Dey, L.P. v. Sunovion Pharmaceuticals, Inc.
715 F.3d 1351
Fed. Cir.2013Background
- Sunovion and Dey owned COPD drug patents involving formoterol in aqueous solution via nebulization; Gao patent (Sunovion) vs. second Dey patent family (filed 2003).
- Sunovion conducted FDA-approved clinical trials, including Study 50, testing Batch 3501A identical to Brovana’s formulation, with home-administered doses over 12 weeks.
- Study 50 participants were informed about the study generic purpose but not the specific Batch 3501A formulation; confidentiality controls were imposed on investigators.
- A fraction of Batch 3501A doses were not returned, and thousands of vials were distributed; the trial ended June 2003, before Dey’s patent applications matured.
- District court held Sunovion’s trial constituted a public use invalidating Dey’s second-family patents; on appeal, the Federal Circuit reversed and remanded for factual evaluation of confidentiality and public-use elements.
- Dey argues the trial was confidential and controlled, not a public use; Sunovion contends it was publicly accessible due to trial exposure and lack of secrecy obligations.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Study 50 constituted a public use under § 102(b). | Dey: trial use was non-public due to confidentiality and controlled disclosure. | Sunovion: trial was public use because information was accessible and not adequately confidential. | Not decided in favor of Sunovion; summary judgment reversed; question remanded for fact-finding. |
| Whether confidentiality obligations destroyed public-use status of the trial. | Dey: confidentiality pledges and controlled access kept the use non-public. | Sunovion: lack of formal confidentiality for patients does not necessarily create public use; protections were sufficient. | Confidentiality concerns create triable issues; reversal and remand. |
| Whether the district court erred by treating the record as undisputed fact requiring remand or direct judgment. | Dey: undisputed facts show non-public use; no remand needed. | Sunovion: factual disputes exist about confidentiality and control; remand appropriate. | There are factual disputes; appellate reversal and remand appropriate. |
Key Cases Cited
- Invitrogen Corp. v. Biocrest Mfg., L.P., 424 F.3d 1374 (Fed. Cir. 2005) (public use analysis includes accessibility or commercial exploitation)
- Bernhardt, L.L.C. v. Collezione Europa USA, Inc., 386 F.3d 1371 (Fed. Cir. 2004) (confidentiality considerations affect public use)
- Allied Colloids Inc. v. Am. Cyanamid Co., 64 F.3d 1570 (Fed. Cir. 1995) (public use may occur when completed invention used in public without restriction)
- Eolas Techs. Inc. v. Microsoft Corp., 399 F.3d 1325 (Fed. Cir. 2005) (third-party use must be sufficiently public; secrecy negates public use)
- Baxter Int’l, Inc. v. COBE Labs., Inc., 88 F.3d 1054 (Fed. Cir. 1996) (public use when observers lacked confidentiality obligations to inventor)
- Konrad v. Bayer, 295 F.3d 1325 (Fed. Cir. 2002) (public possession of claimed features depends on disclosure to public)
- W.L. Gore & Assocs. v. Garlock, Inc., 721 F.2d 1540 (Fed. Cir. 1983) (public use requires public availability; secret uses do not invalidate)
- New Railhead Mfg., L.L.C. v. Vermeer Mfg. Co., 298 F.3d 1290 (Fed. Cir. 2002) (experimental-use context; public knowledge may not equal public use)
- Egbert v. Lippmann, 104 U.S. 333 (U.S. 1881) (public use cannot be avoided by indiscriminate sale or transfer without secrecy)