Novartis v. Watson

Novartis v. Watson

Federal Circuit (2015)

Fitzpatrick Successfully Upholds Validity Of Patents Related To Exelon® Transdermal Patches For Treatment Of Alzheimer’s Disease On Behalf Of Novartis And LTS

On May 21, 2015, a panel of the Federal Circuit composed of Judges Lourie, Taranto, and Hughes affirmed District Court Judge Richard G. Andrews’s ruling in favor of Fitzpatrick’s clients, Novartis and LTS (collectively, “Novartis”), upholding the validity of U.S. Patent Nos. 6,316,023 and 6,335,031. The ’023 and ’031 Patents cover Exelon® Patch, Novartis’s highly successful transdermal patch for the treatment of Alzheimer’s disease, and claim pharmaceutical compositions, transdermal devices, and methods of stabilizing compositions containing rivastigmine and an antioxidant.

The Federal Circuit agreed with Novartis that the District Court did not clearly err in finding that the prior art did not disclose oxidative degradation to be a known problem with rivastigmine and that, therefore, one of ordinary skill would not have had a reason to add an antioxidant to the prior art rivastigmine transdermal formulations. The Federal Circuit affirmed the District Court’s decision that merely finding each of the claimed elements in the prior art does not prove a combination invention obvious because such an invention typically comprises combinations of what, in some sense, is already known. As a result, the Federal Circuit affirmed the validity of the ’023 and ’031 Patents.

The District Court further found that Novartis proved that Watson’s products contained an antioxidant, in a claimed amount, and that the antioxidant functioned to stabilize rivastigmine in those products. Watson did not appeal the decision that the ’023 and ’031 Patents were infringed.

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