Celsis in Vitro, Inc. v. CellzDirect, Inc.
664 F.3d 922
| Fed. Cir. | 2012Background
- Celsis owns the '929 patent covering multi-cryopreserved hepatocytes and alleged LTC infringement through a pooled LiverPool process.
- District court granted a preliminary injunction after a 5‑day evidentiary hearing; LTC sought a stay pending appeal.
- Claim 1/10 require thawing, density gradient fractionation, recovery, and re-cryopreservation without a second density gradient, with >70% viability after final thaw.
- The district court construed density gradient fractionation to mean a gradient-based separation; LTC argued the accused process used a non-gradient medium, but the court rejected this reading.
- The court found likelihood of success on infringement, irreparable harm to Celsis, substantial balance of hardships, and public interest favoring enforcement of the patent; the injunction issued.
- LTC challenged only the infringement and non-obviousness rulings on appeal; the panel affirmed the injunction.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Infringement: does accused process infringe the '929 claims? | Celsis argues it meets all claim steps, including density gradient fractionation. | LTC asserts non-infringement due to a reading of 'without requiring' as prohibiting density gradient in step C. | Yes, likelihood of infringement; the district court did not err in its claim construction. |
| Non-obviousness: is the claimed multi-cryopreservation obvious? | The prior art lacked multi-cryopreservation; the district court properly weighed credibility and evidence. | The combination of known steps with the market need renders the invention obvious under KSR. | District court did not clearly err; record supports non-obviousness at the preliminary stage. |
| Irreparable harm and public interest: are these factors satisfied? | Celsis will suffer price erosion, loss of goodwill, and lost opportunities; these are irreparable. | LTC's harms are recoverable by damages; balance of hardships weighs against injunction. | Irreparable harm and public interest favor injunction; balance of hardships favors Celsis. |
| Bond and scope adjustments: are the injunction’s scope and bond appropriate? | District court’s bond and scope rulings affirmed; no error shown. |
Key Cases Cited
- Abbott Labs. v. Sandoz, Inc., 544 F.3d 1341 (Fed.Cir. 2008) (irreparable harm and balance of harms supported injunctions; patent incentives importance)
- Sanofi-Synthelabo v. Apotex, Inc., 470 F.3d 1368 (Fed.Cir. 2006) (public interest in patent protection; irreparable harm considerations)
- KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (S. Ct. 2007) (flexible, common-sense approach to obviousness; rejects rigid TSM test)
- Amazon.com, Inc. v. Barnes & Noble.com, Inc., 239 F.3d 1341 (Fed.Cir. 2001) (vulnerability standard at preliminary injunction stage; burden shifting nuances)
- Titan Tire Corp. v. Case New Holland, Inc., 566 F.3d 1372 (Fed.Cir. 2009) (burden on challenger to show likelihood of invalidity; consideration of trial burden at injunction stage)