Medicines Co. v. Hospira, Inc.

TMC owns patents relating to bivalirudin, a synthetic peptide anti-coagulant. TMC sells the drug for injection under the Angiomax® brand and, from 1997 to 2006, purchased pharmaceutical batches from BV. In 2005, BV created batches of bivalirudin with levels of impurity above the FDA-approved maximum. TMC’s consultant discovered that certain methods of adding a pH-adjusting solution during compounding minimize the impurity. In 2008, TMC filed patent applications, describing this discovery. A year earlier, TMC had hired BV to prepare batches using the patented method. Each was released for commercial packaging. In 2010, TMC sued, alleging infringement by Hospira’s ANDA filings. The district court found the patents not infringed and not invalid as obvious, indefinite, or under the on-sale bar (35 U.S.C. 102(b)), which applies when, before the critical date, the claimed invention was the subject of a commercial offer for sale and was ready for patenting. The court found that the claimed invention was ready for patenting but not commercially offered for sale. The Federal Circuit initially reversed, but affirmed on reconsideration. To be “on sale” a product must be the subject of a commercial sale or offer for sale; a commercial sale bears the general hallmarks of a sale pursuant to Section 2-106 of the Uniform Commercial Code. No such invalidating commercial sale occurred in this case. View "Medicines Co. v. Hospira, Inc." on Justia Law