Revisiting Roche and the FDA Exemption from Patent Infringement

The Roche court held or found that the use of a patented drug for obtaining FDA approval of a generic before patent expiration constituted patent infringement.  The effect of this ruling was to delay the entry of a competing generic drug to the market.   The Roche court did not find that the common law experiemental use exemption applied to cases of experimentation for the development of a generic drug.

The common law experimental use exemption had never been applied to the development of a generic drug and the Roche court was unwilling to extend it.  Based on the Roche Curt’s Ruling there was a seven to ten year delay in a competitor’s efforts to bring a generic drug to the market.  After the Roche Ruling Congress enacted the FDA exemption from patent infringement. 

The FDA exemption from patent infringement provides for activities that may lead to the development of a generic drug.  This statutory exemption from patent infringement is often the subject of litigation between a patented or branded drug owner and a generic or competitor.  The FDA exemption has been refined and modified significantly from its initial enactment by judicial decisions. The FDA exemption now permits a variety of activities that are desgined to garner FDA approval for the sale of a generic drug. 

This has been and will continue to be a hot top topic in biotech patent litigation.

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