Cephalon, Inc. v. Watson Pharmaceuticals, Inc.
707 F.3d 1330
| Fed. Cir. | 2013Background
- Watson filed an ANDA for a generic fentanyl buccal tablet; Cephalon/SUM asserted theKhankari patents (’604 and ’590) for fentanyl delivery via oral mucosa.
- The district court found Watson’s product noninfringing and held the Khankari patents invalid for lack of enablement.
- On appeal, the Federal Circuit reverses as to enablement but affirms noninfringement.
- The Khankari patents describe saliva-activated effervescent formulations to enhance absorption across oral mucosa, with possible acid/base co-administration.
- Claim construction centered on whether a single-compound effervescent agent suffices or whether co-administration of separate acid source and effervescent base is required.
- Watson bears the burden to prove lack of enablement by clear and convincing evidence; on appeal the court finds insufficient evidence of undue experimentation.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Enablement invalidity for lack of enablement | Cephalon argues the patent teaches-to-use facilitates co-administration; sufficient guidance exist | Watson argues lack of enablement due to need for undue experimentation to co-administer separate acid and base | Enablement reversed; patents not shown to require undue experimentation |
| Noninfringement of Khankari patents | Cephalon contends Watson’s products meet the claimed saliva-activated effervescent agent | Watson argues products do not meet the saliva-activated limitation | Noninfringement affirmed; district court findings not clearly erroneous |
Key Cases Cited
- In re Wands, 858 F.2d 731 (Fed. Cir. 1988) (undue experimentation factors for enablement guidance)
- Enzo Biochem, Inc. v. Calgene, Inc., 188 F.3d 1362 (Fed. Cir. 1999) (provide framework for enablement assessment)
- Ortho-McNeil Pharm., Inc. v. Mylan Labs., Inc., 520 F.3d 1358 (Fed. Cir. 2008) (clinical work does not alone prove undue experimentation)
- White Consolidated Indus., Inc. v. Vega Servo-Control, Inc., 713 F.2d 788 (Fed. Cir. 1983) (extensive experimentation needs justification by the record)