People's Democracy(Weekly Organ of the Communist Party of India (Marxist)
February 20, 2005
patent act has been revised for the third time and an ordinance issued to that
effect. It is like hastening the
death of a dying patient by withdrawing the life support system.
1981, Mrs Indira Gandhi said that the concept of an ordered and developed world
was bound up with the fact that discoveries of medical science would remain free
from the burden of patents and no profiteering would be allowed in matters of
life and death. The Congress of Mrs
Gandhi has now issued an ordinance just opposite of what she had said. India
would now be burdened with the weighty chains of the patent act.
& BJP IN SAME BOAT
water has flown down the Mississippi and the Ganges since Mrs Gandhi’s time.
In 1994, the then defence minister Pranab Mukherjee signed the
multilateral trade negotiations. The Trade Related Intellectual property Rights
(TRIPS) was put in place. It was
decided at the WTO that no nation could have patent rights of its own except
those fashioned after the TRIPS model.
Patent Act formulated by India in 1970 served as a model for the third world. To
make it compatible with TRIPS, three amendments were found to be necessary. Of
these, two amendments were effected earlier in 1999 and 2002. The third
amendment was put in motion on and from January 1, 2005. The applications for
patents, indigenous and foreign, were being received from 1999. The ‘mail
box’ will now be opened.
1995 the BJP organised protest when the patent bill was placed in Rajya Sabha.
On coming to office, however, the BJP rushed through two of the amendments and
tried to effect the third one back in 2003. At that time, 44 intellectuals had
vehemently protested against these steps being taken about the patent act. On
coming to office in 2004, the Congress-led UPA government has no qualms about
stepping into the BJP’s shoes and is keen to have the bill passed.
ASPECTS OF THE 1970 ACT
following were the important aspects of the patent act of 1970:
to give patents for medicines, and in agriculture and chemicals etc.
shorten the time period of patents to 5/7 years for processes and 14 years
demarcate between imports and indigenous production of patented goods.
use compulsory licensing for implementing patents and to spread technology.
fix the upper limits of royalty before the transfer of patents.
positive sides of this act were as below:
the lag-behind in several sectors, progress was made in the production of
two to six years of introduction of new medicines abroad, India could
produce them through alternative methods.
had quite a success in heavy engineering, aluminium, space and nuclear
research, and in the agricultural sector where superior quality seeds have
of more than one hundred basic medicines.
40 per cent of antibiotics, 18 per cent of antibacterial, 70 per cent of
anti-leprosy, 89 per cent of birth control, and 40 per cent of heart
medicines were sold at the cheapest rates in India.
90 per cent of the medicines needed nationwide is produced in India whereas
the figure stood at only 38 per cent back in 1975.
of dependence on imports, more than half of the pesticides and bactericides
are now manufactured here.
export of Indian medicines, especially to third world countries, has
increased by 25 times or more.
number of drugs producing units have grown by six times.
rupee terms, the total manufacture of drugs has increased by 50 times.
is among the countries where drugs are the cheapest.
In the earlier two amendments the following principal changes were incorporated:
the applicant desires to exclusively manufacture and sell the products in
the applicant has received patent rights in any other country on or after
January 1, 1995.
the applicant, even before receiving the patent for the product concerned,
had applied for patent for such articles on January 1 or later.
Even if there is no patent received, the concerned person(s) shall have monopoly rights over the marketing of the product if he had documented and formulated the production process and the product.
following were omitted by the two amendments:
the event of a famine, epidemic, natural disaster, and the occurrence of or
the threat of a particular disease, the union government can give the right
of selling and marketing to some other person(s).
union government reserves the right to fix the price cap on any product of
NDA and the Congress ignored the suggestions and advice of the Law Commission on
the amendments after the passage of the first amendment in Rajya Sabha.
the former director of the National Bureau of Plant Genetic Resources (ICAR), K
L Mehra writes that the non-formal producers of economic assets organised free
exchange of knowledge across groups and along the lines to advance and develop
agriculture and to improve the standard of living, but without documentation
since that was improbable during those earlier times.
also writes that botanists gathered knowledge from peasants and traditional
herbal doctors for free, and that knowledge acquired by generations could not
have any property rights attached. Making patents out of these knowledge bases
is some kind of a theft.
cites neem and says patents have been
taken out for neem products of various
kinds. They include pesticides, bactericides and sweeteners. Indians have been
using neem products for centuries. But
a recent survey reveals that such herbal products as have been patented
represent a value of 48 billion US dollars. Why should not the 250-odd concerns
that have organised these patents for themselves provide royalties to the people
who own the true intellectual property rights to these products?
Article 27 of the TRIPS agreement clearly states speaks of some amount of relief for the member countries, but the union government has not taken advantage of the provisions.
Law Commission has stated that patents should not be instituted in (1)
symptomatic, investigative, and surgical treatment of humans and animals, and
(2) in products and plants directly related to the overall development of a
country, its standard of living, conservation, public health, and environment.
products to be exempted from patents are: (1) the products included in the
system of medicine incorporated in the Indian Medicine Central Council Act,
which are used by the Indian people, and (2) the products and systems of
treatment used for generations by local anthropological groups.
second amendment to the patent act incorporates in full article 5 of the TRIPS.
The exceptions in this regard, i.e., chemicals, medicines, food articles,
and agricultural chemicals, have been duly incorporated in the third amendment
as the ‘deadline’ had been set for January 1, 2005.
were two aspects of the 2003 amendments. The first was a concern to implement
the TRIPS conditionality. Secondly, they were based on certain acts that are
anti-national. The promise and political assurance of social security, that was
given in the second amendment, has been given a go-by in the third amendment.
there was a system where the process could be patented. Now a product itself is
to be given a patent. Even similar products produced through alternative
processes must have to give a royalty to the patent holders of the original
product. As a result, the prices of patented seeds, fertilisers and medicines
are bound to go sky-high.
a patent could be opposed and appealed against within four months of its grant.
The grounds that could be cited were:
invention being patented is common knowledge and is used in the country
patented product is not an invention.
facts and material sources have been wrongly quoted to substantiate the
product patented is part of the traditional system of India or of any other
But the third amendment stipulates that, other than a representation, no opposition to the patent could be lodged before the patent is implemented. This is clearly a sop because, once its marketing starts, there would be no point in opposing a patent. The representation part does not say anything about the length of the hearing on the protest and the ultimate result.
and Thailand have protested against this procedure, but not India. Such an act
cannot be justified, especially because, at least seven per cent of the patent
applications, that is close to 6,000 applications, had been turned down between
1972 and 1987.
signing the TRIPS agreement, India has become enmeshed in the vortices of the
world trade agreement, from which it cannot escape. Until such time when the
third world countries unitedly oppose the agreement, some steps could
conceivably be taken:
the example set by China, it could be decided that if the price of a
patented product is not fixed even after the passage of a stipulated time,
another producer might be compulsorily given a license.
example of some other countries may be emulated and royalty to be given may
be limited to four per cent.
patented for internal consumption may be exported to such third world
countries as do not produce them.
applications for patents in the ‘mail box’ must be considered and
rampant grant of patents checked.
Disputes are still going on the issue of patenting. Discussions are going on, for example, on micro-organisms. The union government has to desist from haste in implementing the patent act. Compulsory licensing exists in scores of developed countries and these countries have never employed any such indiscretion in the implementation of patenting as does India. As India is in a position to export medicines, at a cheap rate, to other countries needing these products, multinational corporations (MNCs) would close down the import and export of generic medicines to such countries if India desists from such exports.
Doha declaration on TRIPS agreement and public health clearly states that all
agreements on patenting must have people’s interests in mind, and that
medicines must not be excluded from the process in this regard.
possible impact of patenting will be made clear if one cites certain examples.
For one, the cost of a medicine will jump tenfold or more. In case of
anti-retroviral drugs used for AIDS cases, the cost would increase from Rs 7,000
per year to Rs two lakh per year. As it is, only 10 per cent of AIDS patients
receive treatment of any kind. The cost of Glivek, an anti-cancer drug, will
stand at Rs 22,000 per ampoule --- 20 times the present Rs 1,100. No less than
39 life saving medicines will be withdrawn from the Indian market. The country
will be at the mercy of the MNCs.
declaring that the TRIPS agreement must not compromise public interest, the
World Health Organisation (WHO) has said that every country must take equal care
of the people’s interests along with those of patent owners. A policy must be
adopted for the poor and less developed countries whom medicines may be supplied
and above phthisis, malaria and diabetes, the incidence of AIDS is dangerously
increasingly in India. Tropical diseases are starting to spread. As per the Doha
declaration, medicines must be produced on an emergency basis and compulsory
licensing implemented. Compulsory licensing can be used in instances of popular
interests, epidemics, natural disasters, and for the conservation of life forms.
The TRIPS agreement has the relevant provisions in the various sub-clauses under
the circumstances, why is the union government bowing down and needlessly
capitulating before the WTO? Cannot it realise that its job is to safeguard the
interests of more than 100 crore people? In many countries of Asia and Africa,
demonstrations have started to take place against the changes in India’s
patent act, as the people of these countries will be grievously hurt by the
increase in the cost of medicines. The reason is that the MNCs will control the
markets and supply medicines at prohibitive costs. On December 6, demonstrations
were organised before the Indian embassy in Paris. The demonstrators argued that
AIDS patients of many African and Asian nations would die as medicines at cheap
rates would no longer be available from India. The struggle to pressurise the
union government into not putting in place the third amendment to the patent
act, indeed to preserve the patent act 1970 itself, must be based on a wide
footing, involving every section of the people. The task brooks no delay.