The US Patent and Trademark Office (USPTO) has granted key patent to Biogen Idec which offers additional protection for Tecfidera (dimethyl fumarate), company's oral therapeutic candidate for the treatment of multiple sclerosis (MS). The key patent No. 8,399,514, which will expire in 2028, covers the dosing regimen of daily administration of 480 mg of Tecfidera.

This regimen is included in the proposed marketing application for Tecfidera, which is currently under review by the US Food and Drug Administration (FDA).

“The patent for this dosing regimen is recognition of the remarkable innovation Tecfidera represents for the MS community,” said George A Scangos, Ph.D., chief executive officer of Biogen Idec. “The tremendous research investment required to study and validate the patented dosing regimen is an example of innovation that leads to meaningful benefits to patients.”

The European Patent Office also recently determined that Biogen Idec’s application for a patent covering the same dosing regimen of Tecfidera is allowable. Once granted, this patent would also expire in 2028.

The Tecfidera dose regimen patents add to the growing portfolio of granted patents covering Tecfidera.

Tecfidera is the only currently known investigational compound for the treatment of relapsing-remitting multiple sclerosis (RRMS) that has experimentally demonstrated activation of the Nrf-2 pathway. This pathway provides a way for cells in the body to defend themselves against inflammation and oxidative stress caused by conditions like MS.

In 2011 and 2012, Biogen Idec announced positive data from DEFINE and CONFIRM, two global, placebo-controlled phase III clinical trials that evaluated 240 mg of Tecfidera, administered either twice a day (BID) or three times a day (TID), for two years. Tecfidera is currently under review by regulatory authorities in the United States, European Union, Australia, Canada and Switzerland.

Biogen Idec discovers, develops and delivers to patients worldwide innovative therapies for the treatment of neurodegenerative diseases, hemophilia and autoimmune disorders.