Transcript More on Section 101

More on Section 101
Patent Law
Prof. Merges
8.30.2012
Main Topics
• Supreme Court Prometheus Opinion
• AMP v Myriad – the gene patent case
Section 101 Orientation
• Recapping Bilski: what is an “abstract idea”?
• How does this objection to patentability
relate to “laws of nature”, which is the heart
of Prometheus and Myriad?
Levels Of Abstraction – In © Law
Story - Main Idea
Plot Outline
Subplots
General Characters and Scenes
Specific Character Elements
Text
Patents for “Abstract Ideas”
Claim covers broad, general idea or
concept: risk hedging in energy markets;
use of an algorithm in any setting or
context; correlation observed in nature
Specific
Application
More abstract:
broader, more
general
Unpatentable
under section 101
Less abstract:
narrower, more
specific
Patentable under
section 101
Mayo v Prometheus
“Phenomena of nature, though just
discovered, mental processes, and
abstract intellectual concepts are not
patentable, as they are the basic tools of
scientific and technological work.”
Gottschalk v. Benson, 409 U.S. 63, 67
(1972). And monopolization of those
tools through the grant of a patent
might tend to impede innovation more
than it would tend to promote it.
[The Prometheus patent] concerns patent claims
covering processes that help doctors who use
thiopurine drugs to treat patients with
autoimmune diseases determine whether a
given dosage level is too low or too high. The
claims purport to apply natural laws describing
the relationships between the concentration in
the blood of certain thiopurine metabolites and
the likelihood that the drug dosage will be
ineffective or induce harmful side-effects
We must determine whether the
claimed processes have transformed
these unpatentable natural laws
into patent-eligible applications of
those laws. We conclude that they
have not done so and that therefore
the processes are not patentable.
Basic idea behind patents
• Correlation between (1) level of
metabolites in the bloodstream, and
(2) effectiveness of thiopurine drug
against autoimmune diseases (e.g.,
Crohn’s disease)
What was the invention?
At the time the discoveries embodied in the patents
were made, scientists already understood that the
levels in a patient's blood of certain metabolites …
were correlated with the likelihood that a
particular dosage of a thiopurine drug could cause
harm or prove ineffective…. But those in the field
did not know the precise correlations between
metabolite levels and likely harm or
ineffectiveness. The patent claims at issue here set
forth processes embodying researchers' findings
that identified these correlations with some
precision.
More specifically, the patents—U.S. Patent No.
6,355,623 (6́23 patent) and U.S. Patent No.
6,680,302 (3́02 patent)—embody findings that
concentrations in a patient's blood of 6–TG or of
6–MMP metabolite beyond a certain level (400
and 7000 picomoles per 8x108 red blood cells,
respectively) indicate that the dosage is likely too
high for the patient, while concentrations in the
blood of 6–TG metabolite lower than a certain
level (about 230 picomoles per 8x108 red blood
cells) indicate that the dosage is likely too low to
be effective.
Claim 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
8x10 8 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 8x10 8 red blood cells indicates a need to decrease the
amount of said drug subsequently administered to said subject.”
“A method of optimizing therapeutic efficacy,
comprising:
“(a) administering a drug; and
“(b) determining the level of 6–T
“wherein the level of 6–thioguanine less than [X]
indicates a need to increase the amount of said
drug subsequently administered to said subject
and
“wherein the level of 6–thioguanine greater than [Y]
indicates a need to decrease the amount of said
drug subsequently administered to said subject.”
[T]he claims inform a relevant audience about
certain laws of nature; any additional steps
consist of well-understood, routine,
conventional activity already engaged in by
the scientific community; and those steps,
when viewed as a whole, add nothing
significant beyond the sum of their parts
taken separately. For these reasons we
believe that the steps are not sufficient to
transform unpaten-table natural correlations
into patentable applications of those
regularities.
Relationship to Flook and Diehr
The claim before us presents a case for
patentability that is weaker than the
(patent-eligible) claim in Diehr and no
stronger than the (unpatentable) claim in
Flook. The[] [claimed] instructions 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.
“A method of optimizing therapeutic efficacy,
comprising:
“(a) administering a drug; and
“(b) determining the level of 6–T
“wherein the level of 6–thioguanine less than [X]
indicates a need to increase the amount of said
drug subsequently administered to said subject
and
“wherein the level of 6–thioguanine greater than [Y]
indicates a need to decrease the amount of said
drug subsequently administered to said subject.”
Back to the policy concern
[T[here is a danger that the grant of patents
that tie up the[] use [of natural laws] will
inhibit future innovation premised upon
them, a danger that becomes acute when a
patented process amounts to no more than
an instruction to “apply the natural law,” or
otherwise forecloses more future invention
than the underlying discovery could
reasonably justify….
Other sections of 35 USC?
• Novelty, nonobviousness, enablement
• These are separate and distinct, not meant to to
do the work of section 101
• But: if these other sections are easier to apply,
and give a clear answer, why not use them first?
Myriad
• The gene
• The patent
• The controversy
BRCA-1
Gene Expression  Protein
Relying on a large set of DNA samples from families
with inherited breast and ovarian cancers, the
inventors correlated the occurrence of cancer in
individual family members with the inheritance
of certain marker DNA sequences. This allowed
the inventors to identify, or “map,” the physical
location of the BRCA genes within the human
genome and to isolate the BRCA genes and
determine their exact nucleotide sequences. This
in turn allowed Myriad to provide BRCA
diagnostic testing services to women. – p. 8
Myriad
• The isolated DNA sequence can
be used in genetic testing to
determine whether a person
carries certain alleles of the
BRCA 1 or 2 gene and is thus at
higher risk for breast or ovarian
cancer.
Claim 1 of U.S. Pat. No. 5,747,282
(issued 1998)
1. An isolated DNA coding for a
BRCA1 polypeptide, said
polypeptide having the amino
acid sequence set forth in SEQ ID
NO: 2.
Association for Molecular Pathology v. United
States PTO
(The “Myriad” Case)
2010 U.S. Dist. LEXIS 35418 (Apr. 5, 2010)
Myriad – district court
• Rejects Learned Hand analysis in
Parke-Davis
• Statement re: 101 was dicta
there
Holding
In light of DNA's unique qualities as a physical
embodiment of information, none of the structural
and functional differences cited by Myriad
between native BRCA1/2 DNA and the isolated
BRCA1/2 DNA claimed in the patents-in-suit render
the claimed DNA. "markedly different." This
conclusion is driven by the overriding importance
of DNA's nucleotide sequence to both its natural
biological function as well as the utility associated
with DNA in its “isolated” form.
. The
preservation of this defining
characteristic of DNA in its native
and isolated forms mandates the
conclusion that the challenged
composition claims are directed
to unpatentable products of
nature.
Am. Fruit Growers (1931)
Manufacture implies a change, but every
change is not manufacture, and yet every
change in an article is the result of treatment,
labor, and manipulation. But something more
is necessary . . . . There must be
transformation; a new and different article
must emerge having a distinctive name,
character, or use.
Myriad in the Federal Circuit
[A]lthough the parties and the
government appear to agree that
isolated DNAs are compositions of
matter, they disagree on whether
and to what degree such molecules
fall within the exception for
products of nature. – p. 10
The distinction, therefore, between a
product of nature and a human-made
invention for purposes of § 101 turns
on a change in the claimed
composition’s identity compared with
what exists in nature. [Patentable:]….
compositions that human intervention
has given “markedly different,” or
“distinctive,” characteristics. – p. 11
Fed Cir Strategy
• Point out the significance of the isolation
• Chromosomes: 80 million – 110 million base
pairs
• Genes: 80,000 bp
• Coding region: 10,200 bp
Distinguishing Parke-Davis
Purified vs. merely isolated:
[I]n nature, isolated DNAs are covalently bonded to
such other materials. Thus, when cleaved, an
isolated DNA molecule is not a purified form of a
natural material, but a distinct chemical entity. In
fact, some forms of isolated DNA require no
purification at all, because DNAs can be
chemically synthesized directly as isolated
molecules.
Dissent: Judge Bryson
• No to long DNA sequences
P. 14
It is also important to dispute the dissent’s
analogy to snapping a leaf from a tree. With
respect, no one could contemplate that
snapping a leaf from a tree would be worthy
of a patent, whereas isolating genes to
provide useful diagnostic tools and medicines
is surely what the patent laws are intended
to encourage and protect. Snapping a leaf
from a tree is a physical separation, not one
creating a new chemical entity.
AMP – Myriad on remand
• Fed Cir August 16, 2012: 103 USPQ2d 1681
• Opinion re-affirms original decision:
“purified” gene claims are patentable under
section 101
Holding
[O]n the limited questions before us, we
conclude that the composition claims and the
screening claim involving growing a
transformed host cell meet the standards for
patent eligibility, while the claimed methods
for “analyzing” or “comparing” do not.
103 USPQ2d at 1696.
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. All new chemical
or biological molecules, whether made by synthesis
or decomposition, are made from natural materials.
For example, virtually every medicine utilized by
today's medical practitioners, and every
manufactured plastic product, is either synthesized
from natural materials (most often petroleum
fractions) or derived from natural plant materials.
But, as such, they are different from natural
materials, even if they are ultimately derived from
them. The same is true of isolated DNA molecules.
Government position
• Middle ground: cDNAs are patentable
• Isolated and purified “naturally ocurring”
DNA is not
• Degree of human intervention
BRCA1 and BRCA2 in their isolated states
are different molecules from DNA that
exists in the body; isolated DNA results
from human intervention to cleave or
synthesize a discrete portion of a native
chromosomal DNA, imparting on that
isolated DNA a distinctive chemical
identity as compared to native DNA.
103 USPQ2d at 1699
“Information Content”
[T]he patent eligibility of an isolated DNA
is not negated because it has similar
informational properties to a different,
more complex natural material. The
claimed isolated DNA molecules are
distinct from their natural existence as
portions of larger entities, and their
informational content is irrelevant to
that fact. -- 103 USPQ2d at 1700
From the dissent
• Isolating lithium using a complex
process
• “Snapping a leaf from a tree”
• Not enough human intervention