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Patent Law
Prof. Merges
Intro to Section 101
1.15.08
Main Themes
• Living Subject matter
• Therapeutic correlations
• Intro to Software and business methods
Chakrabarty: Questions
• 1. Why are “discovered” things not
patentable?
• 2. Why are newly discovered laws of nature
not patentable?
Chakrabarty (cont’d)
• 3. Why isn’t Chakrabarty’s invention just a
newly discovered law of nature?
• 4. Why don’t the Plant Patent Act and the
PVPA show that Congress assumed living
things to be unpatentable?
Chakrabarty (cont’d)
• 5. Why is this decision so important if
Chakrabarty could have obtained process
claims anyway?
• 6. Would a cloned human be patentable
under this decision? How broad is this
holding?
Page 72
“Congress thus recognized that the relevant
distinction was not between living and
inanimate things, but between products of
nature, whether living or not, and humanmade inventions.”
Thesis/antithesis
The Committee Reports accompanying the
1952 Act inform us that Congress intended
statutory subject matter to “include anything
under the sun that is made by man.” S. Rep.
No. 1979, 82d Cong., 2d Sess., 5 (1952) . . .
-- casebook p. 70
This is not to suggest that § 101 has no limits or
that it embraces every discovery. The laws of
nature, physical phenomena, and abstract ideas
have been held not patentable.
Thus, a new mineral discovered in the earth or
a new plant found in the wild is not
patentable subject matter. Likewise, Einstein
could not patent his celebrated law that E =
mc2; nor could Newton have patented the
law of gravity. Such discoveries are
“manifestations of . . . nature, free to all men
and reserved exclusively to none.”
Lab Corp of America v. Metabolite
Labs, Inc.
Metabolite v. Lab Corp. Am.
13. A method for detecting a deficiency of
cobalamin or folate in warmblooded 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.
’658 patent, col. 11, ll. 58-65.
The ’658 patent claims methods for detecting
cobalamin or folate deficiency. Cobalamin
and folate are both B vitamins, commonly
known as B12 and folic acid, respectively. A
deficiency in these vitamins can cause serious
illnesses in humans, including vascular
disease, cognitive dysfunction, birth defects
and cancer. If detected early enough,
however, vitamin supplements readily treat
the deficiency.
Because these B vitamins assist in metabolizing
the amino acid homocysteine, scientists
directly or indirectly assay homocysteine to
screen for cobalamin and folate deficiency.
Proceedings below
The jury found that LabCorp breached its license
agreement with Metabolite, that LabCorp
willfully infringed the ’658 patent, and that
the claims at issue are not invalid. The jury
assessed damages against LabCorp of
$3,652,724.61 for breach of contract and
$1,019,365.01 for infringement. . . . In light of
the finding of willfulness, the district court
doubled the jury’s infringement award to
$2,038,730.02.
“The correlating step is a simple
conclusion that a cobalamin/folate
deficiency exists vel non based on
the assaying step.” – 370 F.3d at
1367.
Supreme Court
• Drafted its own cert question: “First, measure
the level of the relevant amino acids using any
device, whether the device is, or is not,
patented; second, notice whether the amino
acid level is elevated and, if so, conclude that a
vitam in B deficiency exists. Is the patent invalid
because one cannot patent “laws of nature,
natural phenomena, and abstract ideas”?
Official disposition
• Writ of certiorari dismissed as improvidently
granted.
Breyer et al. dissent
• “laws of nature, natural phenomena, and
abstract ideas” excluded from § 101
• “[T]he reason for the exclusion is that
sometimes too much patent protection can
impede rather than “promote the Progress of
Science and useful Arts” . . . . Casebook p.
100
Metabolite v. Lab Corp. Am.
13. A method for detecting a deficiency of
cobalamin or folate in warmblooded 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.
’658 patent, col. 11, ll. 58-65.
Back to claim 13
• because the natural relationship between
homocysteine and vitamin deficiency was
now well known, such “correlating” would
occur automatically in the mind of any
competent physician . . .
But one can reduce any process to a series of
steps. The question is what those steps
embody. And here, aside from the
unpatented test, they embody only the
correlation between homocysteine and
vitamin deficiency that the researchers
uncovered. In my view, that correlation is an
unpatentable “natural phenomenon,” and I
can find nothing in claim 13 that adds
anything more of significance. . . .
-- casebook p. 105
Natural substance patents
• “Purified and isolated” claims
–§ 101 Issues
–Practical advantages
Jokichi Takamine
Jokichi Takamine was born on November 3, 1854 in Takaoka,
Japan. His father, Seichi, was a physician like many of his
ancestors in the Takamine family. Unlike his contemporaries,
Takamine learned English at an early age. He attended schools
in Osaka, Kyoto, and Tokyo, graduating from the college of
science and engineering at the University of Tokyo in 1879.
That year the Japanese government selected Takamine as one
of 12 scholars to pursue graduate studies in Scotland at
Glasgow University and at Anderson College. He returned to
Japan in 1883 and joined the department of agriculture and
commerce.
Takamine (cont’d)
In 1884 Takamine made his first trip to the United
States to attend a Cotton Centennial Exposition,
where he met his future wife, Caroline Field Hitch.
They married in 1884 and had two children. The
family moved to Japan, and continued to work for
the department of agriculture and commerce as
chief of the division of chemistry until 1887. At that
time he formed his own company, the Tokyo Artificial
Fertilizer Company, where he later isolated a starchdigesting enzyme, Takadiastase, from a fungus.
Takimine (cont’d)
In 1894 Takamine moved permanently to United
States, settling in New York City. He opened
his own private laboratory but allowed Parke,
Davis & Company to produce Takadiastase
commercially. In 1901 he isolated and purified
the hormone adrenalin in his laboratory,
becoming the first person to accomplish this
for a glandular hormone. --- Am Chem Soc’y,
J. Chem Ed Online
Takamine’s patents
• ‘176 Product patent
– Why was this valuable?
– Why not a process patent (see Chakrabarty)
• See p. 107
What is the value of a product
patent?
• Mulford used a different process to
precipitate out the final adrenaline product
• Might not have infringed a detailed process
patent if Takamine had claimed narrowly
• See p. 107
Takamine’s patents (cont’d)
• ‘177 Patent
– “Salt” (acid) form of isolated hormone
– Why not at issue here?
• Why claim it?
• How could it have been valid?
– Prior art
Hand’s decision
“While it is of course possible
logically to call this a purification of
the principle, it became for every
practical purpose a new thing
commercially and therapeutically.”
-- p. 108
Hand’s Pragmatism
• “Practical differences”
Vs.
• “Scholastic distinctions”
-- p. 108
Two additional points
• Evidence of patentability: Takamine’s product
displaced the prior products
• “I cannot stop without calling attention to
the extraordinary condition of the law which
makes it possible for a man without any
knowledge of even the rudiments of
chemistry to pass upon such questions as
these . . . .” -- p. 109
Demaine and Fellmeth (cont’d)
Science, Vol 300, Issue 5624, 1375-1376 , 30 May 2003
The challenge is to craft a test to distinguish products of nature
from patentable inventions. A parsimonious solution is a
variant of the "substantial transformation test“ (STT) used in
customs law, in which a product is considered to have
undergone a substantial transformation when it has a "new
and distinct name, character, or use.“ Because name is highly
mutable, the real focus of the test is a change of character or
use.
Recent Commentary
• Eileen M. Kane, Splitting the Gene: DNA Patents and
the Genetic Code, 71 Tenn. L. Rev. 707, 707 (2004)
By scientific and historical criteria, the genetic code can be
characterized as a law of nature and as an essential
component of the public domain in molecular biology.
The Article concludes that the patenting of genes results in
constructive preemption of the genetic code, a result that
is contrary to the Supreme Court's dictate that the laws of
nature are not patentable. This outcome undermines the
legitimacy of genes as patentable subject matter.
In re Comiskey
Claim 1:
A method for mandatory arbitration resolution
regarding one or more unilateral documents
comprising the steps of:
• enrolling a person and one or more unilateral
documents associated with the person in a
mandatory arbitration system at a time prior
to or as of the time of creation of or
execution of the one or more unilateral
documents;
incorporating arbitration language, that is specific to
the enrolled person, in the previously enrolled
unilateral document wherein the arbitration
language provides that any contested issue related
to the unilateral document must be presented to
the mandatory arbitration system, in which the
person and the one or more unilateral documents
are enrolled, for binding arbitration wherein the
contested issue comprises one or more of a
challenge to the documents, interpretation of the
documents, interpretation or application of terms
of the documents and execution of the documents
or terms of the documents;
• requiring a complainant to submit a request
for arbitration resolution to the mandatory
arbitration system wherein the request is
directed to the contested issue related to the
unilateral document containing the
arbitration language;
• conducting arbitration resolution for the
contested issue related to the unilateral
document in response to the request for
arbitration resolution;
providing support to the arbitration; and
determining an award or a decision for the
contested issue related to the unilateral
document in accordance with the
incorporated arbitration language, wherein
the award or the decision is final and binding
with respect to the complainant.
“Product” or system claims
Claim 17:
A system for mandatory arbitration resolution
regarding one or more unilateral documents
comprising:
• a registration module for enrolling a person .
..;
• an arbitration module . . .
Comiskey, 499 F.3d at 1374
State Street Bank explicitly held that business
methods are “subject to the same legal
requirements for patentability as applied to any
other process or method.” Id. at 1375. We must
then consider the requirements of § 101 in
determining whether Comiskey's claims 1 and 32
for a method of mandatory arbitration for
unilateral and contractual documents claim
statutory subject matter.