CAFC protects research tools

The U.S. Court of Appeals for the Federal Circuit has clarified the boundaries of the Hatch-Waxman Act that exempts from patent infringement some research intended to support a submission to the FDA.

The decision interprets 271(e)(1) of the act as applying only narrowly to clinical research done in support of a generic version of a marketed drug, which attorneys said upholds the enforceability of patents covering tools and other patents used upstream in the drug discovery process.


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