933 F.3d 1367
Fed. Cir.2019Background
- Sanofi owns two Orange-Book-listed patents: the ’170 patent claiming cabazitaxel (the compound marketed as Jevtana) and the ’592 patent claiming methods of use. Defendants filed ANDAs seeking to market generic cabazitaxel, prompting district-court litigation and a counterclaim of invalidity.
- Cabazitaxel is a taxane derivative of docetaxel differing by methoxy substitutions at C7 and C10; it was developed to treat docetaxel-resistant cancers and approved in 2010.
- While the district court trial was pending, the Patent Trial and Appeal Board (PTAB) instituted IPR of the ’592 patent and held many claims unpatentable; Sanofi later filed a statutory disclaimer eliminating claims 7, 11, 14–16, and 26 from the patent.
- The district court nonetheless entered judgment finding those disclaimed ’592 claims obvious and also held claims 1–2 of the ’170 patent nonobvious; Sanofi appealed the jurisdictional issue about the disclaimed claims and Fresenius cross‑appealed nonobviousness of the ’170 claims.
- The Federal Circuit vacated the district court’s invalidity judgment as to the disclaimed ’592 claims for lack of an Article III case or controversy at the time of final judgment.
- The Federal Circuit affirmed the district court’s nonobviousness determination as to claims 1 and 2 of the ’170 patent, concluding defendants failed to show a motivation to make the specific C7 and C10 methoxy substitutions or otherwise overcome evidence of secondary considerations.
Issues
| Issue | Sanofi's Argument | Fresenius's Argument | Held |
|---|---|---|---|
| Whether the district court had jurisdiction to declare disclaimed claims of the ’592 patent invalid after Sanofi’s statutory disclaimer | Disclaimer mooted any controversy; once disclaimed the claims "had never existed," so the court lacked authority | The declaratory judgment should stand for "patent certainty" and to preserve possible issue‑preclusion benefits for defendants in future litigation | Vacated: disclaimer mooted the controversy; no Article III case or controversy existed at final judgment, so the invalidity ruling as to those claims was vacated |
| Whether claims 1–2 of the ’170 patent (cabazitaxel compound) were obvious over docetaxel and prior art | Nonobvious: no clear reason a skilled artisan would have been motivated to make the simultaneous C7/C10 methoxy substitutions; secondary considerations (commercial success, long-felt need, failed efforts by others) support nonobviousness | Obvious: a skilled artisan would be motivated to increase lipophilicity to overcome Pgp-mediated resistance and would make small, conservative methoxy changes at C7 and C10 | Affirmed: defendants failed to prove obviousness by clear and convincing evidence; no adequate motivation to make the specific substitutions and secondary considerations weigh against obviousness |
Key Cases Cited
- MedImmune, Inc. v. Genentech, Inc., 549 U.S. 118 (2007) (declaratory-judgment case-or-controversy standard)
- Aetna Life Ins. Co. v. Haworth, 300 U.S. 227 (1937) (distinguishing advisory opinions from justiciable controversies)
- KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007) (obviousness flexible-analysis framework)
- Takeda Chem. Indus., Ltd. v. Alphapharm Pty., Ltd., 492 F.3d 1350 (2007) (need for a rationale to modify a known compound to render a new compound prima facie obvious)
- Microsoft Corp. v. i4i Ltd. P’ship, 564 U.S. 91 (2011) (clear-and-convincing-evidence standard to overcome patent validity presumption)
- Teva Pharm. USA, Inc. v. Novartis Pharm. Corp., 482 F.3d 1330 (2007) (ANDA filing and existing suits can create a concrete Article III controversy)
- Vectra Fitness, Inc. v. TNWK Corp., 162 F.3d 1379 (1998) (effect of disclaimer: removed claims as if they never existed)
- Fresenius USA, Inc. v. Baxter Int’l, Inc., 721 F.3d 1330 (2013) (when cancelling a claim generally moots infringement litigation based on that claim)