This Article examines the recent history of the ways in which the courts have applied the written description requirement to gene patents, with a particular focus on the changes in the law wrought by the July 2002 decision in Enzo Biochem, Inc. v. Gen-Probe Inc. The author begins by describing the written description requirement of 35 U.S.C. § 112 for a patent application. Then, the author discusses recent case law influencing the evolution of the written description requirement for patenting genetic material. Next, he discusses the decision in the first Enzo case, which seemed to follow established case law and articulated that an invention may not be described by its function in order to fulfill the written description requirement. However, the author goes on to discuss the second Enzo decision, in which the Court held that a patent may be described by its function if a known correlation between function and structure exists; the written description requirement may be satisfied by reference in the specification to a deposit of the genetic material in a public depository when the practical difficulties of describing the genetic material make a written description unavailable. These decisions were made relying upon patent guidelines rather than prior case law. The author concludes that this latest Enzo decision has shifted the direction of the development of the written description requirement for DNA patents, but has also created some uncertainty, such as whether litigants should rely on patent guidelines or previous case law.
Duane M. Linstrom,
Spontaneous Mutation: A Sudden Change in the Evolution of the Written Description Requirement as It Applies to Genetic Patents,
San Diego L. Rev.
Available at: https://digital.sandiego.edu/sdlr/vol40/iss3/5