Tag Archives: Clinical Trial

Federal Circuit Holds That Third Party Clinical Trial May Not Constitute Public Use

In Dey, L.P. v. Sunovion Pharmaceuticals, Inc., the Federal Circuit vacated the district court’s grant of summary judgment in favor of Sunovion, and remanded for further consideration of whether Sunovion’s clinical trial constituted a “public use” of the formulation claimed in Dey’s patents. As noted by the court, this case is interesting because most pharmaceutical “public … Continue reading this entry

Clinical Trial Invalidates European Patent

Pharmaceutical inventions usually require human clinical testing in order to obtain regulatory approval to market the new product. Often a patent application is filed before the invention undergoes human testing, but sometimes a human clinical trial may be started—or even completed—first. While U.S. patent law provides that a “public use” of the invention within the … Continue reading this entry

Licensees Obtaining Data from Other Licensees

When a drug candidate is licensed to different licensees in different territories, the ability of each licensee to obtain marketing approval for the product may depend on access to data generated by the other. While license agreements do not always address this issue, there are some terms that can be useful in this type of situation. Case Study … Continue reading this entry