Biogen Secures Tecfidera Patent in EU Until 2028; Generics Not Likely
Granted by the European Patent Office, patent EP2653873 covers the composition and use of dimethyl fumarate at a dose of 480 milligrams per day — Tecfidera’s recommended maintenance dose in the EU — according to a Biogen press release.
The new patent will last until February 2028. That means that Tecfidera’s oral generics — medications that are identical to the brand-name product but are typically sold at a lower price — likely will not enter the European market until the patent expires.
Generic approval follows a rigorous review process to ensure that the generic alternative contains the same active ingredient, strength, dosage form, and route of administration as the original brand-name product — in this case, Tecfidera.
In the U.S., Tecfidera’s patent (No. 8,399,514), also expiring in 2028, was found invalid in a legal challenge against its capacity to protect against generic competition. A U.S. District Court in June 2020 ruled in favor of Mylan Pharmaceuticals (now Viatris) in that challenge, citing the lack of an adequate written description of Tecfidera in its patent.
That ruling allowed the first generic version of Tecfidera in the country two months later. Other generic forms of the medication, such as those produced by Cipla and Lupin, have been subsequently approved in the U.S.
While Biogen has appealed the court’s ruling, the U.S. Court of Appeals for the Federal Circuit rejected its request to revive the patent. The company may now appeal to the U.S. Supreme Court.
Tecfidera was first approved in the U.S. in 2013 for treating adults with relapsing forms of MS — which include clinically isolated syndrome, relapsing-remitting MS (RRMS), and active secondary progressive MS. Its approval for RRMS patients in Europe followed in 2014.
Now available in more than 60 countries, the therapy is the most prescribed oral medication for relapsing MS in the world, according to Biogen. A delayed-release capsule, Tecfidera is known to effectively reduce the rate of MS relapses, slow disease progression, and lower the number of brain lesions.
It is thought to work by lowering inflammation and oxidative stress — a type of cellular damage implicated in MS — in the brain and spinal cord, ultimately preventing further nerve damage.