Celsis in Vitro, Inc. v. CellzDirect, Inc.
664 F.3d 922, 2012 WL 34381 (2012)
Premium Feature
Subscribe to Lexplug to listen to the Case Podcast.
Rule of Law:
A patented method combining known elements is not necessarily obvious if the prior art taught away from the combination, especially in an unpredictable field where a person of ordinary skill in the art would not have had a reasonable expectation of success.
Facts:
- Hepatocytes, a type of liver cell, are critical for laboratory drug testing but have a short lifespan and are available only unpredictably from liver donations.
- Researchers needed a consistent supply of hepatocytes and a method to pool cells from multiple donors to ensure representative test results, but long-term storage was a major obstacle.
- Cryopreservation (freezing) was a known technique, but it was understood to be highly damaging to fragile hepatocytes, leading to a general belief and teaching in the scientific community that a single freeze-thaw cycle was the limit.
- Celsis In Vitro, Inc. developed a method involving freezing and thawing hepatocytes twice (multi-cryopreservation) that resulted in a high viability rate of over 70% of the cells.
- Celsis commercialized this method through its LiverPool™ products, which solved the problems of supply and pooling.
- CellzDirect, Inc. and its parent company, Life Technologies Corporation (LTC), began selling their own pooled, multi-cryopreserved hepatocyte products.
- Celsis developed its method and obtained U.S. Patent No. 7,604,929 covering the process of multi-cryopreservation.
Procedural Posture:
- Celsis In Vitro, Inc. sued CellzDirect, Inc. and Invitrogen Corporation (LTC) for patent infringement in the U.S. District Court for the Northern District of Illinois (a federal trial court).
- Celsis filed a motion for a preliminary injunction to prevent LTC from continuing its allegedly infringing activities during the lawsuit.
- Following a five-day evidentiary hearing, the district court granted Celsis's motion for a preliminary injunction.
- LTC's subsequent motion for a stay of the injunction pending appeal was denied by the district court.
- LTC, as the appellant, appealed the district court's order granting the preliminary injunction to the U.S. Court of Appeals for the Federal Circuit, with Celsis as the appellee.
Premium Content
Subscribe to Lexplug to view the complete brief
You're viewing a preview with Rule of Law, Facts, and Procedural Posture
Issue:
Did the district court abuse its discretion in granting a preliminary injunction by finding that the patent for a method of multiply cryopreserving hepatocytes was likely not invalid for obviousness, where the prior art suggested that repeated freezing would destroy the cells?
Opinions:
Majority - Rader, C.J.
No. The district court did not abuse its discretion in granting the preliminary injunction because Celsis demonstrated a likelihood of success on the merits, including showing that its patent was not invalid for obviousness. The court reasoned that the art of hepatocyte cryopreservation was highly unpredictable, and the prior art actively taught away from multi-cryopreservation, as a person of ordinary skill would have expected a second freeze-thaw cycle to destroy the cells, not preserve them. The court deferred to the district court's credibility determinations disfavoring LTC's experts, whose arguments were based on impermissible hindsight. The majority also affirmed the findings of irreparable harm (price erosion, loss of goodwill), that the balance of harms favored Celsis, and that the public interest in enforcing valid patents supported the injunction.
Dissenting - Gajarsa, J.
Yes. The district court legally erred and abused its discretion by granting the injunction because LTC raised a substantial question as to the patent's validity. The claimed invention is merely a combination of two known techniques (cryopreservation and density gradient fractionation) that are repeated to achieve a desired, albeit predictable, result of high cell viability. The majority's analysis improperly reverts to the rigid teaching-suggestion-motivation test rejected by the Supreme Court in KSR v. Teleflex, ignoring that market need made it obvious to try combining these known elements. Furthermore, the district court applied the wrong legal standard by effectively requiring LTC to prove invalidity by clear and convincing evidence, when it only needed to show the patent's vulnerability to raise a substantial question.
Analysis:
This case illustrates the significant weight given to evidence of 'teaching away' in the prior art when assessing obviousness under 35 U.S.C. § 103, particularly in unpredictable arts like biotechnology. The decision reinforces that a combination of known elements can be patentable if the combination yields surprising and unexpected results that contradict the prevailing expert opinion at the time. The dissent highlights the ongoing tension in patent law post-KSR regarding how to apply the obviousness standard to combination patents without resorting to either the old rigid tests or impermissible hindsight.
