Taft partners Andrew M. Alul and Roshan P. Shrestha, Ph.D., have secured an important, precedent-setting victory for client Apotex in pending patent infringement litigation involving Apotex’s attempt to bring to market a lower-priced generic alternative to the prostate cancer chemotherapy drug Jevtana® (cabazitaxel injection), currently exclusively marketed in the United States by the brand drug company Sanofi.

By way of background, Apotex filed in 2014 with the United States Food and Drug Administration an Abbreviated New Drug Application (ANDA) seeking approval to commercially market its generic version of Jevtana®. In response, Sanofi filed suit in 2015 against Apotex in Federal court in New Jersey (“the prior New Jersey action”) alleging, inter alia, that the use of Apotex’s generic product would infringe U.S. Patent No. 8,927,592 B2 (’592 patent), which claimed methods of treating prostate cancer by administering cabazitaxel. Following a bench trial held in 2018, Apotex secured a judgment that the asserted claims of the ‘592 patent were invalid as being obvious given the prior art (see “Taft Paves the Way for Generic Prostate Cancer Drug”).

While the New Jersey litigation was pending, the ‘592 patent was put into Inter Partes Review (IPR) proceedings at the United States Patent and Trademark Office (PTO) pursuant to the Leahy-Smith America Invents Act, during which Sanofi amended the ‘592 patent to narrow the scope of its claims to avoid the prior art that rendered the patent’s original claims invalid. Thereafter, Sanofi brought suit in Delaware Federal court, asserting the ‘592 patent a second time against Apotex. Sanofi-Aventis U.S. LLC v. Apotex Corp., C.A. No. 20-804-RGA (D. Del.). In response, Apotex moved to dismiss Sanofi’s ‘592 patent infringement claims on claim preclusion (res judicata) grounds. On Sept. 15, 2022, in a case of first impression, the Delaware court granted Apotex’s motion to dismiss, agreeing with Apotex that, because amended patent claims to emerge from an IPR must by statute be the same scope or narrower than the original claims of the patent, the amended ‘592 patent claims created no new rights against infringement that Sanofi did not hold in connection the prior New Jersey action and, therefore, Sanofi’s reassertion of the ‘592 patent against Apotex was barred under the doctrine of claim preclusion. Sanofi-Aventis U.S. LLC v. Apotex Corp., C.A. No. 20-804-RGA, 2022 WL 4244613 (D. Del. Sept. 15, 2022) (adopting Sanofi-Aventis U.S. LLC v. Apotex Corp., C.A. No. 20-804-RGA, 2022 WL 2643532 (D. Del. July 8, 2022)). The court’s decision serves as an important precedent in future patent cases where a patent owner seeks to reassert against a competitor a patent that has been amended during IPR proceedings.