Alcon Research, Ltd. v. Barr Laboratories, Inc.
745 F.3d 1180
| Fed. Cir. | 2014Background
- Alcon owns patents ’287 and ’062 claiming a method of enhancing chemical stability of prostaglandin ophthalmic compositions by adding polyethoxylated castor oil (PECO); claim 19 of ’062 narrows PECO to PEG-5–PEG-200 hydrogenated castor oils.
- Barr filed an ANDA to market a generic travoprost ophthalmic solution; Alcon sued under Hatch‑Waxman, asserting those patents and others (two Orange-Book patents were later not tried).
- After claim construction, the bench trial focused on whether Barr’s ANDA product would infringe (i.e., whether adding PECO to Barr’s specific ANDA formulation would chemically stabilize travoprost) and whether the asserted claims met § 112 (enablement and written description).
- The district court found no infringement (Alcon’s stability data were from different formulations) and held claims 12 (’287) and 19 (’062) invalid for lack of enablement and inadequate written description.
- Barr moved post‑judgment for JMOL/ amendment as to two other Alcon patents that were not tried; the district court denied the motion, treating those claims as removed from the case.
- The Federal Circuit affirmed noninfringement and the denial of Barr’s Rule 59(e) relief, but reversed the § 112 invalidity holdings (enablement and written description), concluding Barr failed to meet the clear-and-convincing burden.
Issues
| Issue | Alcon's Argument | Barr's Argument | Held |
|---|---|---|---|
| Infringement of asserted claims by Barr’s ANDA product | Alcon: its accelerated stability data (Table 7) using same PECO and concentration support extrapolation to Barr’s ANDA formulation and show chemical stabilization | Barr: Alcon offered no direct evidence about Barr’s ANDA formulation; tested formulations materially differ so data are inapplicable | Affirmed noninfringement — Alcon’s data could not reliably be extrapolated to Barr’s different ANDA formulation |
| Enablement under 35 U.S.C. § 112 ¶1 | Alcon: specification and examples enable practice of the claimed one‑step method without undue experimentation | Barr: specification lacks chemical‑stability data, only limited examples, and the technology is unpredictable (many variables) so undue experimentation would be required | Reversed district court — Barr failed to show by clear and convincing evidence that undue experimentation was required; claims are enabled |
| Written‑description under 35 U.S.C. § 112 ¶1 | Alcon: specification sufficiently discloses invention and embodiments; skilled artisan would recognize inventor possessed claimed invention | Barr: claims overreach the specification; disclosure is insufficient (limited data, physical vs chemical stability) | Reversed district court — specification enables a skilled reader to visualize/recognize the claimed invention; written description adequate |
| Denial of Rule 59(e) motion / JMOL as to untried ’383 and ’052 patents | Barr: Alcon presented no evidence on those patents at trial; district court should have entered JMOL of noninfringement | Alcon: Barr never filed a counterclaim for declaratory judgment; patentee chose which claims to try; no fair notice to enter adverse judgment | Affirmed denial — district court did not abuse discretion; claims were effectively removed from trial and Barr had opportunity to seek declaratory relief but did not |
Key Cases Cited
- Amgen Inc. v. Hoechst Marion Roussel, Inc., 314 F.3d 1313 (Fed. Cir.) (infringement factual-findings review)
- Abbott Labs. v. Tor‑Pharm, Inc., 300 F.3d 1367 (Fed. Cir.) (ANDA‑infringement inquiry compares patent to product likely sold after ANDA approval)
- Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir.) (enablement and written‑description are separate § 112 requirements)
- In re Wands, 858 F.2d 731 (Fed. Cir.) (factors for analyzing undue experimentation)
- Lucent Tech., Inc. v. Gateway, Inc., 543 F.3d 710 (Fed. Cir.) (rejecting speculative circumstantial evidence of infringement)
- Pfaff v. Wells Elecs., Inc., 525 U.S. 55 (U.S.) (patentability need not await actual reduction to practice)
- Tol‑O‑Matic, Inc. v. Proma Produkt‑Und Mktg. G.m.b.H., 945 F.2d 1546 (Fed. Cir.) (issue must be actually litigated/fairly placed in issue to support judgment)
- SanDisk Corp. v. Kingston Tech. Co., 695 F.3d 1348 (Fed. Cir.) (patentee’s announcement of dropping claims can remove them from case without formal motion)