IP Law Daily, PATENT—D. Del.: Sandoz’s generic version of prostate cancer drug infringed Sanofi-Aventis patent, (Jun 29, 2023)

By Kevin M. Finson, J.D.

Sandoz failed to show that the asserted patent claims were obvious.

An Abbreviated New Drug Application for a generic prostate cancer drug filed by Sandoz infringed four claims of a Sanofi-Aventis patent associated with its JEVTANA drug because the proposed labeling would encourage providers to administer the drug for the purpose claimed in the original patent, the federal district court in Wilmington, Delaware, has held after a bench trial. Sandoz failed to prove that the asserted patent claims were obvious because there was no showing of reasonable expectation of success in the combination of the relevant prior art references (Sanofi-Aventis U.S. LLC v. Sandoz, Inc., June 26, 2023, Andrews, R.).

Sanofi-Aventis U.S. LLC and Sanofi Mature IP (collectively, Sanofi) were the owners of U.S. Patent No. 10,716,777 (the ’777 patent), which claimed use of the drug cabazitaxel for use in “increasing survival” in patients with metastatic castration resistant prostate cancer “that has progressed during or after treatment with docetaxel.” Sanofi sold cabazitaxel under the name JEVTANA®, and the ’777 patent was listed int eh FDA’s Orange Book. Sandoz, Inc. (Sandoz) filed a New Drug Application (NDA) with the FDA for a cabazitaxel product at a dose of 20 mg/m2, which was approved. Sanofi filed suit for infringement based on Sandoz’s NDA. After a three-day bench trial, the court issued its findings of fact and conclusions of law.

Infringement. Most of the claim limitations and Sandoz’s knowledge of the asserted patent were undisputed, the only infringement issue remaining at trial was whether Sandoz had a specific intent to induce infringement. Sandoz argued that the patent was directed to “increasing survival,” while its product could be used for other purposes including the reduction of pain. Reviewing the labeling disclosed in the NDA, the court found that the label referred to a study which found the drug had the benefit of increasing “overall survival” in the relevant patients, and so the label did show a specific intent to induce infringement.

Obviousness. Sandoz argued that the asserted patent was invalid due to obviousness based on prior art studies showing positive results. The court reviewed the prior art, which consisted primarily of clinical studies, and found that a person of ordinary skill in the art would be motivated to administer cabazitaxel to the prostate cancer patients in question based on promising studies showing effectiveness in other sorts of cancer. However, the court held that while there was motivation to make the attempt, the art at the time was not so clear as to give a reasonable expectation of success. The expert testimony from both sides suggested to the court that the position at the time would be better characterized as “hope and cautious optimism,” which as a matter of law was not sufficient to show the required reasonable expectation of success.

The court directed the parties to submit a final judgment finding infringement and non-obviousness.

The Case is No. 1:20-cv-00804-RGA.

Attorneys: Jack B. Blumenfeld (Morris, Nichols, Arsht & Tunnell LLP) for Sanofi-Aventis U.S. LLC and Sanofi Mature IP. Dominick T. Gattuso (Heyman Enerio Gattuso & Hirzel, LLP) for Sandoz, Inc.

Companies: Sanofi-Aventis U.S. LLC; Sanofi Mature IP; Sandoz, Inc.

Cases: Patent DelawareNews