343 F. Supp. 3d 823
N.D. Ill.2018Background
- Hospira patented Precedex Premix, a ready-to-use 4 µg/mL dexmedetomidine HCl product packaged in Type I glass vials with coated rubber stoppers; Hospira asserted claim 6 of U.S. Patent No. 8,648,106 and claim 8 of U.S. Patent No. 9,616,049 against Fresenius Kabi after Fresenius filed an ANDA.
- Precedex Concentrate (100 µg/mL) had long been marketed with label instructions to dilute to 4 µg/mL; Dexdomitor (veterinary) and industry references described ready-to-use formulations and glass primary packaging.
- Hospira developed stability data for 4 µg/mL premix (example in '106 patent showing ~2.3% loss at 5 months); additional batches and ANDA data (including Fresenius’s) showed ≤ ~2% loss at five months under room-temperature storage in Type I glass with coated stoppers.
- Fresenius conceded its proposed product would infringe the asserted claims but defended on invalidity grounds, arguing obviousness (including inherency of the "about 2%" stability limitation).
- After a five-day bench trial, the court found Fresenius proved by clear and convincing evidence that the asserted claims are invalid as obvious.
Issues
| Issue | Hospira's Argument | Fresenius Kabi's Argument | Held |
|---|---|---|---|
| Whether claim 6 of the '106 Patent (4 µg/mL premix in sealed glass showing "no more than about 2%" loss at 5 months) is obvious | The stability "about 2%" limitation is not inherent in the prior art; POSA would not have had reasonable expectation of success | Prior art (Precedex Concentrate, Dexdomitor, industry guidance) taught a ready-to-use 4 µg/mL premix in glass with coated stoppers; stability limitation is inherent and/or expected | Obvious; claim 6 invalid (court finds inherency of about-2% limitation and reasonable expectation of success) |
| Whether claim 8 of the '049 Patent (same premix + pH ~2–10) is obvious | Similar: Hospira argued novelty/non-obviousness based on stability and other properties | Prior art disclosed concentration and pH range (Precedex label pH 4.5–7.0 falls within claimed 2–10); motivations to combine and expectation of success exist | Obvious; claim 8 invalid |
| Whether inherency requires exclusion of alternative embodiments | Hospira argued Fresenius must exclude possibilities that prior-art combination could fail the limitation | Fresenius argued need only show at least one embodiment (the 4 µg/mL preferred embodiment) necessarily exhibits the limitation | Court: inherency need only be shown for the relevant embodiment; Fresenius met the high inherency standard by clear and convincing evidence |
| Weight of secondary considerations (failure of others, long-felt need, unexpected results) | Hospira pointed to long-felt need and alleged others failed to make premix meeting the limitation | Fresenius noted blocking patent ('214) limited others' ability to compete and showed expected results per industry practice | Court: secondary considerations weak or neutral (blocking patent and lack of evidence of failed attempts); expected — not unexpected — results support obviousness |
Key Cases Cited
- KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007) (governing obviousness analysis and motivation-to-combine principles)
- PAR Pharm., Inc. v. TWI Pharm., Inc., 773 F.3d 1186 (Fed. Cir. 2014) (limits on using inherency in obviousness: property must necessarily result)
- Millennium Pharm., Inc. v. Sandoz Inc., 862 F.3d 1356 (Fed. Cir. 2017) (inventor’s path cannot establish obviousness; caution on hindsight)
- In re Cuozzo Speed Techs., LLC, 793 F.3d 1268 (Fed. Cir. 2015) (broad claims covering obvious embodiments are unpatentable)
- Santarus, Inc. v. Par Pharm., Inc., 694 F.3d 1344 (Fed. Cir. 2012) (inherent properties do not render an obvious formulation nonobvious)
- Acorda Therapeutics, Inc. v. Roxane Labs., Inc., 903 F.3d 1310 (Fed. Cir. 2018) (discussion of expectation of success and relevance of inherent properties)
- Honeywell Int'l Inc. v. Mexichem Amanco Holding S.A., 865 F.3d 1348 (Fed. Cir. 2017) (inherent properties and unexpectedness in obviousness analysis)
- Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348 (Fed. Cir. 2007) (teaching from multiple sources may be combined for obviousness)
- Novo Nordisk A/S v. Caraco Pharm. Labs., Ltd., 719 F.3d 1346 (Fed. Cir. 2013) (presumption of validity from PTO findings does not impose added burden in district court invalidity cases)
- In re Cyclobenzaprine Hydrochloride Extended-Release Capsule Patent Litig., 676 F.3d 1063 (Fed. Cir. 2012) (failed attempts by others can be potent evidence against obviousness when adequately shown)