PharmaStem Therapeutics, Inc. v. Viacell, Inc. (Fed. Cir. 2007)
PharmaStem sued six defendants for infringement of its broadly written patents covering cryopreserved umbilical cord stem cells useful for hematopoietic reconstitution. The defendants offer cryopreservation of umbilical cord blood to serve the donor later in life. A jury found infringement and validity, but the district court set aside the verdict — holding that the patents were not infringed.
Defendant’s Ads Not Specific Enough: The defendants advertised that their product would aid in hematopoietic reconstitution. However, the district court found (and the CAFC agreed) that the ads were insufficient to serve as an admission that the stem cells were "in an amount sufficient to effect hematopoietic reconstitution of a human adult" as required by the claims. This decision stands to reinforce the principle that a patentee must prove infringement of every limitation of every element of any asserted claim.
Infringe the Whole Claim: PharmaStem’s method claims include collecting, preserving, and using the stem cells . The defendants, however, are only responsible for collecting and preserving the cells. Transplant physicians do the rest.
PharmaStem argued contributory infringement under 271(c) — alleging that the defendants sold or offered to sell a component of a patented method especially adapted for infringement. Of course, the defendants do not sell stem cell blood — rather they are “merely bailees”. Because 271(c) requires sale of a product, there is no infringement here.
Invention is Obvious: When asserting obviousness based on a combination of prior art references, the patent challenger must show that a PHOSITA “ would have had reason to attempt to … carry out the claimed process, and  would have had a reasonable expectation of success in doing so.”
Reason to attempt:
In view of the prior art references, the first part of that test is plainly satisfied here. The idea of using cryopreserved cord blood to effect hematopoietic reconstitution was not new at the time [of filing]. Two of the prior art references…suggest using cord blood for that purpose. Two others…suggest cryopreservation and storage of the cord blood until needed. Accordingly, this is not a case in which there is any serious question whether there was a suggestion or motivation to devise the patented composition or process.
Expectation of Success: The inventors appear to have conclusively proven that umbilical cord blood is capable of hematopoietic reconstitution. Unfortunately for them, completing a proof is not necessarily inventive. Rather, prior scientists strong suspicion of the capability creates an expectation of success so strong that “no reasonable jury” could find the patent valid.
While the inventors may have proved conclusively what was strongly suspected before—that umbilical cord blood is capable of hematopoietic reconstitution—and while their work may have significantly advanced the state of the science of hematopoietic transplantations by eliminating any doubt as to the presence of stem cells in cord blood, the mouse experiments and the conclusions drawn from them were not inventive in nature. Instead, the inventors merely used routine research methods to prove what was already believed to be the case. Scientific confirmation of what was already believed to be true may be a valuable contribution, but it does not give rise to a patentable invention.
Holding: Patent is invalid and not infringed.
[More to come on this case]