Novartis Pharmaceuticals Corporation v. Mylan Pharmaceuticals Inc. and Mylan Inc.

Novartis Pharmaceuticals Corporation v. Mylan Pharmaceuticals Inc. and Mylan Inc.

D.N.J. (2011)

Fitzpatrick Successfully Defends Drug Lescol® on Behalf of Client Novartis

On January 20, 2011, Fitzpatrick won summary judgment on behalf of its client Novartis and against generic drug maker Mylan in a Hatch-Waxman suit involving Novartis’s patent for its anticholesterol drug Lescol.

Mylan had sought FDA approval to market a generic copy of Lescol, and had challenged the enforceability of Novartis’s patent based upon two equitable defenses: prosecution laches and patent misuse.

In August 2010, Mylan moved for summary judgment upon its prosecution laches defense, and Novartis moved for summary judgment against both defenses. After oral argument on the motions on November 9, 2010, U.S. District Judge Sheridan granted Novartis’s case-dispositive summary judgment motion and denied Mylan’s summary judgment motion. In an opinion dated January 26, 2011, Judge Sheridan ruled that Novartis did not unjustifiably delay its prosecution of the Lescol patent to trigger prosecution laches, and did not impermissibly broaden the temporal scope of the patent to commit patent misuse.

Novartis’s litigation team was led by Fitzpatrick partners Nicholas Kallas, Diego Scambia and Christopher Loh, with associates Brian O’Reilly, Margaret Scoolidge and Cheney Huang. Fitzpatrick’s co-counsel in the suit was McCarter & English.