Transcript Bilski: Will It Affect Bioscience Method Claims? CLE hours

Bilski: Will It Affect
Bioscience Method Claims?
Mark T. Skoog, Ph.D.
Merchant & Gould
MIPLA Biotech/Chemical Law Committee
November 2009
Introduction
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Before Bilski
Bilski Briefly
Amicus Briefs
Claims to Consider
– From the Briefs
– From A Pending Application
• A Recent Federal Circuit Decision
• What Is To Be Done?
Introduction, cont’d
• Patentable subject matter (35
U.S.C. § 101)
• Not patentability (§§§ 102, 103,
or 112)
Before Bilski
• Anything under the sun that is made
by man
– A useful, concrete, and tangible result
was persuasive, and little need to
excuse data gathering
– Certainly no need to recite or assert a
machine or transformation
– Who could possibly think that
detecting, assaying, etc. could be done
without a machine or transformation?
The Bilski Test
A claimed process is patentable under
35 U.S.C. § 101 if (a) the process is
tied to a particular machine or
apparatus, or (b)§ the process
transforms a particular article into a
different state or thing (The Machine
or Transformation Test).
The Bilski Test, cont’d
Involvement of the machine or
transformation must not be
insignificant, extra-solution activity,
such as gathering data.
A claim simply to natural phenomena,
mental processes, and/or abstract
ideas is not patentable.
The Bilski Questions
1. Whether the Federal Circuit erred by
holding that a “process” must be tied to a
particular machine or apparatus, or
transform a particular article into a different
state or thing (“machine-or-transformation”
test), to be eligible for patenting under 35
U.S.C. § 101, despite this Court’s precedent
declining to limit the broad statutory grant
of patent eligibility for “any” new and
useful process beyond excluding patents for
“laws of nature, physical phenomena, and
abstract ideas.”
The Bilski Questions
2. Whether the Federal Circuit’s
“machine-or-transformation” test for
patent eligibility, which effectively
forecloses meaningful patent
protection to many business methods,
contradicts the clear Congressional
intent that patents protect “method[s]
of doing or conducting business.” 35
U.S.C. § 273.
The Amicus Briefs
• Invoke
– “Any”
– The Wisdom of the Supreme Court
• Flexibility (citing KSR and Festo)
– Personalized Medicine
– Thomas Jefferson or Abraham
Lincoln
The Amicus Briefs
• Decry
– Rigid Tests
– Destruction of the Pharmaceutical and
Biotech Industries and their existing
patent portfolios
– Increased Suffering and Death
PhRMA’s Brief
• “[S]ignificant risk”
– that lower courts will find “critical medical
processes that make use of pharmaceuticals”
to be unpatentable
• Transformation
– Use of pharmaceuticals involves
transformation of the medicine and the
patient
• Doubt
– Due to Prometheus case
– For medical processes that do not use
pharmaceuticals
PhRMA’s Brief
• If Bilski test stands:
– Under that test, medical processes,
particularly processes involving
administering pharmaceuticals, are
patentable; or
– The test is limited to business method
patents and other tests may be
appropriate for medical-process or
other patents.
Method of Treatment Claims
• PhRMA worries
• Practitioners worry less about
method of treatment claims and
more about diagnostic methods
– Clearly there’s a transformation
involved!
• And, the Federal Circuit agrees
BIO’s Brief
• Claims to diagnosing or prognosing
diseases and to biomarkers
– Processes employing correlations
– These process inventions are not
abstract ideas, laws of nature, or
natural phenomena. Rather each
provides a useful and tangible end,
potentially bringing the industry
closer to addressing serious societal
issues, including those due to
unsolved medical needs.
BIO’s Brief
– Inventions that also are specific and
concrete (are not abstract ideas), that
result from human intervention (are
not natural phenomena) and that are
applications yielding a new and useful
end (are not laws of nature).
BIO’s Hypothetical Claims
1. A method of diagnosing Disease X
in a patient in need thereof, which
comprises detecting elevated
Protein Y levels in a body fluid
sample from said patient.
BIO’s Hypothetical Claims
2. A method of determining whether a
malignant tumor in a patient in need
thereof is susceptible to Anti-Cancer
Drug X, which comprises measuring the
level of expression of Gene Y in said
malignant tumor compared to a control
non-malignant tissue from said patient,
wherein expression levels of Gene Y in
said malignant tumor greater than twice
that of said control non-malignant tissue
correlate with susceptibility of said
tumor to Anti-Cancer Drug X.
BIO’s Hypothetical Claims
3. A process for determining blood
oxygenation including: determining
a blood pressure pulse wave;
deriving a blood oxygenation
parameter from the pulse wave
using equation X; and
communicating the blood
oxygenation parameter to medical
personnel.
BIO’s Real Claims
• U.S. Patent No. 5,674,680
– 1. A method for predicting the time of
onset of the development of clinical
signs of immunodeficiency [AIDS] …
determining … ; and
correlating … .
– Used to develop drug cocktails
BIO’s Real Claims
• U.S. Patent No. 6,395,481
– 21. A method for screening
individuals for variation in
glucuronidation activity comprising
detecting polymorphisms … ; and
determining … .
– Used to identify patients who require
a low dose of chemotherapy for
colorectal cancer.
BIO’s Real Claims
• U.S. Patent No. 4,968,603
– 1. A method for screening patients to
determine disease status, said method
comprising: measuring … HER-2 …
gene… ; and
classifying … .
– Currently, HER-2 testing is required
to determine whether a breast cancer
patient can receive Herceptin therapy.
Other Amicus Briefs
• Caris Diagnostics
• Medtronic
• Prometheus Laboratories
Cases Discussed by Amici
• Three Supreme Court Justices, in the dissent in
Lab Corp., would have found a diagnostic
method to be unpatentable subject matter.
Lab. Corp. of Am. Holdings v. Metabolite
Labs., Inc., 126 S. Ct. 2921 (2006)
• 13. A method for detecting a deficiency of
cobalamin or folate … comprising … :
assaying … elevated level of … homocysteine;
and
correlating …with a deficiency of cobalamin or
folate.
Cases Discussed by Amici
• In an unpublished decision that’s shorter
than the claim, the Federal Circuit stated:
– “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.”
– Non-precedential disposition 2008 WL
5273107 (Fed. Cir. Dec. 19, 2008)
Cases Discussed by Amici
1. 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.
A Recent Federal Circuit
Decision
• Prometheus v. Mayo
Prometheus v. Mayo
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 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.
Prometheus v. Mayo
• Since court found a transformation, they
did not address the machine prong of the
test
• “The 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.”
Prometheus v. Mayo
• “The asserted claims are in effect claims
to methods of treatment, which are
always transformative when a defined
group of drugs is administered to the
body to ameliorate the effects of an
undesired condition.”
• It’s a metabolite that’s active, so a
transformation “is the entire purpose of
administering these drugs.”
Prometheus v. Mayo
• “Determining the levels of 6-TG or
6-MMP in a subject necessarily
involves a transformation, for those
levels cannot be determined by
mere inspection.”
• Although the “wherein” clauses are
mental steps, they are only part of
the claimed method.
Classen and Prometheus
• Classen wasn’t treating
– Figuring out how to treat others
– “Mere” data gathering
Supreme Court Oral
Arguments
• And, the justices said …
A Case Study
• Independent Claims
– 1. A method for predicting the
response of a patient to a drug
employed in the treatment of X
condition, the method comprising:
determining the level of Y gene
expression in the patient’s tissue.
A Case Study
– 2. A method for monitoring drug
response in a patient receiving
treatment for …
– 3. A method of determining the
likelihood of a subject developing …
A Case Study
• The Specification
– The isolated tissue was treated with A
[a transformation].
– The quality and quantity of RNA was
measured by spectrometry and gel
electrophoresis [in a process that
includes a machine and a
transformation].
A Case Study
– Gene expression profiling was
performed by a microarray procedure
that is known in the art [and that
involves a transformation and a
machine].
– Y, which is a secreted protein, can be
detected in a tissue sample in
measurable quantities [using a process
that involves a transformation and a
machine].
What Is To Be Done?
• For applications being written:
– Include disclosure satisfying machine
or transformation test; and
– Include disclosure for traditional
claims
• For applications filed but not yet
examined:
– Wait (and hope for clear and speedy
resolution)
What Is To Be Done?
– The wait could be long or short:
• In Bilski, Supreme Court addresses only
business methods
• Remand to Federal Circuit
• USPTO changes its examination
procedures to reflect decisions of
Supreme Court and Federal Circuit
What Is To Be Done?
• For applications currently being
examined:
– Continue prosecution until decision(s)
rendered
– Suspend prosecution
– Appeal
– Accept narrow claims and file a
continuation or divisional
What Is To Be Done?
• For issued patents with too narrow
claims:
– Continuation or divisional pending?
– Reissue?
Thank You
Mark Skoog
[email protected]