Patents Arising From Confirmation of Suspected Presence of Stem Cells in Umbilical Cord Blood Were Invalid Due to Obviousness

Case: Pharmastem Therapeutics, Inc. v. Viacell, Inc. (Fed. Cir. No. 05-1490, 05-1551, 7/9/07)

The One Sentence Summary: Patents for the treatment of patients using cryogenically preserved umbilical cord stem cells were not infringed, and were invalid due to obviousness where the inventors merely confirmed the suspected presence of stem cells in umbilical cord blood through routine experiments.


What They Were Fighting About: Plaintiff obtained jury verdicts against defendants for infringement of patents regarding the use of cryogenically preserved umbilical cord stem cells for patients with compromised immune systems. Despite the jury's verdicts for plaintiff, the district court entered judgment as a matter of law ("JMOL") for defendants, holding that there was no infringement.

Federal Circuit Holdings:

• The district court properly granted JMOL against plaintiff when plaintiff failed to produce evidence that defendants' cryogenically preserved umbilical cord blood cells contained enough cells in an "amount sufficient to effect hematopoietic reconstitution of a human adult" as provided in the claims.
• The district court properly ruled on JMOL that a molecular biology expert should not have been allowed to testify when she only drew conclusions from defendants' marketing materials.
• The district court properly granted JMOL for defendants on contributory infringement of the method claims which called for cryogenically preserving blood and using it in transplants. The defendants which stored the blood did not do the transplanting, so there was no direct infringement. Moreover, defendants did not own the preserved blood; rather, they held it as bailees for the families. Thus, in providing the blood to the doctors for transplanting, the defendants did not make a sale of a product used for an infringing process under 35 U.S.C. § 271(c). Sale of a service cannot be the basis of liability under section 271(c).
  
• The patents were invalid due to obviousness. The admissions of the inventors in the specifications were binding as to what was in the prior art before, and their attempts to recharacterize the prior art at trial should have been rejected.
• Citing the Supreme Court's opinion in KSR, the panel held that the routine experiments conducted by the inventors to confirm the suspected presence of stem cells in umbilical cords was valuable, but did not give rise to a patentable invention.
• Deference to the patent examiner's decision to grant the patents on reexamination did not preclude the court's holding on invalidity due to obviousness where the examiner's reasons for granting the patent were incorrect.