On September 7, 2005, the Federal Circuit in In re Fisher upheld the PTO’s final rejection for lack of utility of a patent application for certain DNA sequence fragments generated from maize plants. The court, supporting a heightened utility standard, adopted the “real-world” test for establishing substantial and specific utility required by the PTO. This decision severely limits the granting of patent rights to DNA sequence fragments, which are capable of having value within the biotech community as research tools. This comment proposes the restoration of a less stringent utility standard to more correctly reflect the purposes of patent law and advocates the use of licensing regulations as a solution to the DNA-patenting dilemma.
Diana A. Villamil, Redefining Utility In Determining The Patentability Of DNA Sequences, 5 J. Marshall Rev. Intell. Prop. L. 238 (2006)