Forward Pharma Files Lawsuit Against Biogen Over Tecfidera Sales In Germany

(RTTNews) - Forward Pharma A/S (FWP) said Tuesday it has filed a lawsuit against Biogen Idec GmbH, Biogen Idec International GmbH and Biogen Idec Ltd (BIIB) in the Regional Court in Dusseldorf, alleging infringement of its German utility model DE 20 2005 022 112 due to Biogen Idec's marketing of Tecfidera in Germany. With this lawsuit Forward Pharma ("the company") does not seek to stop sales of Tecfidera to MS patients, but rather seeks damages for what the company believes are Biogen's unlawful sales of Tecfidera in Germany.

Tecfidera is a product containing dimethyl fumarate (DMF) as the active ingredient for the treatment of MS. It was approved by the European Commission in January 2014. Worldwide sales of Tecfidera as reported by Biogen Idec for the previous 4 quarters totaled nearly $2.4 billion, including $317 million of ex-US sales. Per Biogen Idec, third quarter Tecfidera sales in Germany represented approximately 75% of the reported $149 million in ex-US Tecfidera sales.

Forward Pharma is asserting its German utility model DE 20 2005 022 112 with regard to Tecfidera which Biogen Idec markets and sells with a label instructing a daily dose of 480 mg. The company believes its utility model precludes anyone from selling in Germany, without Forward Pharma's consent, pharmaceuticals with DMF as the sole active pharmaceutical ingredient for the treatment of MS at a daily dose of 480 mg. Although utility models are registered without substantive examination, the company believes in the validity and enforceability of its utility model.

Forward Pharma expects that the Regional Court in Dusseldorf will render a decision before the end of 2015 and if the court agrees with Forward Pharma's assertion, the court will declare that damages are owed to Forward Pharma based on sales of Tecfidera® in Germany from July 5, 2014 until October 7, 2015, and compensation for unjust enrichment from April 24, 2014.

The German utility model is one of several avenues through which Forward Pharma is advancing its intellectual property in Europe, including three patent applications numbered EP14172390.8, EP14172396.5, and EP14172398.1. Each of these applications claims treating MS with 480 mg of DMF per day.

Peder M. Andersen, CEO of Forward Pharma said, "Forward Pharma and its predecessors have been developing therapies containing DMF for over ten years. Based on this work, we have accumulated a strong portfolio of intellectual property rights."