Professional Documents
Culture Documents
Patents Class 15
Patents Class 15
309
35 U.S.C. § 101
The patent- eligible subject matter requirement of § 101 sets forth the
kinds of inventions that can be patented:
As technology has matured, the courts have wrestled with boundary issues.
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35 U.S.C. § 101
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DIAMOND V.
CHAKRABARTY
Chakrabarty sought to patent three
types of claims:
An inoculum comprised of a
carrier material f loating on water,
and the new bacteria ( method of
use )
C. C. P. A.: Rev’ d → “The fact that microorganisms are alive is w/o
legal significance” (Rich, J.)
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DIAMOND V.
CHAKRABARTY
Does § 101 say anything about living matter?
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DIAMOND V.
CHAKRABARTY
Allowed patents on a genetically- modified bacterium because it had
“ markedly different characteristics from any found in nature.”
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MAYO V.
PROMETHEUS
PSM AND BASIC PRINICPLES
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MAYO V.
PROMETHEUS
PSM AND BASIC PRINICPLES
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MAYO V.
PROMETHEUS
Claims were directed to optimizing the efficacy of a drug:
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MAYO V.
PROMETHEUS
1. . A me thod of o pt im iz in g t h e r a p e u t ic e ffica c y for tr e a t me nt of
an immune - me dia te d ga s t r o i n t e s t i n a l disorder, c o mp ri s i ng :
(a) a d m i n i s t e r i n g a drug pr ov id in g 6 - t hi og ua ni ne to a
s ubjec t having said immune - me dia te d g a s t r o i n t e s t i n a l
dis orde r; and
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MAYO V.
PROMETHEUS
1.. A method of optimizing therapeutic efficacy for treatment of an
immune- mediated gastrointestina l disorder, comprising:
“Beyond picking out the relevant audience, namely those who administer doses
of thiopurine drugs, the claim simply tells doctors to: ( 1 ) measure (somehow)
the current level of the relevant metabolite, ( 2 ) use the particular
(unpatentable) laws of nature (which the claim sets forth) to calculate the
current toxicity/inefficacy limits, and ( 3 ) reconsider the drug dosage in light
of the law.”
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MAYO V.
PROMETHEUS
1.. A method of optimizing therapeutic efficacy for treatment of an
immune- mediated gastrointestina l disorder, comprising:
The claims provide “instructions” that “add nothing specific to the laws
of nature other than what is well- understood, routine, conventional
activity, previously engaged in by those in the field.”
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MAYO’S “INVENTIVE
CONCEPT”
Mayo demands an “inventive concept sufficient to ensure that the
patent in practice amounts to significantly more than a patent
upon the natural law itself.”
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MAYO’S “INVENTIVE
CONCEPT”
The Court also noted how the additional steps recited in the claimed
invention “consist of well- understood, routine, conventional activity
already engaged in by the scientific community.”
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MAYO’S “INVENTIVE
CONCEPT”
An alternative, less restrictive, view of inventive concept supports a
prohibition on a GENERIC APPLICATION of a law of nature.
So Mayo can be read to require the claim to offer more than a law of
nature and instructions to “apply it.”
Under either reading, the claims in Mayo are problematic as they show
no more than an underlying correlation between thioguanine levels and
efficacy.
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MYRIAD:
Myriad discovered the precise location and sequence of what are now
known as the BRCA 1 and BRCA 2 genes.
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MYRIAD:
Thus, many patients seek genetic testing to see if they have mutations
in their genes that are associated with a significantly increased risk of
breast or ovarian cancer.
327
MYRIAD:
cDNA → man- made DNA which contains only coding sequences, w/o
introns.
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WHAT DID MYRIAD
Myriad sequenced the two genes and found that each is a version of a normal
gene that has been corrupted by mutations that alter the DNA sequence.
TIMELINE
1994 : Myriad identified and isolated BRCA 1 it from the rest of the DNA and
the tangle of protein that form chromosome number 17 .
1995 : Myriad identified and isolated BRCA 2 , which resides on chromosome
number 13 .
1997 / 1998 : Myriad received seven patents on the two isolated genes, various
DNA fragments within them, and several method claims.
Post- issuance: Myriad aggressively enforced its patents . . . .
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WHAT DID MYRIAD CLAIM IN
ITS PATENTS?
COMPOSITION OF M AT TER CLAIMS directed to isolated DNA
[composition of matter claims ]
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PARKE-DAVIS H.K.
189 F. 95 (C.C.S.D.N.Y.
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MYRIAD:
DISTRICT COURT (S.D.N.Y.
“In light of DN A’s unique qualities as a physical embodiment of
information, none of the structural and functional differences cited by
Myriad between native BRCA 1 / 2 DNA and the isolated BRCA 1 / 2 DNA
claimed in the patents- in- suit render the claimed DNA ‘ markedly
different.’ ”
332
MYRIAD:
FEDERAL CIRCUIT
REVERSED District Court ( 2 - 1 ) – composition of matter claims to
“isolated” DNA are patent eligible
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MYRIAD @ CAFC:
“ISOLATED” DNA WAS PATENT
ELIGIBLE
“Isolated DNA is not purified DNA. Purification makes pure what was
the same material, but was previously impure.”
Not the case here because “claimed isolated DNA molecules do not
exist as in nature within a physical mixture to be purified” – they need
to be “chemically cleaved [i. e. covalent bond broken] from their
chemical combination with other genetic materials. [Accordingly, this
is not Parke- Davis .]”
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MYRIAD @ CAFC:
JUDGE MOORE’S CONCURRENCE
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MYRIAD @ CAFC:
JUDGE LOURIE ON HUMAN INGENUITY
“The isolated DNA molecules
before us are not found in nature.
They are obtained in the laboratory
and are man- made, the product of
human ingenuity . While they are
prepared from products of nature,
so is every other composition of
matter.”
336
MYRIAD @ CAFC:
JUDGE BRYSON’S
Disagreed with bond- breaking/ part of larger
structure reasoning
Nearly 20 % of the genome— more than 4 , 000 genes— are already covered
by at least one U. S. patent (including genes for Alzheimer ’s disease, colon
cancer, asthma, and insulin production)
The Court wants the subject- matter categories of § 101 to do real work
that other patentability criteria cannot do ( Mayo )
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MYRIAD
569 U.S. 576
The PTO’s past practices are NOT entitled to deference.
cDNA is patentable.
■ Why? cDNA “does not present the same obstacles to patentability as
naturally occurring, isolated DNA segments” because “creation of a
cDNA sequence from mRNA results in an exons-only molecule that is
not naturally occurring” and as such was patent eligible.
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MYRIAD: IMPLICATIONS
CLAIM DRAFTING. It’s clear that any claimed DNA with an altered sequence
or with other chemical structures not found in nature likely will pass the
patent eligibility hurdle.
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