Abraxis Bioscience, Inc. v. NAVINTA LLC
625 F.3d 1359
| Fed. Cir. | 2010Background
- Abraxis markets Naropin® with ropivacaine; patents '086, '524, and '489 relate to ropivacaine use at low concentrations for treating pain.
- Assets, patents, and title were transferred via a 2006 Asset Purchase Agreement (APA) between AstraZeneca UK and Abraxis, with a June 28, 2006 closing date.
- Intellectual Property Assignment Agreement (IPAA) in 2006 purported to assign the asserted patents to Abraxis, but title remained with Astra L and AZ-AB at the time.
- Navinta filed an ANDA for generic Naropin® in 2006; Abraxis sued Navinta and asserted infringement under multiple patents.
- Abraxis sought to rely on nunc pro tunc and later assignments to cure lack of standing; district court held Abraxis lacked standing at filing.
- A seven-day bench trial occurred in 2009; district court found infringement theories and set a future effective date for Navinta’s approval, contingent on patent expirations.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Did Abraxis have standing at filing? | Abraxis owned the asserted patents on filing date. | Title remained with Astra entities; no standing. | Abraxis lacked standing; dismissal required. |
| Can reparative assignments cure standing after filing? | March 15, 2007 and November 12, 2007 assignments retroactively cured standing. | Retroactive assignments cannot cure lack of standing at filing. | Retroactive assignments cannot cure pre-filing lack of standing. |
| Does New York law permit retroactive transfer to confer standing? | The APA and related documents evidenced intent to transfer as of Closing Date. | Standing requires present title at filing; retroactivity cannot defeat initial defect. | New York law supports transfer as of Closing Date; standing failed nonetheless due to pre-filing defect. |
| Does Enzo or other 'promise to assign' precedent apply to this case? | Pre-suit agreements can retroactively confer rights via later documents. | Retroactive cures do not fix lack of standing at filing; Enzo does not apply. | Enzo and related cases do not salvage standing; holding upheld. |
| If standing is lacking, can the merits be reviewed? | Merits may be reviewed if standing route is cured. | Without standing, merits review is improper. | Merits not reviewable; case remanded to dismiss without prejudice. |
Key Cases Cited
- Speedplay, Inc. v. Bebop, Inc., 211 F.3d 1245 (Fed. Cir. 2000) (contractual rights and retroactivity in patent assignments)
- Bd. of Trs. of Leland Stanford Junior Univ. v. Roche Molecular Sys., Inc., 583 F.3d 832 (Fed. Cir. 2009) (promise to assign vs. present assignment in patent transfers)
- Arachnid, Inc. v. Merit Indus., Inc., 939 F.2d 1574 (Fed. Cir. 1991) (right to sue for past infringement must be express)
- Enzo APA & Son, Inc. v. Geapag A.G., 134 F.3d 1090 (Fed. Cir. 1998) (nunc pro tunc assignments not sufficient to confer retroactive standing)
- Gaia Techs., Inc. v. Reconversion Techs., Inc., 93 F.3d 774 (Fed. Cir. 1996) (standing and ownership in patent transfer context; title importance)
- Keene Corp. v. United States, 508 U.S. 200 (U.S. 1993) (standing and jurisdictional fundamentals in actions)
- Paradise Creations, Inc. v. UV Sales, Inc., 315 F.3d 1304 (Fed. Cir. 2003) (standing and ownership principles in patent actions)