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.

Patent

Read the full 777 word article

How to gain access

Continue reading with a
two-week free trial.