Rapid Litig. Mgmt. v. Cellzdirect, Inc., No. 15-1570 (Fed. Cir. 2016)
Annotate this CaseHepatocytes, a type of liver cell, are useful for testing, diagnostic, and treatment purposes. Fresh hepatocytes can only be obtained from liver resections or non-transplantable livers of organ donors; their lifespan is short. Supply is erratic. Before the 929 patent, scientists developed “cryopreservation” techniques, but the process could damage the hepatocytes and was unsuitable for multi-donor hepatocyte pools. Prevailing wisdom was that hepatocytes could be frozen only once before being used or discarded. The 929 parent's inventors discovered that some hepatocytes can survive multiple freeze-thaw cycles and developed an improved process: subjecting thawed cells to density gradient fractionation to separate viable from non-viable cells; recovering the viable cells; and refreezing the viable cells. After refreezing only the viable cells, the preserved hepatocyte preparations can be thawed and used later without unacceptable loss of viability. Hepatocyte samples from single donors can be pooled into a composite preparation that can be refrozen for later use. In an infringement suit, the court found the patent invalid under 35 U.S.C. 101, as directed to a patent-ineligible law of nature—that hepatocytes can survive multiple freeze-thaw cycles—and that the patented process lacks the requisite inventive concept. The Federal Circuit vacated. That each of the individual steps (freezing, thawing, and separating) were known independently in the art does not make the claim unpatentable; patent-eligibility does not turn on ease of execution or obviousness of application.
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