Ben Venue Laboratories v. Novartis Pharmaceuticals Corp.

Ben Venue Laboratories v. Novartis Pharmaceuticals Corp.

D.N.J. (1998)

In one of the first decisions on the proper listing of a patent in the FDA Orange Book, Fitzpatrick prevailed on behalf of its client Novartis in defeating a declaratory judgment preliminary injunction, with the Court holding that Novartis’s crystalline pamidronate disodium patent covered its Aredia® product. In particular, the Court held that, although Aredia® did not contain the patented crystalline pamidronate, it was manufactured using it and therefore the patented drug substance, under the FDA regulations, was a component of the Aredia® drug product and the patent was properly listed. The generic Ben Venue did not appeal that decision. Novartis was represented by Fitzpatrick partner Nicholas N. Kallas.