Allergan win bars Sandoz’s Lumigan generic

Drug company Sandoz, the generic arm of Novartis, may not market generic versions of Allergan’s eye drop solution Lumigan before the last patent covering it expires in 2027, a district court decided on January 14.

Lumigan is used to treat high eye pressure for those with open-angle glaucoma or ocular hypertension. It was approved by the US Food and Drug Administration (FDA) in 2010.

Pharma company Allergan filed suit at the US District Court for the Eastern District of Texas in 2011, after Sandoz filed an Abbreviated New Drug Application with the FDA seeking approval to make and sell Bimatoprost Ophthalmic Solution, 0.01% – a generic version of Lumigan.

Lupin, Hi-Tech Pharmacal and Watson later joined the case as defendants.

Allergan claimed that the four companies infringed five of its patents covering the Lumigan solution. The defendants argued the patents were invalid for reasons primarily based on obviousness.

In its decision, the court ordered a permanent injunction against Sandoz et al prohibiting them from commercially manufacturing and selling generic versions of Lumigan in the US.

Jonathan Singer, head of the life sciences litigation practice at law firm Fish & Richardson, who led Allergan’s legal team with lawyers Juanita Brooks and Douglas McCann, said: “We are very pleased for our client Allergan and to have had the privilege of representing them in this case.

“This is a victory for all companies that put their R&D dollars into developing new and important products that address the unmet medical needs of patients around the world.”

When contacted by LSIPR, Sandoz did not respond to a request for comment.