Setback: Biogen loses bid to revive patent on Mylan blockbuster MS drug Tecfidera

A trial court was correct when it invalidated a patent on the medicine, the U.S. Court of Appeals for the Federal Circuit ruled. In a related ruling, the court also affirmed a decision by a review board within the U.S. Patent and Trademark office.

Shares of Biogen plunged by as much as 3.15% to a 12-month low of $228.68 before recovering slightly. They were at $231.33 at 12:08 p.m.

"Viewing the record before us in its totality, we discern no clear error in the district court's judgment that Mylan established its burden of showing, by clear and convincing evidence, that the asserted '514 Patent claims are invalid for lack of written description," U.S. Circuit Judge Jimmie Reyna wrote for the three-judge panel in an opinion issued Tuesday in Washington about the trial court's ruling.

The patent covers the twice-daily pill given at a dose of 480 milligrams, but a federal judge in June 2020 ruled that the patent application didn't make that clear when it was first filed. Viatris Inc., formerly known as Mylan NV, began selling a generic version of Tecfidera after winning the ruling in federal court in West Virginia.

The Patent Trial and Appeal Board rejected other invalidity arguments Viatris had raised. Biogen had to win both appeals to have the patent revived.

A Biogen spokesperson said the Cambridge, Massachusetts-based company "is disappointed with this decision, which is specific to the United States."

Representatives of Viatris didn't immediately respond to a request for comment.

A federal judge in Delaware later said she was bound to follow the West Virginia ruling, opening the door to other generic-drug makers including Novartis AG's Sandoz unit, Cadila Healthcare Ltd., and Shilpa Medicare Ltd.

Biogen had been counting on the patent to block low-cost rivals of the blockbuster drug until 2028. A patent on the drug's active ingredient expired in June 2020.

Viatris began selling generic versions of Tecfidera in August 2020 after the Federal Circuit refused to block the sales while the appeal is considered.

For Biogen, sales have plunged. U.S. sales of Tecfidera were $520.1 million in the first nine months of the year, about 78% less than the year-earlier period, the company reported in October.

Tecfidera, on the market since 2013, has been key to the company's fortunes while it struggles to find new medicines to make up for declining revenue.

Brian Abrahams, an analyst with RBC Capital Markets, wrote in a Tuesday note that "this is the likely conclusion of the case, which we note will likely will solidify the generic entrants in the marketplace and make them unlikely to be displaced."

In a dissenting opinion, U.S. Circuit Judge Kathleen O'Malley said she thought the Delaware judge was wrong to find she was bound by the West Virginia decision.

"Because I believe the entire course of the district court's analysis might well change if the court were to adjust the lens through which it considers the evidence and testimony, I would remand for reconsideration of the record," O'Malley wrote, "with the understanding that the patent is not about clinical efficacy — it is about therapeutic effect — and that the written description and obviousness inquiries are not the same."

The U.S. Food and Drug Administration, in a controversial June 7 decision, granted the experimental Alzheimer's drug aducanumab an accelerated approval, which means Biogen will need to conduct more research to establish its benefits for it to remain on the market.

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The agency has come under fire for that decision, with top researchers who advised the FDA on the case calling it a "regulatory failure" for granting the approval and the heads of two congressional committees questioning the "apparent anomalies" in the agency's review.

The appeal of the patent board case is Mylan Pharmaceuticals Inc. v. Biogen MA Inc, 20-1673, and of the West Virginia case is Biogen International GmbH v. Mylan Pharmaceuticals Inc., 20-1933, both U.S. Court of Appeals for the Federal Circuit (Washington).