AstraZeneca UK Ltd. v. Aurobindo Pharma Ltd.
703 F.3d 511
| Fed. Cir. | 2012Background
- Hatch-Waxman patent litigation over Crestor rosuvastatin under 21 U.S.C. § 355/j; ANDA challengers seek to invalidate the '314 reissue and its parent '440 patent.
- Plaintiffs Shionogi and AstraZeneca hold the rosuvastatin-related patents; Defendants include Aurobindo, Mylan, Apotex, Cobalt entities, Sun, Teva, Par, Sandoz.
- District Court held the '314 patent valid, enforceable, and infringed; all defendants conceded infringement except Apotex Corp.
- The case involves validity challenges on obviousness and inequitable conduct regarding the '314/ '440 patents, and a reissue controversy under 35 U.S.C. § 251.
- The district court also addressed whether Apotex U.S. is liable as the ANDA “submitter” under § 271(e)(2)(A) for infringement.
- Concurrence discusses Apotex U.S.’s liability as submitter and the scope of “submit” under § 271(e)(2).
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Obviousness of rosuvastatin | Pfizer argues prior art teaches lead compound lb making rosuvastatin obvious | Defendants contend motivation to combine and predictable path to rosuvastatin | Not obvious; district court correct; lack of motivation and unexpected results |
| Inequitable conduct | Therasense standard shows intentional concealment | No clear and convincing evidence of intent to deceive PTO | Not proven; no reversible abuse of discretion |
| Reissue validity | Reissue properly corrected an error and narrowed claims | Reissue constitutes improper correction of deliberate overlap with Sandoz | Valid reissue; error and intent not shown to render invalid |
| Infringement and Apotex U.S. liability | Apotex U.S. liable as submitter under § 271(e)(2)(A) through signing/filing the ANDA | Apotex U.S. merely an agent; not liable | Apotex U.S. liable as submitter; district court affirmed infringement against all defendants |
| Scope of submitter liability (agency/intent) | Linked entity with intent to benefit from ANDA sale should be liable | Agency framework limits liability to principal submitter only | Liability extended where submitter intends to benefit from ANDA approval; court adopted broader standard |
Key Cases Cited
- Pfizer, Inc. v. Apotex, Inc., 480 F.3d 1348 (Fed. Cir. 2007) (burden of proving obviousness and expectation of success in patent validity)
- Therasense, Inc. v. Becton, Dickinson and Co., 649 F.3d 1276 (Fed. Cir. 2011) (clear and convincing standard for inequitable conduct; materiality and intent separate)
- In re Serenkin, 479 F.3d 1359 (Fed. Cir. 2007) (reissue requires error without deceptive intent; deliberate actions outside § 251 scope)
- In re Youman, 679 F.3d 1335 (Fed. Cir. 2012) (reissue requires inadvertent error; not every defect qualifies as correctible error)
- Hewlett-Packard Co. v. Bausch & Lomb, Inc., 882 F.2d 1556 (Fed. Cir. 1989) (reissue requires inadvertence or mistake; deliberate overlap cannot justify)
- Kingsdown Med. Consultants, Ltd. v. Hollister Inc., 863 F.2d 867 (Fed. Cir. 1988) (gross negligence alone does not prove deceit in inequitable conduct)
- Tanaka (In re Tanaka), 640 F.3d 1246 (Fed. Cir. 2011) (limits of reissue when broad genus claims and narrow dependent claims; proper remediation)
- Gen. Radio Co. v. Allen B. Du Mont Labs., Inc., 129 F.2d 608 (3d Cir. 1942) (diligence in seeking reissue; delay can bar reissue)