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messengerrushBiotechnology

Feb 22, 2013 (4 years and 5 months ago)

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Patentable Subject Matter

Prof Merges


1.12.10

Agenda



Old business: finish yesterday



Introduction to patents



Patentable subject matter

John Stuart Mill


Mill argues that the
moral worth of
actions is to be
judged in terms of
the consequences of
those actions
. In this
he contrasts his own
view with that of
those who appealed
to moral intuitions.

The utilitarian perspective



“The greatest good for the greatest number”



“Rights” follow only from calculations of collective
welfare



“Natural rights” are “nonsense on stilts”


Jeremy
Bentham



Jeremy Bentham, A Critical Examination of the
Declaration of Rights, in
Bentham's Political Thought
257,
269 (Bhikhu Parekh ed., 1973).

Utilitarianism applied



Derek E. Bambauer, Faulty Math: The Economics
of Legalizing
The Grey Album
, 59 Ala. L. Rev. 345
(2008)



“prevailing utilitarian calculus” for derivative
work right in copyright
cannot be defended



Utilitarian talk masks “hidden” normative concerns
(labor
-
desert, personality)

Introduction to the Patent System


Quick history



Purpose of system: “to promote the progress
of science and the useful arts”



Importance of
claims

in understanding how
patents work

Consensus: patents are utilitaian



But: even with this most “practical” branch of
IP law, there are elements of natural rights
present:



Adam Mossoff,
Rethinking the Development
of Patents: An Intellectual History, 1550
-
1800, 52 HASTINGS L. J. 1255 (2001).

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

How did this case get to the
Supreme Court?



What did patent examiner do with
claims?



What is the “Patent Office Board of
Appeals”?



Appeal then to old CCPA (now Federal
Circuit)

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).

Alexander Hamilton

Section 101 Categories in
Chakrabarty



Manufacture: p. 129



Composition of Matter



“chemical union or mechanical mixture”

The now
-
famous punch
-
line




P 130: Legislative history


獴慴畴潲礠污湧l慧攬aㄹ㔲⁁捴



“Anything under the sun
that is made by
[humans]”




Laws of nature



Physical phenomena



Abstract ideas

What are the limits?

The Court’s examples of
unpatentable things


p. 130


“a new mineral discovered in the earth,
or a new plant found in the wild”


Einstein’s “law” (E=mc
2
)


Newton’s law of gravitation

How is Chakrabarty’s oil
-
eating 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

. . .”
--

p 130

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?

PPA/PVPA

Chakrabarty
Patent

Utility Patents

PPA/PVPA

Chakrabarty
Patent

Utility Patents

X

“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.



Profits Pending examines the devastating affects of
these patents on life, from the blatant theft of
cultural resources to slowing down research into
deadly diseases. Once used to reward the
inventiveness of American scientists and
entrepreneurs, the patent system is now being
abused to control scientific exploration into human
biology and to create monopolies over the world's
food sources. Instead of promoting scientific
research, patents on life now destroy crucial
elements of the scientific method such as the free
exchange of ideas between researchers. Profits
Pending demonstrates that patents on life may
ultimately destroy the biotechnology industry and
ultimately hinder the innovation the American
economy depends on.

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.


“Purified and isolated”
claims


§

101 Issues


Practical advantages


Natural substance patents

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.”

--

p. 99

Hand’s Pragmatism


“Practical differences”


Vs.



“Scholastic distinctions”

P. 136

“But even if it were an extracted product
without change, there is no rule that
such products are not patentable . . .”

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

Critiques

“Reinventing the double Helix: a novel and nonobvious
reconceptualization of the biotechnology patent”



55 Stanford Law Review 303 (2002); Demaine, Linda J.; Fellmeth,
Aaron Xavier

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 [rulings].