Sanofi wins SCOTUS stay of Lantus patent dispute

Pharmaceutical company Sanofi has been granted a stay by the US Supreme Court in its ongoing patent litigation battle with Netherlands-based Mylan over glargine ( Lantus), a treatment for type 2 diabetes.

In an application, filed on Friday, February 7, the French multinational drugmaker said a December 2019 decision by the US Court of Appeals for the Federal Circuit, affirming that claims in patents related to Lantus (numbers 7,476,652 and 7,713,930) are unpatentable for obviousness, and should be stopped from going into effect, at least on a temporary basis.

“This application [from Sanofi] presents a compelling case for certiorari [as the] Federal Circuit issued an erroneous decision on an indisputably important question of patent law,” added the court documents.

“For the foregoing reasons, Sanofi respectfully requests that the court stay the issuance of the Federal Circuit’s mandate, or, if the mandate has been issued, direct that the mandate be recalled and stayed, pending the disposition of Sanofi’s petition for a writ of certiorari,” said Sanofi.

On February 10, SCOTUS agreed, giving Mylan until today (Thursday, February 13) to respond.

In 2017, Mylan filed for inter partes review of the two Sanofi patents, which protect Sanofi’s glargine reformulation. The Patent Trial and Appeal Board ( PTAB) instituted a review and found the patents invalid as obvious.

Sanofi appealed in 2018, and also brought an infringement action against Mylan in the US District Court, District Court of New Jersey on the ‘652 and ‘930 patents.

Pursuant to the Hatch-Waxman Act, the New Jersey court entered a 30-month stay of US Food and Drug Administration approval of Mylan’s pending application.

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