Patentable Subject Matter
Prof Merges
1.10.12
Agenda
• Current § 101 Controversies
• Intro to patentable subject matter
– Chakrabarty and Parke-Davis
Supreme Court
• Mayo Collaborative Services v. Prometheus
Laboratories, Inc., Supreme Court, No. 101150; decision below, 581 F.3d 1336 (Fed. Cir.
2009)
– Oral argument: Dec. 7, 2011
– Summary at PatentlyO blog, Dec. 8, 2011
Patent in Prometheus
• Medical correlation or observation
• Process: “Step 1: Measure X. Step 2: If level
below __, administer drug. If level above __,
decrease drug dosage.”
Purified gene patent case
• Association for Molecular Pathology v. U.S.
Patent and Trademark Office, 653 F.3d 1329
(Fed. Cir. 2011)
• Questions Presented: 1. Are human genes
patentable?
• Cert petition filed 12/7/2011
Introduction to the Patent System
• Quick history: see casebook
• Purpose of system: “to promote the progress
of science and the useful arts”
• Importance of claims in understanding how
patents work
Basic patent procedure
• File for patent in Patent and Trademark Office
(PTO)
• Examiner assigned to application; 2-4 year
process to obtain patent (on average)
• Final rejections can be appealed to
administrative board in PTO
Court review of PTO
• Can appeal adverse ruling of PTO Board of
Appeals to an appellate court
• Before 1982: Court of Customs and Patent
Appeals (CCPA)
• 1982 and after: US Court of Appeals for the
Federal Circuit (unified patent appeals court)
Who is Chakrabarty?
• Ananda Chakrabarty, PhD is a
distinguished professor of
microbiology and immunology at
the University of Illinois College
of Medicine. His most notable
creation is a biology-based
solution for cleaning up toxic
spills using the generically
engineered Pseudomonas (today
classified as Burkholderia
cepacia or B. cepacia).
Ananda Chakrabarty
Chakrabarty: Claims
• Process claims
• “Inoculum” including a carrier
(combination claim)
• “the bacteria themselves”
Chakrabarty Claims: p. 129
1. A bacterium from the genus Pseudomonas
containing therein at least two stable
energy-generating plasmids, each of said
plasmids providing a separate
hydrocarbon degradative pathway.
Chakrabarty
• How many different types of claims?
Chakrabarty
• How many different types of claims?
•WHY?
Chakrabarty
• Process claims – never a problem
– Why not?
• Process comprising steps of (1) , (2),
(3), where (2) involves living subject
matter
Combination claims
• “An inoculum” . . .
• Also allowed
• Why?
Combination claims
SUBJECT MATTER
§ 101 Inventions Patentable
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.
Subject Matter: Overview
§ 101 Categories
• Process
• Machine
• Manufacture
• Composition of Matter
• Improvements
History of Section 101
• 1793 Act – “authored by Thomas
Jefferson” -- ?
• Edward C. Walterscheid, The Use and
Abuse of History: The Supreme Court’s
Interpretation of Thomas Jefferson’s
Influence on the Patent Law, 39 IDEA
195 (1999).
Section 101 Categories in
Chakrabarty
• Manufacture
• Composition of Matter
– “chemical union or mechanical mixture”
The now-famous punch-line
• Legislative history  statutory
language, 1952 Act
–“Anything under the sun
that is made by
[humans]”
What are the limits?
• Laws of nature
• Physical phenomena
• Abstract ideas
The Court’s examples of
unpatentable things
“a new mineral discovered in the earth,
or a new plant found in the wild”
Einstein’s “law” (E=mc2)
Newton’s law of gravitation
How is Chakrabarty’s oileating bacterium different?
• “His claim is not to a hitherto
unknown natural phenomenon,
but to a nonnaturally ocurring
manufacture or composition of
matter – a product of human
ingenuity . . .”
Contrast (?) with Kalo
• Combining species into convenient
plant-root inoculant
• How is this different from
Chakrabarty’s invention?
What are the limits?
• “not nature’s handiwork, but his own”
– How does this limit the scope of patent
law?
– Is it predictable? Too open-ended?
Counter-arguments
• Plant-specific Acts
• Congress should make IP
policy, not the courts
What about plant-specific Acts?
• Implicit argument:
–Expressio unius/exclusio
alterius?
Utility Patents
PPA/PVPA
Chakrabarty
Patent
Utility Patents
PPA/PVPA
X
Chakrabarty
Patent
“Expressio Unius/Exclusio Alterius”
All Utility Patents
PPA/PVPA
Chakrabarty
Patent
Second argument: Congress
ought to make policy
• History of patents on living
subject matter
• Comparative Institutional
Competence
The Life Sciences and § 101
• A Brief history
– Plant-specific acts, 1930 & 1970
– Early biotech – 1973-1980
– Early animal modification: Ex parte Allen,
1987
– Gene patents: 1990-today
– Gene therapy: mid-1990s-today
– Dolly the sheep: late 1990s
– Stem cell research: late 1990s-today
Commoncouragepress.com
Somebody owns your genes. Through the U.S.
patent system, corporations and universities
have claimed property rights not just on the
rice and corn at your dinner table but also on
you. Moving beyond patenting and "owning"
diseases like staph, tuberculosis, and SARS,
one American corporation owns the genetic
heritage of the entire population of Iceland. A
university has property rights on all human
clones-even though human cloning is still
being debated in Congress. Another
company claims to have invented "junk"
DNA. Through its patents, it stakes a claim to
the research on 95% of human DNA.
Though we are only at the earliest stage of
the establishment of patent monopolies
over genes, cell lines, and even organisms,
the current struggle over access to AIDS
drugs is a harbinger of problems ahead.
AIDS drug costs are a clear example of the
use of patent monopolies to drive up the
price of therapy.
Natural substance patents
• “Purified and isolated”
claims
–§ 101 Issues
–Practical advantages
Jokichi Takamine
Jokichi Takamine
Jokichi Takamine was born on November 3,
1854 in Takaoka, Japan. He graduated 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)
He worked 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 starch-digesting
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: The Legend
Takamine’s patents
• ‘176 Product patent
– Why was this valuable?
– Why not a process patent (see
Chakrabarty)
Takamine’s patents (cont’d)
• ‘177 Patent
– “Salt” (acid) form of isolated hormone
– Usually “salt” is applied to an ionic
compound produced by reacting an acid
with a base.
– Why not at issue here? Claims were
amended during prosecution.
• How could it have been valid?
– Prior art
Judge Hand’s Decision
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.”
Hand’s Pragmatism
• “Practical differences”
Vs.
• “Scholastic distinctions”
Hand
“But even if it were an extracted product
without change, there is no rule that
such products are not patentable . . .”