Medicines Co. v. Hospira, Inc., No. 14-1469 (Fed. Cir. 2018)Annotate this Case
TMC owns patents relating to the drug bivalirudin, a synthetic peptide anti-coagulant. TMC sells the drug for injection under the Angiomax® brand and purchased pharmaceutical batches from BV. In 2005, BV created batches of bivalirudin with levels of impurity that exceeded FDA-approved maximums. TMC's consultant discovered that certain methods of adding a pH-adjusting solution during the compounding process minimize the impurity. In 2008, TMC filed 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 in 2015. In 2018 the Federal Circuit affirmed the noninfringement findings and remanded the case for a determination of whether the on-sale bar applies. The Distribution Agreement was a commercial offer for sale but for the on-sale bar to apply, the invention, as defined by the patent’s claims, must be on sale. The district court did not reach that question, concerning the new process.
This opinion or order relates to an opinion or order originally issued on July 2, 2015.