Los Angeles – The United States Court of Appeals for the Federal Circuit recently held in Classen Immunotherapies v. Biogen IDEC that certain methods of scientific research pertaining to a particular field of study may be patentable. Classen Immunotherapies was issued a patent for testing an immunization schedule against a control group. Researchers would then use the results of the tests to adjust the immunization schedule in both timing and dosage.
The patent states that the schedule of infant immunization can have significant effects in the advancement of chronic disorders such as diabetes. The patent is a method of determining which immunization schedule minimizes the risk of development of chronic disorders. Once the optimal immunization schedules were determined, Classen planned to implement that schedule to prevent risk of development of chronic disorders in infants and children.
The action arose when defendant Biogen IDEC, allegedly began using the Classen testing method and discovered the optimal immunization schedule for diabetes and other ailments. Classen brought an action against Biogen IDEC for patent infringement which was then appealed to the Federal Circuit. The Federal Circuit held that the immunization schedule research method contained patentable subject matter under 35 U.S.C. § 101.
Prior to the decision of the United States Supreme Court in Bilski v. Kappos, an invention had to qualify for patent protection under the machine-or-transformation test. The machine-or-transformation test pertains to process patents and requires that, for a process to be patentable, it must be either implemented with a machine or transform an article into another. In Bikski, the Supreme Court held that the machine-or-transformation test was not the only appropriate test for patentability, but instead should be regarded as a useful tool or guiding principle.
In this case, the Federal Circuit noted that one of the steps in the research process, “reviewing the relevant literature,” was not fatal to the patent’s validity. Though this was a “mental step” in contrast to a physical step, the patent contained physical steps such as immunizing on a fixed schedule. Because the methods were directed toward a specific useful goal and included physical steps such as immunizing on a certain schedule, the processes were eligible for patentability.
The Federal Circuit ultimately held that two of the three Classen patents contained patentable subject matter under 35 U.S.C. § 101. However, a third Classen patent that did not pertain to an immunization schedule was found to be invalid.