285 F. Supp. 3d 776
D. Del.2018Background
- Hospira sued Amneal (ANDA filer) alleging infringement of patents claiming ready-to-use 4 µg/mL dexmedetomidine premix formulations in sealed glass containers (asserted patents: '158, '470, '527, '106). ANDA sought approval for 50 mL and 100 mL glass vials.
- Precedex concentrate (100 µg/mL) and its 2010 label (which instructs dilution to 4 µg/mL in 0.9% NaCl) were prior art; Trissel (2002 compatibility study) also in evidence. A separate compound patent ('214) on dexmedetomidine expired July 15, 2013 and limited market entry pre‑expiration.
- Disputed claim terms: "ready to use" (court adopted "suitable for administration to a patient without dilution") and "sealed glass container" (court adopted "a glass container that is closed tightly to maintain sterility"). Parties stipulated ANDA products met all claim limitations except (initially) sealed glass and the '106 patent’s "no more than about 2% decrease" at five months.
- Bench trial addressed validity (obviousness, anticipation, indefiniteness, inherency) and infringement (including whether ANDA specification triggers Sunovion binding infringement). Court made both factual findings and legal conclusions.
- Outcomes in brief: claims of '158, '470, and '527 found invalid as obvious; claim 6 of '106 found not invalid. Amneal found to infringe asserted claims of '158, '470, '527 (fact) and claim 6 of '106 (as a matter of law under Sunovion).
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Construction of "ready to use" | Means "suitable for administration upon manufacture without dilution or reconstitution" | Means "requiring no further dilution or reconstitution before administration" | Court construes as "suitable for administration to a patient without dilution" |
| Construction of "sealed glass container" | Agrees with court’s proposed definition (so long as includes "glass") | Agreed to court’s proposed definition (opposing added tamper-evident requirement) | Court construes as "a glass container that is closed tightly to maintain sterility" |
| Obviousness of claims in '158, '470, '527 | Prior art did not teach ready-to-use 4 µg/mL premix or suggest manufacture; commercial success supports nonobviousness | Precedex concentrate + 2010 label + packaging knowledge and market desire for ready-to-use drugs would motivate and give reasonable expectation of success | Court: claims 3–4 of '158, claim 4 of '470, claim 5 of '527 are obvious (invalid) |
| Obviousness / Inherency of '106 claim 6 ("no more than about 2% decrease at ≥5 months") | Not inherent in prior art; examples offered by defendant rely on Hospira’s own development data; no clear-and-convincing inherency proof | Claimed stability is inherent in 4 µg/mL dex in 0.9% NaCl in sealed glass; offered multiple stability examples and interrogatory matter | Court: Defendant failed to prove inherency/obviousness of claim 6; '106 claim 6 not invalid |
| Anticipation by Trissel | Trissel’s control (4 µg/mL in glass tube) meets claim limitations | Trissel samples were for compatibility testing, not intended as patient‑administered drug; lacked "ready-to-use" and stability disclosures | Court: Defendant failed to prove anticipation by Trissel |
| Indefiniteness of '106 claim 6 (measurement conditions) | Ambiguity whether 2% measured under accelerated or long-term conditions renders claim indefinite | Claim context and specification point to long-term (room temp) storage as relevant | Court: claim 6 sufficiently definite; long-term conditions are the appropriate measure |
| Infringement — sealed glass container | ANDA documents and expert testimony show vial + stopper + seal and passing dye ingress test | N/A (no post-trial defense contesting sealed glass) | Court: ANDA products meet sealed glass container limitation (infringing) |
| Infringement — "no more than about 2%" at 5 months | ANDA does not directly state 2% at 5 months; measurement variability undermines certainty | ANDA spec requires ≤10% loss at 24 months (via HPLC potency); because concentration cannot increase, ≤10% at 24 months necessarily implies ≤10% at 5 months and thus includes ≤~2% | Court: Under Sunovion court found ANDA specification controls and includes products meeting the claimed 2% at 5 months — infringement as a matter of law; plaintiff’s statistical models insufficiently reliable for alternate fact-based proving |
Key Cases Cited
- Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir.) (claim construction focuses on claim language, specification, prosecution history)
- Markman v. Westview Instruments, Inc., 517 U.S. 370 (1996) (claims define the invention; court construes claims)
- KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007) (obviousness analysis and motivation to combine)
- Teva Pharms. USA, Inc. v. Sandoz, Inc., 135 S. Ct. 831 (2015) (role of factual findings in claim construction)
- Sunovion Pharms., Inc. v. Teva Pharms. USA, Inc., 731 F.3d 1271 (Fed. Cir.) (ANDA specification can establish infringement as a matter of law)
- Graham v. John Deere Co., 383 U.S. 1 (1966) (framework for obviousness analysis)
- Nautilus, Inc. v. Biosig Instruments, Inc., 134 S. Ct. 2120 (2014) (definiteness standard: reasonable certainty)
- Par Pharm., Inc. v. TWi Pharms., Inc., 773 F.3d 1186 (Fed. Cir.) (inherency and obviousness standards)