On October 30, 2008, the en banc Federal Circuit issued a decision in In re Bilski. The opinion addresses the eligibility of patent subject matter under 35 U.S.C. §101. Although the claims at issue in Bilski relate to business methods, the court articulates a test for subject matter eligibility that may be applied to claims drawn to biotechnological and medical processes. Companies with inventions in these areas cannot afford to ignore Bilski’s potential effect, both on claim drafting and enforcement actions.
In its majority opinion, the Federal Circuit adopts the “machine or transformation” test for patent eligibility. In this process, an invention will meet the requirements for patentability if (1) it is tied to a particular machine or apparatus, or (2) it transforms a particular article into a different state or thing.
To impart patent eligibility, “the use of a specific machine or transformation of an article must impose meaningful limits on the claim’s scope.” The transformation of an article “must be central to the purpose of the claimed process.” In most cases, merely “gathering data would not constitute a transformation of any article.”