Biogen's last-gasp effort to reinstate Tecfidera patent fails at Supreme Court

In going all the way to the United States Supreme Court in a bid to reinstate the patent of blockbuster drug Tecfidera, Biogen was throwing a desperation Hail Mary.

On Monday morning, the attempt was swatted away as the court decided not to hear the case. The ruling clears the way for Viatris to continue marketing its generic version of the drug, which launched more than two years ago.

Biogen’s exclusivity on the multiple sclerosis drug wasn’t due to expire until 2028 but two years ago, a U.S. district court ruled that Tecfidera’s critical ‘514 patent was invalid.

In November of 2021, a U.S. appeals court declined to resurrect the patent. Then in March of this year, Bigen’s bid for a rehearing was denied, leaving the Supreme Court as the last remaining option.

To bolster its case, Biogen lined up the support of prominent legal advocacy group, The Chemistry and the Law Division (CHAL) of the American Chemical Society.

In a filing, CHAL claimed that if the prior court decision was upheld, it would impose a “heightened standard for patent prosecution that conflicts with the statute and precedent.”

Biogen was immediately damaged by the patent ruling. After garnering sales of $4.4 billion for Tecfidera in 2019, the figure fell to $3.8 billion in 2020 and $1.95 billion last year.

More competition for Tecfidera is on the way from generics manufacturers Lupin and Glenmark, who gained approval for their copycat versions in October of 2020. Several other companies including Accord, Amneal, Cipla and Hetero also have approvals in hand for Tecfidera generics.