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

Statutory Disclaimer of Claims Moots Hatch-Waxman Litigation Alleging Obviousness

Sanofi-Aventis U.S., LLC v. Dr. Reddy’s Laboratories, Inc., __ F.3d __, 2019 WL ___ (Fed. Cir. Aug. 14, 2019) (LOURIE, Moore, Taranto) (D.N.J.: Shipp) (3 of 5 stars)

Fed Cir vacates Hatch-Waxman judgment of obviousness as to claims of one Sanofi patent, affirms judgment confirming nonobviousness as to claims of another. Sanofi’s patents relate to the compound cabazitaxel (marketed by Sanofi as Jevtana), used to treat certain drug-resistant prostate cancers. Because Sanofi filed a statutory disclaimer of various claims during IPR of the first patent, no case or controversy existed as to them at the time of the judgment. The opinion rejects defendants’ argument that they still faced some uncertainty about whether some of their arguments (e.g., issue or claim preclusion) would bar future suits from Sanofi even should it obtain new claims during the IPR. This is not a case where there is a sufficient controversy even absent any risk of infringement because Defendants did not identify “other concrete and imminent harm traceable to the claims.” Op. at 9. It discusses how some of Defendants’ requested relief sought advisory opinions, and Defendants’ failure to establish that certain case findings (which Defendants sought to preserve) would actually be material to future litigation.

As to the other Sanofi patent, the district court did not clearly err in concluding that Fresenius (one of the defendants) had not proved obviousness. This aspect of the opinion is highly fact-based. The opinion rejects Fresenius’s contention that, under Bristol-Myers Squibb, 752 F.3d 967 (Fed. Cir. 2014), small changes to a known compound would be obvious to try.

KEYWORDS: DISCLAIMER; CASE OR CONTROVERSY; JUSTICIABILITY; OBVIOUSNESS (NO)