Download Richard A. Spinello, Sarah Cabral Presentation

Introduction
The Patentability of Human Genes
Is patenting human genes moral?
Should it be legal?
Should there be international intervention?
DNA:
The Molecule Of Life
Patents
Arguments For:
Arguments Against:
Investment
Protection
Impedes cumulative
innovation
Innovator would be
unable to recover
costs
Free Rider problem
Administering
patent system
results in social
costs
Social welfare
increase
Foregone consumer
surplus
U.S. Patents
U.S. Law: Patents must be novel, useful, and either
a process, machine, manufacture, or composition of
matter
Diamond v. Chakrabarty [1980]
“anything under the sun made by man”
Patentable - Genetically altered life
Unpatentable - Laws of nature, Physical
Phenomena, Abstract Ideas
Isolated DNA:
Invention or Discovery?
Invention
Discovery
Isolating DNA from its
natural environment
makes it an invention
Isolated DNA is a
product of nature
The extraction
process results in
changes to its
molecular structure
Isolating DNA from
the thousands of
nucleotides does not
give it a new utility
Gene Patenting over the
past 30 years
Over 2,600 patents for isolated DNA have
been awarded from the U.S. Patent and
Trademark Office
Opponents: Societal harm has resulted from
monopolistic patents that exclude research
on the genome
Supporters: Patent protection induces
biotech innovations
Myriad Genetics Case
Association for Molecular Pathology v. United
States PTO [2010, 2011]
In 1997, Myriad was awarded patents
covering the isolated DNA sequences BRCA 1
and 2 and associated diagnostic methods
Preempted anyone else from working with
BRCA genes without permission
Myriad Genetics Case (cont’d)
Lawsuit by genetic researchers arguing that
BRCA genes are products of nature
The District Court rejected all product and
process patents in 2010
The Federal Appeals Court reversed the
decision in 2011
Case will now be heard by Supreme Court
Legal Analysis
Why has the issue of utility been ignored by
courts?
In the case of human genes, too much
protection impedes innovation
Strive for a more legally nuanced outcome
Moral Analysis
According to Locke, human labor gives rise to
property rights only when:
…it transforms or adapts something from the
state of nature
…there remains enough resources of the
same quality for others to appropriate
(strong)
or
…others are not made worse off by the
appropriation of resources (weak)
Moral Analysis (cont’d)
Lockean analysis would determine that isolated
DNA cannot be claimed as someone’s property,
since:
…isolated DNA is discovered not invented
…isolated DNA, when patented, does not
provide others with an “equal opportunity” to
utilize valuable genetic resources
…isolated DNA, when patented, makes others
worse off
International Controversy
According to TRIPS:
…patents apply to any invention, product and/or
process that is novel, inventive and applicable to the
relevant industry (Art. 27.1)
…three types of inventions that can be excluded from
patentability, 1. inventions contrary to morality, 2.
diagnostic, therapeutic, and surgical methods for the
treatment of humans or animals, and 3. plants and
animals other than microorganisms (Art. 27.2, Art.
27.3a, Art 27.3b)
…compulsory licensing and government use without
the authorization of the patent holder are allowed
under certain conditions (Art. 31)
2002 TRIPS Survey
Article 27.3(b) is ambiguous, such that
member nations can:
…exclude gene patenting
…allow gene patenting
…allow for the protection of the specific use
of the gene disclosed in the patent but not
the gene, itself
Countries in which it is possible to patent
biological material isolated from its natural
environment: Bulgaria, Canada, Australia,
Switzerland, Czech Republic, European
Communities, Estonia, Hong Kong, Iceland,
Japan, Norway, Poland, and the United States
Amending TRIPS to Exclude
Human Genes from Patentability
Arguments For:
Arguments Against:
Patent holders and
applicants are from
developed countries
Patents stimulate
investment in the
advancement of
medical science
Patents prevent those
in developing countries
from using patented
material
Patents generate
benefits to mankind
The patenting of
human genes is
unethical; it privatizes
and commercializes life
itself
If the patentability
requirements were
respected in full,
human genes would be
patent-ineligible
Representative Nations
Divided
No amendment: Reps. from Switzerland, the
United States, the European Union, Japan,
and Australia, and Canada
Possible amendment: Reps. from Brazil,
Venezuela, Ecuador, Pakistan, Zimbabwe,
Nigeria (on behalf of the African Group), and
Angola (on behalf of the Least-Developed
Countries Group)
Conclusions
Gene patents are unwarranted
Patents for genetic tests derived from
working with genes such as BRCA are valid, if
they meet the requirements for process
patents
An amendment to TRIPS is unnecessary, since
isolated DNA should be excluded from
patentability based on the current TRIPS
patent criteria
TRIPS council should offer specific
recommendations encouraging member
nations to view isolated DNA patent-ineligible