The document summarizes a presentation on biotechnology patents that covers topics such as the written description requirement, patentable subject matter, and recent relevant court cases. It provides a primer on biotechnology including DNA, proteins, recombinant DNA technology, and therapeutic biotech products. Examples of patented biotech inventions like Enbrel and monoclonal antibodies are also discussed.
Biotechnology Written Description, Enablement, and Patent Eligibility
1. www.schwabe.com
Biotechnology Patents:
Technology, Written Description,
and Patentable Subject Matter
University of Washington School of Law
Advanced Patent Law
Gary M. Myles, Ph.D.
Schwabe, Williamson & Wyatt
February 1, 2010
Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
2. www.schwabe.com
Topics Covered
• Biotechnology Primer
– The Technology of Biotechnology
– Biotechnology Products
• Written Description Requirement
– U. of California v. Eli Lilly (Fed. Cir. 1997), Superenablement
– Enzo v. Gen-Probe (Fed. Cir. 2002), Rader Dissent
– Ariad v. Lilly (Fed. Cir. 2009)
• Patentable Subject Matter
– In re Bilski (Fed. Cir. 2008), Patentability of Method Claims
– Classen v. Biogen (Fed. Cir. 2008)
– Prometheus v. Mayo (Fed. Cir. 2009)
– Ariad v. Lilly (D. Mass, 2007)
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A Biotechnology Primer
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Biotechnology vs. Pharmaceutical
• Biotechnology: The use of
biomolecules to treat disease
• Pharmaceutical: The use of small
molecules to treat disease
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What are Biomolecules?
• Genetic Material
– DNA
– RNA
• Proteins
– Receptors and Ligands
– Enzymes
– Antibodies
• Lipids
• Carbohydrates
Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
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Therapeutic Biotech Products
• Nucleic Acid-based Therapeutics
– DNA-based Cancer Vaccines
– RNAi and antisense
– Viral Vectors for Gene Therapy
• Protein-based Therapeutics
– Cytokines and Soluble Receptors
– Vaccines against Infectious Disease
– Antibodies and other Immunotherapeutics
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• Therapeutic Proteins
are expressed
through Recombinant
DNA Technology
Recombinant Protein
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Seattle Biotechnology Products Approved for
Marketing by the FDA
BEXXAR Corixa/GlaxoSmithKline CD20-positive
Non-Hodgkins Lymphoma
Cialis ICOS/Eli Lilly Erectile Dysfunction Nov 2003
Enbrel Immunex/Amgen Rheumatoid Arthritis Nov. 1998
Recothrom ZymoGenetics Surgical Bleeding May 2008
Provenge Dendreon Prostate Cancer Pending
Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
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Recombinant Proteins as Therapeutics
• Cytokines, such as
tumor necrosis factor,
promote an
inflammatory
response
• Causes the clinical
problems associated
with autoimmune
disorders such as
rheumatoid arthritis
Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
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Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
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Recombinant Proteins as Therapeutics
• Enbrel (Immunex/Amgen)
– Recombinant soluble TNF•-R
– Binds soluble, extracellular TNF• thereby
preventing its binding to cellular TNF •-R
– Therapeutic efficacy for the auto-immune
disease rheumatoid arthritis (RA)
Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
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Anti-CD20 Antibodies
• Non-Hodgkin’s Lymphoma
– B-cells expressing CD20, a phosphoprotein
found on the surface of >90% of B cells from
peripheral blood or lymphoid organs
Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
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Cialis (Lilly/ICOS)
• Cialis is a
phosphodiesterase
type 5 (PDE5)
inhibitor marketed
for treating erectile
dysfunction
Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
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Patentability of Biotech
Inventions
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The Statutory Requirements
for Patentability
• Prior Art
– 35 U.S.C. § 102 Novelty
• Single reference
• Discloses every element of claimed invention
– 35 U.S.C. § 103 Non-obviousness
• Multiple references
• Predictability
• Motivation to combine
• Teach or suggest claimed invention
• Reasonable expectation of success
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The Statutory Requirements
for Patentability
• Disclosure Requirements
– 35 U.S.C. § 101 Patentability/Utility
• Statutory subject matter
• Specific, substantial, and credible utility
– 35 U.S.C. § 112, ¶ 1 Specification
• Enablement
• Written Description
• Best Mode
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35 U.S.C. § 112, ¶ 1
Written Description Requirement
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35 U.S.C. § 112, ¶ 1 Written Description
The SPECIFICATION shall contain a written
description of the invention, and of the manner
and process of making and using it, in such full,
clear, concise, and exact terms as to enable any
person skilled in the art to which it pertains
… to make and use the same, and shall set
forth the best mode contemplated by the
inventor of carrying out his invention.
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U. of California v. Lilly (Fed. Cir. 1997)
• Facts
– UC disclosed:
• Cloned rat cDNA encoding insulin protein
• Amino acid sequences of human insulin protein
• General method for obtaining the human cDNA
– UC claimed:
1. A recombinant plasmid replicable in procaryotic
host containing within its nucleotide sequence a
subsequence having the structure of the reverse
transcript of an mRNA of a vertebrate, which mRNA
encodes insulin.
5. A recombinant procaryotic microorganism modified
so that it contains a nucleotide sequence having the
structure of the reverse transcript of an mRNA of a
human, which mRNA encodes insulin.
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U. of California v. Lilly (Fed. Cir. 1997)
• District Court
– Held claims invalid under § 112, ¶ 1,
because “the specification, although it
provided an adequate written description of
rat cDNA, did not provide an adequate
written description of the cDNA required by
the asserted claims.”
Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
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U. of California v. Lilly (Fed. Cir. 1997)
• Federal Circuit Upholds District Court
– Claim 5 invalid
• “whether or not [Example 6] provides an enabling disclosure,
it does not provide a written description of the cDNA encoding
human insulin.”
– Claim 1 invalid
• A description of rat insulin cDNA is not a description of the
broad classes [genra] of vertebrate or mammalian insulin
cDNA
• A description of a chemical genus ‘requires a precise
definition, such as by structure, formula, [or] chemical name.’
Quoting, Fiers v. Revel 984 F.2d at 1171
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U. of California v. Lilly (Fed. Cir. 1997)
• Written description becomes a super-
enablement requirement
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Enzo v. Gen-Probe (Fed. Cir. 2002)
• Rader Dissent
– History of the Written Description Requirement
• “Written description” first appears in Patent Act of
1793
• Evans v. Eaton (1822), S. Ct. construed
description requirement to be an enablement
requirement
• J.E.M. AG Supply (2001), S. Ct. acknowledged
only enablement as the disclosure quid pro quo of
Patent Act
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Enzo v. Gen-Probe (Fed. Cir. 2002)
• Rader Dissent, cont.
– In re Ruschig (1967), CCPA first separated new WD
requirement from enablement
• To police priority: Whether new claim/amended
claim entitled to priority
• Converted § 132 new matter rejection into § 112
WD rejection
• “The function of the description requirement is to
ensure that the inventor had possession, as of the
filing date of the application relied on, of the
specific subject matter later claimed by him.”
Judge Rich
Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
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Enzo v. Gen-Probe (Fed. Cir. 2002)
• Rader Dissent, cont.
– In re Kaslow (Fed. Cir. 1983)
• “The test for determining compliance with the WD
requirement is whether the disclosure of the
application as originally filed reasonably conveys to
the artisan that the inventor had possession at the
time of the later claimed subject matter, rather
than the presence or absence of literal support in
the specification for the claim language.”
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Ariad v. Lilly (Fed. Cir. 2009)
• Ariad Claims:
95. [A method for reducing, in eukaryotic cells,
the level of expression of genes which are
activated by extracellular influences which
induce NF-•B-mediated intracellular signaling,
the method comprising reducing NF-•B activity
in the cells such that expression of said genes
is reduced], carried out on human cells.
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Ariad v. Lilly (Fed. Cir. 2009)
• District Court
– April 28, 2006, held claims infringed and not
invalid for anticipation, lack of enablement,
and lack of written description
– August 2006, held claims directed to
patentable subject matter (see below)
Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
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Ariad v. Lilly (Fed. Cir. 2009)
• Federal Circuit
– In Rochester v. Searle, held similar method
claims invalid for lack or written description
“A method for selectively inhibiting PGHS-2
activity in a human host, comprising
administering a non-steroidal compound that
selectively inhibits activity of the PGHS-2
gene product to a human host in need of
such treatment.”
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Ariad v. Lilly (Fed. Cir. 2009)
• Federal Circuit
– Rochester v. Searle, cont.
– Patent disclosure did not disclose any suitable
compounds
– Moreover, “Rochester did not present any
evidence that the ordinarily skilled artisan
would be able to identify any compound based
on [the specification’s] vague functional
description.”
Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
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Ariad v. Lilly (Fed. Cir. 2009)
• Federal Circuit
– “Regardless of whether the asserted claims recite a
compound, Ariad still must describe some way of
performing the claimed methods. … the
specification suggests only the use of the three
classes of molecules*** to achieve NF-•B reduction.”
– *** The three classes of molecules include
• Specific Inhibitors
• Dominantly interfering molecules
• Decoy molecules
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Ariad v. Lilly (Fed. Cir. 2009)
• Federal Circuit
“Thus, to satisfy the written description
requirement for the asserted claims, the
specification must demonstrate that Ariad
possessed the claimed methods by
sufficiently disclosing molecules capable of
reducing NF-•B activity.” Capon
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Ariad v. Lilly (Fed. Cir. 2009)
• Federal Circuit
“A vague functional description and an invitation
for further research does not constitute written
disclosure of a specific inhibitor.
***
written description requires more than a ‘mere
wish or plan for obtaining the claimed
chemical invention.’ ” UC v. Eli Lilly
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Ariad v. Lilly (Fed. Cir. 2009)
• Federal Circuit
– Judge Linn’s Concurrance
“I write separately to emphasize … my belief that our
engrafting of a separate written description
requirement onto 35 USC 112, paragraph 1 is
misguided.
***
[S]ection 112, paragraph 1 requires no more of the
specification than a disclosure that is sufficient to
enable a person having ordinary skill in the art to
make and use the invention.”
Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
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Ariad v. Lilly (Fed. Cir. 2009)
• Ariad appeals to Federal Circuit for en banc
review
– Whether 35 U.S.C. § 112, ¶ 1, contains a written
description requirement separate from an enablement
requirement
– If a separate written description requirement is set
forth in the statute, what is the scope and purpose of
the requirement?
• On August 21, 2009, Federal Circuit grants en
banc review, vacating the court’s April 3, 2009
opinion
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Ariad v. Lilly (Fed. Cir. 2009)
• Ariad Amicus Brief
• Lilly Amicus Brief
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Practice Tips – Claim Drafting
• Broad claims • Better claims
• The goal is to get valid claims that will
read on a competitor’s infringing
composition/method/device
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Practice Tip –
Draft Nested Claims from Broad to
Narrow
1. Broad Independent Claim
2. Narrow Dependent Claim
3. Still Narrower Dependent Claim
4. Narrowest “Picture” Claim
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Practice Tips – The Specification
• Support broad claims with multiple
actual and prophetic examples
representative of the full claim scope
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Practice Tip --
Disclosure of Single Embodiments is Risky
Claim Construction
OK if construed reads on:
· Your commercial product
· Competitor’s commercial product
35 U.S.C. § 112, ¶1
Bend, OR | Portland, OR | Salem, OR | Seattle, WA |
“Invalid”
Vancouver, WA
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Practice Tip --
Disclose Multiple Embodiments
Claim Construction
35 U.S.C. § 112, ¶1
“Not Invalid”
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35 U.S.C. § 101
Utility/Patentable Subject Matter
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35 U.S.C. §101 Inventions
Patentable/Utility
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
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The Utility Requirement
• Historically was rarely an obstacle to a
patent
• In the late 1990s, became a substantial
hurdle in chemistry and biotechnology
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The Utility Requirement
• Lowell v. Lewis (MA 1817), Justice Story
– “All that the law requires is, that the invention
should not be frivolous or injurious to the well-
being, good policy, or sound morals of society.
… But if the invention steers wide of these
objections, whether it be more or less useful is a
circumstance very material to the interest of the
patentee, but of no importance to the public. If it
not be extensively useful, it will silently sink into
contempt and disregard.”
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The Utility Requirement
• Brenner v. Manson (S. Ct., 1966), Justice Fortas
– Due to the unpredictability of the art, disclosure not sufficient
to show likelihood that the steroid produced would function
similar to its homologues (i.e. no credible utility).
– “A process patent in the chemical field, which has not been
developed and pointed to the degree of specific utility,
creates a monopoly of knowledge which should be granted
only if clearly commanded by the statute.”
– “The basic quid pro quo contemplated by the Constitution
and Congress for granting a patent monopoly is the benefit
derived by the public from an invention with substantial
utility.”
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The Utility Requirement
• Utility Guidelines (USPTO 1999)
– An invention fulfills the utility requirement if:
• The invention has a well-established use (well
known, immediately apparent) in the art
OR
• The applicant has disclosed
– a specific utility for the subject matter claimed
– a substantial, real world, utility
– A credible utility that is logical, factual, operable to a
PHOSA
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35 U.S.C. §101 Inventions
Patentable/Utility
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
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Patentable Subject Matter:
Fundamental Principles
• Funk Bros. v. Kalo (S.Ct. 1948)
– Mixed culture of root-nodule bacteria for inoculating seeds of
leguminous plants
• No patentable subject matter
– Each species infects same group of plants
– No species acquires a different use
– No change in the individual bacteria
– No change in their individual utilities
– Use in combination does not improve natural functioning
– “Manifestations of nature are free to all men and reserved exclusively to
none”
• Laws of nature
– E = mc2
– Law of gravity
• Physical phenomena
• Principles
• Abstract ideas
• Products of nature
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Patentable Subject Matter:
Fundamental Principles
• Diamond v. Chakrabarty (S.Ct. 1980)
– Chakrabarty:
• Created oil-eating bacterium
• Claimed “a bacterium from the genus Pseudomonas
containing therein at least two stable energy-
generating plasmids, each of said plasmids providing
a separate hydrocarbon degradative pathway.”
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Patentable Subject Matter:
Fundamental Principles
• Diamond v. Chakrabarty (S.Ct. 1980), cont.
– USPTO
• Rejected claim because a bacterium is
– A “product of nature”
– A living thing
– Supreme Court
• Upholds validity of Chakrabarty’s claim
– “Anything under the sun that is made by man”
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Are These Inventions Patentable?
• “Biologically pure” bacterial culture
– Yes per CCPA in In re Bergy (1977)
– The culture is not a “product of nature” because the culture did not exist in nature in
its pure form
• “Purified and isolated” DNA sequences
– Yes per Fed. Cir. In Amgen v. Chugai (1991)
• “Purified and isolated” stem cells
– Yes per USPTO (see, Q. Todd Dickinson,
www.ogc.doc.gov/ogc/legreg/testimon/106f/dickinson0112.htm)
• Hydrostatically altered Pacific polyploid oysters, which grow larger than normal oysters
– Yes per Ex parte Allen (BPAI 1987)
• A transgenic non-human mammal all of whose germ cells and somatic cells contain a
recombinant activated oncogene sequence …
– Yes per Phil Leder, US Patent No. 4,736,866; “The Harvard Mouse”
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LabCorp v. Metabolite (S.Ct. 2006)
• Claim at issue
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
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LabCorp v. Metabolite (S.Ct. 2006)
• Lower Courts
– Upheld the patent claim’s validity and found
that LabCorp infringed the claim
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LabCorp v. Metabolite (S.Ct. 2006)
• Supreme Court
– Granted cert to determine whether claim is
invalid because it seeks to “claim a monopoly
over a basic scientific relationship”
(cobalamin/folate = homocysteine)
– Dismissed writ of certiorari as improvidently
granted
– Justice Breyer dissented (joined by Stevens
and Souter)
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LabCorp v. Metabolite (S.Ct. 2006)
• Breyer dissent
– Laws of nature are unpatentable because “sometimes
too much patent protection can impede rather than
‘promote the Progress of Science and useful Arts.’ ”
U.S. Const., Art 1, § 8
– Policy for Unpatentable Subject Matter
• “the enormous potential for rent seeking that would be created
if property rights could be obtained in [those basic principles]”
and
• “the enormous transaction costs that would be imposed on
would-be users”
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LabCorp v. Metabolite (S.Ct. 2006)
• LabCorp
– “If the Court were to uphold this vague claim,
anyone could obtain a patent on any scientific
correlation -- that there is a link between fact A
and fact B -- merely by drafting a patent
claiming no more than ‘test for fact A and
correlate with fact B’ … ”
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LabCorp v. Metabolite (S.Ct. 2006)
• Metabolite
– Detecting a vitamin deficiency, with discrete
testing and correlating steps, is:
• Patentable as a “process”
• A patentable “application of a law of nature”
– (1) It entails a physical transformation of matter
» alteration of a blood sample during whatever test is used …
– (2) It produces a useful, concrete, and tangible result
» detection of a vitamin deficiency
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LabCorp v. Metabolite (S.Ct. 2006)
• Breyer
– “There can be little doubt that the correlation between
homocysteine and vitamin deficiency set forth in claim
13 is a ‘natural phenomenon’
– “[t]he process described in claim 13 is not a process
for transforming blood or any other matter. Claim 13’s
process instructs the user to
• (1) obtain test results and
• (2) think about them”
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A Few Questions?
• Should a method for diagnosing a disease based
on taking a measurement and correlating that
measurement with a disease state be
patentable?
• Should we reward the intellectual contribution
even in the absence of a physical
transformation?
• Why should a physical transformation be
required?
• Isn’t the key intellectual contribution the
observation of the relationship, not the
methodology for making a measurement?
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In re Bilski (Fed. Cir. 2008)
Claim 1. A method for managing the
consumption risk costs of a commodity sold
by a commodity provider at a fixed price
comprising the steps of:
(a) initiating a series of transactions … ;
(b) identifying market participants … ; and
(c) initiating a series of transactions … .
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In re Bilski (Fed. Cir. 2008)
• Examiner rejected claims as directed to
unpatentable subject matter under § 101
• BPAI affirmed the Examiner’s § 101 rejections
• Federal Circuit ordered en banc review and, on
October 30, 2008, issued a 9-3 decision affirming
BPAI’s § 101 rejections
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In re Bilski (Fed. Cir. 2008)
• Federal Circuit (Citing Diamond v. Diehr)
– A “process” under § 101 excludes:
• Fundamental principles
– Laws of nature
– Natural phenomena
– Abstract ideas (including mathematical algorithms)
• Mental processes
– Processes of human thinking
– Systems that depend for their operation on human
intelligence alone
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In re Bilski (Fed. Cir. 2008)
• The § 101 inquiry
– If a claim preempts substantially all uses of
a fundamental principle, it is unpatentable
subject matter
– If a claim preempts only a particular
application of a fundamental principle, it is
patentable subject matter
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In re Bilski (Fed. Cir. 2008)
• Federal Circuit applies a machine-or-
transformation test to determine
preemption of a fundamental principle
– A claimed process is directed to patentable
subject matter under § 101 if it:
(1) is tied to a particular machine or apparatus; or
(2) transforms a particular article into a different
state or thing
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The Supreme Court will Review In re Bilski
• Questions presented:
– Whether the CAFC 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. . . .
– Whether the Federal Circuit’s “machine-or-
transformation” test for patent eligibility . . .
contradicts the clear Congressional intent that
patents protect “method[s] of doing or
conducting business.” 35 U.S.C. § 273
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Diagnostic Tools and Personalized Medicine:
The Future of Biotechnology?
• Genomic Personalized Medicine
– Information about a patient's genotype or
gene expression profile used to tailor
medical care
• Provide a specific therapy for an individual's
disease
• Initiate a preventative measure suited to an
individual
• “Rational drug design" based on knowledge of
disease pathophysiology
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Diagnostic Tools and Personalized Medicine:
The Future of Biotechnology?
• Breast Cancer as an Example
– Identify overexpression of HER2 in a subset of
breast cancer patients
– Indicate treatment of HER2 positive patients
with HER2-specific therapy (e.g., Herceptin)
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Classen v. Biogen (DC MD 2006)
• Classen claims:
– A method of determining whether an
immunization schedule affects the incidence
or severity of a chronic immune-mediated
disorder…, comprising
• immunization …; and
• comparison of the incidence of chronic immune
mediated disorders … relative to a control group
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Classen v. Biogen (DC MD 2006)
• DC MD
– “The [ ] patent does not claim a specific technique or
technical process of testing [ ] safety
– Instead, the [ ] patent describes only a general inquiry
of whether the proposed correlation between an
immunization schedule and the incidence of chronic
disorders exists
– As such, the process is indistinguishable from the idea
itself
– Accordingly, the [ ] patent seeks to patent an
unpatentable natural phenomenon”
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Classen v. Biogen (CAFC 2008)
• Federal Circuit
– “In light of our decision in In re Bilski … 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’
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86. www.schwabe.com
Ariad v. Eli Lilly (DC MA 2007)
• Claim:
A method of inhibiting the expression of a gene
whose transcription is regulated by NF-•B in a
eukaryotic cell comprising the step of:
– reducing NF-•B activity in the cell such that the
expression of said gene is inhibited
• No particular agent or substance need be used,
nor any particular steps performed, to reduce
NF-•B activity in order to practice the invention
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Ariad v. Eli Lilly (DC MA 2007)
• Lilly alleged that Ariad’s claims are directed to
unpatentable subject matter
– The claims encompass the NF-•B autoregulatory loop, a natural
process in cells that operates to reduce the activity of NF-•B
– Natural phenomena are excluded from patentable subject matter
• Ariad alleged that the claims are valid because:
– Patent claims a process, which is subject matter specifically
allowed by statute; and
– Autoregulatory Loop is only a theory and has not been proven to
exist in human cells in vivo
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88. www.schwabe.com
Ariad v. Eli Lilly (DC Mass 2007)
• DC Mass
– “While not all processes are patentable, I find that Lilly has
failed to show that the proposed model of the Autoregulatory
Loop actually exists in nature and thus that a natural
phenomenon is encompassed by the [ ] patent’s claims”
• Holman’s Biotech IP Blog
– “The court’s reasoning in Ariad was quite bizarre … The court
appears to have been bamboozled into adopting an unduly
narrow definition of the relevant natural phenomenon, and
then found that the evidence supporting this narrowly defined
phenomenon was insufficient to overcome the statutory
presumption in favor of patent validity”
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89. www.schwabe.com
Prometheus v. Mayo (SD CA 2008)
• Prometheus Claim 1
– A method of optimizing therapeutic efficacy…,
comprising:
• administering a drug providing 6-thioguanine to a
subject…; and
• determining the level of 6-thioguanine in said
subject … wherein
– 6-thioguanine less than about 230 pmol per 8x108 red
blood cells indicates a need to increase the amount of
said drug
– 6-thioguanine greater than about 400 pmol per 8x108 red
blood cells indicates a need to decrease the amount of
said drug
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90. www.schwabe.com
Prometheus v. Mayo (SD CA 2008)
• District Court
– Claimed correlations between certain thiopurine drug
metabolite levels and therapeutic efficacy and toxicity
are natural phenomena
• Result from innate metabolic activity in human body
• Inventors did not “create” the correlation; the correlation
results from a natural body process
• Claims wholly preempt use of the correlations
– The only practical use of the correlation is in drug treatment for
autoimmune diseases
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91. www.schwabe.com
Prometheus v. Mayo (Fed. Cir. 2009)
• September 2009, Federal Circuit reverses
district court upholding patentability of
methods for calibrating a drug dosage
under 35 USC § 101
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Prometheus v. Mayo (Fed. Cir. 2009)
• Federal Circuit, cont.
– Applying the Bilski Machine or Transformation
test, CAFC rules that the required
administration of a drug “transforms an article
into a different state or thing.”
– Distinguish diagnosis claims that merely
require data gathering and correlation rather
than an injection or drugs
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93. www.schwabe.com
Prometheus v. Mayo
• In October 2009, Mayo Clinic filed a petition for
writ of certiorari to the U.S. Supreme Court
• Question Presented
“Whether 35 U.S.C. § 101 is satisfied by a patent
claim that covers observed correlations between
patient test results and patient health, so that the
claim effectively preempts all uses of these
naturally occurring correlations”
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94. www.schwabe.com
Lingering Question
• In a method claim, is a physical
transformation a meaningful distinction
over an intellectual transformation?
• Compare
– Method of optimizing, comprising measuring,
administering, and measuring
– Method of diagnosing, comprising measuring,
correlating measurement to disease
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95. www.schwabe.com
To Do List:
• Is the death of a written description requirement
that is separate from the enablement
requirement imminent?
– Read amicus briefs in and be on the lookout for Ariad
v. Lilly (Fed. Circ. 2010)
• Will the machine or transformation test for
determining patentability of methods survive?
– Are diagnostic method claims doomed?
– Be on the lookout for Bilski v. Kappos (S.Ct. 2010)
Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA
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Thank You!
Gary M. Myles, Ph.D.
Schwabe, Williamson & Wyatt
gmyles@schwabe.com
(206) 407-1513
Bend, OR | Portland, OR | Salem, OR | Seattle, WA | Vancouver, WA