VALEANT PHARMACEUTICALS NORTH AMERICA LLC v. ZYDUS PHARMACEUTICALS (USA) INC.
3:18-cv-13635
D.N.J.May 7, 2020Background
- Plaintiffs (Valeant et al.) sued Defendants (Zydus entities) for patent infringement arising from an ANDA to market a generic of Jublia (efinaconazole 10%).
- Eight of nine asserted patents use the term “nail”; the parties dispute whether “nail” means the entire nail unit (plaintiffs’ plain meaning argued by Defendants) or only the nail plate (Plaintiffs’ proposed construction).
- Patent specifications describe the nail plate as a thick, hard, keratinous barrier about 100× thicker than stratum corneum and discuss topical treatment penetration into/through a nail into the nail bed.
- Defendants relied on specification language about “nail removal” and contended a POSA would understand topical treatment may be applied to the whole nail unit or to the nail bed following removal of the nail plate.
- The parties submitted Markman briefing and waived an oral hearing due to COVID-19; the Court issued claim construction by opinion.
- Ruling: the Court construed the disputed term “nail” to mean “nail plate.”
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Proper construction of “nail” in the patents | “Nail” means “nail plate”; specification language (properties, thickness, barrier) shows term refers to the plate and distinguishes nail plate from nail bed | “Nail” has its plain and ordinary meaning as the nail unit (plate + bed); “or nail bed” is not redundant because topical treatment may target the whole unit or the bed after plate removal | “Nail” construed as “nail plate” — specification language supports plate-only meaning; defendants’ redundancy and dependent-claim arguments rejected |
Key Cases Cited
- Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (claim construction focuses on what a person of ordinary skill would understand; use intrinsic evidence first)
- Markman v. Westview Instruments, Inc., 52 F.3d 967 (Fed. Cir. 1995) (claim construction is a question of law for the court)
- Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576 (Fed. Cir. 1996) (start with intrinsic evidence; dictionaries may be used when ordinary meaning is apparent)
- Ventana Med. Sys., Inc. v. Biogenex Labs., Inc., 473 F.3d 1173 (Fed. Cir. 2006) (clear disavowal in specification/prosecution can narrow claim scope)
- Innogenetics, N.V. v. Abbott Labs., 512 F.3d 1363 (Fed. Cir. 2008) (do not import limitations from the specification into claims)
- E.I. Du Pont de Nemours v. Phillips Petroleum Co., 849 F.2d 1430 (Fed. Cir. 1988) (court cannot broaden or narrow claims beyond what patentee set forth)
- Acumed LLC v. Stryker Corp., 483 F.3d 800 (Fed. Cir. 2007) (two-step infringement analysis: claim construction, then comparison to accused product)