The standard for patent eligible subject matter under 35 U.S.C.
§ 101 remains amorphous despite the Federal Circuit's
recent decision in Classen Immunotherapies, Inc. v. Biogen
IDEC (Fed. Cir. No. 2006-1634,-1649) (August 31, 2011). In
a 2-1 decision, the Federal Circuit held that a process claim
directed to comparing two immunization schedules and then
administering the more favorable immunization schedule was eligible
for patent protection under 35 U.S.C. § 101. According to the
Federal Circuit, it was the immunization step that took the claims
from "abstract scientific principle to specific
application." In contrast, claims that did not contain the
immunization step were held not to be patentable under 35 U.S.C.
§ 101. The Federal Circuit noted, however, that it was not
adopting any categorical rules and was instead applying limits to
subject matter eligibility narrowly in accordance with the Supreme
Court's guidance in Bilski.
Citing several public policy reasons, Chief Judge Rader filed
additional views in which he opined that the Federal Circuit should
refrain from limiting subject matter eligibility under § 101.
In particular, Judge Rader believes that eligibility restrictions
lead to "claim-drafting ingenuity" to overcome the
restrictions, which adds to the cost and complexity of the patent
system. Moreover, there are multiple sections of 35 U.S.C. (such as
§ 112) that already provide adequate protection against vague
claims.
What This Means for You
Classen may open the door wider for overcoming Bilski attacks when the disputed claims have a step comprising a physical act. This view is especially true given that at least some Federal Circuit judges have shown a reluctance to hold claims invalid under § 101. Disputed claims, however, that are a close call under § 101 may be more vulnerable to successful attacks in view of other requirements for patentability, including those set forth in § 112. In any event, it is possible that the holding in Classen will be significantly impacted if the Supreme Court holds next summer that the claims in the Prometheus
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