The Federal Circuit reversed the district court’s finding that the patent owner had not commercially offered the claimed pharmaceutical invention for sale before the critical date, because the company hired by the patent owner to manufacture the product had only sold manufacturing services, not pharmaceutical batches and because the batches fall under the experimental use exception.  The court rejected both reasons. 

First, it held that the on sale bar is intended to preclude attempts by the inventor to profit from commercial use of an invention for more than a year before an application for the patent is filed.  Here, the  company hired by the patent owner to make the product performed services to prove to the FDA that the product met the FDA’s specifications and each batch was marked with commercial codes and sent to the patent owner for commercial packaging.  Second, the use was not experimental, because experimental uses cannot occur after a reduction to practice.  The patent owner contended that it could not have reduced to practice the invention at that time, because it did not appreciate that it had the invention at that time.  But, where an invention is on sale, conception is not required to establish reduction to practice.

The Medicines Co. v. Hospira, Inc., Case Nos. 2014-1469, -1504 (July 2, 2015); Opinion by: Hughes, joined by Dyk and Wallach; Appealed From: District Court for the District of Delaware, Andrews, J. Read the full opinion here.

Jump to Page