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Federal Circuit Gives Infringement Claim the Cold Shoulder

By Vanessa Palacio

Mother Nature lends a hand to the In Vitro Corporation in a recent Federal Circuit decision that reminds us of the broad spectrum of innovation in the biomedical industry. In this case, freezing liver cells twice is considered new and useful enough to earn a patent. Earlier this month, the U.S. Court of Appeals for the Federal Circuit held that a method allowing hepatocytes, a type of liver cell used for testing, diagnostic, and treatment purposes, to be frozen and thawed more than once is patentable subject matter under Section 101 of the Patent Act, 35 U.S.C. § 101, despite the fact that it relies on naturally occurring phenomena. Hepatocytes have been used for various applications, including analysis of developmental drug metabolism, drug toxicity, or other effects on the liver. Prior to the invention of the patent at issue, the use of hepatocytes was limited, however, due to various issues, including:

  • their short lifespan
  • problems with prior cryptopreservation techniques, where the cells were frozen then thawed, with poor numbers of viable cells recovered
  • problems with prior cryptopreservation techniques with lack of suitability for preparing multi-donor cell pools, to approximate average liver cells and test for impacts on a representative population

After discovering certain hepatocytes are capable of surviving multiple freeze-thaw cycles, scientists at In Vitro, Inc. designed a new way of preserving these cells, obtaining a patent from the United States Patent and Trademark Office (USPTO).  Their improved process consisted of: (A) separating viable cells from non-viable ones following freezing and thawing; (B) recovering the viable cells; and (C) refreezing the viable cells. As a result of this improved process, the prepared cells could be immediately thawed and used, with 70% viability. After obtaining the patent, In Vitro and its parent company filed a patent infringement suit against a competitor, Cellzdirect, Inc.[1]Cellzdirect challenged the validity of In Vitro’s patent under Section 101 of the Patent Act, and the District Court ruled the patent was invalid as “directed to a law of nature.” On appeal, the Federal Circuit reversed, critically rejecting the idea of automatic invalidity of subject matter related to, but not effectively claiming, the operation of a natural law. This is consistent with the treatment of previous life-science claims in cases going back over 35 years.[2] The Federal Circuit explained that the claims are simply not directed to the cells’ ability to survive multiple freeze-thaw cycles, but rather, toward a new preservation technique itself, the “method of producing” the cells. The Federal Circuit also noted that the patent itself did “not lock up the natural law in its entirety” and the defendant had “already managed to engineer around the patent.” The decision reinforces the policy rationale behind intellectual property protection: encouraging innovation.


[1] In Vitro’s parent company, Celsis Holdings, Inc., transferred its interest in the related litigation to Rapid Litigation Management.   [2] See, e.g., Association for Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107 (2013) (isolated human deoxyribonucleic acid, DNA, was not patent-eligible because it was naturally occurring, but synthetically created complementary DNA containing same protein-coding information but omitting non-coding portions found in nature was not naturally-occurring and therefore patent-eligible); Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012) (method for calibrating proper dosage of thiopurine drugs for autoimmune disease treatment effectively claimed underlying laws of nature and was not patent-eligible subject matter); and Diamond v. Chakrabarty, 447 U.S. 303 (1980) (live, human-made microorganisms were patentable subject matter, rejecting blanket invalidity for live organisms).

© Hall, Lamb, Hall & Leto, P.A. 2018. All rights reserved.