Rapid Litigation Management Ltd. v. CellzDirect, Inc.
827 F.3d 1042 (Fed. Cir. 2016)
Authored by Gesué Staltari
Statement of Facts: Plaintiffs-Appellants Rapid Litigation Management Ltd. and In Vitro, Inc., (collectively, “IVT”) hold U.S. Patent No. 7,604,929 (“the ‘929 Patent”), which outlines a method of hepatocyte cryopreservation. Hepatocytes are a type of liver cell that is useful for a variety of testing and medical purposes. They also have short lifespans. As a result, researchers often freeze the cells to preserve them. This damages or renders useless many of the cells, leading researchers to believe that they could freeze and thaw the cells only once before using or discarding them. The inventors of the ‘929 Patent, however, found that some hepatocytes could survive multiple freeze-thaw cycles and still be viable for testing and medical purposes. The ‘929 Patent describes a method of collecting these resilient hepatocytes by subjecting a pool of previously frozen and thawed hepatocytes from multiple donors to density gradient fractionation—which separates viable from non-viable hepatocytes—and then refreezing the viable cells. This process yields a much higher proportion of viable hepatocytes after the second thaw, allowing researchers to more easily prepare and pool samples from multiple donors.
Procedural History: IVT sued Defendants-Appellees CellzDirect, Inc. and Invitrogen Corporation (collectively, “LTC”) for infringing the ‘929 Patent. LTC filed a motion for summary judgment of invalidity under 35 U.S.C. §§ 101 and 112. The United States District Court for the Northern District of Illinois applied the Supreme Court’s two-step framework for determining invalidity under § 101, set forth in Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1294 (2012), finding that the ‘929 Patent was (1) “directed to an ineligible law of nature: [that] hepatocytes are capable of surviving multiple freeze-thaw cycles” and (2) that “the patented process lack[ed] the requisite inventive concept.” Celsis In Vitro, Inc. v. CellzDirect, Inc., 83 F. Supp. 3d 774, 784-85 (N.D. Ill. 2015). Accordingly, the District Court granted LTC’s motion and dismissed the case with prejudice. IVT appealed to the Federal Circuit.
Question Presented: Whether the ‘929 Patent claims are directed to a patent-ineligible concept under 35 U.S.C. § 101.
Holding: The ‘929 Patent claims are not directed to a patent-ineligible concept and, even if they were, they improved an existing technological process sufficiently to transform the process into an inventive patent-eligible application of the concept. Therefore, the Federal Circuit vacated the District Court’s judgment and remanded the case.
Reasoning: The Federal Circuit applied the two-part Mayo test to the ‘929 Patent de novo. The Mayo test gives meaning to an important exception to 35 U.S.C. § 101—which provides the statutory basis for patenting new processes, machines, and improvements—namely, that “laws of nature, natural phenomena, and abstract ideas are not patentable.” Alice Corp. v. CLS Bank Int’l, 134 S. Ct. 2347, 2354 (2014). The first prong of the Mayo test asks whether the patent claims are “directed to [a] patent-ineligible concept.” Mayo, 132 S. Ct. at 1294, 1296-97. If the answer is yes, the inquiry advances to step two, which asks whether the patent is sufficiently inventive to “transform the nature of the claim into a patent-eligible application.” Alice Corp, 134 S. Ct. at 2354 (internal quotations omitted). This requires more than “well-understood, routine, conventional activity already engaged in by the scientific community.” Mayo, 132 S. Ct. at 1294.
At step one, the Federal Circuit found that the ‘929 Patent was not directed to a patent-ineligible concept. In so finding, the court noted that the ‘929 Patent was directed not to the ability of hepatocytes to survive multiple freeze-thaw cycles, as the District Court had found, but to a new laboratory technique for hepatocyte preservation and sample creation. As the court explained, that a claimant can describe a patent principally by the “natural ability of the subject matter” (for example, describing a cancer treatment as “cancer cells’ inability to survive chemotherapy”) does not mean that patent is ineligible under § 101. Nor does the ‘929 Patent attempt to patent a new type of resilient hepatocyte. Rather, the ‘929 Patent uses a natural discovery to improve a prior art. Specifically, the ‘929 Patent involves multiple freeze-thaw cycles and pooling cells from multiple donors. This method, in particular the pooling of hepatocytes from multiple donors after multiple freeze-thaw cycles, was the subject of the patent. In this respect, the Federal Circuit distinguished the ‘929 Patent from those found ineligible in Funk Bros. Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948), and Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013), both of which involved attempts to patent end-products.
The Federal Circuit also addressed the second step of the Mayo test. The court noted that, despite LTC’s contentions, the ‘929 Patent had significant inventive qualities. Most notably, the ‘929 Patent process repeatedly froze hepatocytes while conventional practice was to freeze and thaw them once before using or disposing of them. Further, that each step of the technique described in the ‘929 Patent was known to the general scientific community did not reduce its inventive quality. Indeed, as the Federal Circuit noted, the general scientific community “taught away from multiple freezings.” This made the ‘929 patent’s multiple freeze-thaw method all the more innovative. Thus, the patent fell within § 101.
The court ended its discussion by adding two points. First, the simplicity of a method has no bearing on its patent eligibility. Rather ease of application and obviousness are concerns dealt with in other portions of the Patent Act. Second, the ‘929 Patent is not overbroad, such that it would interfere with future innovation by “lock[ing] up the natural law in its entirety.” Rapid Litigation, 827 F.3d at 1052. Indeed, by the time of the decision, “LTC ha[d] already managed to engineer around the patent.” Id. (quoting Celsis In Vitro, Inc. v. CellzDirect, Inc., 83 F. Supp. 3d 774 (N.D. Ill. 2015)).