Merck Sharp & Dohme Corp. v. Hospira, Inc.
874 F.3d 724
| Fed. Cir. | 2017Background
- Merck owns U.S. Patent No. 6,486,150 (the ’150 patent) claiming a 3-step process to produce a stable ertapenem (an antibiotic) CO2-adduct formulation: (1) charge a CO2 source solution pH ~6.0–12.0, (2) add base and active ingredient to maintain pH ~6.0–9.0 at –3°C to 15°C, and (3) lyophilize to <10% moisture.
- Hospira filed an ANDA seeking to market a generic of Merck’s Invanz® (ertapenem CO2-adduct); Merck sued for infringement of the ’150 and an earlier ’323 patent.
- The District Court found Hospira would infringe the asserted claims of the ’150 patent but held those claims invalid for obviousness over the ’323 patent and WO 98/18800 (Almarsson). The court treated the claimed steps as routine implementation of prior-art principles.
- District court found prior art taught forming the CO2 adduct at pH 6–9, use of NaOH to adjust pH, and standard lyophilization; low temperatures were known to reduce degradation.
- The court credited Merck’s secondary evidence (commercial success, copying) but concluded it did not overcome the strong prima facie case of obviousness.
- On appeal the Federal Circuit majority affirmed; Judge Newman dissented, arguing the court misapplied Graham’s framework by relegating objective indicia to rebuttal and improperly shifting burdens.
Issues
| Issue | Merck's Argument | Hospira's Argument | Held |
|---|---|---|---|
| Whether claims 21–34 of the ’150 patent are obvious over the ’323 patent or Almarsson | Merck: claims are nonobvious because prior art did not disclose the claimed sequence, simultaneous base addition, specific temperature range, or <10% moisture; prior art focused on dimerization not hydrolysis and taught away | Hospira: claim 21 recites routine manufacturing steps implementing prior-art teachings (pH range, CO2 adduct formation, low temp, lyophilization); missing details are ordinary experimentation | Court: Affirmed obviousness — prior art taught core principles; the claimed order and experimental details would have been arrived at by routine experimentation |
| Proper role and weight of objective indicia (commercial success, copying) in obviousness analysis | Merck: district court undervalued secondary considerations; objective indicia are independent, often most probative evidence of nonobviousness | Hospira: district court properly weighed objective evidence and found it insufficient to overcome strong prima facie case | Court: Majority—objective evidence insufficient to overcome obviousness. Dissent—court erred by treating secondary considerations as rebuttal rather than part of whole analysis |
| Whether routine experimentation can supply missing claim limitations | Merck: missing limitations are inventive results of extensive research, not routine tweaks | Hospira: these are conventional parameters a skilled artisan would use (pH control, low temp, lyophilization) | Court: Routine experimentation could supply the details; not inventive |
| Standard of review and application of Graham/KSR | Merck: district court wrongly invoked ‘‘common sense’’ to supply limitations; misapplied Graham factors | Hospira: application of Graham/KSR appropriate; motivation and predictability supported combination | Court: Applied governing law; reviewed fact findings for clear error and legal conclusions de novo; majority upheld result, dissent urged stricter adherence to Graham framework |
Key Cases Cited
- Graham v. John Deere Co., 383 U.S. 1 (1966) (establishes the four-factor framework for obviousness)
- KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398 (2007) (endorses flexible obviousness inquiry; permits common-sense reasoning)
- Apple Inc. v. Samsung Elecs. Co., 839 F.3d 1034 (Fed. Cir. 2016) (en banc) (obviousness requires consideration of all Graham factors including secondary considerations)
- United States v. U.S. Gypsum Co., 333 U.S. 364 (1948) (standard for clear-error review of facts)
- Golden Blount, Inc. v. Robert H. Peterson Co., 365 F.3d 1054 (Fed. Cir. 2004) (bench-trial appellate review standard)
- Merck & Co. v. Teva Pharm. USA, Inc., 395 F.3d 1364 (Fed. Cir. 2005) (commercial success may be weakened where market entry was precluded by other patents)