COPENHAGEN, Denmark, Nov. 18, 2014 (GLOBE NEWSWIRE) -- Forward Pharma A/S (Nasdaq:FWP) announced today that it has filed a lawsuit against Biogen Idec GmbH, Biogen Idec International GmbH and Biogen Idec Ltd. 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 Idec'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."
Links to information of the "Utility model" in Germany: http://dpma.de/english/utility_models/index.html
Utility Model Act (in German): http://www.gesetze-im-internet.de/gebrmg
Utility Model Ordinance (in German): http://www.justlaw.de/gesetze/Gebrauchsmusterverordnung-GebrMV.htm
About Forward Pharma:
Forward Pharma A/S is a Danish biopharmaceutical company (the "Company or "Forward Pharma") preparing to initiate a Phase 3 clinical trial using FP187, a proprietary formulation of dimethyl fumarate, or DMF, for the treatment of multiple sclerosis, or MS, patients. Since our founding in 2005, we have worked to advance unique formulations of DMF, an immune modulator, as a therapeutic to improve the health and well-being of patients with immune disorders including MS. FP187, our clinical candidate, is a DMF formulation in a delayed and slow release oral dose, which we plan to advance for the treatment of relapsing remitting MS, or RRMS, and other immune disorders, such as psoriasis.
Our principal executive offices are located at Østergade 24A, 1, 1100 Copenhagen K, Denmark and our American Depositary Shares are publicly traded on NASDAQ Stock Market (symbol: FWP). For more information about the Company's products and developments, please visit our web site at www.forward-pharma.com.
Forward Pharma A/S Media Contact:
Sharon Klahre, Director, Investor Relations
Forward Pharma USA, LLC
7 Skyline Drive
Hawthorne, NY 10532
Andy Brimmer / Dan Katcher / Jennifer Beugelmans
Joele Frank, Wilkinson Brimmer Katcher
Forward Looking Statements:
Certain statements in this press release may constitute "forward-looking statements" of the Company within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to: statements which contain language such as: "believe,""expect," "hope," "would" and "potential." Forward-looking statements are predictions only which involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from those expressed in such statements. Many such risks, uncertainties and other factors are taken into account as part of our assumptions underlying these forward-looking statements and include, among others, the following: the Company's ability to obtain issued patents with protective claims; the commencement of any patent interference or infringement action; the Company's ability to prevail in or obtain a favorable decision in any such action; and the Company's ability to recover damages in any such action; uncertainties relating to our development plans; risks and uncertainties related to the scope, validity; and the enforceability of our intellectual property rights in general and the impact on us of patents and other intellectual property of third parties. Given the uncertainties, assumptions and risk factors associated with this type of information, including those described above, investors are cautioned that the information may not be appropriate for other purposes.