Sanofi launches patent infringement lawsuit against Mylan over diabetes pen

Sanofi has launched a lawsuit against Mylan as part of a dispute that alleges that the latter infringed upon 18 of the French drugmaker’s patents, in particular its disposable insulin glargine pre-filled pen Lantus as well as vial-drug diabetes products.

The suit was filed with the US District Court for the District of New Jersey following Mylan’s submission of a new drug application in mid-September.

"The complaint has been prompted by a notification, received from Mylan to mid-September, in which Mylan claimed to have filed with the FDA application for approval of a new drug […] to insulin glargine in a pre-filled pen and vial," Sanofi said.

This is not the first time that Sanofi has levered legal action to protect perceived attacks on Lantus, launching proceedings against Eli Lilly in 2014, though the situation was amicably resolved: Lilly agreed to pay royalties of sales of Basaglar, its biosimilar version of Lantus, to Sanofi in addition to delaying the launch its launch for six months in the US.  

Despite this, since its launch, Basaglar has cut deeply into Lantus’ sales in the US and Europe.

In the past, Sanofi has also unleashed a further two complaints against MSD regarding patent infringement of Lantus.