The Medicines Company has reached a settlement agreement with the law firm WilmerHale resolving all its potential claims against WilmerHale related to the principal U.S. patent covering the product bivalirudin (Angiomax), U.S. Patent No. 5,196,404 (the 404 patent).
Under the settlement, Medicines said it will receive approximately $18 million up front from WilmerHale's professional liability insurers to cover certain past expenses. An additional $214 million will be available for damages in the event a generic bivalirudin is sold in the U.S. before June 15, 2015, as a result of the extension of the '404 patent being held invalid on the basis that the application for the extension was not timely filed.
Of the additional $214 million, approximately $99 million would be from WilmerHale's insurers and $115 million would be from the Washington, D.C.-based WilmerHale itself after payments from insurance are exhausted. Payments by WilmerHale itself are limited to a maximum of $2.88 million per calendar quarter.
"This settlement allows both firms to move on to build our respective businesses. The $18 million upfront payment to us is essentially reimbursement for the expenses incurred as we advocated in Washington and pursued legal action against the government -- where we eventually won,” Clive A. Meanwell, MD, PhD, chairman and CEO of Medicines. “The additional $214 million represents a form of insurance for us in case the district court's decision is overturned and a generic firm enters the market prematurely. Throughout the process of addressing the PTO's [U.S. Patent and Trademark Office] denial of our patent term extension filing, WilmerHale has stood by The Medicines Company in an honorable and exemplary way. WilmerHale assisted in the efforts to reverse the PTO's action.
“While both firms believe the district court's decision will be sustained in any future proceedings, the decision remains open to future challenge, including the pending appeal by a generic company. The Medicines Company and WilmerHale have entered into this agreement to establish a fair and equitable resolution of this matter if the district court's decision ultimately is not sustained. The relationship between our company and WilmerHale remains very strong. We reserve our rights to pursue other parties with respect to this matter in the future," Meanwell continued.
In 2001, the PTO rejected Medicines' application under the Hatch-Waxman Act for an extension of the '404 patent's term because, in the PTO's view, the application was not timely filed. In August 2010, Medicines won a lawsuit in federal district court that challenged the PTO's denial of the application. The judge in that case held that the filing was timely made. The Medicines Company has additional Angiomax patents that expire in 2028.