Law School Case Brief
Rapid Litig. Mgmt. v. CellzDirect, Inc. - 827 F.3d 1042
The U.S. Supreme Court has articulated a two-part test for distinguishing patents that claim one of the patent-ineligible exceptions from those that claim patent-eligible applications of those concepts. Step one asks whether the claim is directed to one of the patent-ineligible concepts. If the answer is no, the inquiry is over: the claim falls within the ambit of 35 U.S.C.S. § 101. If the answer is yes, the inquiry moves to step two, which asks whether, considered both individually and as an ordered combination, the additional elements transform the nature of the claim into a patent-eligible application. At step two, more is required than well-understood, routine, conventional activity already engaged in by the scientific community, which fails to transform the claim into significantly more than a patent upon the ineligible concept itself.
Hepatocytes are a type of liver cell that have a number of attributes useful for testing, diagnostic, and treatment purposes. Certain factors, however, limit their use: fresh hepatocytes can only be obtained from liver resections or non-transplantable livers of organ donors, and their lifespan is short. Supply is thus erratic, making availability limited and unpredictable. Prior to the invention of the U.S. Patent No. 7,604,929 ('929 patent), scientists developed "cryopreservation" techniques to preserve hepatocytes for later use.
The prior art cryopreservation method had its problems, however; the cryo-process could damage the hepatocytes, leading to poor recovery numbers of viable cells. The inventors of the '929 patent discovered that some fraction of hepatocytes are capable of surviving multiple freeze-thaw cycles. The unexpected outcome was that cells twice frozen behaved like cells that were once frozen. Armed with this discovery, the inventors developed an improved process of preserving hepatocytes, claimed in the '929 patent. In general, the improved process comprises: (A) subjecting previously frozen and thawed cells to density gradient fractionation to separate viable cells from non-viable ones; (B) recovering the viable cells; and (C) refreezing the viable cells. The claims specify that the resulting hepatocyte preparation can be thawed and used immediately, exhibiting 70% viability after the second thaw.
Plaintiff Rapid Litigation Management Ltd., f/k/a Celsis Holdings, Inc./In Vitro Inc. (IVT) sued Defendants Cellzdirect, Inc. and its wholly-owned subsidiary, Invitrogen Corp. (LTC ) for infringing the '929 patent. In response, LTC filed a motion for summary judgment of invalidity. The district court rendered summary judgment in favor of LTC, determining that '929 patent is invalid under 35 U.S.C. § 10. The '929 patent is directed to a patent-ineligible law of nature—that hepatocytes are capable of surviving multiple freeze-thaw cycles—and that the patented process lacked the requisite inventive concept.
Was plaintiff IVT’s '929 patent invalid?
Because the '929 patent claims were not directed to a patent-ineligible concept, United States Court of Appeals for the Federal Circuit vacated and remanded the case for further proceedings. The Supreme Court had recently articulated a two-part test for distinguishing patents that claim one of the patent-ineligible exceptions from those that claim patent-eligible applications of those concepts. Step one asks whether the claim is "directed to one of the patent-ineligible concepts." If the answer is no, the inquiry is over: the claim falls within the ambit of § 101. If the answer is yes, the inquiry moves to step two, which asks whether, considered both individually and as an ordered combination, "the additional elements 'transform the nature of the claim' into a patent-eligible application." Step two is described "as a search for an 'inventive concept.’” At step two, more is required than "well-understood, routine, conventional activity already engaged in by the scientific community," which fails to transform the claim into "significantly more than a patent upon the" ineligible concept itself.
The '929 patent does not simply claim hepatocytes' ability to survive multiple freeze-thaw cycles. The '929 patent instead claims a "method of producing a desired preparation of multi-cryopreserved hepatocytes. This new and improved technique, for producing a tangible and useful result, falls squarely outside those categories of inventions that are "directed to" patent-ineligible concepts.
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