Source: https://www.patentdocs.org/2010/07/bilski-v-kappos-what-effects-on-biotechnology-patents.html
Timestamp: 2019-04-19 10:39:09+00:00

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Patent Docs: Bilski v. Kappos: What Effects on Biotechnology Patents?
Bilski v. Kappos: What Effects on Biotechnology Patents?
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.
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).
[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.
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.
A very interesting development, but also potentially very worrying/alarming. I originally thought that AMP v. USPTO might be the first of these cases where the Federal Circuit would grapple with the "fuzzy" ruling from SCOTUS in Bilski about what is patent-eligible under 35 USC 101. But I also recognized the tension between Prometheus and Classen. How the Federal Circuit will reconcile this tension in view of this "fuzzy" Bilski ruling from SCOTUS is anyone's guess.
One point I'd like to add, is that 5 justices seem to believe that little patentable subject matter falls outside the MOT test.
Granted, one of the five justices in this group is retiring, but his likely replacement signed the government's brief endorsing the MOT test.
In addition, no justices seemed to believe that patentable subject matter stretched as broadly as any method producing a “useful, concrete, and tangible result”.
I see the court's "affirmance" of the MOT test as a failsafe - if you can draft a claim for your invention that passes the test, your subject matter is patent-eligible. I also agree that the CAFC's "UCT" test from State Street is (or at least can be) overbroad. I am still thinking about a consistent rationale for making the distinction between Prometheus and Classen (and Metabolite), but it certainly appears that claims reciting technological steps that cannot be cast as mere "data comparisons" are more likely than not to pass muster.

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