Regulatory review exception

Integra Lifesciences I, Ltd. v. Merck KGaA, Nos. 02-1052, -1065 (Fed. Cir. July 27, 2007)

The Federal Circuit ruled on the Supreme Court’s broad interpretation of the regulatory review exemption to patent infringement, also known as the Bolar exemption. The Federal Circuit reversed its previous decision of infringement, holding that Merck’s preclinical development activities that were ultimately not the subject of a submission to United States Food and Drug Administration (FDA) were still exempt from infringement under the regulatory review exemption.  

Eli Lilly & Co. v. Medtronic, Inc. - 496 U.S. 661 (1990) (United States Supreme Court)

The Supreme Court held that the scope of the regulatory review exemption covers the use of patented inventions reasonably related to the development and submission of information needed to obtain marketing approval of medical devices under the Federal Food, Drug, and Cosmetic Act.

Amgen Inc. v. Chugai Pharmaceutical Co. (US District Court, District of Massachusetts - 706 F. Supp. 94 1989)

The Court ruled that the export/import of samples of a biological product protected by patent for the conduct of stability studies "solely for uses reasonably related to the development and submission of information under" reporting requirements of federal drug laws, is permitted under the regulatory review exemption.

Canada-Patent Protection of Pharmaceutical Products, Report of the Panel, WTO, WT/DS114/R (2000)

A WTO dispute settlement panel ruled that:

(1) Regulatory review exception – that permits competitors to use a patented invention, without the authorization of the patent holder, for the purposes of obtaining marketing approval – is consistent with the Agreement on the Trade-Related Aspects of Intellectual Property Rights (TRIPS);

Case Summary

Roche Products Inc. v. Bolar Pharmaceutical Co., 733 F.2d 858 (Fed. Cir. 04/23/1984)

The Court of Appeals for the Federal Circuit (CAFC) ruled that the experimental use exception in US patent law is truly narrow. Where the subject matter of a patent is made or used as an experiment, whether for the gratification of scientific tastes, or for curiosity, or for amusement, the interests of the patentee are not antagonized, the sole effect being of an intellectual character in the promotion of the employer's knowledge or the relaxation afforded to his mind.

Case Summary