On July 5, 2016, the Federal Circuit vacated and remanded a district court decision holding that U.S. Patent No. 7,604,929, which is directed to a method of cryopreservation of hepatocytes (liver cells) was invalid under 35 U.S.C. § 101 because it was directed to a patent-ineligible concept.  In reaching its decision, the Court distinguished recent cases addressing patent eligibility in the biotechnology industry.  The opinion emphasizes that method claims implicating a law of nature are not necessarily patent ineligible, so long as the method is directed to a “new and useful laboratory technique.”

The claims at issue are generally directed to a method of cryopreservation of hepatocytes that would enable the hepatocytes to withstand multiple rounds of freezing and thawing. The prior art generally taught that, once cryopreservation was performed once on hepatocytes, the cells would not remain viable for further testing if frozen a second time.  The claimed method reportedly preserves the viability of the hepatocytes so that they can be refrozen and studied on a second occasion.

The district court invalidated the patent claims under both prongs of the Supreme Court’s patent eligibility framework set forth in Alice Corp. v. CLS Bank Int’l.  Under that test, the district court found that the claims were directed to a patent-ineligible law of nature (“the discovery that hepatocytes are capable of surviving multiple freeze-thaw cycles”).  The district court also held that the claims lacked an inventive concept because the claims were directed to the “reappli[cation of] a well-understood freezing process.”  The Federal Circuit found error with the district court’s first conclusion, stating, “[T]he claims are simply not directed to the ability of hepatocytes to survive multiple freeze-thaw cycles.  Rather, the claims of the ’929 patent are directed to a new and useful laboratory technique for preserving hepatocytes.”  (emphasis added).  Although there was a new discovery related to the ability of hepatocytes to survive multiple freeze-thaw cycles, the Court emphasized that “that is not where [the inventors] stopped, nor is it what they patented.”

This decision follows the Supreme Court’s recent decision not to grant a petition for certiorari to review the Federal Circuit’s holding in the Sequenom case that claims directed to a cell‑free fetal DNA diagnostic method were invalid under 35 U.S.C. § 101.  The Court, in its recent decision, differentiated the claimed method from that of Sequenom and other recent cases decided under 35 U.S.C. § 101, noting that the “end result” and “essence” of the claimed methods in those cases were directed to patent-ineligible concepts.  The Court emphasized that the claims at issue here were directed to a “method of producing” a preparation of hepatocytes, and that “the natural ability of the subject matter to undergo the process does not make the claim ‘directed to’ that natural ability.”  Finally, the Court explained that this case differs because the art taught that cryopreservation steps could only be performed once the cellular viability was compromised, and the claimed process was directed to repetition of cryopreservation steps.  In essence, a new step was added, and there was not a mere application of known prior art steps to a newly-discovered natural law.