Federal officials Tuesday gave Biogen Idec Inc. 15-year patent protection for its multiple sclerosis pill Tecfidera, which is awaiting US regulatory approval.
The biotechnology company, based in Weston, said the US Patent Office granted a patent covering the 480-milligram daily dose for dimethyl fumarate, the active ingredient in Tecfridera, through 2028. That is the dosing amount sought in Biogen Idec’s new drug application, which the Food and Drug Administration is expected to rule on this month.
“It’s a very good outcome for Biogen Idec and for multiple sclerosis patients as well,” said Steven Holtzman, the company executive vice president for corporate development.
The patent will hold off the entry of generic competition longer than previously anticipated. It will do so by preventing competitors from deploying oral MS drugs using the same active ingredient at the dosing level Biogen Idec found effective in late-stage clinical trials. Biogen Idec is proposing that patients take two 240-milligram Tecfidera capsules daily.
Biogen Idec has received a “notice of allowance” for a similar patent in the European Union, the last administrative step before the patent is granted, Holtzman said. The company previously secured US and European patents covering the drug’s method of treating MS with the active ingredient. Those patents, which did not include the dosing regimen, expire in 2020, though the company would have the potential to extend both through the early 2020s.
The idea of extending them further grew out of the company’s recognition that the drug could prove effective at a lower dosage than the 700 milligrams given at earlier-stage trials.
“In clinical trials, we made the key discovery that by administering Tecfidera at this (480-milligram) dose we got good results in amelioration of the disease,” Holtzman said, noting that the dosing regimen ultimately “qualified as an invention” before the US Patent Office.
If the FDA grants approval, Tecfidera would become Biogen Idec’s third MS drug on the market in the United States. It currently sells Avonex, an interferon that was one of the first treatments for the autoimmune disease, and the newer drug Tysabri. The disease affects the brain and central nervous systems of about 400,000 Americans and 2.5 million people globally.