By Kevin E. Noonan --
Although long-anticipated, the Supreme Court's opinion in Bilski v. Kappos did not provide much in terms of "pellucid" teachings regarding the metes and bounds of patent-eligible subject matter. Against this backdrop, the Court decided on Tuesday to grant certiorari, vacate the Federal Circuit's decision below, and remand to the appellate court two cases related to medical diagnostic claims: Prometheus Laboratories, Inc. v. Mayo Collaborative Services and Classen Immunotherapies, Inc. v. Biogen Idec. On earlier appeals, the Federal Circuit decided that the claims in Prometheus were patent-eligible under the "machine-or-transformation" (MOT) test, and that the claims in Classen were not. How the Federal Circuit decides these cases on remand, and whether its decision(s) change, will provide the first inklings of how the CAFC will implement whatever insights the Bilski decision may provide.
The types of claims in these cases and the grounds
for the Federal Circuit's disparate decisions may be informative. In Prometheus,
the claims recited methods for determining whether treatment for immune-related
gastrointestinal disorders needed adjustment, i.e., whether the amount of a drug administered to treat the
disorder should be changed. The
asserted claims of the patents-in-suit specifically relate to methods for
identifying the administered drug, thiopurine, or metabolites thereof, in red
blood cells of a patient. Claim 1
of the '623 patent was cited in the Federal Circuit opinion as being
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 level 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 level 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.
The Federal Circuit reversed a finding by the District Court on summary judgment that the claims were not patent-eligible under 35 U.S.C. § 101 (as expressly influenced by Justice Breyer's dissent in Laboratory Corp. v. Metabolite Labs., Inc. ("LabCorp")). The Federal Circuit (in an opinion by Judge Lourie, joined by (then) Chief Judge Michel and the Honorable Ron Clark, District Judge of the U.S. District Court for the Eastern District of Texas, sitting by designation) held that the administering and determining steps, dismissed by the District Court as constituting mere "necessary data-gathering steps," were instead transformative and thus satisfied the transformation prong of the Bilski MOT test. Judge Lourie's opinion stated that "[t]he transformation is of the human body following administration of a drug and the various chemical and physical changes of the drug's metabolites that enable their concentrations to be determined." The Court found that these steps were essentially "method of treatment" steps, "which are always transformative when a defined group of drugs is administered to a body to alleviate the effects of an undesired condition" (emphasis added). A human body to which drugs such as thiopurines are administered "necessarily undergoes a transformation," the Court said, since "the drugs do not pass through the body untouched without affecting it," something the Court characterized as "the entire purpose of administering the drugs." The opinion rejected Mayo's contention that the transformations are the result of "natural processes" because "quite literally every transformation of physical matter can be described as occurring according to natural processes and natural law." But this transformation encompassing the administering step of the asserted claims are not "natural processes" according to the Court: "[i]t is virtually self-evident that a process for a chemical or physical transformation of physical objects or substances is patent-eligible subject matter (emphasis in the original text). Finally, the Federal Circuit opined that the District Court erred in deciding that Prometheus' asserted claims "wholly preempted" the use of correlations between metabolites of thiopurine drugs and their toxicity and efficacy. Rather, according to the Court, the claims utilize, not preempt, the correlations of natural processes "in a series of specific steps" that are patent-eligible subject matter according to the statute, citing Diehr and its analogous use of the Arrhenius equation for curing rubber (a transformative step). "Regardless" of this issue, the Court held, satisfaction of the MOT test renders the claims patent-eligible and thus "they do not preempt a fundamental principle."
In Classen, on the other hand, the Federal Circuit summarily rejected the claims based on failure to satisfy the Bilski MOT test (in a 69-word opinion that was shorter than the claims at issue). The claims in Classen's U.S. Patent No. 5,723,283 were directed to methods for 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. Although the Classen claims recited "immunizing" steps (that could be considered to be analogous to the "administering" steps in the Prometheus claims), they also recited a step of "comparing" the "incidence, prevalence, frequency or severity" of the immune-mediated disorder between the experimental and control groups, making it easier to characterize the immunization step as a mere "data-gathering" step.
The use of the "comparing" language was reminiscent of the claims in the LabCorp case, which was criticized by Justice Breyer in his dissent from the Court's decision not to decide the patent-eligibility of claims for determining whether a patient had a vitamin deficiency. In LabCorp, the claim at issue was directed to a method for detecting a deficiency of cobalamin (vitamin B12) or folate having the steps of assaying a body fluid for an elevated level of total homocysteine and correlating an elevated level of total homocysteine in said body fluid with a deficiency of cobalamin or folate. There are clear parallels between the structure of the LabCorp claim and the Classen claim. Each recites a preamble directed to identifying a biological phenomenon (a vitamin deficiency in LabCorp, a chronic immune-related disorder related to a acute immunization schedule in Classen), comprising an unambiguous diagnostic/tangible step (assaying a bodily fluid to detect elevated homocysteine levels in LabCorp, immunizing mammals with one or more doses of one or more immunogens, according to an immunization schedule in Classen), followed by an interpreting step (correlating elevated homocysteine with the vitamin deficiency in LabCorp, comparing the incidence, prevalence, frequency or severity of chronic immune-mediated disorders in mammals immunized according to the immunization schedule in Classen).
The Supreme Court's Bilski decision provides no clear instruction for resolving the different results in the Prometheus and Classen cases; indeed, the Court (for the first time since the Hilton Davis case) appears content to let the Federal Circuit develop its case law on the extent to which tests other than the MOT test are used to determine patent-eligibility. For biotechnology, it remains the case that including active, technology-dependent steps in method claims is prudent, and to draft claims that minimize the likelihood that the invention will be characterized as merely an "abstract idea." In this regard, dicta from the Bilski opinion provides a certain level of comfort that the Court (or at least some members of the Court) understand the proper protocol for performing claim analysis. For example, the opinion noted that the judiciary "does not have carte blanche to impose other limitations that are inconsistent with the text and the statute's purpose and design." And in a portion of the "majority" opinion joined by Justice Scalia, Justice Kennedy reminds us that a court "needs to consider the invention as a whole, rather than 'dissect[ing] the claims into old and new elements and then . . . ignor[ing] the presence of the old elements in the analysis,'" citing Diamond v. Diehr. However, this is arguably just the analytic mistake Justice Breyer made in his LabCorp dissent, where he argued that:
[H]ere, aside from the unpatented test, [the claims] embody only the correlation between homocysteine and vitamin deficiency that the researchers uncovered. In my view, that correlation is an unpatentable "natural phenomenon," and I can find nothing in claim 13 that adds anything more of significance.
(emphasis added). On the other hand, the four "concurring" Justices clearly believe that the scope of patent eligibility is (and must be) limited by the Constitutional prescription that a patent "Promote the Progress of . . . the Useful Arts," and that Justice Breyer's antipathy to medical diagnostic patents retains some currency on the Court:
For even when patents encourage innovation and disclosure, "too much patent protection can impede rather than 'promote the Progress of . . . useful Arts.'" Laboratory Corp. of America Holdings v. Metabolite Laboratories, Inc., 548 U. S. 124, 126–127 (2006) (BREYER, J., dissenting from dismissal of certiorari). . . . Patents "can discourage research by impeding the free exchange of information," for example, by forcing people to "avoid the use of potentially patented ideas, by leading them to conduct costly and time-consuming searches of existing or pending patents, by requiring complex licensing arrangements, and by raising the costs of using the patented" methods. Id., at 127.
Thus, even as the Federal Circuit develops additional tests for patent-eligibility of method claims, it is incumbent on patent applicants and their lawyers to recognize these tensions in the High Court's attitudes about patenting and to ensure that their claims are clearly directed to patent-eligible subject matter. This is difficult to do prospectively, and there is little comfort that the Federal Circuit will soon provide more concrete standards for satisfying the rather nebulous test enunciated by the Supreme Court (at least until the Court decides the time has come to once again administer some corrective patent jurisprudence to the appellate court). However, unless the Supreme Court (by inclination or constitution of new Justices) changes its rather 19th Century attitude regarding patents (something that Justice Kennedy's distinctions between patents from the Industrial Age and those from the (current) Information Age suggests may be possible), applicants will continue to need to use the few distinctions the Court has provided to protect biotechnology inventions.