Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057 (Fed. Cir. 2011).
In 2010, the United States Supreme Court levied a decision in Bilski v. Kappos that cast further doubt over what exactly constitutes patentable subject matter under 35 U.S.C. [section] 101 by striking down the Court of Appeals for the Federal Circuit's machine-or-transformation test. (1) As the sole test of what constituted patent-eligible subject matter, the machine-or-transformation test determined patent eligibility based on the claimed subject matter either being implemented by a particular machine specifically tailored for such a purpose or on the claimed matter's ability to transform an article from one form to another. (2) Bilski replaced this test with a case-by-case factual inquiry under the patent policy rationale that applying a hard and fast rule, the machine-or-transformation test, was arbitrarily restricting patentable subject matter. (3) Now, courts have been tasked with applying the individual facts of each case challenging 35 U.S.C. [section] 101 to the patent eligibility trio: Benson, (4) Flook, (5) and Diehr. (6) However, the machine-or-transformation test is still a factor to be considered by the courts. (7) Meaning, if an invention satisfies the machine-or-transformation test, it qualifies as patentable subject matter. However, failing the test is not per se dispositive of failing to meet the requirements of 35 U.S.C. [section] 101.
The recent case of Classen Immunotherapies, Inc. v. Biogen IDEC (8) presented the Federal Circuit with one of its first opportunities to apply the new post-Bilski patent eligibility standard. Unfortunately, the post-Bilski standard appeared difficult to apply - potentially because the cases making up the patent eligibility trio are inherently inconsistent with one another. Regardless, Classen Immunotherapies does not bode well for the future of 35 U.S.C. [section] 101 cases, as it showcased the continued difficulties the Federal Circuit is having with patent-eligible subject matter and, surprisingly, showed the frustrations that Chief Judge Randall Rader feels toward 35 U.S.C. [section] 101 challenges in general. (9) Writing separately, Chief Judge Rader made a point of stressing the pitfalls of the Federal Circuit entertaining subject matter eligibility challenges and forewarned of the implications this and all 35 U.S.C. [section] 101 challenges have on the future of claim drafting. (10)
This Note will examine whether the cases comprising the eligible subject matter trio are inherently inconsistent. In looking at this issue, this Note will ask if Classen Immunotherapies can be reconciled with the patent eligibility trio, or if both the case and Judge Rader's concerns could have been dealt with more effectively by applying 35 U.S.C. [section] 101 as a last resort, and instead determining patent eligibility via 35 U.S.C. [section][section] 102, 103, and 112. It is fundamentally more difficult, expensive, and time consuming to ascertain which category of patentable subject matter a claimed invention falls into, or if the claimed matter satisfies the patent eligibility trio, than it is to determine whether the requirements of novelty, obviousness, and enablement have been satisfied. This is especially so given the creative means with which practitioners will draft claims to "satisfy" the requirements.
II. Facts & Holding
Classen Immunotherapies, Inc. v. Biogen IDEC involved three patents covering inventions created by Dr. John Barthelow Classen and assigned to his company, Classen Immunotherapies, Inc. (Plaintiff). (11) Specifically, the patents included United States Patent Nos. 6,638,739 ('739), 6,420,139 ('139), and 5,723,283 ('283). (12) Dr. Classen determined that the schedule used to immunize infants against infectious diseases could affect the later onset of chronic immune-mediated disorders such as cancer and diabetes. …