Sanofi-Aventis U.S., LLC v. Dr. Reddy’s Labs., Inc.

Plaintiff’s disclaimer of claims found invalid by the PTAB mooted any controversy before the appellate court associated with that patent, and a second patent-in-suit was not invalid because the district court did not err in rejecting the defendants’ obviousness challenge.

August 14, 2019

GENERICally Speaking: A Hatch Waxman Litigation Bulletin

Case Name: Sanofi-Aventis U.S., LLC v. Dr. Reddy’s Labs., Inc., No. 2018-1804, 2019 U.S. App. LEXIS 24141 (Fed. Cir. Aug. 14, 2019) (Circuit Judges Lourie, Moore, and Taranto presiding; Opinion by Lourie, J.) (Appeal from D.N.J., Shipp, J.) 

Drug Product and Patent(s)-in-Suit: Jevtana® (cabazitaxel); U.S. Patents Nos. 8,927,592 (“the ’592 patent”) and 5,847,170 (“the ’170 patent”)

Nature of the Case and Issue(s) Presented: The 170 and 592 patents claim the compound cabazitaxel and its method of use. Cabazitaxel treats certain drug resistant prostate cancers and belongs to a family of compounds known as taxanes. Prior to approving Jevtana, FDA had previously approved two other taxanes, including paclitaxel and docetaxel.

While the district court case was pending, the PTAB instituted IPR of the 592 patent and, after trial commenced, the PTAB held claims 1-5 and 7-30 invalid as obvious. Sanofi appealed the Board’s decision denying its motion to amend, but did not appeal the decision that claims 7, 11, 16-16, and 26 were invalid as obvious. Instead, Sanofi filed a statutory disclaimer of those claims. After the disclaimer was filed, the district court entered its post-trial order, finding (i) that the statutory disclaimer did not divest the court of jurisdiction and that the claims of the 592 patent were invalid as obvious, and (ii) that the 170 patent was not invalid as obvious. 

Why Sanofi-Aventis prevailed: First, the Federal Circuit found that Sanofi’s disclaimer mooted any controversy over the 592 patent. Defendants argued that vacating the district court’s decision would cause them to lose the possible benefit of an issue preclusion defense, should Sanofi obtain amended claims in the PTAB and later assert those claims against defendants. The Federal Circuit was unpersuaded, explaining that: (i) the relevance of the disclaimed claims to a possible issue preclusion defense was speculative; and (ii) even if relevant, defendants could not establish that the judgment pertaining to those claims was material to a possible future suit. The Federal Circuit noted that it could not issue an advisory opinion on a theoretical dispute.

With respect to the ’170 patent, the parties agreed that docetaxel was the closest prior art, but disagreed whether a POSA would have been motivated to replace the C7 and C10 hydroxyl groups of docetaxel with the methoxy groups of cabazitaxel. Defendants cited to literature contemplating this replacement, but the Federal Circuit was unpersuaded. In particular, the references investigated structurally different compounds and did not address taxanes. Further, the Federal Circuit agreed with the district court’s conclusion that Defendants’ expert cherry-picked data in the references and that a POSA would have been motivated to perform the substitution not just at the C7 and C10 position, but at any of C2, C4, C5, C7-C14, C2’, or C3’. Therefore, the district court did not err in rejecting the defendants’ obviousness challenge to the 170 patent. 

Oren D. Langer

Partner

Managing Partner, New York Office
Member of Executive Board

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