Sanofi v. Watson Laboratories Inc.
875 F.3d 636
| Fed. Cir. | 2017Background
- Sanofi owns patents: the ’800 (composition, expires 2019) and the ’167 (method to reduce cardiovascular hospitalization, expires 2029) covering dronedarone (Multaq®). Sanofi sued Watson and Sandoz under 35 U.S.C. § 271(e)(2) after paragraph IV ANDA certifications.
- District court found inducement of infringement for most asserted claims of the ’167 patent (based on defendants’ proposed labels) and infringement of numerous claims of the ’800 patent; it rejected defendants’ obviousness challenges to the ’167 claims and their prosecution-disclaimer argument as to the ’800 claims.
- Relevant clinical evidence: EURIDIS/ADONIS trials (2001–2003) showed reduced recurrence of AF and post-hoc suggested reduced hospitalization; ANDROMEDA (safety trial) showed increased mortality leading to early termination; ATHENA (2005–2008) was designed to test reduction in cardiovascular hospitalization or death and produced positive results (published post‑critical date).
- The critical obviousness date is Feb 11, 2008 (one year before ’167 priority date); ATHENA results post‑date that. Hohnloser 2008 described ATHENA and included the statement that reduced rehospitalization was “expected.”
- The Multaq® label (proposed for generics unchanged) indicates: “is indicated to reduce the risk of hospitalization for atrial fibrillation” and directs readers to the Clinical Studies section, which highlights ATHENA’s positive results for the patient population matching the ’167 claims; ANDROMEDA and PALLAS are described as negative safety studies.
Issues
| Issue | Sanofi's Argument | Watson/Sandoz Argument | Held |
|---|---|---|---|
| Inducement of the ’167 patent by generic labels | Labels expressly indicate reduction in hospitalization and point to ATHENA; label encourages prescribers to use dronedarone on patients falling within the patent claims, showing specific intent to induce | Labels permit substantial non‑infringing uses; inducement should not be found when product has legitimate noninfringing uses | Affirmed: label content and circumstantial evidence supported inference of specific intent to induce infringement; substantial noninfringing uses do not preclude inducement liability |
| Obviousness of the ’167 claims as of Feb 2008 | (Sanofi) Prior art did not give a person of ordinary skill a reasonable expectation that dronedarone would reduce cardiovascular hospitalization in the claimed population | (Watson/Sandoz) Prior art (EURIDIS/ADONIS post‑hoc and Hohnloser 2008) gave reasonable expectation of success | Affirmed: district court did not clearly err in finding no reasonable expectation of success and thus nonobviousness |
| Scope of ’800 claims re: polysorbate surfactants (prosecution disclaimer) | (Sanofi) No disclaimer applied to later continuation claims because the narrowing amendment was specific to the earlier ’493 prosecution and not adopted in the ’800 claims | (Watson/Sandoz) Prosecuting the parent with an explicit exclusion of polysorbate constituted a disclaimer that should limit the ’800 continuation claims | Affirmed: no prosecution disclaimer; later claims lacking the explicit limitation are not automatically limited by the parent’s narrowing amendment |
| Evidentiary weight of pre‑ATHENA statements (“it is expected”) | (Sanofi) Those statements reflect hypotheses and do not create a reasonable expectation of success before ATHENA results | (Watson/Sandoz) Hohnloser 2008 and proposed ATHENA enrollee language show a concrete expectation supporting obviousness | Held for Sanofi: district court reasonably credited testimony that such statements were hypothesis/post‑hoc and did not establish a reasonable expectation of success |
Key Cases Cited
- Commil USA, LLC v. Cisco Sys., Inc., 135 S. Ct. 1920 (2015) (inducement requires knowledge that induced acts constitute infringement)
- Global‑Tech Appliances, Inc. v. SEB S.A., 563 U.S. 754 (2011) (willful blindness and knowledge standards for inducement)
- Metro‑Goldwyn‑Mayer Studios Inc. v. Grokster Ltd., 545 U.S. 913 (2005) (distribution with intent to promote infringing use supports inducement liability)
- DSU Med. Corp. v. JMS Co., 471 F.3d 1293 (Fed. Cir. 2006) (specific intent to encourage infringement required for inducement)
- AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042 (Fed. Cir. 2010) (upholding inducement based on labeling without explicit limiting language)
- Takeda Pharm. USA, Inc. v. West‑Ward Pharm. Corp., 785 F.3d 625 (Fed. Cir. 2015) (label must encourage, recommend, or promote infringement when inducement is based on a label)
- Eli Lilly & Co. v. Teva Parenteral Medicines, Inc., 845 F.3d 1357 (Fed. Cir. 2017) (continuing to seek FDA approval of instructions can show specific intent to induce depending on clarity of label)
- Saunders Grp., Inc. v. Comfortrac, Inc., 492 F.3d 1326 (Fed. Cir. 2007) (prosecution disclaimer directed to specific claim terms omitted in continuations does not necessarily apply)
- Regents of Univ. of Minn. v. AGA Med. Corp., 717 F.3d 929 (Fed. Cir. 2013) (prosecution disclaimer typically applies only where subsequent patent contains same claim limitation)