Merck & Co., Inc. and Merck Sharp & Dohme Corp. v. Sandoz Inc.

Merck & Co., Inc. and Merck Sharp & Dohme Corp. v. Sandoz Inc.

D.N.J. (2012)

Fitzpatrick Obtains Summary Judgment On Defendant Sandoz's Obviousness Defense For Merck's Antifungal Formulation Patent Covering Cancidas®

On January 30, 2012, Judge Stanley R. Chesler of the United States District Court for the District of New Jersey granted summary judgment in favor of our client Merck & Co., Inc. and Merck Sharp & Dohme Corp. (“Merck”) and against Defendant Sandoz Inc. (“Sandoz”) on its sole-remaining obviousness defense to patent infringement. Sandoz sought FDA approval of its Abbreviated New Drug Application to market generic versions of Merck’s life-saving antifungal drug products, Cancidas®. The patent at issue was U.S. Patent No. 5,952,300, a patent covering injectable formulations of caspofungin, a potent antifungal agent used to treat systemic fungal infections.

In his opinion, Judge Chesler found that Sandoz, while arguing that the invention was “obvious to try,” had failed to meet its burden of proving that a skilled artisan would have recognized a finite number of identified, predictable solutions as required by the Supreme Court in its KSR opinion. In particular, Judge Chesler criticized Sandoz for its attempt to show “obvious to try” by merely “pointing to the evidence that many of the steps in the development process were well-known.” Moreover, Judge Chesler found the deposition testimony of Sandoz’s expert formulation witness to be “devastating to Sandoz’s obviousness case” as he conceded that the formulation technology at issue is “very hard to predict.