September 6, 2011
Following a remand from the U.S. Supreme Court, on August 31, 2011, the Federal Circuit issued a split decision in a case involving whether three of Classen’s patents claim immunization methods eligible for patent protection under 35 U.S.C. 101. The decision, Classen Immunotherapies, Inc. v. Biogen Idec et al., follows earlier decisions this year on patent-eligible subject matter. The Classen decision is expected to have significant ramifications in the life sciences field.
According to the court, Dr. John Barthelow Classen, the inventor of the patents at issue, discovered that “the schedule of infant immunization for infectious diseases can affect the later occurrence of chronic immune-mediated disorders.” Dr. Classen likewise determined that immunization should be conducted on the schedule that presents the lowest risk. Based on these concepts, the inventor obtained a number of patents involving methods for immunization, three of which were asserted against the defendant. The method claimed in two of the patents explicitly specified the step of immunizing in view of a lower risk immunization schedule. The third patent specified comparison of immunization between a treatment group and a control group. This third patent did not require the affirmative step of immunizing.
In its prior decision, the Federal Circuit had held the Classen patent claims invalid as being ineligible for patent protection. The court had reasoned that because none of the three Classen patented methods were associated with a machine and did not transform matter, the claims failed to pass the Federal Circuit’s “machine or transformation of matter” test. After Classen appealed to the Supreme Court, however, the Court issued its decision in Bilski v. Kappos (discussed earlier) loosening the standard for patent eligibility. The Supreme Court then vacated the Classen decision and remanded for consideration in view of the Bilski decision.
On remand, the panel majority wrote “[w]e conclude that the claims of the subject matter of two of the three Classen patents is eligible under §101 to be considered for patentability, although we recognize that the claims may not meet the substantive criteria of patentability as set forth in §101, §103 and §112.” Continuing to express fidelity to the Supreme Court’s Bilski decision, the Federal Circuit acknowledged the Court’s instruction that “[r]ather than adapting categorical rules that might have wide-ranging and unforeseen impacts,” exclusions from patent-eligibility should be applied “narrowly.”
The court concluded that the claims in Classen’s first two patents were “directed to a method of lowering the risk of chronic immune-mediated disorder, including the physical step of immunization on the predetermined schedule.” The court found these claims to be eligible for patent protection because these claims were not limited merely to abstract mental steps. The presence of a mental step in these patent claims was not fatal, because the claims also included a physical step of immunizing in accordance with the lower-risk schedule, “thus moving from abstract scientific principle to specific application.”
The court held, however, that the third patent did not pass the coarse patent-eligibility filter of the patent statute. Classen argued that the claims were infringed whenever “a health care provider reads the relevant literature and selects and uses an immunization schedule that is of lower risk for development of a chronic immune-mediated disorder.” The Federal Circuit determined that, unlike the first two patents, this patent did not require using the information for carrying out an immunizing step. Rather, this patent specified merely the idea of comparing known immunization results from the scientific literature. The court distinguished between a physical step (immunizing) and mere data gathering or insignificant extra-solution activity, holding that claims that specified a physical step were eligible for patent protection, while those that merely specified data gathering or insufficient extra-solution activity were not.
Judge Moore dissented, and argued that all three patents were invalid. The patent “claims are not directed to any specific treatment step or drugs or even specific chronic immune disorder.” Judge Moore concluded the patents merely claimed the principle discovery that “changing the timing of immunization may change the incidence of chronic immune mediated disorders” that “Classen now seeks to keep for himself.” Judge Moore regarded the immunizing recited in the first two patent claims as post-solution activity that “does not transform the unpatentable principle—that a correlation exists between vaccination schedules in incidence of chronic immune disease—into a patentable process.”
Finally, in an interesting separate opinion, Judge Rader, joined by Judge Newman, stated “additional views” expressing frustration with recent court cases on patent eligibility. Despite the broad language of §101, “[i]n the last several years, this court has confronted a rising number of challenges under 35 U.S.C. §101” in which “litigants continue to urge this court to impose limitations not present in the statute.” Judge Rader advocated a policy-based rationale for the court “to decline to accept invitations to restrict subject matter eligibility.” Judge Rader argued “eligibility restrictions” lead to “a healthy dose of claim drafting ingenuity” that adds to the cost and complexity of the patent system and “may cause technology research to shift to countries where protection is not so difficult or expensive.”
The Classen decision provides guidance both prospectively for drafting patent applications and retrospectively for asserting or defending against charges of patent infringement in the life sciences field and in the emerging field of personalized medicine. For more information, please contact Fitch Even partner Kendrew H. Colton, the author of this alert.