Amgen Inc. v. Sanofi, Aventisub LLC
872 F.3d 1367
Fed. Cir.2017Background
- Patents at issue claim a genus of monoclonal antibodies that bind specific amino-acid residues on PCSK9 and block PCSK9–LDL receptor binding; priority date January 9, 2008.
- Amgen owns the patents and developed Repatha (evolocumab); Sanofi/Regeneron developed Praluent (alirocumab) and stipulated infringement.
- District court excluded all post-priority-date evidence (including Praluent) offered by Appellants to attack written description and enablement, and gave a jury instruction allowing written-description satisfaction by disclosure of a "newly-characterized antigen" if antibody production was routine.
- Appellants moved for JMOL of invalidity (no written description, no enablement); district court denied and granted Appellees JMOL of non-obviousness after excluding two prior-art PCT references as not supported by their provisionals.
- District court entered a permanent injunction against Praluent; this appeal follows and the injunction was stayed pending appeal.
Issues
| Issue | Appellants' Argument | Appellees' Argument | Held |
|---|---|---|---|
| Admissibility of post-priority-date evidence for written description | Post-priority species (including Praluent) are relevant to show the patentee did not disclose a representative number of species | Written-description is judged as of the filing date; post-priority evidence is irrelevant unless it illuminates the art at filing | Reversed: post-priority evidence may be admissible to show lack of representative species; district court erred to categorically exclude it |
| Admissibility of post-priority-date evidence for enablement | Post-priority evidence can show the extent of experimentation and whether claims were enabled without undue experimentation | Enablement is assessed as of filing; post-priority evidence irrelevant unless it illuminates state of the art | Reversed: exclusion was error; new trial on enablement warranted |
| Jury instruction permitting antigen disclosure to satisfy written description | Instruction improperly allows written-description to be satisfied merely by showing antigen disclosure plus routine antibody production | Relied on PTO Guidelines and cases (Enzo/Noelle/Centocor) supporting the test in some contexts | Reversed: instruction legally unsound; permitting jurors to equate "routine make-and-use" with written-description violates Ariad and may mislead jury |
| Exclusion of Novartis and Schering PCT references as prior art | Provisional applications underpin the PCTs and qualify them as §102(e) prior art if provisionals provide written description support | Provisionals must themselves provide written-description support for the PCT claims; Appellants offered no proof | Affirmed: district court properly excluded the PCTs under Dynamic Drinkware and related authority; JMOL of non-obviousness proper |
Key Cases Cited
- Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir.) (written-description requires proof patentee possessed claimed invention; genus requires representative species or common structural features)
- AbbVie Deutschland GmbH & Co. v. Janssen Biotech, Inc., 759 F.3d 1285 (Fed. Cir.) (post-filing accused antibody used in written-description analysis; relevant to representativeness question)
- Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956 (Fed. Cir.) (discussed PTO Guidelines recognizing functional descriptions may satisfy written description when structure–function correlation is known)
- Noelle v. Lederman, 355 F.3d 1343 (Fed. Cir.) (antibody claims cannot claim priority absent structural disclosure of antibody or antigen)
- Centocor Ortho Biotech, Inc. v. Abbott Labs., 636 F.3d 1341 (Fed. Cir.) (criticized the "newly-characterized antigen" test; held antibody claims invalid for lack of written description)
- In re Hogan, 559 F.2d 595 (CCPA) (applicant cannot be required to disclose later-developed forms; distinguishes uses of post-filing evidence)
- Dynamic Drinkware, LLC v. National Graphics, Inc., 800 F.3d 1375 (Fed. Cir.) (a provisional must provide adequate written description to afford priority for later applications used as prior art)
- Genentech, Inc. v. Novo Nordisk A/S, 108 F.3d 1361 (Fed. Cir.) (enablement requires teaching full scope without undue experimentation)
- eBay, Inc. v. MercExchange, L.L.C., 547 U.S. 388 (U.S.) (four-factor test required for permanent injunctions)