On Aug 14, 2019, Federal Circuit affirmed-in-part & vacated-in-part district court’s decision regarding Jevtana® compound & method of use patent.
This appeal concerns Sanofi’s patent US 5,847,170 & US 8,927,592. The US’ 170 patent claims cabazitaxel compound & US’ 592 patent claims method of treatment of prostate cancer with cabazitaxel. Defendants (Fresenius, Dr Reddy’s lab, Sandoz, Accord, Apotex, Actavis & Mylan) filed ANDA with USFDA to market generic version of Jevtana®. Sanofi sued defendants under Hatch-Waxman regulation for infringement.While the litigation was pending some defendants challenged US’592 in PTAB. After oral hearing PTAB found claim 1-5 & 7-30 invalid as obvious. PTAB also denied Sanofi’s motion to amend the claims. Sanofi then disclaimed claims 7, 11, 14–16, 26 and informed the district court accordingly. But district court still ruled that disclaimed are invalid. Sanofi appealed because as per them there was no case or controversy as claims were cancelled. Defendants cross-appealed & took position that there was case or controversy & district court did not err. Defendants also appealed district court’s decision which found claims 1-2 of US’170 valid.
a. Appeal regarding case or controversy –
On appeal, Sanofi argues that after it disclaimed the particular claims, there was no longer a case or controversy regarding those claims, and the district court thus lacked authority to invalidate them. Defendants responded that there may still have been a case or controversy over the disclaimed claims depending on the merits of their potential future issue or claim preclusion defense, which Defendants could raise if Sanofi succeeds in amending claims of the ’592 patent & then asserts the amended claims against Defendants.
Federal Circuit said that Article III empowers federal courts to adjudicate only “Cases” and “Controversies.” To satisfy the case or controversy requirement in the declaratory judgment context, the parties’ dispute must be “‘real and substantial” rather than mere hypothetical state of facts. Further, “an actual controversy must be extant at all stages of review, not merely at the time the complaint is filed. When Sanofi disclaimed the disclaimed claims, it “effectively eliminated those claims from the . . . patent,” Vectra Fitness, Inc. v. TNWK Corp., 162 F.3d 1379, 1383 (Fed. Cir. 1998), leaving the ’592 patent “as though the disclaimed claim(s) had ‘never existed,’” Genetics Inst., LLC v. Novartis Vaccines & Diagnostics, Inc., 655 F.3d 1291, 1299 (Fed. Cir. 2011). Defendants here point to no such concrete and realistic threat created by the effectively nonexistent disclaimed claims. Therefore, Defendants’ reliance on Teva[Teva Pharmaceuticals USA, Inc. v. Novartis Pharmaceuticals Corp., 482 F.3d 1330 (Fed. Cir. 2007)] is misplaced.
Defendants further alleged that if court vacates the district court’s judgment of invalidity of the disclaimed claims, then Defendants will lose the possible benefit of an issue preclusion defense based on that judgment should Sanofi obtain amended claims and assert them against Defendants. Federal Circuit, however, concluded that this alleged injury did not provide a case or controversy at the time of the court’s judgment. Because the relevance of the disclaimed claims to a possible issue preclusion defense was merely speculative. Second, even assuming that Defendants’ stake in the district court’s judgment concerning the disclaimed claims was sufficiently imminent, they have not established that the judgment pertaining to those claims is material to a possible future suit. Defendants have not shown the existence of a case or controversy over the disclaimed claims at the time the district court entered judgment. The district court thus lacked authority & therefore Federal Circuit vacated court’s judgment with respect to disclaimed claims.
b. Appeal regarding validity of claims 1 & 2 of US’170–