549 F. App'x 934
Fed. Cir.2013Background
- Appellants Teva and Par seek generic Lovaza approval; district court found infringement, no invalidity under 35 U.S.C. §103 or §102(b), and no inequitable conduct; verdict and judgment entered for Pronova; on appeal, public-use §102(b) issue central; district court’s handling of prior uses scrutinized; Norsk Hydro shipped K-80/K-85 samples to Skrinska with no confidentiality restrictions; the shipments disclosed formulation via certificates of analysis; Skrinska tested samples and disclosed information to others; the ’077 patent expired, rendering some issues moot; court ultimately reverses on §102(b) and remands for judgment in Appellants’ favor; analysis focuses on whether the sampling and testing constitutes invalidating public use; court agrees Norsk Hydro’s action created public access to the invention before the critical date; other issues (obviousness, inequitable conduct, unenforceability) deemed moot.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether Norsk Hydro’s shipment of samples to Skrinska was a public use under §102(b) | Pronova argues no invalidating use since disclosures lacked completeness or secrecy restrictions | Teva/Par contend testing and unrestricted disclosure constitutes public use | Yes; the shipment and testing disclosed all claimed aspects without secrecy, constituting invalidating public use |
| What constitutes public access under §102(b) in this context | Pronova claims limited disclosures or confidentiality would preclude public use | Appellants argue lack of confidentiality does not negate public use when testing occurs | Public access occurred due to unrestricted, full disclosure to a skilled researcher capable of further disclosure |
| Scope of disclosure required for a finding of public use | Pronova asserts not all aspects were disclosed in the shipments | Teva/Par assert full formulation disclosed via certificate of analysis and testing | All aspects of the claimed invention were disclosed; disclosure to Skrinska sufficed for public use |
| Whether the other alleged pre-critical-date uses (Peterson, Davis, Nordøy) affect §102(b) analysis | Pronova argues those uses were not actual uses by others for the invention | Appellants contend these were commercial or experimental uses influencing public use | Not necessary to determine after §102(b) finding; moot for §667 patent due to invalidating public use finding |
| Whether any issues regarding the ’077 patent are moot | Pronova seeks relief under Drug Price Act; no need if patent expired | Expiration moots issues | Moot; no further consideration needed |
Key Cases Cited
- In Invitrogen Corp. v. Biocrest Mfg., L.P., 424 F.3d 1374 (Fed. Cir. 2005) (public use includes accessible or commercially exploited uses; considers experiments and secrecy factors)
- Lough v. Brunswick Corp., 86 F.3d 1113 (Fed. Cir. 1996) (invalidating public use where inventor loses control over disclosed invention)
- Beachcombers, Int’l, Inc. v. Wildewood Creative Products, Inc., 31 F.3d 1154 (Fed. Cir. 1994) (public demonstration can invalidate if detailed and unconfined)
- Dey, L.P. v. Sunovion Pharm., Inc., 715 F.3d 1351 (Fed. Cir. 2013) (public use depends on confidentiality and disclosure scope)
- Motionless Keyboard Co. v. Microsoft Corp., 486 F.3d 1376 (Fed. Cir. 2007) (public use requires full disclosure of claimed invention or lack of NDA protections)
- Netscape Commc’ns Corp. v. Konrad, 295 F.3d 1315 (Fed. Cir. 2002) (public use requires accessibility or commercial exploitation with proper control)
- Eolas Technologies Inc. v. Microsoft Corp., 399 F.3d 1325 (Fed. Cir. 2005) (demonstration to educated observers without NDA can be public use)
- Pfaff v. Wells Electronics, Inc., 525 U.S. 55 (Supreme Court 1998) (two ways to satisfy ready-for-patenting: reduction to practice or enabling disclosures)
- W.L. Gore & Assocs., Inc. v. Garlock, Inc., 721 F.2d 1540 (Fed. Cir. 1983) (extent of disclosure required to trigger public use; disclosures must reveal process)