The Medicines Co v. Hospira, Inc., No. 14-1469 (Fed. Cir. 2015)
Annotate this CaseTMC owns patents relating to the drug 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 Laboratories. In 2005, BV created batches of bivalirudin with levels of impurity that exceeded the FDA approved maximum. TMC hired a consultant, who discovered that certain methods of adding a pH-adjusting solution during the compounding process minimize the impurity. In 2008, TMC filed two patent applications, describing this discovery. A year before filing these applications, TMC hired BV to prepare batches of bivalirudin using the patented method. Each was released to TMC for commercial packaging. In 2010, TMC sued Hospira, 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 under 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 reversed, finding that the batches prepared by BV were sold to TMC and not prepared primarily for experimental purposes.
The court issued a subsequent related opinion or order on November 13, 2015.
The court issued a subsequent related opinion or order on March 11, 2016.
The court issued a subsequent related opinion or order on July 11, 2016.
The court issued a subsequent related opinion or order on February 6, 2018.
Some case metadata and case summaries were written with the help of AI, which can produce inaccuracies. You should read the full case before relying on it for legal research purposes.
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.