2. 案件歷程
Federal District Court of
Southern District of New
York (S.D.N.Y.) Mayo Collaborative Services v.
Prometheus Laboratories, Inc.
(C.A.F.C)
Federal Court of
Appeals, Federal Circuit
(C.A.F.C.)
Petition for Certiorari
Mayo Collaborative Services v.
Certiorari granted in light
Prometheus
of Prometheus Laboratories, Inc.(S.C)
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3. 故事是這麼發生的…
BRCA 1 BRCA 2
Chromosome 17
創業
Breast,
Ovarian
cancer
Gene sequencing & diagnose
Founded in 1991
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4. 接著…
Univ. of Utah
Myriad
3,000 USD./test
競爭
vs.
Others
1000 USD./test
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5. 當事人
• Plaintiffs
• Researchers
Drs. Kazazian, Ganguly (University of Pennsylvania School of medicine, Genetic
Diagnostic Lab.), Ostrer (New York University)…
• Organizations
AMP (Association for Molecular Pathology), ACMG (American College of Medical
Genetics), ASCP (American Society for Clinical Pathology), CAP (College of
American Pathologists)
• Patients
• Defendants
• USPTO
• Myriad Genetics, Inc. (Salt Lake City)
former co owner and exclusive licensee
• UURF (The University of Utah Research Foundation)
an owner or part owner of each patent.
• Amici
• American Civil Liberty Union (ACLU) , Public Patent
Foundation (PUBPAT)
9. 專利內容-基因序列
• Claim 1 of the „282 patent
An isolated DNA coding for a BCRA1 polypeptide, said
polypeptide having the amino acid sequence set forth in
SEQ. ID. NO: 2.
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10. 專利內容－診斷方法（1）
• Claim 1 of the ‟ 999 patent
– A method for detecting a germline alteration in a BRCA1
gene, said alterations set forth in Table 12A, 14, 18 or 19 in
a human which comprises
• analyzing a sequence of a BRCA 1 gene or BRCA1
RNA from a human sample or
• analyzing a sequence of BRCA1 cDNA made from
mRNA from said human sample with the proviso that
said germline alteration is not a deletion of 4
nucleotides corresponding to base numbers 4184-4187
of SEQ ID. NO:1.
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11. 專利內容－診斷方法（2）
• Claim 2 of „857 patent
– A method for diagnosing a predisposition for
breast cancer in a human subject which comprises
• comparing the germline sequence of the BRCA2 gene
or the sequence of its mRNA in a tissue sample from
said subject with
• the germline sequence of the wild- type BRCA2 gene or
the sequence of its mRNA,
wherein an alteration in the germline sequence of the
BRCA2 gene or the sequence of its mRNA of the subject
indicates a predisposition to said cancer.
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12. 專利內容－診斷方法（3）
• Claim 20 of the „282 patent
– A method for screening potential cancer therapeutics
which comprises
• growing a transformed eukaryotic host cell containing an
altered BRCA1 gene causing cancer and the presence of a
compound suspected of being a cancer therapeutic,
• growing said transformed eukaryotic host cell in the absence
of said compound,
• determining the rate of growth of said host cell in the
presence of said compound and the rate of growth of said
host cell in the absence of the said compound and
comparing the growth rate of said host cells,
wherein a slower rate of said host cell in the presence of said
compound is indicative of a cancer therapeutic.
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15. 專利的例外？
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.
－35 USC § 101 - Inventions patentable
Statutory Subject Matter
Not products of nature
Not natural phenomena
Not abstract ideas
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16. 過去判決－否定
In American Fruit Growers, the Supreme Court
rejected patent claims covering fruit whose skin
had beer treated with mold-resistant borax.
In Funk Brothers, a mixture of bacteria couldn‟t
be patented, since it “did not create a state of
inhibition or of non- inhibition.”
In General Electronic, a purified tungsten couldn‟t
be patented, since it ”existed in nature and
doubtless has existed for centuries.”
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17. 過去判決- 肯定
In Chakrabarty, the micro-organism in question
was a bacterium that had been genetically
engineered to break down multiple components
of crude oil.
In Merck, the Fourth Circuit considered the
validity of a patent claiming a Vitamin B12
composition useful for treating pernicious
anemia.
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18. 過去判決－結論
This requirement that an invention possess
“markedly different” characteristics for purpose
of section 101 reflects the oft- repeated
requirement that an invention have “a new or
distinctive from, quality, or property” from a
product of nature…
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19. 法院說法比一比
D.C. C.A.F.C.
• What makes DNA unique not only • The claim covers molecules that
its chemical structure, but also the hardly exist in natural status.
information it conveys.
• The isolated DNA is free of some
• Even defined by polypeptides, the other components in the cell.
functional structure remain the same.
For example, BRCA2 without
• The different chemical structure are introns shrink to just 80,000
just the result of purification. nucleotides in comparison with
those normal with introns can
have near 102,000 nucleotides.
Not Patentable Patentable
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21. 「方法」可以專利嗎？
• In Biliski, claim 1 of „892 patent
• 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.
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22. Machine and Transformation Test
(1) it is tied to a particular machine or apparatus, or
(2) it transforms a particular article into a different
state or thing.”
(3) In addition, “the use of a specific machine or
transformation of an article must impose meaningful
limits on the claim„s scope to impart patent-
eligibility,” and “ the involvement of the machine or
transformation in the claimed process must not
merely be insignificant extra-solution activity.”
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23. 診斷方法的例子－Prometheus
• In Prometheus, 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 per mole 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 per mole per 8x108
red blood cells indicates a need to decrease the amount of said drug
subsequently administered to said subject.
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24. 診斷方法的例子－Prometheus
• The “determining” step was itself construed to include the
extraction and measurement of metabolite concentrations,
such as high pressure liquid chromatography.
• Transformation exist as human body as well as the chemical
and physical changes of the drug‟s metabolites.
• The “determining” step alone was transformative and central
to the claimed method since determining the levels of the
metabolites in a subject necessarily involves a transformation,
for those levels can’t be determined by mere inspection.
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25. 法院說法比一比
D.C. / C.A.F.C
• The words “analyzing and comparing”, in contrast to
“determining the metabolite level ”, refers to only
abstract mental process.
• Without specifying how about the words “analyzing
and comparing” impose no meaningful limitation on
the claim.
Not Patentable
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26. 法院說法比一比
D.C. C.A.F.C.
• Viewed in entirety, the essence of the • Specific host cells transformed with
claim is to compare the cell growth BCRA gene.
rate.
• Satisfying the transformation test,
• To compare is just a basic scientific including these transformative steps:
rule that slower growth rate of the • 1. host cells growing with a
cell. Inserting DNA or compound into altered BCRA1 gene
host cells can only be regarded as • 2. to determine growth rate with
preparatory data gathering step. or without the compound, which
can’t be merely speculated.
• If the compound shows no • 3. these steps are central to the
effect, transformation won’t happen. claimed process
Not Patentable Patentable
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27. 最高法院重新考慮Prometheus一案…
• A well- understood, routine, conventional
activity previously engaged in by researchers
in the field.
• Granting patent would risk disproportionately
tying up the use of natural law, inhibiting
their use in the making of further discoveries.
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29. 專利對生技業的重要性？
Startup
• Market Power
• Market Value
Mature Company
• IP fences
• Prevent substitutes
Sales • Stream revenue
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30. 專利與創新的關係？
Alternatives
Backup compounds
Preventing new tech. from
selling, manufacturing…only
Core to prolong old products’ life
Substitute
Invention cycle…
competition
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