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. (13)
The three patents state that ... when one or more immunogens ... is first administered at an early age (typically prior to 42 days of age), it can substantially decrease the incidence, frequency, prevalence or severity of, or prevent, at least one chronic immune mediated disorder, and/or a surrogate marker thereof. (14)
As a result, the scope of Dr. Classen's three assigned patents claimed that possible immunization schedules were to be screened and compared, the lowest risk schedule identified, and the vaccine administered on the schedule that offered the lowest occurrence of chronic disease. (15)
Plaintiff alleged that its patents, specifically '139 and '739, were infringed when a healthcare provider reviewed the "relevant literature" and selected a particular immunization schedule that was of lower risk regarding the onset of immune mediated disorders and followed said schedule when performing immunizations. (16) Plaintiff also claimed that even if no change to the schedule was made, both '139 and '739 were infringed when the relevant literature was reviewed. (17) Finally, Plaintiff claimed that the '283 patent was infringed when the relevant literature was reviewed, regardless of whether the one reviewing the literature is "a producer of vaccines, a health care provider, or a concerned parent," and in spite of the fact that no immunizations were performed in accordance with the relevant literature. (18)
The alleged infringers, Biogen IDEC, GlaxoSmithkline, Merck & Co., Inc., et al. (Defendants), moved for summary judgment at the district court level, claiming, among other defenses, that Plaintiff's patents failed to meet the requirements of statutory patentable subject matter under 35 U.S.C. [section] 101. (19) Because Plaintiff's patents claimed a correlation between vaccination schedules and the incidence of immune mediated disorders, the patents claimed a natural phenomenon; Defendants asserted that Plaintiff's patents merely covered an abstract idea. (20) The court determined that Plaintiffs three patents were claiming merely abstract ideas, as "'thinking about'" the risk of potential vaccinations was a mental process and thus not patentable. (21) Plaintiff appealed the decision to the Court of Appeals for the Federal Circuit, and the Federal Circuit affirmed, applying the holding of In re Bilski that without a machine or transformation of matter, the patents covered ineligible subject matter. (22)
Plaintiff applied for a writ of certiorari, which was granted by the United States Supreme Court. (23) However, after the outcome in Bilski v. Kappos, in 2010 the Supreme Court remanded the case to the Court of Appeals for the Federal Circuit, as the decision in Bilski v. Kappos eliminated the strict machine-or-transformation test as the exclusive test for patentability. (24) On remand, Defendants argued that Plaintiff's patents encompassed merely reading already published materials, that the comparing of immunization schedules and selecting the lowest risk schedule was something performed exclusively in the mind, and, citing Parker v. Flook, that the immunization itself, no matter how conventional, cannot turn an unpatentable principle into a patentable process. (25) Plaintiff rebutted Defendants' contentions and argued that Dr. Classen had discovered a new method of immunizing infants that lowered the risk of future immune mediated disease and that even though particular claims, perhaps, were overbroad, others were directed specifically toward "specific immunogens, specific immunization schedules, and specific immune-mediated disorders." (26) Thus, Plaintiff argued, the methods were not "'abstract.'" (27)
The Federal Circuit, on remand, referenced several cases in making its final determination. Citing to Bilski v. Kappos, the Federal Circuit relied on the reiteration of the Supreme Court that barring patent eligibility under 35 U.S.C. [section] 101 should be done sparingly, as [section] 101 is only a threshold test. (28) However, the Federal Circuit was careful to note Justice Stevens' concurrence in Bilski that "' [t]he Court, in sum, never provides a satisfying account of what constitutes an unpatentable abstract idea.'" (29) Also, relying upon In re Prater, the court recognized that the mere inclusion of a mental process within a patent was not, itself, fatal. (30) But, the Court in Bilski reaffirmed "the prohibition against patenting abstract ideas," and that merely "attempting to limit the use of a formula to a particular technological" field or "adding insignificant post-solution activity" cannot circumvent the bar of patenting abstract ideas. (31)
Citing to Association for Molecular Pathology v. United States Patent and Trademark Office, the Federal Circuit distinguished '283 from '139 and '739, in that the '283 patent failed to contain a claimed immunization step. (32)
"[M]ethods that simply collect and compare data, without applying the data in a step of the overall method, may fail to …