Although it is not yet a bright line, the Federal Circuit has considerably decreased the fuzziness of the distinction between patent-eligible and patent-ineligible inventions, at least where the exception to 35 U.S.C. § 101 is a law of nature. In Rapid Litigation Management Ltd. v. Cellzdirect, Inc., Appeal No. 2015-1570 (Fed. Cir. July 5, 2016), the Federal Circuit reversed the district court’s holding of invalidity under § 101, ruling that the district court erred in applying both step 1 and step 2 of the Supreme Court’s framework for determining patent eligibility. See Alice Corp. v. CLS Bank Int’l, 134 S. Ct. 2347, 2355 (2014).
The district court held that the patent in suit is directed to a law of nature—that hepatocytes, a type of liver cell, are capable of surviving multiple freeze-thaw cycles—and that the patented process lacks the requisite inventive concept. Hepatocytes have a number of uses, such as for investigating how drugs may be metabolized by the liver or measuring a drug’s effect on liver biology, but their availability is limited and their life span is short. The prior art disclosed freezing hepatocytes (“cryopreservation”), thawing them when needed, and recovering the viable cells using density gradient fractionation, but persons of ordinary skill in the art understood that that process could damage the cells and lead to poor recoveries of viable cells. Moreover, pooled samples from multiple donors, desirable to create a collection of cells approximating average liver cells, could be created only by accumulating and freezing cells from single donors and then thawing and combining them for immediate use. Those skilled in the art believed that cryopreservation could be employed only once, and cryopreservation could damage cells, which severely limited the creation of pooled cells.
The inventors’ discovery was a law of nature: that a fraction of hepatocytes can survive multiple freeze-thaw cycles. Based on that discovery, the inventors claimed a method of producing a collection of hepatocytes by subjecting previously frozen and thawed cells to fractionation to separate and recover viable cells, and refreezing the viable cells, which, after being thawed again, exhibit 70 percent viability. Thus, claim 1 recites: Continue Reading