Biotech Patent Eligibility: A New Hope

Kim, Eugene

The practical effect of the Supreme Court’s decisions in Mayo Collaborative Services v. Prometheus Laboratories, Inc. and Alice Corporation Pty. v. CLS Bank International has been to deny patent eligibility to innovative patent applications and patents, particularly in the fields of biotechnology and computer software. On July 5, 2016, the Federal Circuit in Rapid Litigation Management Ltd. v. CellzDirect, Inc. ruled that the claimed methods of cryopreserving hepatocyte cells are patent eligible under 35 U.S.C. § 101 because they are not directed to a natural phenomenon. The patentees discovered that some cells in a hepatocyte pool could survive multiple freeze-thaw cycles. The claims recite a method of producing a preparation of hepatocytes that can be frozen and thawed at least twice. The method steps include freezing and thawing a sample of hepatocytes, performing density fractionation to separate viable and non-viable cells, recovering the viable hepatocytes, and refreezing the recovered hepatocytes.The Federal Circuit decided that, although dependent on a natural phenomenon, the inventors’ claims were a patent eligible application of their natural discovery. As a result, the court may have opened up a new avenue for patent seekers to circumvent the restrictive eligibility requirements established by the Supreme Court.

This Note provides a brief history of patent eligibility doctrine and the cases leading up to the decision in CellzDirect. It next analyzes the CellzDirect decision and its possible interpretations. Finally, it argues that this case represents an effort by the Federal Circuit to limit the Supreme Court’s extreme anti-patent position in Mayo and Alice by cabining the eligibility restrictions to diagnostic discoveries.

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November 26, 2019