Seed sovereignty |
Alert on Patent Law
The Patents (Second Amendment) Bill, 1999 (Bill XLIX of 1999)
The WTO TRIPs Agreement is under review and the government's rush to introduce a second Patents Act amendment within the same year is not a response to TRIPs obligations but to the pressure of global pharmaceutical and agri-chemical and biotech industry. The following key changes introduced through the Amendment Bill in the 1970 Act, highlight the bias in the Bill for the biotech industry which is being rejected worldwide by producers and consumers on grounds of ethics ecological impacts and health hazards.
The definition of "invention"
The definition has been redrafted as:
(j) "invention" means a new product or process involving an inventive step and capable of industrial application
and
(ja) "inventive step" means a feature that makes the invention not obvious to a person skilled in the art.
The reason given is that this in is consonance with international practices and consistent wit TRIPs Agreement. However nowhere in TRIPS is the term "invention" defined.
Further in the review submissions made to the TRIPs Council the majority of Third World countries have asked for a change in TRIPs to ensure that no life form will be treated as an invention.
What is not an invention
The Second Amendment of the Patent Act, 1970 has clearly biased the Act in favour of monopolies over life forms in the hands of the biotech industry.
There are three key amendments that open the doors for such a monopoly:
1. Plants have been excluded from the domain of Article 3(i) as subject matter that will not be considered as an invention. [Clause d(ii) of Bill]
2. While plants and animals are mentioned as an exclusion, this is restricted to an ambiguously defined phrase "essentially biological processes for production and propagation of plants and animals". [Clause 4(e) of Bill]
3. Biochemical, biotechnological and microbiological processes have been defined as "chemical" processes, thus allowing animals and plants derived from biotechnology as patentable subject matter. [Clause 5 of Bill]
The Patent Amendment Bill is therefore FOR patenting of life.
This draft goes counter to India's submissions in the WTO for the review of TRIPs. It also undermines the efforts of African countries to exclude patents on life in the review of the TRIPs agreement. The Bill also counters the growing citizen call on "No patents on life".
Other elements of the Bill which threaten public interest are:
a) The reversal of burden of proof [Clause 50]
b) Applications for patents shall be kept secret for a period of eighteen months [Clause 11A]
c) Even though the existing TRIPs agreement gives upto the year 2004 for product patents in medicines and agri-chemicals the Bill is rushing product patents long before the required period, thus threatening to create monopolies in the vital sectors of food and medicine.
Article 27.3(b) of TRIPs on which much of the Amendment is focussed is under review and there is no reason to rush into its implementation. India herself has asked for changes in the Article and it is nothing but double standards to call for a review at the international level and pushing for a bad law at the national level.
Could this unnecessary rush be a part of a "Green Room" deal in Seattle?
Changes proposed for the
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Clause in the Patent (Amendment) Act, 1998 |
Proposed amendment |
Justification on grounds of national interest consistent with TRIPs Clauses |
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Section 2, sub-clause 2 "Notwithstanding any thing contained in sub-section (1), a claim for patent of an invention for a substance itself intended for use, or capable of being used, as medicine or drug, except the medicine or drug specified under sub-clause (v) of clause (l) of sub-section (1) section 2, may be made and shall be dealt, without prejudice to the other provisions of this Act, in the manner provided in Chapter IV A". |
The Following need to be inserted as sub-section (2) of Section 2 in the Patent (Amendments) Bill, 1998: "(2) Notwithstanding any thing contained in sub-section (1), a claim for patent of an invention for a substance itself intended for use, or capable of being used, as medicine or drug, except the medicine or drug specified under sub-clause (ii), (iii) and (v) of clause (l) of sub-section (1) section 2 of the principal Act, may be made and shall be dealt, without prejudice to the other provisions of this Act, in the manner provided in Chapter IV A". The following also need to be inserted as sub-section (3) of section 2 of the Bill 1998: "No Patent or 'Exclusive Marketing Rights' shall be granted for the insecticides, germicides and fungicides based on indigenous knowledge e.g. Neem pesticides". |
Exemption of sub-clause (ii) is needed to make it consistent with Chapter II, Section 3 (i) of the principal Act 1970, on "What is not an Invention", especially in the biotechnology. This exemption is also allowed under Article 27.3 (a) of the TRIPs Agreement of the WTO. Exemption of sub-clause (iii) can be justified on grounds of public health, under the provisions of Article 27.2 of the TRIPs Agreement of the WTO. The inclusion of sub-section (3) of section 2 in the Bill can be justified under the provisions of Article 7 and 8 of the TRIPs Agreement. For a biodiversity rich country like India, the exemption of pesticides based on plants and the plants based indigenous knowledge from EMR's and patents is necessary to prevent biopiracy. " height="0">Clause in the Patent (Amendment) Act, 1998 |
Proposed amendment | Justification on grounds of national interest consistent with TRIPs Clauses |
157A. Definition of "Security of India". |
To be inserted as sub-section (c) and (d) of Section 8 of the Patent (Amendments) Bill, 1998: (c) take any action including the revocation of any patent on the food crops and any varieties derived out of the indigenous varieties of India to protect India's Food Security. (d) take any action including revocation of any patent on the technologies developed out of genetic engineering and biotechnology, which will affect our biodiversity and ecological security. (e) relates to any biological or chemical produced through genetic engineering and biotechnology to be used as biological weapons.
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TRIPs allows the exclusions of plants from patentability and offers "sui generis" option for crops and plants in Art. 27. 3 (b). For Example "Terminator Technology" TRIPS offers exclusions of such technologies on the ground of environmental protection. Convention on Biological Diversity (CBD) requires such exclusion in Article 19. |
Briefing on the Patent (Amendment) Bill, 1998
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The Patent (Amendment) Act 1998 is merely an Amendment to grant EMR's. It is not an amendment to stop biopiracy as was the commitment made by the Central Government through the Attorney General on 16th Nov 1998 in response to the case on Basmati filed by the Research Foundation for Science, Technology Ecology in the Supreme Court.
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The Amendment thus facilitates Biopiracy, promotes monopolies and will threaten the ecological, economic and food and health security of the Indian people.
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The Amendment allows EMR's in medicine and drugs, which were excluded from product patents in the earlier Act, without appropriate changes in the definition of "invention" to take into account new challenges emerging from Biopiracy and Biotechnology, and prevent patenting of indigenous knowledge, or of techniques and products which are hazardous to the environment, biodiversity and human health.
With a mere introduction of clauses allowing EMR's without other changes and safeguards, the Amendment will become a means for protection of Biopiracy and introduction of biohazards.
A. Ecological Security and Biodiversity Security
B. Food Security
C. Health Security
D. Economic Security
References:These concerns for security should be used to exclude patents which threatens any dimensions of the "Security of India".
Sub-clause (ii), (iii) (iv) and (v) of clause (l) on what is "medicine or drug", of sub-section (1) of Section 2, of the Indian Patent Act, 1970 (the Principal Act):
(ii) "all substances intended to be used for or in the diagnosis, treatment, mitigation or prevention of diseases in human beings or animals",
(iii) "all substances intended to be used for or in the maintenance of public health, or the prevention or control of any epidemic disease among human beings or animals",
(iv) "insecticides, germicides fungicides, weedicides and all other substances intended to be used for the protection or preservation of plants",
(v) "all chemical substances which are ordinarily used as intermediates in the preparation or manufacture of any of the medicines or substances above referred to".
Chapter II, Section 3 (i) of the Indian Patent Act 1970 (the Principal Act):
"(i) any process for the medicinal, surgical, curative, prophylactic or other treatment of human beings or any process for a similar treatment of animals or plants to render them free of disease or to increase their economic value or that of their products".
Article 27. 3 (b) of the TRIPs Agreement of the WTO:
Members may also exclude from patentability,