Geneva, 4 Oct
by Chakravarthi Raghavan
In a paper (Doc IP/C/W/209)
submitted to the recent meeting of the Council for TRIPS, the United
States has suggested that patenting of life forms does not amount to
ownership but only preventing others from taking certain actions.
A trade observer said this would be then a case of 'bonded labour' of
the patented gene for 20 years (the normal life of a patent). "You
don't own a bonded labour, just prevent him from doing things for
himself or others."
The US paper also argues there is no need to define 'micro-organism',
but the ordinary dictionary meaning could be used for interpretation!
[Art. 27.3 of TRIPS says: Members may exclude from patentability:
(a) ....
(b) plants and animals other than micro-organisms, and essentially
biological processes for the production of plants or animals other than
non-biological and micro-biological processes. However, Members shall
provide for the protection of plant varieties either by patents or by
an effective sui generis system or by any combination thereof. The
provisions of this subparagraph shall be reviewed four years after the
date of entry into force of the WTO Agreement.]
The US paper says on micro-organisms:
"Some Members have asked about the meaning of the term
'micro-organisms', expressing uncertainty regarding what Art. 27.3(b)
requires be patentable and what can be excluded from patentability.
The Budapest Treaty on the International Recognition of the Deposit of
Microorganisms for the Purposes of Patent Procedure, done at Budapest
on 28 April 1977, does not include a definition of the term
micro-organism although it does define other, seemingly unambiguous
terms such as 'patent procedure', 'intergovernmental industrial
property organization' and 'industrial property office'. The Treaty
regulations also do not define 'micro-organisms'.
[The simple explanation would appear to be that the entire scheme of
WIPO treaties, while laying down rights of holders and duties of states
to provide national treatment etc, in effect leaves acceding countries
to make their own laws and define the patents. The problems have arisen
because the WTO/TRIPS has gone beyond and has sought to lay down
uniform minimum standards of protection]
The US paper continues:
"The WIPO Committee of Experts on Biotechnological Inventions and
Industrial Property, which met between 1984 and 1988, also did not
define the term 'micro-organism', although the term was used frequently
in the discussions, as is reflected in the reports of the meetings of
that Committee. The reason for the lack of definition is reflected in
the Comparative Study of Patent Practices in the Field of Biotechnology
Related Mainly to Micro-biological Inventions, dated 20 January 1988,
prepared jointly by the European patent Office, the Japanese Patent
Office, and the US Patent and Trademark Office. Page 3 of that document
contains the following under the heading 'Definition of Microorganisms,
If Any'.
None of the laws administered by any of the offices contains a formal
definition of the term 'micro-organism.' Where definitions are used in
either classification definitions or administrative guidelines, the
term is defined as a non-exclusive list of organisms which are included
within the scope of that term. As noted by the EPO, it does not seem
expedient to introduce such a definition as the rapid evolution in the
field of microbiology would necessitate its frequent updating."
"The principles of international law regarding the interpretation of
treaties and international agreements should be used to determining
what is meant by the term micro-organism in Article 27.3(b) of the
TRIPS Agreement. Articles 31 and 32 of the Vienna convention on the Law
of Treaties require, inter alia, that treaties be interpreted 'in good
faith in accordance with the ordinary meaning to be given to the terms
of treaty in their context and the light of its object and purpose.'
The Concise Oxford Dictionary of Current English defines
'micro-organism' as 'an organism not visible to the naked eye,
e.g.bacteriums or virus.' That definition should be sufficient to
distinguish plants and animals generally from micro-organisms for
purposes of the discussion in the TRIPs Council.
"To be patentable a micro-organism cannot be as it exists in nature.
The patent granted by the US Patent and Trade Mark Office, to which
India refers in its paper (IP/C/W/161, page 3, paragraph 8), claims a
biologically pure culture of streptomyces violaceus which is capable of
producing the antibiotic BU-3839T in a recoverable quantity upon
cultivation in a culture medium containing assimilable sources of
carbon and nitrogen under submerged aerobic conditions. The claim and
specification, when compared to available prior art, makes it clear
that the invention is new, involves an inventive step, and is capable
of industrial application, as required under TRIPS Art.27.1. What is
claimed does not exist naturally. The patent, therefore, is granted for
an invention, and not merely a discovery. The key to what should be
patentable as a micro-organism is not what name is given the biological
material which the invention is based, but the subject claimed; is that
a subject matter new, does it involve an inventible step,and is it
capable of industrial application. If the subject matters meets these
criteria, Art.27.3(b) requires that it be patentable."
.....
On issues about ethical considerations against life patents, says the
US paper:
"Several Members have referred to ethical concerns regarding the extent
to which private ownership should apply to life forms. Many of thee
concerns result from a misunderstanding regarding the nature of the
rights provided by a patent. As we have noted previously and Article 28
makes clear, a patent claiming a plant or animal does not represent
private ownership of life forms. A patent gives its owner, for a
limited period of time, the right to prevent others from taking certain
actions in relation to a protected invention. The patent does not give
its owner the right to take those actions itself.
"In light of some of the interventions made during previous meetings of
the TRIPS Council, a point we stressed in our previous paper bears
repeating. Holding a patent on an isolated, identified and modified
gene does not amount to ownership of the gene itself. A patent claiming
an isolated, identified and modified gene taken from a human being
certainly would not provide any property rights with regard to the
source from which the original gene was obtained.
"Excluding particular subject matter from patentability will not
prevent research in particular fields. Research will go forward in any
area in which individual scientists and institutions have an interest.
The patent system plays a significant, often critical role in
determining whether the broad results of research that promise benefits
to mankind are developed into products and processes that will realise
those benefits. It is no accident that countries with strong patent
systems, where exclusions from patentability are few, are also
countries with strong private industries covering the broad range of
technology, providing jobs and contributing to the creation of capital
that can be invested further. Similar kinds of encouragement can be
observed in relation to the development of industries related to other
forms of intellectual property as well."
(The US paper also deals with sui generis systems, indigenous
knowledge, and the compatibility of the CBD and the TRIPS. These will
be reproduced in subsequent issues)
Environment: Arctic Pollution linked to Sites in North America
Washington, Oct 3 (IPS/Danielle Knight) - Toxic pollution that has
mysteriously entered Canada's pristine Arctic region has now been
linked to air emission s from specific municipal waste incinerators,
cement kilns and industrial plants in the United States, Canada and
Mexico, according to a new study released Tuesday.
Although there are few pollution sources in Nunavut, the region of
Arctic Canada studied, it is on the receiving end of toxic pollutants
known as dioxin that have been transported over long distances by the
prevailing air currents, says the report by the Center for Biology of
Natural Systems of Queens College in New York.
"Decision makers now have the ability to determine where dioxin is
coming from and where it is going," says Greg Block with the North
American Commission for Environmental Co-operation, a Montreal-based
inter-governmental organisation set up under the North American Free
Trade Agreement (NAFTA).
"This will be very helpful in prioritising cost-effective efforts to
reduce exposure," he says.
Block's organisation commissioned the report.
Dioxin are one of a dozen types of chemicals known as Persistent
Organic Pollutants or POPs, which accumulate in the fat of animals.
Dioxin, proven to cause cancer, immune deficiency and harmful
reproductive and developmental effects, are unintentionally produced as
by-products of incineration and industrial processes.
According to scientists, POPs are capable of being transported long
distances through the environment and end up settling in colder regions
because of weather patterns.
The study released Tuesday was a response to numerous scientific
reports that revealed high amounts of dioxin in the food chain in the
polar regions and blood supply of indigenous people living in the
Arctic, known as the Inuit.
In Nunavut, for example, even thought there are no significant sources
of dioxin within 500 kilometres, dioxin concentrations in Inuit mothers
breast milk are twice the levels observed in southern Quebec.
Now for the first time, this study reveals where exactly the dioxin
originated.
The authors of the study hope this will aid international and regional
efforts to reduce dioxin at the source so that it never ends up in the
food chain.
"The only possible way of dealing with the issue is going to the source
and preventing or reducing the amount of dioxin that comes out of that
source," says Barry Commoner, a scientist at Queens College who headed
the research study.
Using mathematical and meteorological models, the study analyses 1996
-1997 data obtained by Canadian, Mexican and US environmental
regulatory agencies. The model estimated the amount of dioxin emitted
by each source in the three countries at its geographical location.
Using weather and climate data, the model then predicted which dioxin
would reach various locations in Nunavut.
Overall the greatest contribution, about 70 to 82 percent, of dioxin in
Nunavut is coming from US sources.
About two-thirds of the total dioxin emission is caused by municipal
waste incinerators, medical waste incinerators, cement kilns burning
hazardous waste and backyard trash burning. Iron sintering, and copper
and aluminum s melting, are other major sources of dioxin, according to
the report.
While the contamination problem can seem overwhelming, the realistic
possibility of adequately stopping the pollution at specific sources is
strengthened by the study's finding that most of the airborne dioxin
deposited in Nunavut originates from an extremely small number of
individual sources.
Six of the total North American sources identified as emitting the most
dioxin, for example, are located in the industrialised eastern half of
the United States. These include three municipal waste incinerators,
two iron sintering plants and one copper smelter.
Canadian sources contribute between 11 and 25 percent of dioxin
reaching Nunavut, while Mexican sources contribute about five to 11
percent. The largest amount of dioxin emitted by a single Canadian
source was a municipal waste incinerator in Quebec.
No single Mexican source is ranked in the top 35 percent of sites
listed. Since the model used in the study relies on data from 1996 and
1997, the current amount of dioxin coming from the reported sources are
likely to be much different because of recent pollution regulations,
says Block.
"The snapshot could look different today since 1997 air quality
regulations have come into place," he says.
Michael McCally, an expert on dioxin who teaches at New York's Mount
Sinai School of Medicine called the report "tremendously significant".
"We have known for a long time that native communities living in the
Arctic circle thousands of miles from industry had high levels of
dioxin in their blood and tissue samples and now we have specified
where the dioxin is actually coming from," he told IPS in a phone
interview.
Indigenous leaders are praising the researchers for finally pinpointing
the exact location of pollution sources that they said have
contaminated their communities for decades.
"For us, this particular study is very important," says Sheila Watt
Cloutier, an Inuit leader in Canada.
Tens of thousands of Inuit people living in Nunavut territory depend on
Caribou for food. Past studies have found that Caribou herds in the
region are contaminated by dioxin.
"Human exposure to dioxin is almost entirely (98 percent) through
animal foods, especially those that are rich in fat," according to the
report released today.
In Washington on Tuesday afternoon, indigenous leaders throughout North
America held a press conference in front of the US State Department.
They called for lawmakers to take tougher national and international
action on eliminating Persistent Organic Pollutants at the source.
"From the Great Lake tribes to the Native villages of Alaska, dioxin,
DDT, PCB and other chemicals are in the bodies of our traditional food
web - from the fish we eat - to the bodies of our people," says Tom
Goldtooth, director of the Indigenous Environmental Network, an
advocacy group based in the state of Minnesota.
In December in Johannesburg, South Africa, nations will begin the final
negotiating session of an international treaty that seeks to eliminate
POPs.
Environmentalists and indigenous groups alike have accused the United
States of trying to weaken the treaty.
Shawn Larson, who works with Alaska Community Action on Toxics, a
Native American advocacy group, says her village is very concerned
about the health effects - like cancer, diabetes and learning
disabilities that she says POPs are causing.
"I have come here on behalf of my people to ask that the United States
government owns up to its responsibility to protect us as a people,"
she told reporters on Tuesday.