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Medical Method Held Not Patentable
Recent Appeals Decision finds Medical Procedure is not Patentable Subject Matter, Citing In re Bilski
by John R. Harris
A recent decision from the Court of Appeals for the Federal Circuit
(CAFC) has raised serious questions about how to patent processes or
methods for diagnosing or treating diseases. The case is Classen Immunotherapies, Inc. v. Biogen IDEC et al.,
Case No. 2006-1634, -1649 (Fed. Cir. Dec. 19, 2008)
(nonprecedential). The patent involved in the case was U.S. Patent
No. 5,723,283 (“the ‘283 Patent”) entitled “Method and Composition
for an Early Vaccine to Protect Against Both Common Infectious Diseases
and Chronic Immune Mediated Disorders or Their Sequelae,” owned by
Classen Immunotherapies, Inc., a company based in Maryland.
Classen Immunotherapies had sued a number of pharmaceutical and
other health-care companies for patent infringement in Maryland
including GlaxoSmithKline, Merck & Co., Chiron Corporation, and
various Kaiser-Permanente entities. The defendants in the case
obtained a summary judgment from the district court in Maryland that
the claims of the ‘283 Patent were invalid under 35 U.S.C. § 101, which
is known as the “patentable subject matter” requirement for
patentability. This part of the patent laws states that “whoever
invents or discovers any new and useful process, machine, manufacture,
or composition of matter, or any new and useful improvement thereof,
may obtain a patent therefor, subject to the conditions and
requirements of this title [Title 35, U.S.C.]”
Over the years, the case law interpreting this statute has explored
the extent to which a process or an improvement to a process may be
considered patentable subject matter. Many patents have been
issued by the U.S. Patent & Trademark Office for various types of
processes (also called procedures, methods, etc.). These so-called
“method patents” or “process patents” cover a wide range of
technological fields, including computer software, materials
processing, chemistry and chemical manufacture, business methods, as
well as medical and surgical procedures.
Claim 1 of the ‘283 Patent involved a method for determining the effect of an immunization schedule:
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.
Note that the claim in the patent did not involve any specific type
of immunization – just the effect of an immunization
schedule. Note also that the last step of the process (“comparing
…”) arguably does not result in any specific recited benefit or utility
to the treatment group.
The case did not involve the patentability of the method under the
criteria of novelty and nonobviousness, which are more frequently the
source of a challenge to patentability of an invention. The U.S.
Patent Office considered those issues to some degree when deciding to
grant the patent in 1998. There were no questions about novelty or
nonobviousness mentioned by the CAFC in its opinion.
In finding claim 1 unpatentable, the CAFC simply said that:
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.
This was the extent of the opinion – one short paragraph. But
the message from the court was clear: the reasoning of the In re Bilski case applies to claims of this nature. (In re Bernard L. Bilski and Rand A. Warsaw, Case No. 2007-1130, October 30, 2008). In that case, the CAFC held in an en banc
decision that, in order to constitute patentable subject matter, a
process must satisfy either one (or both) of the following
tests: (1) the process must be tied to a particular machine or
apparatus, and/or (2) the process must physically transform an article
into a different state or thing. These tests are called the
“machine-or-transformation” test, although in actuality two separate
tests are involved. (For more information about the In re Bilski decision, see the October 2008 MMM Intellectual Property NewsFlash, “New Appeals Decision Will Affect Computer and Process Patents - Case Summary of In re Bilski Decision: Patentable Processes Must Involve Physical Transformation or Be Tied to a Particular Machine.”)
 The Classen decision was designated by the CAFC as
“nonprecedential.” Prior to December 1, 2006, the CAFC was fairly
harsh in prohibiting the citation of nonprecedential opinions in
arguments and briefs before the court. Under the current rules of
practice before the CAFC (namely, Rule 32.1), parties may now cite a
nonprecedential opinion in briefs and arguments. But it is not
clear what effect or influence such nonprecedential opinions will have
on lower courts or on the CAFC itself. The designation of the
decision as nonprecedential might be viewed as a signal to the
community that the court is not through with the question of the
patentability of medical procedures, and perhaps has significant
misgivings about the ruling or its effect.
According to CAFC Practice Rule 32.1(b), an opinion or order which
is designated as nonprecedential is one determined by the panel issuing
it as not adding significantly to the body of law. In the Classen
case, this suggests that the deciding panel of three judges believed
that the language of the claim was so clearly nontransformative or tied
to a particular machine that the issue was not worth significant
discussion. The troubling part of the case is the implicit
extension of the In re Bilski reasoning to medical procedures
patents, and the failure to discuss and consider the transformative
effect of immunization of mammals from a prior susceptible state to a
later, immunized, and arguably less disease-susceptible state. But
the claim stopped with the “comparing…” step and did not include any
further steps that could be viewed as transformative.
Some partial comfort might be drawn from the fact that the claim in the ‘283 Patent was clearly not directed to immunizing mammals
– it was directed to the notion of “determining whether an immunization
schedule affects the … disorder.” This claim thus clearly lacked
any readily identifiable transformative effect, as the potential
beneficial effort of the alleged invention is assessment of an
immunization schedule, not facilitation of a treatment itself.
Perhaps (and this is the author’s speculation), the Classen
invention would have more likely survived the subject-matter validity
challenge if it included steps designed to be transformative on the
state of mammals from unimmunized to immunized. Or perhaps (and
again speculation), had the inventor further studied the various
markers recited in the claim and determined some modification of the
immunization schedule, and had that modification resulted in a
measurable improvement in the disease incidence of the treatment group
of mammals, the patentable subject matter challenge would have been a
closer question.
The claims in the Classen case are similar to those addressed in a 2006 U.S. Supreme Court decision of Laboratory Corp. of America (LabCorp) v. Metabolite Laboratories, Inc., 548 U.S. 124 (2006). That case revolved around claim 13 of Metabolite’s U.S. Patent No. 4,940,658:
13. A
method for detecting a deficiency of cobalamin or folate in
warm-blooded animals comprising 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.
The question presented in that case was as follows: Whether a
method patent setting forth an indefinite, undescribed, and
non-enabling step directing a party simply to “correlat[e]” test
results can validly claim a monopoly over a basic scientific
relationship used in medical treatment such that any doctor necessarily
infringes the patent merely by thinking about the relationship after
looking at a test result? The Supreme Court did not reach this
question on the merits and dismissed a petition for certiorari on
procedural grounds. But three justices in a dissenting opinion,
led by Justice Breyer, would have heard the case and would have found
the patent invalid:
There can be little doubt that the correlation between homocysteine
and vitamin deficiency set forth in claim 13 is a “natural phenomenon.”
. . . [The claimed] process instructs the user to (1)obtain test
results and (2) think about them. . . . At most, respondents have
simply described the natural law at issue in the abstract patent
language of a “process.” But they cannot avoid the fact that the
process is no more than an instruction to read some numbers in light of
medical knowledge.
The dissent in the LabCorp case also took shots at the State Street Bank decision that started the business method patent craze, and arguably influenced the CAFC to some degree in its In re Bilski ruling.
These rulings raise questions about the viability of patents that
involve medical procedures and patents that are not tied closely to
particular machines (such as particular medical devices) or clearly
result in some kind of tangible, visible, measurable
transformation. One particular question from the Classen
case is whether a patient (a mammal) that receives immunizations
according to a schedule would not be considered a transformation of an
article (a mammal) from one state (unimmunized) to another state
(immunized)? Is a mammal or other biological entity not considered
an “article” that can be transformed by a method? But note
carefully – the claim did not recite that any animals in the treatment
group were transformed by the immunization.
Moreover, certain medical diagnosis procedures, such as early
diagnosis of cancer by detection of tumor markers, are not clearly
“tied to a particular machine or apparatus” nor do they “transform a
particular article into a different state or thing.” There are
hundreds of patents directed to these procedures. Will diagnosis
procedure patents be held invalid based on the LabCorp, Classen, and In re Bilski cases?
Another case working its way through the CAFC may provide some more answers soon. The case of Prometheus Laboratories, Inc. v. Mayo Collaborative Services and Mayo Clinic Rochester, Case No. 2008-1403 (CAFC), involves the following medical treatment procedure claim:
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 a level of 6-thioguanine or 6-methyl-mercaptopurine in said
subject having said immune-mediated gastrointestinal disorder,
wherein
a level of 6-thioguanine less than about 230 pmol per 8 x 108 red blood
cells indicates a need to increase the amount of said drug subsequently
administered to said subject and wherein a level of 6-thioguanine
greater than about 400 pmol per 8 x 108 red blood cells or a level of
6-methyl-mercaptopurine greater than about 7000 pmol per 8 x 108 red
blood cells indicates a need to decrease the amount of said drug.
Note that this claim recites “determining a level” of a substance as
its final step, which does not immediately seem to involve either a
distinct transformation or a particular machine.
The district court in this case relied heavily upon the dissent in the LabCorp case in finding no patentable subject matter. The American Intellectual Property Law Association (AIPLA) has filed an amicus
brief in this case urging the CAFC to not proscribe patents for the
entire field of biomedical diagnostic tools. It is widely accepted
that such tools are very important in medicine and that the courts
should not remove the incentives to innovate in this area. (The
case is still in the briefing stage as of this writing.)
It is apparent that the Supreme Court and the CAFC are in a mood to
more closely scrutinize any kind of process patent for patentable
subject matter. Claims of already-issued patents that do not
readily satisfy the “machine-or-transformation” test are now at greater
risk of being held invalid if an attempt is made to enforce
them. Companies in the medical procedures fields that are seeking
patents may want to re-examine their patent filings and, in the right
case, file amended claim sets or reissue applications.
If you have questions about the Classen decision, the LabCorp decision, the In re Bilski
decision, medical procedures or diagnostics patents, medical devices
patents, patent application writing, patent enforceability, or other
issues involved in the patent system, please contact either of the
following attorneys:
John R. Harris, Author and Editor (jrh@mmmlaw.com) 404.504.7720
Ping Wang, M.D., Partner, Editor (pwang@mmmlaw.com) 202.842.0217
NOTE: This article represents the
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