On August 28, 2015, the Biotechnology Industry Organization (BIO) filed an amicus brief in another important patent eligibility case currently before the Federal Circuit, Rapid Litigation Management (formerly Celsis In Vitro) v. Cellzdirect. The claims at issue are directed towards a "method for freezing hepatocytes multiple times without further significant loss of cell health and viability." The method has three steps: (1) previously frozen cells are thawed, (2) nonviable cells are separated from viable ones using a “density gradient fractionation,” and then (3) viable cells are cryopreserved for later use. In the decision below, the District Court invalidated the claims, finding them to be directed towards patent ineligible subject matter.In applying the first step of the Mayo two-step test for patent eligibility, the District Court found that the “patent is directed to an ineligible law of nature: the discovery that hepatocytes are capable of surviving multiple freeze-thaw cycles.” In the second step, the court found the claimed method to lack sufficient “inventive concept,” because claimed elements such as freezing cells and the use of density gradient fractionation were found to be “well understood.”
In its brief, BIO urges the Federal Circuit to clarify the boundaries regarding the scope of the term “law of nature,” and argues that hepatocytes are not subject to repeated freezing in nature under the conditions of the claimed methods, and thus that the claim does not implicate a law of nature. The brief also argues that the district court’s approach, which essentially “requires an undefined ‘something else,’ that cannot be satisfied by the application of known techniques and reagents to a newly recognized natural phenomenon, threatens the availability of patent protection for a host of important innovations spanning the length and breadth of biotechnology.”
BIO also argues that “[b]ecause of its well-developed record on the non-obviousness of the claimed invention, this case may present a good opportunity for this court to clarify the interplay between Section 103 and Step II of the Mayo/Alice framework."