The Supreme Court’s Prometheus (2012) and Alice (2014) decisions, discussed in these pages here and here, erected a wall of patent ineligibility that has stymied efforts at patenting most diagnostic methods and many categories of computer-related inventions. While this wall of patent ineligibility is old news, it is noteworthy that the Federal Circuit has made and enlarged a hole in this wall through which some patent applications can now escape rejection.
The wall of patent ineligibility. In Prometheus and Alice, the Court eliminated from eligibility for patent protection any invention directed to what it said was an “implicit exception” in the patent laws. That exception excludes patents for a law of nature, a natural phenomenon, or an abstract idea. The Court said that an invention of this type would be ineligible for patenting unless the claims in the application for the invention were deemed to define an “inventive concept” that amounts to “significantly more” than the law of nature, natural phenomenon, or abstract idea to which the patent claims are said to be directed.
The Court’s stated rationale for the decisions was that claims directed too closely to one of these concepts would improperly monopolize “the basic tools of scientific and technological work” resulting in a “preemption” of the advance of science and technology Because the patent law already required patent claims to define a specific practical application of such a concept, the Court’s rationale makes little sense.
The Court has laid out a two-step process to determine whether the “implicit exception” to patent eligibility disqualifies claims in a patent application or a patent: (1) determine whether the patent claims are directed to a law of nature, natural phenomenon, or abstract idea, and (2) if so, determine whether those claims can escape ineligibility by defining an “inventive concept” that amounts to “significantly more” than the ineligible concept. Evaluating patent claims according to this two-step process is fraught with subjectivity.
The Federal Circuit fashions a hole in the wall. Although the Federal Circuit is bound by Supreme Court precedent, the parade of appeals since Alice has of necessity required the Federal Circuit to develop some rules for distinguishing between claims that are patent-eligible and claims that are not. Although the vast majority of decisions in this parade have affirmed ineligibility determinations, the Federal Circuit has decided a number of cases in favor of patent eligibility. DDR Holdings (2015, discussed here), Enfish (May, 2016, discussed here), and six more recent decisions point the way for at least some patent claims to get through the wall of patent ineligibility.
Rapid Litigation Management Ltd. v. CellzDirect, Inc. (July 2016) is the only one of these decisions that concerns the law-of-nature exception to patent eligibility. That case involved hepatocytes, which are a type of liver cell used for testing, diagnosis, and treatment. Before the invention in question, the hepatocyte cells were frozen in order to maintain them in inventory and, when needed, thawed for use. Because freezing damages these cells, it was thereafter necessary to determine which of the thawed cells remained viable. Refreezing the thawed cells was rejected as an option, owing to the damage inflicted by freezing the first time. The invention involved (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 were invalidated in the lower court. In step one of the two-step process, the trial court held that the claims were “directed to an ineligible law of nature: the discovery that hepatocytes are capable of surviving multiple freeze-thaw cycles.” At step two, the court determined that “the patented process lacks the requisite inventive concept,” observing that, upon discovering the cells’ capability of surviving multiple freeze-thaw cycles, the inventors simply “reapplied a well-understood freezing process.”
The Federal Circuit reversed, finding that the claims are not simply directed to the ability of hepatocytes to survive multiple freeze-thaw cycles. Rather, the claims are directed to “a new and useful laboratory technique for preserving hepatocytes. This type of constructive process, carried out by an artisan to achieve ‘a new and useful end,’ is precisely the type of claim that is eligible for patenting.”
In CellzDirect, the technological wrinkle—refreezing of cells thought not to be able to withstand refreezing—made the difference in achieving eligibility status. The different characterizations of this wrinkle by the Federal Circuit and the lower court highlight the subjective nature of the test that the Supreme Court now requires the lower courts to apply. More...
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