Process Claims With Physical Implementation Steps May Be Patent-Eligible
Classen v. Biogen Idec (decided 8/31/11)By: Janice A. Vatland
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What This Means to You
- When pursuing process claims, particularly those that may be interpreted as being directed only to information gathering, consider including active steps where the obtained information is put to some use (central to the purpose of the process).
- Consider filing reissue applications to add process claims with active steps, particularly if there are no pending applications that may be used to do so..
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Overview
The US Court of Appeals for the Federal Circuit (Federal Circuit) again dealt with the patentability of process claims in Classen Immunotherapies, Inc. v.Biogen Idec, et al., which was on remand from the US Supreme Court after the Bilski decision determined the “Machine-or-Transformation” test is not the exclusive test for patent eligibility.
In Classen, the Federal Circuit found that process claims containing data gathering steps that also include a step that is a physical implementation using the information gained, may be patent-eligible.
The Federal Circuit also found that the statutory safe harbor protection for infringing acts in drug and medical device development (35 U.S.C. § 271(e)(1)) does not shelter post-marketing approval activities.
Case Background
To frame what processes are excluded from patentability as laws of nature, physical phenomena, or abstract ideas, the Federal Circuit has generally used the Machine-or-Transformation test, which provides that a claimed process is patentable if: (1) it is tied to a particular machine or apparatus; or (2) it transforms a particular article into a different state or thing. But the involvement of the machine or transformation in the claimed process must not merely be insignificant extra-solution activity, and the transformation must be central to the purpose of the claimed process and not merely a data gathering step.
In this case, Classen asserted three patents against multiple defendants for participating in studies evaluating the risks associated with different vaccination schedules and reporting on vaccine effects. The claims are generally directed to methods of immunizing or methods of determining whether an immunization schedule affects the incidence or severity of a disorder.
In the district court case, the defendants moved for summary judgment on the basis the claims were not patentable-eligible under 35 U.S.C. § 101. They also argued that because their reporting of vaccine relationships of recommendations were in conformity with FDA regulations, their alleged infringing activities were sheltered under the safe harbor exemption provided by 35 U.S.C. § 271(e)(1). Classen countered that the exemption is limited to pre-marketing approval activities.
The district court granted summary judgment, agreeing with the defendants that the claims were directed to an abstract idea and that the defendants’ activities did not infringe, based on the safe harbor exemption of 35 U.S.C. § 271(e)(1).
The Federal Circuit originally upheld the district court’s decision, after which Classen sought and was granted certiorari by the Supreme Court. However, the Supreme Court vacated and remanded to the Federal Circuit after it issued its Bilski decision in June 2010.
Decision
The second time around, the Federal Circuit found that the claims of two of the patents were directed to specific, tangible applications central to the process, as they included active steps of immunization and, therefore, were patent-eligible. However, the court found the third patent to be invalid, as the claims only included steps of collecting and comparing data without an application of the information gained.
The Federal Circuit also found that post-marketing approval activities were not sheltered by 35 U.S.C. § 271(e)(1).
Takeaways
While the Machine-or-Transformation test is not the only test by which to determine patent eligibility, and the Federal Circuit did not strictly apply it for this decision, it is still a useful tool for determining patent eligibility under 35 U.S.C. § 101. Further, the logic that patent eligibility may be imparted by including a transformation step that is central to the purpose of the claimed process and not merely a data gathering step appears to still apply.
However, it is important to note that it is still not completely clear what transformation steps are “central to the purpose of the claim” and necessarily render a process claim patent-eligible. Nevertheless, the case does demonstrate the current leaning of the Federal Circuit to apply 35 U.S.C. § 101 as a “coarse eligibility filter” with other statutory requirements placing more meaningful limits on patentability.
