Indivior Inc. v. Mylan Techs. Inc.
298 F. Supp. 3d 775
D. Del.2018Background
- Indivior/MonoSol sued Alvogen (ANDA No. 205954) alleging infringement of process and composition claims of U.S. Pat. Nos. 8,900,497 (’497) and 8,603,514 (’514) for Suboxone® sublingual film; bench trial held Sept. 26–27, 2017.
- Disputed claim elements focused on drying: the '497 claim requires "rapidly evaporating... to form a visco-elastic film within about the first 4.0 minutes," and the '514 claims require a film "dried without solely employing conventional convection air drying from the top."
- Alvogen’s commercial process uses a modified S‑Coater flotation oven with top impingement nozzles and disabled bottom air; some limited contact between web and lower plenum and brief drag‑bar contact occur.
- Parties stipulated that all other claim limitations were met except (1) the "dried/drying" limitation and (2) the "visco‑elastic film" limitation; Alvogen conceded "rapidly evaporating."
- The court weighed expert rheology evidence (viscosity vs. shear rate plots) and airflow/heat transfer measurements to determine whether Alvogen’s technique was "conventional" and whether a viscoelastic solid formed within four minutes.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Alvogen’s process meets the "dried"/"drying" limitation (i.e., is not "solely employing conventional convection air drying from the top") | Alvogen’s dryer is "highly unconventional" (modified flotation oven, web drags on floor, multi‑zone control) and/or film is substantially dried from the bottom (drag bars, web/plenum contact, under‑web airflow) | The technique is conventional top‑down impingement drying (bottom air disabled); any bottom heat/airflow/contact is negligible and not a substantial contributor to drying | Held for Alvogen: Plaintiff failed to prove non‑conventional technique or substantial bottom drying; drying is "conventional convection air drying from the top" |
| Whether drag bars, web/plenum contact or under‑web airflow cause "substantial" bottom drying | These features produce meaningful bottom drying contribution (air velocity ratios, exhibit vs. commercial batch moisture equivalence) | Contact and drag bars provide negligible heat transfer; under‑web airflow measurements are variable and at most incidental; equal moisture can be explained by other factors | Held for Alvogen: evidence of bottom drying was insubstantial or equivocal; Plaintiffs did not meet preponderance burden |
| Whether Alvogen forms a "visco‑elastic film" (viscoelastic solid) within about 4 minutes | Rheology analysis (Prud'homme) of Alvogen’s measured complex viscosity vs. shear rate shows slope ≤ −1 in low‑stress region, indicating a viscoelastic solid within 4 minutes | Data are limited (single/small samples), measured at different temperature than in oven, slope calculation imprecise and not statistically significant; videos show flow consistent with liquid | Held for Alvogen: Plaintiff failed to prove viscoelastic solid formed within 4 minutes—slope analysis unreliable and not statistically significant; visual evidence equivocal |
Key Cases Cited
- Markman v. Westview Instruments, Inc., 52 F.3d 967 (Fed. Cir.) (en banc) (claim construction is a question of law)
- Markman v. Westview Instruments, Inc., 517 U.S. 370 (1996) (affirming claim construction framework)
- Bai v. L & L Wings, Inc., 160 F.3d 1350 (Fed. Cir. 1998) (infringement is a question of fact)
- Kahn v. General Motors Corp., 135 F.3d 1472 (Fed. Cir. 1998) (literal infringement requires every claim limitation)
- Bayer AG v. Elan Pharm. Research Corp., 212 F.3d 1241 (Fed. Cir. 2000) (absence of a claim limitation precludes literal infringement)
- SmithKline Diagnostics, Inc. v. Helena Labs. Corp., 859 F.2d 878 (Fed. Cir. 1988) (patent owner’s burden to prove infringement by preponderance)
- Glaxo, Inc. v. Novopharm, Ltd., 110 F.3d 1562 (Fed. Cir. 1997) (ANDA filing as an act of infringement under § 271(e)(2))
- Medicines Co. v. Mylan, Inc., 853 F.3d 1296 (Fed. Cir. 2017) (cautioning against results‑oriented claim constructions)