Allergan, Inc. v. Sandoz Inc.
796 F.3d 1293
Fed. Cir.2015Background
- Glaucoma treatment Lumigan 0.03% (bimatoprost with 50 ppm BAK) approved in 2001; BAK is cytotoxic and high concentrations raise safety concerns.
- Allergan developed Lumigan 0.01% with 200 ppm BAK, yielding similar efficacy with less hyperemia; FDA approved Lumigan 0.01% in 2010.
- Allergan owns multiple patents (‘504, ‘353, ‘118, ‘605, ‘479) claiming Lumigan 0.01% formulations and uses; these are listed in the Orange Book.
- Sandoz, Lupin, Hi-Tech, and Watson filed ANDAs to generic Lumigan 0.01% before patent expiry; Allergan sued in E.D. Texas consolidated action.
- The asserted claims all cover compositions of 0.01% bimatoprost with 200 ppm BAK, with Group I claims adding a pH approximately 7.3 and Group II claims requiring a specific clinical profile.
- The district court held the claims nonobvious, not lacking written description or enablement, and that Hi-Tech infringed the Group I claims both literally and under the doctrine of equivalents.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Obviousness of claimed formulation over prior art | Sandoz/Lupin/Hi-Tech argue ranges render obviousness; Galderma burden shift not triggered | Allergan contends prior art taught away and there are unexpected results | Not obvious; teaching away and unexpected results support nonobviousness |
| Written description adequacy for Group II claims | Group II lacks explicit efficacy/hyperemia data | Specifications disclose Lumigan 0.01% as best mode with claimed formulation | Written description adequate; district court erred only to rely on clinical protocol not part of spec; outcome preserved |
| Enablement of Group II claims | Lack of efficacy data implies lack of enablement | Spec disclosures (0.01%/200 ppm BAK) enable skilled artisan | Not invalid for lack of enablement; disclosures enable making and using claimed invention |
| Infringement of Group I claims by Hi-Tech | Hi-Tech product would infringe under literal or DOE due to pH ~7.3 | Construction of pH around 7.3 and prosecution history limits DOE | Literal infringement established; no need to resolve DOE issue |
Key Cases Cited
- Galderma v. Tolmar, 737 F.3d 738 (Fed. Cir. 2013) (burden shifts to patentee to prove teaching away/unexpected results when prior art ranges are broad)
- In re Mouttet, 686 F.3d 1322 (Fed. Cir. 2012) (inherent teachings in prior art; nonobviousness strong when prior art discourages path)
- In re Peterson, 315 F.3d 1325 (Fed. Cir. 2003) (disclosed ranges may encompass many compounds; need evidence of nonobviousness)
- In re Applied Materials, 692 F.3d 1289 (Fed. Cir. 2012) (unpredictable interactions can render combinations nonobvious)
- KSR Int’l Co. v. Teleflex, 550 U.S. 398 (U.S. 2007) (flexible, common-sense approach to obviousness (prior art ranges; motivation/expectation))
- Enzo Biochem v. Gen-Probe, 323 F.3d 956 (Fed. Cir. 2002) (written description requires enabling identification of claimed subject matter)
- Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336 (Fed. Cir. 2010) (en banc: written description and enablement standards refined)
- Alcon Research Ltd. v. Barr Labs., Inc., 745 F.3d 1180 (Fed. Cir. 2014) (separation of written description and enablement inquiries)