Novartis Pharmaceuticals Corporation et al v. Noven Pharmaceuticals Inc.

Novartis Pharmaceuticals Corporation et al v. Noven Pharmaceuticals Inc.

D. Del. (2015)

Fitzpatrick Once Again Successfully Defends Patent Related To Exelon® Transdermal Patches

On August 31, 2015, Judge Richard G. Andrews of the District of Delaware ruled in favor of Fitzpatrick’s clients, Novartis and LTS (collectively, “Novartis”), upholding the validity of U.S. Patent No. 6,335,031. The ’031 patent covers Exelon® Patch, Novartis’s highly successful transdermal patch for the treatment of Alzheimer’s disease, and claims compositions, transdermal devices and methods of stabilizing compositions comprising rivastigmine and an antioxidant.

Judge Andrews rejected Noven’s arguments that the ’031 patent was obvious. Novartis successfully established that it was unknown prior to the ’031 patent that rivastigmine was susceptible to oxidative degradation. In particular, Novartis demonstrated that a person of ordinary skill in the art would not have known that rivastigmine was susceptible to oxidative degradation based on its chemical structure or the prior art concerning rivastigmine. Because the problem was not known, the discovery that rivastigmine oxidative degrades and the solution to that problem were an inventive contribution worthy of patent protection.

Judge Andrews further rejected Noven’s arguments that the ’031 patent was invalid over U.S. Patent No. 5,602,176 for obviousness-type double patenting. Novartis successfully argued that Noven’s double patenting arguments failed as a matter of law because the common ownership requirement was not met. Novartis also successfully argued, in the alternative, that the prior art did not disclose rivastigmine’s susceptibility to oxidative degradation and the addition of an antioxidant rendered the ’031 and ’176 patents patentably distinct.

Shortly before the trial, Noven stipulated that its ANDA products infringe the asserted claims of the ’031 patent.

Fitzpatrick previously obtained judgment upholding the validity of ’031 patent and related U.S. Patent No. 6,316,023, and finding that Watson’s generic rivastigmine transdermal patches, if approved, will infringe the ’023 and ’031 patents. Earlier this year, that decision was affirmed by the Federal Circuit.

The Fitzpatrick team was led by partners Charlotte Jacobsen, Nicholas Kallas, Christopher Loh, Daniel Minion and Dominick Conde, with associates Jared Stringham and Lisa Butler.