EU judges cut Biogen’s monopoly on multiple sclerosis drug Tecfidera

(CN) — Tecfidera, Biogen’s blockbuster multiple sclerosis drug, just lost its bonus year of market protection on Wednesday after Europe’s General Court struck down the European Commission’s decision, saying the extension had no solid legal footing.

The ruling is a major win for generic drugmakers including Mylan, Teva, Polpharma, Zentiva, Hexal and Aliud. They each filed lawsuits for the same purpose — Brussels wrongly treated dimethyl fumarate (DMF), the active ingredient in Tecfidera, as a new discovery.

Tecfidera, a key treatment for multiple sclerosis, has been a cash cow for Biogen, and with market exclusivity, each extra year carries billion-dollar stakes.

The fight centers on how Tecfidera compares with Fumaderm, a 1994 German drug that combined DMF with monoethyl fumarate salts to treat psoriasis. A decade later, Biogen marketed DMF alone as Tecfidera, a treatment for multiple sclerosis. The commission approved it, granting it a fresh “global marketing authorization,” starting a new period of exclusivity.

That designation proved crucial when Biogen sought an extra 12 months of protection. EU rules permit a one-year extension if a drug demonstrates new clinical benefits, and in 2023, the commission agreed to delay the introduction of generics for another year.

Sven Bostyn, associate professor of innovation law at the University of Copenhagen, warned before the ruling that letting companies “split off individual compounds from earlier authorisations and claim them separately as a new active substance” risked monopoly stretching and higher prices. He questioned whether DMF should have been considered new at all, given its role in Fumaderm.

Generic rivals agreed, arguing Tecfidera should never have been split off since DMF was always Fumaderm’s main active ingredient and Biogen had already used its full exclusivity.

The judges sided with the generics, ruling Brussels had gone too far. In the Teva ruling, they wrote the commission “was not entitled to conclude that Tecfidera was covered by a different global marketing authorisation than Fumaderm” without first checking or consulting the CHMP, the EU’s expert panel on medicines, about the role of Fumaderm’s MEF salts. The dispute hinged on whether those salts were true active ingredients or just fillers.

The same reasoning carried through the Polpharma and Zentiva cases. The court noted Biogen never initially asked for DMF to be treated as a new active substance. That idea only surfaced later, after the commission in 2013 prodded regulators to reclassify DMF as a new medicine. The judges said the shift didn’t hold up.

By tossing all eight cases, the court effectively erased Biogen’s extra year of exclusivity, paving the way for generic dimethyl fumarate to reach European markets sooner, a move expected to reduce costs for patients and ease the strain on healthcare systems.

Spiros Drosos, Counsel at Covington & Burling and a former head of litigation at the European Medicines Agency, said the rulings show just how tough the EU courts can be. He pointed out that “the eight-year deadline for securing an additional year of market protection will be enforced very strictly, even in exceptional circumstances,” and added that the fight over Tecfidera is another example of how messy exclusivity battles have become in Luxembourg.

Suzanne Rab, a barrister at Matrix Chambers, called the ruling “a masterclass in regulatory discipline.” She stressed that the judges made clear “strict time limits for regulatory protection must be adhered to” and that regulators should not hand out extra exclusivity without hard proof a compound is truly new.

She said the takeaway is simple: patient access and generic entry come first, not stretched monopolies. Courts are likely to take a tougher line from here, she added, and generic manufacturers should view the decision as a green light to push back more boldly against shaky exclusivity claims.

The ruling lands hard on Biogen. Having tied its fortunes closely to Tecfidera, the company threw its weight behind the commission in court, but with the annulments now on the books, its options look slim.

In a brief statement, Teva said it was “reassured to see the General Court confirm the correct application of the relevant legislation.”

The commission hasn’t commented yet on the annulments. Meanwhile, generic makers are expected to move quickly with their applications, taking the string of court wins as a clear signal that the road is now open.

This may not be the end of the story. The commission and Biogen can still take the fight to the EU’s top court in Luxembourg, which would have the final say on whether the annulments hold.

Courthouse News reporter Eunseo Hong is based in the Netherlands.