Mylan Wins Court Decision Against Biogen’s Tecfidera Patent

Mylan says U.S. District Court for the Northern District of West Virginia invalidated Biogen’s Tecfidera patent for lack of written description.

• The ᾿514 patent claimed methods of treating multiple sclerosis (MS) using a dose of 480 mg/day of dimethyl fumarate delayed release capsules
• Decision clears the way for Mylan’s launch of its dimethyl fumarate product upon the receipt of FDA approval
• The ‘514 patent could have otherwise delayed generic competition until 2028
• Biogen’s total IQVIA sales in the U.S. for the 12 months ending April 30, 2020, were approximately $3.78 billion for Tecfidera

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