Dimethyl Fumarate - USA

Patent Trial and Appeal Board (“PTAB”) of the United States Patent and Trademark Office (“USPTO”) decided in Patent Interference No. 106,023 regarding claims of Forward Pharma’s patent application 11/576,871 (the “’871 application”) that cover a method of treating multiple sclerosis (“MS”) with a 480 mg per day dose of DMF, the approved dose of Tecfidera®. In this decision, the PTAB ruled that the claims of the ’871 application are not patentable due to a lack of adequate written description.

For the second time in this month, Biogen has prevailed in a high-stakes legal dispute over patents on its blockbuster multiple sclerosis treatment Tecfidera.  The other case in which IPR filed by the Coalition for Affordable Drugs, a group led by hedge fund manager Kyle Bass, was dismissed on March 21, 2017.

In January, Biogen agreed to pay Forward Pharma $1.25 billion to license the Danish company’s intellectual property. The interference win now means that Biogen won’t owe royalties to Forward and will keep patent exclusivity on dimethyl fumarate through 2028. But Biogen may still owe Forward royalties in other jurisdictions such as Europe.