After the U.S. Court of Appeals for the Federal Circuit scuttled Biogen’s bid for a rehearing on its Tecfidera patent case in March, the big biotech was left with few options but to appeal to the Supreme Court. Now, as the high court considers whether to take up the case, Biogen has snared the support of a prominent science and legal advocacy group.
Monday, The Chemistry and the Law Division (CHAL) of the American Chemical Society put its chips behind Biogen, whose once-stalwart multiple sclerosis franchise is already feeling the sting of generics from Mylan, now known as Viatris. Meanwhile, copycats from other generic drugmakers, such as Lupin and Glenmark, are circling the gates.
If earlier court decisions invalidating Biogen’s so-called ‘514 patent on Tecfidera go unchecked, “confusion” among patent practitioners and “[fundamental]” changes to patent application requirement could ensue, CHAL argued in court documents filed this week.
Biogen’s ‘514 patent was originally due to expire in 2028, but in the Summer of 2020, a U.S. district judge ruled in Viatris’ favor, invalidating the Tecfidera patent and putting years of monopoly sales in jeopardy.
Viatris, which boasts the first oral multiple sclerosis generic on the U.S. market, moved ahead with the launch of its Tecfidera copycat in August 2020.
The Biogen patent in question refers to methods of treating MS by oral administration of a specific dose of dimethyl fumarate, or Tecfidera. Viatris originally argued that the claims of Biogen’s ‘514 patent were invalid because Biogen didn't adequately describe its invention in the patent application. A district court and an appeals court agreed with that argument in prior rulings.
In developing Tecfidera, Biogen ultimately determined that a 480 mg daily dose proved the most therapeutically effective. However, the district court held, and the court of appeals affirmed, that Biogen’s disclosure failed to prove definitive knowledge of best dose at the time of the '514 patent application. The court reasoned that Biogen had yet to run phase 3 clinical trials when it filed its application and noted that the company only listed the 480 mg dose once and therefore “did not have proof of the efficacy of the claimed dose,” CHAL explained in the court filing.
But the courts’ decisions, if upheld, would impose a “heightened standard for patent prosecution that conflicts with the statute and precedent,” CHAL contended in its SCOTUS filing.
Meanwhile, the courts’ earlier decisions misapplied a previous lawsuit between Ariad Pharmaceuticals and Eli Lilly, CHAL said. In Ariad’s case, the company’s patent description was deemed insufficient because it failed to identify different compounds that were required for the invention to work. By contrast, Biogen’s patent “described and linked all elements of the claimed invention, including the “effective … dose,” CHAL continued.
Back in November, a U.S. appeals court declined to resurrect Biogen’s ‘514 patent, after which the company filed for a rehearing. In March, however, the U.S. Court of Appeals for the Federal Circuit rejected the company’s bid. SCOTUS’ decision on whether to take the case is due this summer.
Tecfidera sales clocked in at $1.95 billion globally in 2021, with $680.6 million of that haul coming from the U.S. That’s a big drop from the $2.67 billion Tecfidera made in the U.S. alone in 2020—the last year before generics started to hit the scene.
“The generic competition for Tecfidera has significantly reduced our Tecfidera revenue and is expected to continue to have a substantial and increasing negative impact on our U.S. Tecfidera revenue in the future,” Biogen said in a securities filing earlier this year.