Aventis Pharma S.A. v. Hospira, Inc.
675 F.3d 1324
| Fed. Cir. | 2012Background
- Aventis sued Hospira and Apotex for infringement of the ’561 and ’512 patents related to docetaxel formulations (Taxotere).
- The district court held claim 5 of the ’561 patent and claim 7 of the ’512 patent invalid for obviousness; found infringement of claim 5; held both patents unenforceable for inequitable conduct.
- The patents aim to reduce anaphylactic reactions and alcohol intoxication by using surfactants other than Cremophor and by lowering ethanol content in perfusions/stock solutions.
- Claim 5 of the ’561 patent recites a perfusion with specific limits on ethanol and polysorbate and no anaphylactic/alcoholic manifestations.
- Claim 7 of the ’512 patent claims a composition with reduced ethanol, and, after correction, is argued to be obvious in light of prior art; the court addressed construction and obviousness.
- The appellate court affirms the district court’s constructions and holdings.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Construction of perfusion in claim 5 of the ’561 patent | Sanofi contends “perfusion” includes eight-hour stability | Hospira/Apotex argue perfusion has ordinary meaning without eight-hour limit | affirmed district court’s plain-meaning construction (no eight-hour limitation) |
| Meaning of “essentially free or free of ethanol” in claim 7 of the ’512 patent | Sanofi argued a narrow interpretation | District court correctly treated stock solutions as obvious; overlap with prior art | unnecessary to decide beyond stock-solution obviousness; claim 7 affirmed on obviousness grounds |
| Obviousness of claim 5 of the ’561 patent | N/A in brief; focus on construction | Prior art (GV and Vidal) renders claim 5 obvious | affirmed district court’s obviousness ruling |
| Inequitable conduct by withholding GV and Vidal references | Sanofi contends finding of intent was not the single most reasonable inference | Evidence supports intent to deceive PTO; good-cause amendments were proper | affirmed district court’s inequitable conduct ruling |
Key Cases Cited
- Therasense, Inc. v. Becton, Dickinson & Co., 649 F.3d 1276 (Fed. Cir. 2011) (clear, convincing standard; but-for materiality; no sliding scale for intent and materiality)
- Phillips v. AWH Corp., 415 F.3d 1303 (Fed. Cir. 2005) (claim terms interpreted by ordinary meaning in light of specification)
- KSR Int’l Co. v. Teleflex, Inc., 550 U.S. 398 (U.S. 2007) (obviousness standard; flexible approach to predictable variations)
- Liebel-Flarsheim Co. v. Medrad, Inc., 358 F.3d 898 (Fed. Cir. 2004) (extrinsic evidence can inform ordinary meaning of claim terms)
- Cybor Corp. v. FAS Techs., 138 F.3d 1448 (Fed. Cir. 1998) (claim construction is a question of law; de novo review)
- Eli Lilly & Co. v. Teva Pharms. USA, Inc., 619 F.3d 1329 (Fed. Cir. 2010) (clear error standard for factual findings in obviousness)
- Star Scientific, Inc. v. R.J. Reynolds Tobacco Co., 537 F.3d 1357 (Fed. Cir. 2008) (standard for evaluating intent in inequitable conduct)