Roche Products, Inc. v. Bolar Pharmaceutical Co.

1984), was a court case in the United States related to the manufacturing of generic pharmaceuticals.

Roche was a brand-name pharmaceutical company which made and sold a sleep aid Dalmane, the active ingredient of which Flurazepam was protected by patent.

[1] Before patent expiration, Bolar used the patented chemical in experiments to determine if its generic product was bioequivalent to Dalmane in order to obtain FDA approval for its generic version of Dalmane.

The court rejected this argument, stating that such policy decisions should be made by Congress.

[1] Shortly after Roche v. Bolar was decided, Congress did pass a law permitting use of patented products in experiments for the purpose of obtaining FDA approval (section 271-e-1 of the Drug Price Competition and Patent Term Restoration Act, informally known as the "Hatch-Waxman Act" [Public Law 98-417], which established the modern system for FDA approval of generic drugs).