The Federal Circuit vacated a summary judgment of invalidity under 35 U.S.C. § 101 after disagreeing with a district court that claims of U.S. Patent No. 7,604,929 were “directed to a patent-ineligible law of nature–that hepatocytes [liver cells] are capable of surviving multiple freeze-thaw cycles–and that the patented process lacks the requisite inventive concept.” Rapid Litigation Management, Ltd. V. Cellzdirect, Inc., No. 2015-1570 (Fed. Cir. July 5, 2016). Reading this case for broader lessons on Section 101 validity – as I read all cases that implement the Mayo/Alice patent-eligibility test – the main lesson to be drawn here is that outcomes under Section 101 remain highly situational. Patent-eligibility determinations, even more than other questions of patent law, frustratingly depend on the context of the litigation, specific words that may or may not be included in a patent claim, and, let’s be honest, the particular judge or judges hearing the case.
Here, in an opinion authored by Chief Judge Prost and joined by Judges Moore and Stoll, the Federal Circuit concluded that the present claims were “simply not directed to the ability of hepatocytes to survive multiple freeze-thaw cycles.” The court explained that
[t]he end result of the ‘929 patent claims is not simply an observation or detection of the ability of hepatocytes to survive multiple freeze-thaw cycles. Rather, the claims are directed to a new and useful method of preserving hepatocyte cells. Indeed, the claims recite a “method of producing a desired preparation of multi-cryopreserved hepatocytes.” ‘929 patent col. 19 l. 56-col. 20 l. 20 (emphasis added). Through the recited steps, the patented invention achieves a better way of preserving hepatocytes. The ‘929 patent claims are like thousands of others that recite processes to achieve a desired outcome, e.g., methods of producing things, or methods of treating disease. That one way of describing the process is to describe the natural ability of the subject matter to undergo the process does not make the claim “directed to” that natural ability.
The claims here were distinguishable from claims invalidated in Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013) and Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1373-74 (Fed. Cir. 2015), cert. denied, No. 15-1182 (June 27, 2016). Claims in those cases included method steps but ultimately were directed to unpatentable end results, in contrast to the claims here, which were directed to “new and vastly useful” method steps.
The court ended by addressing that “the crux of [the accused infringer’s] argument seems to be that, once it was discovered that hepatocytes could survive multiple freeze-thaw cycles, it would have been a simple task to repeat the known freeze-thaw process to arrive at the claimed invention.” This argument carried no weight because “patent-eligibility does not turn on ease of execution or obviousness of application.” Moreover, “while pre-emption is not the test for determining pa-tent-eligibility,” the claims here did not “lock up the natural law in its entirety.”
And yet, in so many decisions – and in examination at the USPTO – it seems that patent-eligibility does turn on distinguishability from the prior art, and concern about the breadth of claims. Having only a lay understanding of the claims in this case, I offer no view on either the novelty or breadth of the claims. But click on the above link and read claim 1 of the ’929 patent, and think about whether you could have predicted the outcome of this case – at either the district court or the Federal Circuit – from the patent alone.