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Case Brief Summary & Legal Analysis
tl;dr: A generic drug maker used a patented compound for FDA testing before the patent expired. The court held this was patent infringement, rejecting the “experimental use” defense because the tests were for commercial purposes, not philosophical inquiry.
Legal Significance: The decision narrowly defined the common law experimental use defense, holding it inapplicable to commercially motivated activities like FDA testing. This ruling prompted Congress to create a statutory safe harbor (the Hatch-Waxman Act) to permit such testing.
Roche Products, Inc. v. Bolar Pharmaceutical Co., Inc. Law School Study Guide
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Case Facts & Court Holding
Key Facts & Case Background
Plaintiff Roche Products, Inc. (Roche) held the patent for flurazepam hydrochloride, the active ingredient in its successful prescription sleeping pill, Dalmane. The patent was set to expire on January 17, 1984. Defendant Bolar Pharmaceutical Co., Inc. (Bolar), a generic drug manufacturer, intended to market a generic version of Dalmane as soon as Roche’s patent expired. To meet the Food and Drug Administration’s (FDA) pre-marketing approval requirements, Bolar needed to conduct extensive testing, including bioequivalency and stability studies. In mid-1983, while Roche’s patent was still in force, Bolar imported 5 kilograms of the patented compound and began using it to conduct the tests necessary for its FDA application. Bolar’s sole purpose for using the compound was to generate data for regulatory submission; it did not intend to sell its generic drug until after the patent expired. Roche sued for patent infringement, seeking an injunction to stop Bolar’s testing activities. The district court found for Bolar, holding that the use was non-infringing under the experimental use doctrine. Roche appealed.
Court Holding & Legal Precedent
Issue: Does the use of a patented invention for testing and investigation strictly related to obtaining FDA approval for a generic drug to be marketed after the patent’s expiration constitute patent infringement under 35 U.S.C. § 271(a)?
Yes. The use of a patented invention to conduct federally mandated tests Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit es
IRAC Legal Analysis
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IRAC (Issue, Rule, Analysis, Conclusion) is the exact format professors want to see in your exam answers. Our exclusive Flash-to-Full briefs combine holding, analysis, and rule statements formatted to match what A+ students produce in exams. These structured briefs help reinforce the essential legal reasoning patterns expected in law school.
Legal Issue
Does the use of a patented invention for testing and investigation strictly related to obtaining FDA approval for a generic drug to be marketed after the patent’s expiration constitute patent infringement under 35 U.S.C. § 271(a)?
Conclusion
This decision established that commercially motivated testing for regulatory approval constitutes patent Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea
Legal Rule
The use of a patented invention is an act of infringement under Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepte
Legal Analysis
The Federal Circuit reversed the district court, finding its application of the Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum. Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum. Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum. Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in culpa qui officia deserunt mollit anim id est laborum. Lorem ipsum dolor sit amet, consectetur adipiscing elit, sed do eiusmod tempor incididunt ut labore et do
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Flash Summary
- The use of a patented invention for FDA-mandated testing to prepare