PARSIPPANY, NJ, Oct 03, 2011 (MARKETWIRE via COMTEX) --
The Medicines Company (NASDAQ: MDCO) today announced that it has settled the lawsuits filed by MDCO in the U.S. District Court for the District of Delaware relating to the Abbreviated New Drug Applications (ANDAs) filed by Teva Parenteral Medicines, Inc. and its affiliate, Pliva Hrvatska d.o.o. (collectively "Teva"), for generic versions of Angiomax(R) (bivalirudin for injection). The settlement includes a license by MDCO to Teva Pharmaceuticals USA, Inc. and its affiliates under which Teva may launch a generic bivalirudin product under one of its ANDAs in the U.S. on June 30, 2019. In certain limited circumstances, MDCO's license to Teva would become effective prior to June 30, 2019.


As part of the agreement, Teva admits that the two patents asserted in the lawsuits are valid and enforceable against, and would be infringed by, Teva's proposed generic bivalirudin products. The patents at issue in the litigation are listed in the Orange Book and expire on July 27, 2028.

MDCO also entered into an agreement with Teva under which Teva will supply bivalirudin active pharmaceutical ingredient (API) to MDCO. This provides an additional source of API to support planned growth of product use.

"This result reflects our continued confidence in the strength of our patents, and we will continue to vigorously defend our intellectual property," said Dr. Clive Meanwell, Chairman and CEO of The Medicines Company. "We are delighted to partner with Teva who will provide us needed additional manufacturing capacity and a second source of high quality Angiomax(R) active ingredient which we can finish, fill and supply to our hospital customers for millions of patients."

As required by law, MDCO and Teva will submit the agreements to the U.S. Federal Trade Commission and the U.S. Department of Justice.

Background on the litigation now settled.

On September 4, 2009, MDCO announced that it had received a Paragraph IV Certification Notice Letter from Teva notifying MDCO that Teva had submitted ANDAs to the Food and Drug Administration for approval to market generic versions of Angiomax(R). On October 8, 2009 and December 28, 2009, MDCO filed patent infringement lawsuits against the Teva defendants. The complaints, which were filed in the U.S. District Court for the District of Delaware, alleged infringement of U.S. Patent Nos. 7,582, 727 and 7,598,343, which expire on July 27, 2028.

MDCO remains in infringement litigations involving U.S. Patent Nos. 7,582, 727 and 7,598,343 with APP Pharmaceuticals, Hospira, Mylan Pharmaceuticals, and Dr. Reddy's Laboratories.

About The Medicines Company The Medicines Company (NASDAQ: MDCO) provides medical solutions to improve health outcomes for patients in acute and intensive care hospitals worldwide. These solutions comprise medicines and knowledge that directly impact the survival and well-being of critically ill patients. The Medicines Company's website is www.themedicinescompany.com