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
representative:

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 8×10⁸ 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 8×10⁸ 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.