The FDA Exemption from Patent Infringement, what is it?

The Food and Drug Administration’s (FDA) exemption (35 USC 271 (e) (1)) from Patent Infringement is a limited exemption enacted by Congress to permit the use of a patented drug for the purpose of determining the bio-equivalency of a generic drug.  This form of pre-clinical and clinical trial research is necessary to obtain the FDA’s approval for competing products.

The FDA exemption is also referred to as the Hatch-Waxman Act.   It has also been interpreted broadly by the US Supreme Court to cover medical devices, as well, as upstream and downstream phases of research in product development.   See. Eli Lilly and Company v. Medtronic Inc., 496 U.S. 661, 670-1, 110 S.Ct. 2683, 2689-90, (1990) and Merck KGAA v. Integra Life Sciences Inc., 125 S.Ct. 2372, 2380-1, (2005).

The continued growth of the FDA exemption has led to concerns over a bio-tech research tool patent owner’s ability to assert a patent infringement claim.  For an in-depth discussion of the pharmaceutical industry, concerns of bio-tech research tool patent owners and the impact of the FDA Exemption see our Patent Publications section.

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