Facts of the Case

Integra Lifesciences sued Merck for supplying an Integra patented compound to other drug companies for use in preclinical research. In response, Merck claimed its actions were allowed under the federal law that said it was not an act of patent infringement to use or import a patented invention into the United States, if the invention was used only in ways related to the development and submission of information under a federal drug law (such as the law governing submission of data to the FDA). The district court ruled against Merck and awarded Integra damages. The Federal Circuit affirmed the judgment but ordered a modification of damages.

Question

Did federal law allow the use of patented inventions in preclinical research, the results of which were not ultimately included in a submission to the FDA?

Conclusion

Yes. Justice Antonin Scalia delivered the Court's unanimous opinion that federal law allowed the use of patented compounds in preclinical studies, as long as there was a reasonable basis to believe the compound could be the subject of an FDA submission. The Court reasoned that federal law provided "a wide berth for the use of patented drugs in activities related to the federal regulatiory process" and that "this necessarily included preclinical studies." Because federal law required only a "reasonable relation" to FDA submission, information gathered on the patented invention (a compound in this case) did not necessarily need to be submitted to the FDA to be exempt from patent protection.