Nabi and Roxane Laboratories settle patent infringement lawsuit

The settlement between Fresenius Medical Care Holdings, Roxane Laboratories and Nabi was made to the mutual satisfaction of all parties and was reviewed and accepted by the US District Court of Ohio. The terms of the settlement are confidential and the court dismissed the case with prejudice and without costs. As a result of this settlement, Nabi is not required to pay any sums to the other parties.

Nabi filed this lawsuit on September 27, 2005 under the Hatch-Waxman Act in response to a Paragraph IV Certification letter submitted by Roxane to the company concerning Roxane’s filing of an abbreviated new drug application with the FDA to market a generic version of the company’s PhosLo GelCaps. Nabi filed the lawsuit on the basis that Roxane Laboratories’s submission of its ANDA and its proposed generic product infringed a patent held by the Company.

On November 12, 2006, Nabi completed the sale of PhosLo and related intellectual property to Fresenius USA Manufacturing. While Fresenius assumed primary responsibility for the intellectual property dispute, Nabi remained subject to a counterclaim by Roxane that alleged violations of antitrust law and, therefore, responsible for defense costs and for any liability arising from the counterclaim.