Intellectual Property > IP Newsflash > Patent Directed to Liver Cell Preservation Valid Under Section 101
08 Jul '16

The Federal Circuit vacated and remanded a district court’s summary judgment determination that U.S. Patent No. 7,604,929 (“’929 patent”) is invalid under 35 U.S.C. § 101. The district court determined that the ’929 patent is directed to a patent-ineligible law of nature. The patent claims a process of preserving hepatocytes, a liver cell that can be used for testing, diagnostic, and treatment purposes. The district court concluded the patent claimed an ineligible law of nature: that hepatocytes are capable of surviving multiple freeze-thaw cycles. The district court also determined that the patented process lacks the requisite inventive concept and instead simply applied a well-understood freezing process.

The Federal Circuit, however, determined the invention was patent eligible under Section 101.  Applying the Supreme Court’s two-step process, the Court decided the claims of the ’929 patent are “directed to new and useful laboratory technique for preserving hepatocytes,” and not just an observation of the ability of hepatocytes to survive multiple freeze-thaw cycles. The inventors did discover the cells’ ability to survive multiple freeze-thaw cycles, but their patent went beyond that discovery to claim a new and improved way of preserving hepatocyte cells for later use. 

Moreover, even though the Court determined the patent was not “directed to” patent ineligible subject matter, it still proceeded to step two of the analysis. The Court concluded that the claims of the ’929 patent, even if they were directed to a law of nature, would still be valid because the claims recite an improved process for preserving hepatocytes. The Court specifically stated that the individual steps of freezing and thawing as claimed were well known, but the process of repeating these steps for preserving liver cells “was itself far from routine and conventional,” particularly in view of the fact that the prior art taught away from multiple freezings.  The Court therefore vacated the grant of summary judgment and remanded the case for further proceedings.

Rapid Litigation Management LTD. v. Cellzdirect, Inc., No. 2015-1570 (Fed. Cir. July 5, 2016).