Introduction
Many patent claims in the life science industries are directed to diagnostic methods. These methods generally involve obtaining clinical data from a patient or a group of patients, and then either using the data to establish a reference for comparison, or comparing the data to reference data to determine if the patient or patients suffers from or is at risk for some particular malady. For example, claim 1 of US 5,723,283 reads,
1. A method of determining whether an immunization schedule affects the incidence or severity of a chronic immune-mediated disorder in a treatment group of mammals, relative to a control group of mammals, which comprises immunizing mammals in the treatment group of mammals with one or more doses of one or more immunogens, according to said immunization schedule, and comparing the incidence, prevalence, frequency or severity of said chronic immune-mediated disorder or the level of a marker of such a disorder, in the treatment group, with that in the control group.
Nothwithstanding the fact that the USPTO has issued many such claims, the validity of many of these claims is now in doubt, due to a recent appellate court decision, In re Bilski. In that decision, the Court of Appeals for the Federal Circuit (CAFC) set forth a new standard for what constitutes subject matter that is eligible for patent protection. The court’s ruling could prove to be a stumbling block for parties seeking to patent diagnostic methods.
Background
In 1997, Bilski filed a U.S. patent application for a method for managing risks in commodity sales – what is often called a “business method” patent application. After the Patent Office rejected all 11 claims as being directed to unpatentable subject matter, the applicants appealed to the CAFC.
The “Machine or Transformation Test”
The court’s en banc decision[1] focused on whether or not the claimed method constituted, in the words of the statute, a “new and useful process”. The court stated that under Supreme Court case law, “a claim is not a patent-eligible ‘process’ if it claims ‘laws of nature, natural phenomena, [or] abstract ideas’”. To paraphrase the court’s decision, if a process claim is directed to a fundamental principle (a law of nature, a natural phenomenon, or an abstract idea) or a mental process, and that claim pre-empts substantially all uses of that fundamental principle, then the process is not eligible for patent protection. If, however, the claim forecloses only the use of a particular application of a fundamental principle, the claimed process is patent-eligible (and subject to further review for compliance with the other requirements for patentability).
How does one know if a claimed process pre-empts all other uses of a fundamental principle? Again citing Supreme Court precedent, the CAFC linked pre-emption to the so-called “machine or transformation test” (hereinafter “MOTT”):
“The Supreme Court, however, has enunciated a definitive test to determine whether a process claim is tailored narrowly enough to encompass only a particular application of a fundamental principle rather than to pre-empt the principle itself. A claimed process is surely patent-eligible under § 101 if: (1) it is tied to a particular machine or apparatus, or (2) it transforms a particular article into a different state or thing.”
The CAFC explained that this is so because a claimed process involving a fundamental principle that is tied to a particular machine or apparatus would not pre-empt uses of the principle (a) using a different machine, or (b) using the specified machine in a manner different that than recited in the claim. Similarly, “a claimed process that transforms a particular article to a specified different state or thing by applying a fundamental principle would not pre-empt the use of the principle to transform any other article, to transform the same article but in a manner not covered by the claim, or to do anything other than transform the specified article.”
The Court’s Corollaries
In addition to explaining that the MOTT is the test to be used in determining whether or not a method or process claim is directed to patent-eligible subject matter, the CAFC noted that the Supreme Court had provided several corollaries to this test. First, merely limiting a method claim to a particular field of use – as opposed to limiting the claim to use of a particular machine – is insufficient to confer patent-eligibility. In the words of the court, “Pre-emption of all uses of a fundamental principle in all fields and pre-emption of all uses of the principle in only one field both indicate that the claim is not limited to a particular application of the principle.”
Second, said the court, “Even if a claim recites a specific machine or a particular transformation of a specific article, the recited machine or transformation must not constitute mere ‘insignificant post [or extra-] solution activity.’” Such “insignificant” “extra-solution” activities could include, for example, steps of gathering, recording, or displaying data.
Third, the court noted that even if a claimed process is both novel and non-obvious, that process is not patentable if it does not pass the MOTT.
Finally, the court noted that as long as the claim as a whole meets the MOTT, the claim is patent-eligible, even if some elements of the claim do not themselves meet the test.
Possible Impact on Diagnostic Method Claims
The CAFC concluded that Bilski’s claimed method failed the MOTT, and thus was ineligible for patent protection. Of interest in this report, however, is the impact the court’s decision may have on diagnostic method claims.
Returning to claim 1 of US 5,723,283, one might think that the step of immunizing mammals constitutes a physical transformation: the injection of an immunogen results in a change in the blood chemistry of the immunized mammal and in the production of high levels of particular antibodies. Thus this claim would seem to be directed to patent-eligible subject matter. But in a terse post-Bilski decision, In re Classen, the CAFC ruled that the process of claim 1 was patent-ineligible:
In light of our decision in In re Bilski, 545 F.3d 943 (Fed. Cir. 2008) (en banc), we affirm the district court’s grant of summary judgment that these claims are invalid under 35 U.S.C. § 101. Dr. Classen’s claims are neither “tied to a particular machine or apparatus” nor do they “transform[ ] a particular article into a different state or thing.” Bilski, 545 F.3d at 954. Therefore we affirm.
In the absence of stated reasoning, one can only speculate about the court’s logic, but apparently the Classen court reasoned as follows:
(a) Even if the immunization step of Classen’s claim amounted to a physical transformation, that step was merely extra-solution activity (data generating or gathering), and therefore, in accordance with the court’s second corollary in Bilski, the immunization step could not impart to the claim the physical transformation required by the MOTT.
(b) The remainder of the claimed method, viz. comparing the data collected to assess the efficacy of the immunization schedule, did not involve a physical transform and was not tied to a particular machine, and therefore failed the MOTT.
Given the court’s insistence in Bilski that it was merely adhering to established Supreme Court precedent, the court’s decision in Classen should perhaps be unsurprising: in a 1989 decision, In re Grams, which relied on the same Supreme Court cases that the Bilski court relied on, the CAFC rejected a similar claim as patent-ineligible. The claim in Grams was directed to a method for diagnosing an abnormal condition in an individual. The method involved conducting laboratory tests on an individual to generate data, and then manipulating the data and comparing the results to predetermined values. The data-generating step was held to be insignificant extra-solution activity, and – in accordance with the same Supreme Court cases upon which the Bilski court later relied – the data manipulating steps were held to be an algorithm per se, and therefore patent-ineligible.
Implications for Diagnostic Method Patents
The CAFC’s decision in Bilski calls into question the validity of many issued claims and the allowability of many pending claims. See, for example, claim 1 of Technion’s US 7,442,496 (issued two days before the Bilski decision). Furthermore, a large number of method claims (not only in the life sciences) have issued post-Bilski that apparently do not survive the MOTT (see, e.g. US 7,491,499). Presumably this is due to the claims having been allowed before Bilski or shortly thereafter, before the USPTO issued a memorandum to examiners in January 2009 instructing them how to implement Bilski. Thus patentees would do well to check all of their issued method claims, both pre- and post-Bilski, for compliance with the MOTT.
The upshot of Bilski for life sciences applicants and their attorneys is that they now need to concern themselves not only with novelty and non-obviousness, but with patent-eligibility as well. They need to be careful in how they claim diagnostic methods, and to be sure that the methods as claimed pass the MOTT. In those instances in which the claim may fail the MOTT, alternatives should be considered, such as converting the claim to a method of treatment claim and adding steps that recite administering a drug to the patient.
[1] En banc decisions are heard before the full court, and can only be overturned by another en banc decision of the same court or by the Supreme Court. Thus the ruling in Bilski is likely to stand for many years to come, unless the Supreme Court agrees to hear a further appeal.
