Allergan, Inc. v. Sandoz Inc.
726 F.3d 1286
| Fed. Cir. | 2013Background
- This is a Hatch-Waxman case involving Allergan’s Combigan®, a fixed combination of 0.2% brimonidine and 0.5% timolol for glaucoma, against Sandoz and others who filed ANDAs to market generics.
- All asserted claims of Allergan’s four Orange Book patents ('258, '976, '463, '149) were challenged for invalidity under 35 U.S.C. § 103; Allergan challenged claim construction for the '149 patent.
- A bench trial followed a claim construction ruling; summary judgment of non-infringement for the '149 patent claims 1-3 was granted prior to trial, with infringement stipulated for the other asserted claims.
- The district court held that none of the asserted claims were invalid under § 103, and the court adopted Allergan’s proposed claim constructions for the '149 patent claims.
- On appeal, the Federal Circuit reversed in part, invalidating the '463 patent as obvious, and held that Sandoz failed to prove by clear and convincing evidence that claim 4 of the '149 patent was obvious; claim construction was affirmed.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether the '463 patent claims are obvious | Sandoz argued the claims were obvious over DeSantis and other prior art. | Allergan contended the district court correctly found non-obviousness given unpredictability and secondary considerations. | The claims are invalid as obvious. |
| Whether claim 4 of the '149 patent is obvious | Sandoz argued the method of reducing daily doses would be obvious. | Allergan urged lack of evidence that the dosing reduction would be obvious or that it would incur no loss of efficacy. | Claim 4 is not invalid as obvious. |
| Whether the district court erred in claim construction for the '149 patent | Sandoz urged a construction broader than the district court’s; Allergan urged a narrower construction tied to separate compositions. | Sandoz urged serial administration interpretation; Allergan argued the court correctly contrasted fixed-combination versus separate compositions. | No error in the district court’s construction. |
Key Cases Cited
- Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348 (Fed. Cir. 2007) (reasonable expectation of success supports obviousness findings)
- Graham v. John Deere Co., 383 U.S. 1 (U.S. 1966) (establishes factual framework for obviousness analysis)
- KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (U.S. 2007) (teaches flexible framework for obviousness including common sense and motivation to combine)
- Knoll Pharm Co., Inc. v. Teva Pharms. USA, Inc., 367 F.3d 1381 (Fed. Cir. 2004) (FDA considerations can be relevant to obviousness)
- Bristol-Myers Squibb Co. v. Ben Venue Labs., 246 F.3d 1368 (Fed. Cir. 2001) (newly discovered results of known processes directed to the same purpose are not patentable)
- Abbott Labs. v. Baxter Pharm. Prods., 471 F.3d 1363 (Fed. Cir. 2006) (newly discovered results of known processes directed to the same purpose are not patentable)
- In re Cruciferous Sprout Litig., 301 F.3d 1343 (Fed. Cir. 2002) (inherency doctrine; new or inherent properties do not render a claim patentable)
- ArcelorMittal France v. AK Steel Corp., 700 F.3d 1314 (Fed. Cir. 2012) (case law on obviousness and claim scope considerations)
- Muniauction, Inc. v. Thomson Corp., 532 F.3d 1318 (Fed. Cir. 2008) (prior art considerations and obviousness analysis)
- In re Soni, 54 F.3d 746 (Fed. Cir. 1995) (secondary considerations in obviousness analysis)