Forward Pharma Sues Biogen Idec Over Tecfidera Sales In Germany

Published: Nov 18, 2014

Forward Pharma Sues Biogen Idec Over Tecfidera(R) Sales in Germany

November 18, 2014

By Riley McDermid, Breaking News Editor

Danish biopharmaceutical firm Forward Pharma A/S said Tuesday that it has filed a lawsuit against Biogen Idec GmbH, Biogen Idec International GmbH and Biogen Idec Ltd in a German court alleging the company infringed on its marketing of multiple sclerosis drug Tecfidera, and demanding damages that could well reach into the millions of dollars.

Tecfidera contains dimethyl fumarate (DMF) as the active ingredient for the treatment of MS and was approved by the European Commission in January 2014. Forward has long held patents on DMF and is vigilant about enforcing possible infringement.

The company filed the suit in the Regional Court in Dusseldorf, detailing what it says is infringement of its German utility model DE 20 2005 022 112 under Biogen Idec's marketing of Tecfidera in Germany. Forward said it does not want to stop sales of Tecfidera, but instead seeks unspecified damages for “unlawful sales” in Germany.

The money at stake if the court finds in Forward’s favor is likely to be substantial: Sales of Tecfidera in Germany accounted for around 75 percent of the $149 million made outside of the U.S. in the third quarter alone. Worldwide, sales of Tecfidera have raked in almost $2.4 billion in the previous four quarters, with about $317 million of that coming from sales made outside of the U.S.

Forward did not say Tuesday how much it would be seeking in compensatory damages, but it did underscore its intention to mount a strong defense of infringement of its intellectual property right.

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,” said the company in a statement.

“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,” it continued. “Although utility models are registered without substantive examination, the Company believes in the validity and enforceability of its utility model.”

Forward said it expects that the court to render a decision before the end of 2015, potentially declaring that damages based on sales of Tecfidera in Germany from July 5, 2014 until Oct. 7, 2015, and compensation for “unjust enrichment” from April 24, 2014.

"Forward Pharma and its predecessors have been developing therapies containing DMF for over 10 years,” said Peder Andersen, CEO of Forward Pharma, in a statement. “Based on this work, we have accumulated a strong portfolio of intellectual property rights."

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