D. Del. (2014)
Fitzpatrick Successfully Asserts Patents Related To Exelon® Transdermal Patches For Treatment Of Alzheimer’s Disease On Behalf Of Novartis and LTS
On June 18, 2014, 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 Nos. 6,316,023 and 6,335,031, and finding that Watson’s generic rivastigmine transdermal patches, if approved, will infringe the ’023 and ’031 patents. 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.
Judge Andrews 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. He rejected Watson’s counterarguments that the antioxidant was an incidental spectator molecule and the stability of rivastigmine in Watson’s products was not due to the antioxidant.
Judge Andrews further rejected Watson’s arguments that the ’023 and ’031 patents were obvious. Novartis successfully established that it was unknown prior to the ’023 and ’031 patents that rivastigmine was susceptible oxidative degradation. Because the problem was not known, there would have been no reason to add an antioxidant to any rivastigmine formulation. As a result, the ’023 and ’031 patents were valid.
The Fitzpatrick team was led by partners Nick Kallas, Chris Loh and Charlotte Jacobsen, with associates Daniel Minion, Lisa Butler, Galen Rahmlow and Jared Stringham.