Transcript Document

Patent Eligible
Subject Matter
in the United States
Jorge A. Goldstein, Ph.D., Esq.
Washington, DC, USA
July 21, 2015International Judicial
Academy
Washington DC March 26, 2010
1091840.1 March 25, 2010
Outline
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Patents in multiple dimensions
Patent “eligibility” vs. “ability.”
The US statutory scheme
Eligibility: from Chakrabarty to
Bilski
• Cutting edge issues:
Diagnostic genetics
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Patents In Six Dimensions
Historical: Venetian Code; Statute of Monopolies;
French Assembly; Thomas Jefferson
Constitutional - legal: U.S. Constitution Art I,
Section 8 “…to promote the progress of science
and the useful arts…”
Human: Creative ideas belong to creator
Technological: Exclusivity promotes disclosure
Commercial: Exclusivity promotes investment in
risky enterprises
Political - economic: The developing world
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Examples from the Extremes
• Ideal: A synthetic drug patented
worldwide by Merck (or, after US
Bayh Dole Act, by the Harvard
Chemistry Department and licensed
to Merck), and used in France.
• Cutting edge: An online business
method patented worldwide by the
Harvard Business School, and used
in Gambia.
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Patent Eligibility
• What subject matter is eligible?
– Easy:
• Machines, synthetic drugs, methods of
industrial manufacture
– Harder:
• Purified natural products (antibiotics,
genes?); Live products? (microbes,
plants, animals?)
• Software? Algorithms?
• New methods of doing business?
• Natural phenomena in disguise? (genetic
correlations?)
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Patentability
What are the universal requirements for
obtaining patent protection on an eligible
invention?
– Usefulness / industrial applicability
– Novelty
– Non obviousness / inventive step
– A proper filing with full disclosure
• Full description
• Reproducibility
• (In the US: Best mode)
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U.S. Statute on Eligibility
• 35 U.S.C. § 101
– 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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Legal Precedents in the U.S. :
Eligible Products of Nature
• Such patents claim isolated
molecules not their natural form:
– 1912: Adrenalin… practically free
from gland tissue
– 1970: Prostaglandin… in
sufficiently pure form…
– 1979: Strawberry flavoring
comprising... substantially pure
2-methyl-2-pentanoic acid
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Legal Precedents in the US:
Eligible Live Inventions
• 1977: Biologically pure culture of
Streptomyces vellosus
• 1980: Diamond v. Chakrabarty (Supreme Ct)
– Human-made micro-organisms eligible.
– Broad dicta: “…anything under the sun
made by man…”
• 1985: Ex Parte Hibberd (USPTO Board)
– Plants eligible (in addition to plant patents
and the UPOV-based PVPA.)
• 1987: Ex Parte Allen (USPTO Commissioner)
– Higher animals eligible
– 1988: First animal patent issued to Harvard
University for a cancer-susceptible
transgenic mouse (the “onco-mouse”)
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Patents for Human Therapeutic Genes:
Human Erythropoietin
Amgen’s US Patent 4,703,008
Issued Oct 1987.
Claim 1:
1. A purified and isolated DNA
sequence encoding erythropoietin, said
DNA sequence selected from the group
consisting of:
(a) the DNA sequences set out in FIGS. 5
and 6 or their complementary strands [the
human erythropoietin gene] …
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First Detour
Q:
A:
Who “owns” your genes?
Depends if they are:
(1)in your body (you do) or
(2)having been extracted,
and now in a test tube
(the hospital or lab)
See: Moore v. Regents of U. of California (1990)
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Detour (II)
Q:
A:
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If you arrange with the lab for
you to preserve ownership of
your genes after isolation, who
owns them?
You do.
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Detour (III)
Q:
A:
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If I have a patent on your
isolated genes, can you
commercialize them?
No. You own the tangible,
personal property, but I own
the intangible, intellectual
property.
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Detour (IV)
Q:
A:
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Can I use my patent on the
isolated genes I now own to stop
you from metabolizing?
Of course not! Patents cover
isolated genes not the genes in
the natural context.
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Patents for Methods of
Human Genetic Diagnoses
• Genetic diagnoses use
correlations between isolated
human gene sequence variants
(e.g. mutants or SNPs) and
disease.
– Examples: Huntington’s (MGH) or
Cystic Fibrosis (U Michigan and
HSC Toronto); BRCA1 and BRCA2
breast cancer (U Utah)
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Second Detour: In re Bilski (2008)
Eligibility of Abstract Methods
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 between said
commodity provider and consumers of said commodity
wherein said consumers purchase said commodity at a
fixed rate based upon historical averages, said fixed
rate corresponding to a risk position of said consumer;
(b) identifying market participants for said commodity
having a counter-risk position to said consumers; and
(c) initiating a series of transactions between said
commodity provider and said market participants at a
second fixed rate such that said series of market
participant transactions balances the risk position of
said series of consumer transactions.
This is a method of hedging risk, i.e., a business method
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Bilski:
Court of Appeals Analysis
• Bilski’s claim is clearly to a process
• Although claim meets the dictionary
definition of a process, that
definition has been limited by the
U.S. Supreme Court, e.g.,
– Eligible processes cannot include
laws of nature, natural phenomena,
or abstract ideas.
– Eligibility requires a two step test: That
the process be tied to (A) a machine or
(B) to transformation of an article
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Analysis of the “Machine
or Transformation” Test
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(A) Machine: Is the Bilski claim to a financial
process tied to a particular machine?
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No, Bilski admitted their claim is not limited to a
particular machine or apparatus
(B) Transformation: What type of things
constitute “articles of matter”?
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Physical objects or substances? YES, “articles”
Electronic signals and data? MAYBE
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If data represents a physical object, e.g., transformation
of data representing body tissues into a visual depiction
on a display? YES, “article.”
Gathering data and making a determination based on
that data? NO, not “article.”
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Application Of “Transformation”
Sub-Test to Bilski facts
So, does the Bilski claim transform an article of
matter?
The data in Bilski’s claims represents legal
relationships and business risks, which are not
physical objects or substances
The data itself is not representative of physical
objects or substances
Thus the claims neither involve the transformation of
any physical object or substance, nor an electronic
signal representative of any physical object or
substance.
Conclusion: Hedge process not eligible under
either machine or transformation
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In October 2009 Bilski was argued
before the Supreme Court
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The USPTO argued for affirmance.
Mr. Bilski argued for reversal.
Case is under advisement.
20 amicus curiae briefs were filed.
One from the American Medical
Association and the American
College of Medical Genetics…why?
– Patents in the fields of diagnostic
genetics and personalized
medicine
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1989: Pure Diagnostic Algorithms
not Eligible - In re Grams
• 1. A method of diagnosing an abnormal
condition in an individual…[with] data resulting
from a plurality of …chemical and biological
constituents… comprising
• [a] performing [a] plurality of clinical
laboratory tests on the individual…
• [b] producing…a first quantity representative
of the condition of the individual;
• [c] comparing the first quantity to a first
predetermined value…
• [d] upon determining…that the individual's
condition is abnormal, successively testing…;
and
• [e] identifying…a subset of parameters
corresponding… to [the] abnormal condition…
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2009: Pharmacodiagnostics Claim
Eligible - Prometheus v Mayo
• A method of optimizing therapeutic efficacy
for treatment of an immune mediated
gastrointestinal disorder, comprising:
• (a) administering a drug providing 6thioguanine to a subject…; and
• (b) determining the level of 6-thioguanine in
said subject…,
• 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…
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Prometheus v Mayo (2009) (cont’d)
• Court of Appeals held that both the steps:
– “(a) administering a drug…” and
– “(b) determining the level…” are
transformative.
The steps are neither just natural
correlations nor data gathering steps
In contrast, the ineligible claims in Grams
were data-gathering steps followed by
an algorithm
Conclusion: Eligible
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2009: Bio-Reference Labs v Ipsogen
• U.S.Patent No.7,429,456, Claim 1:
An in vitro method to determine the presence
of the G1849T mutation in the JAK2 gene in a
human patient comprising:
a) obtaining and analyzing a nucleic acid sample
from the human patient;
b) detecting a T in the JAK2 gene at position
2343 of SEQ ID NO 2 in the sample; and
c) recording the presence of a T in the JAK2
gene at position 2343 of SEQ ID NO 2 in the
sample.
Is this claim patent eligible under Bilski and
Grams?
Stay tuned…
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2009: Association for Molecular Pathology et al
v US PTO
• BRCA1/2 gene patent case brought by the
ACLU in the U.S. District Ct in New York
• November 1, 2009: Case survived a motion to
dismiss
• Judge Sweet said:
– “The patents [might] grant Myriad ownership rights
over products of nature, laws of nature, natural
phenomena, abstract ideas and basic human
knowledge and thought in violation of the First
Amendment ‘s protection over freedom of
thought. Myriad’s ownership of correlations
between certain BRCA1/2 mutations and an
increased risk of breast and/or ovarian cancer [might
have] inhibited further research on BRCA1/2 as well
as genes that interact with BRCA1/2.”
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Conclusions
• Thirty years of expansion of
patent eligibility: animals,
plants, genes, genetic
diagnostics, software, business
methods.
• Courts are now being asked to
draw sharper lines
• So far the legislature
(Congress) has stayed out of it
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Contact Information
Jorge A. Goldstein, Ph.D., Esq.
Sterne Kessler Goldstein & Fox PLLC
1100 New York Ave
Washington DC 20005
Tel 202-772-8609 (direct)
Fax 202 371 2540
E Mail : [email protected]
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