Since the Federal Circuit issued its In re Bilski decision in October of 2008, there has been significant trepidation in the biotechnology community concerning its impact. Recent decisions from the Federal Circuit and guidelines from the PTO have begun to shed light on this subject and, while conflicting, offer a ray of hope for biotech claims.

Bilski

In re Bilski, (545 F.3d 943; 88 (Fed. Cir. 2008)) articulates a “definitive test” for determining whether a claimed process is patent-eligible. Under this so-called “machine or transformation” test, a claimed process is patent eligible only 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 test has two further aspects: (1) “the use of a specific machine or transformation must impose meaningful limits on the claim’s scope,” and (2) “the involvement of the machine or transformation in the claimed process must not merely be insignificant extra-solution activity.” In other words, “one cannot ground the transformative nature of a process in a step that is merely a ‘data-gathering’ step.”

There has been a great deal of concern in the biotech and clinical chemistry fields since Bilski, centered around how the decision will be applied to patents claiming tests related to personalized medicine, where a patient is administered a compound, and a biomarker is measured in the patient to determine a course of treatment. The question lies in where the “machine or transformation” is found in such diagnostic method patent claims.

The Supreme Court has granted certiorari and will hear argument in In re Bilski on November 9, 2009.

Classen Immunotherapies

Courts have already applied Bilski to invalidate patent claims related to biotechnology or diagnostic methods. For example, in Classen Immunotherapies v. Biogen Idec (2006 WL 6161856 (D.Md. Aug. 16, 2006)), the Maryland district court invalidated a claim for:

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.

The district court held that the claim “describes only a general inquiry of whether the proposed correlation between an immunization schedule and the incidence of chronic disorders exists. As such, the process is indistinguishable from the idea itself.” The Federal Circuit affirmed the lower court in an opinion of less than 100 words. (304 Fed. Appx. 866, 2008 WL 5273107 (C.A.Fed. (Md.) Dec. 19, 2008)).

Prometheus Laboratories

Given the possible impact of Bilski on biotechnology and related fields, every case to which Bilski might apply is being closely watched. The most recent case, Prometheus Laboratories Inc. v. Mayo Collaborative Services (No. 08-1403 (Fed. Cir. Sept. 16, 2009)) was argued on August 5, 2009 and the Federal Circuit issued its opinion on September 16, 2009. In less than a week, virtually every major blog, on-line discussion or publication, and many academics issued articles related to the decision and trying to interpret the direction the courts will take.

An exemplary claim from the one of patents at issue in Prometheus (U.S. Patent No. 6,355,623) is reproduced below.

1. A method of optimizing therapeutic efficacy for treatment of an immune mediated gastrointestinal disorder, comprising:

(a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and

(b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,

wherein the levels of 6-thioguanine less than about 230 pmol per 8x108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and wherein the levels of 6-thioguanine greater than about 400 pmol per 8x108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

In contrast to Classen Immunotherapies, the Federal Circuit found this claim patent-eligible. During oral argument, there was already some indication of the rationale on which the court might rely. For example, in response to Mayo’s argument that a transformation arising from treating the body is an unpatentable “natural process,” Judge Lourie responded that any method of treatment “operates by a natural process but is patentable” and that the claim involved, in fact, a method of treatment. Judge Michel also indicated that the claims at issue were not “mere data gathering,” which is unpatentable, but are “data gathering plus something else.” (See “Invention Particularity, Preemption are Focus of Oral Arguments on Drug Test Patentability” Patent Trademark and Copyright Journal (BNA)August 14, 2009.)

In Prometheus, the Federal Circuit held that the “machine or transformation” requirement could be met by biotech patent claims because the human body is transformed by the administering step (step (a)), and stated “[w]hen administering a drug… the human body necessarily undergoes a transformation. The drugs do not pass through the body untouched.” The court also concluded that the “determining step” (step (b)) “is also transformative and central to the claimed methods.” The court states “[d]etermining the levels of 6-TG or 6-MMP in a subject necessarily involves a transformation, for those levels cannot be determined by mere inspection. Some form of manipulation…is necessary to extract the metabolites from a bodily sample and determine their concentration.”

The Federal Circuit then addressed why, in this case, the transformations are not “merely insignificant extra-solution activity,” stating:

While it is true that the administering and determining steps gather useful data, it is also clear that the presence of those two steps in the claimed processes is not “merely” for the purpose of gathering data. Instead the administering and determining steps are part of a treatment protocol. (emphasis added)

The Federal Circuit concluded that Prometheus’s methods claims contained patent-eligible subject matter. The court did not address the novelty or unobviousness of the claimed processes.

PTO Guidelines

The Patent Office recently issued guidelines for determining subject matter eligibility for process claims under the machine or transformation test (http://www.uspto.gov/web/offices/pac/dapp/opla/2009-08-25_interim_101_instructions.pdf), although there is no mention of applying the test to biotechnology patents. This could reflect the PTO’s reluctance to apply the test in this area, or it could signal that the PTO is simply not yet ready to reach a policy for such claims. It would be surprising, however, if the test were not used by examiners to reject biotechnology claims under 35 USC § 101.

Where do we go from here?

Although the law is still in flux, Prometheus provides some guidance to patent applicants. To show that “the machine or the transformation is central to the purpose of the claims,” claims should recite “the application of a natural phenomenon in a series of transformative steps comprising a particular method of treatment.” The transformation, which results from a claimed administration step, must be central to the claim and should not preclude use of the administering step in other methods, which would likely be interpreted as “mere data gathering” or an attempt to patent a natural phenomenon. For example, a claim referring only to the application of a mathematical algorithm or mental process after the administration step would likely be invalid, as has previously been held by the Federal Circuit. Although in Prometheus the Federal Circuit did not specifically point to claim language that will take a claim outside of the mental process realm, it is likely that the court viewed the recitation of “a need to decrease the amount of said drug subsequently administered to said subject” as a step beyond mere data gathering, which transformed the claim into a method of treatment. Although it is somewhat difficult to square Prometheus and Classen, the claim in Classen may have fallen short because it stopped with making the comparison, and did not provide direction for how to appropriately modify treatment.

As a precaution, applications should include at least a few examples involving use of a “machine,” as well as specific examples and methods. Where appropriate, broader equivalents to the “machine” should be described and possibly claimed using means plus function claim language.

Patent applicants and their counsel should continue to monitor the direction the law takes for diagnostic process claims. The courts will likely continue to conclude that administering a substance results in a transformation. However, the inquiry does not end there. At least for now, the key seems to be in tying the transformative step to a particular treatment method. One way to do this appears to be by providing direction to the clinician based on the test results; the more specific the results, the safer one will be. Although Bilski did not involve diagnostic method claims, it remains to be seen whether the Supreme Court’s decision will address diagnostic methods, or whether it will be limited to the facts presented by the litigants in Bilski.

Finally, it would be prudent for patent applicants to file continuation applications after allowance so that, once the dust settles, claims can be amended as necessary to assure a finding of validity by the courts.