Case Name: Sanofi-Aventis U.S. LLC v. Sandoz, Inc., No. 20-804-RGA, 2023 WL 4175334 (D. Del. June 26, 2023) (Andrews, J.)

Drug Product and Patent(s)-in-Suit: Jevtana® (cabazitaxel); U.S. Patent No. 10,716,777 (“the ’777 patent”)

Nature of the Case and Issue(s) Presented: Jevtana is administered “in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen.” Metastatic castration-resistant prostate cancer (“mCRPC”) is prostate cancer that has spread beyond the prostate and has become resistant to the hormonal therapies used as a first line of defense. The ‘777 patent claims a method for increasing survival when administering an H2 antagonist prior to administering 20 to 25 mg of cabazitaxel to a patient with mCRPC that has progressed through treatment with docetaxel. After a four-day bench trial, the court found the ’777 patent infringed and not invalid for obviousness.

Why Sanofi-Aventis Prevailed: With respect to infringement, Sandoz argued that its label did not establish a specific intent to induce infringement. In particular, Sandoz argued that its label did not establish that cabazitaxel be administered with the “intentional purpose” of increasing survival. Sanofi argued that when a health care professional (“HCP”) looks at the label, his or her main goal when administering the drug is to extend the patient’s life. In response, Sandoz argued that “its product is indicated not for increasing mCRPC patient’s survival, but for the treatment of patients with mCRPC.” Next, Sandoz argued that where its label mentions “survival,” it is not referring to “increasing survival” as used in the ’777 patent. Moreover, Sandoz argued that its product must have benefits beyond just increasing overall survival since it removed certain prescribing information from its label. The court disagreed with all four of Sandoz’s arguments, finding that a POSA reading the label would conclude that its goal was to improve “overall survival.”

With respect to obviousness, the parties agreed that although the compound cabazitaxel was known, the prior art did not teach that it could be used to increase survival rates of patients with mCRPC. The parties also agreed that the art did not teach using a H2 antagonist as a premedication for cabazitaxel. As to motivation to combine, Sandoz argued that the prior art teachings in combination with a Sanofi clinical trial would have provided the motivation for a skilled artisan to use cabazitaxel to increase a patient's survival. In response, Plaintiffs argued, at least with respect to docetaxel-sensitive patients, that a skilled artisan would continue to treat with docetaxel rather than switch to a new drug. The court agreed with Sandoz and concluded that a POSA would have been motivated to administer cabazitaxel to mCRPC patients with the hopes of increasing survival. With respect to expectation of success, Sandoz acknowledged that a skilled artisan might not have had a reasonable expectation of success for all patients, but that the art suggested increased survival for at least some patients having received a 20-25 mg dose of cabazitaxel. Further, Sandoz pointed to Sanofi’s clinical trial as support for a skilled artisan’s reasonable expectation of success. Sanofi argued that Sandoz misinterpreted the art and explained that the sample size in each paper was “small” and that the patients’ responses were not significant. Sanofi also explained that the prior art “questioned whether the drug would be tolerable at the doses necessary for anticancer activity.” Finally, Sanofi argued that the clinical trial was irrelevant because it was “conducted on a different cancer.” The court concluded that “cautious optimism” was not sufficient and found that Sandoz has not demonstrated a reasonable likelihood of success.