The Patents (Third) Amendment Bill,
which might be tabled in Parliament during the coming winter session, is a Bill
which will pave the way for a new patent law.
As India is a member of the World Trade Organization, it has to have a new patent law to fulfil the obligations under the TRIPS (Trade-Related Aspects of Intellectual Property Rights) agreement.
The new law, which will recognise intellectual property rights, is supposed to come into force on January 1, ??05. The process of drafting the new Act involves modifying the Indian Patent Act (IPA), which was enacted in 1970, in a phased manner.
India became a member of the Paris Convention and the Patent Cooperation Treaty (PCT) with effect from December 7, 1998. Since then, two amendments, namely the Patents Amendment in April 1999 and the Second Amendment in May 2002, were enacted.
The Third Amendment is the last amendment before a new Indian Patent Act is created. This may now be done though an ordinance if the January 1 deadline is to be met.
What are the objectives of the new Bill?
The stated objectives of the new Bill is to further amend IPA (1970), not only make the law TRIPS compliant, but also to simplify and rationalise the procedures for grant of patents.
The salient objectives of the Bill are to introduce the product patent regime for all inventions, to delete the provisions relating to EMRs which will become redundant with the advent of the Product Patent regime and to introduce the provision of grant of Compulsory Licenses to supply drugs to countries which have no manufacturing capacities to meet their acute public health problems as per the TRIPS Agreement on the DOHA Declaration on Public Health, and to strengthen issues related to national security.
Why is the amendment necessary?
India is a signatory to the PCT. Following the Indian Parliament??s ratification of the treaty, the country has adopted provisions for PCT compliance in the Patents Act.
This is what the World Intellectual Property Organization (WIPO) officially states of the PCT: ??The PCT makes it possible to seek patent protection for an invention simultaneously in each of a large number of countries by filing an ??international?? patent application. Such an application may be filed by anyone who is a national or resident of any contracting state.??
For an understanding without prejudice, the PCT is meant to deal with harmonisation of patent filing procedures, with an aim to give the least hardship to seekers of patents and cut the costs of seeking patents.
As India is a member of the World Trade Organization, it has to have a new patent law to fulfil the obligations under the TRIPS (Trade-Related Aspects of Intellectual Property Rights) agreement.
The new law, which will recognise intellectual property rights, is supposed to come into force on January 1, ??05. The process of drafting the new Act involves modifying the Indian Patent Act (IPA), which was enacted in 1970, in a phased manner.
India became a member of the Paris Convention and the Patent Cooperation Treaty (PCT) with effect from December 7, 1998. Since then, two amendments, namely the Patents Amendment in April 1999 and the Second Amendment in May 2002, were enacted.
The Third Amendment is the last amendment before a new Indian Patent Act is created. This may now be done though an ordinance if the January 1 deadline is to be met.
What are the objectives of the new Bill?
The stated objectives of the new Bill is to further amend IPA (1970), not only make the law TRIPS compliant, but also to simplify and rationalise the procedures for grant of patents.
The salient objectives of the Bill are to introduce the product patent regime for all inventions, to delete the provisions relating to EMRs which will become redundant with the advent of the Product Patent regime and to introduce the provision of grant of Compulsory Licenses to supply drugs to countries which have no manufacturing capacities to meet their acute public health problems as per the TRIPS Agreement on the DOHA Declaration on Public Health, and to strengthen issues related to national security.
Why is the amendment necessary?
India is a signatory to the PCT. Following the Indian Parliament??s ratification of the treaty, the country has adopted provisions for PCT compliance in the Patents Act.
This is what the World Intellectual Property Organization (WIPO) officially states of the PCT: ??The PCT makes it possible to seek patent protection for an invention simultaneously in each of a large number of countries by filing an ??international?? patent application. Such an application may be filed by anyone who is a national or resident of any contracting state.??
For an understanding without prejudice, the PCT is meant to deal with harmonisation of patent filing procedures, with an aim to give the least hardship to seekers of patents and cut the costs of seeking patents.
Towards this end, it aims to put in place a system for international patent filing. As a result of pursuing these objectives, the PCT delves into areas like defining parameters for patent examination and the criteria for examination and grant of patents.
Thus, it becomes a treaty that governs technical questions too, and according to some, a vehicle to impinge on sovereign rights of nations to decide on ??patentable subject matter.?? Hence, all countries that have ratified the PCT in their national laws, including India, have to modify their patent laws to comply with the PCT.
How was the Indian Patent Act of 1970 different?
In the Indian Patent Act 1970, food, medicines and drugs including substances obtained by chemical processes were granted only process and not product patent. The 1970 Patents Act defines what are not inventions.
Among others, these include ??inventions?? which are frivolous, which are contradictory to established natural law, those which are contrary to law or morality/injurious to public health and discoveries of a scientific principle or the formulation of abstract theory.
Also out are a mere discovery of any new use for a known sub-stance or the mere use of known process or machine unless such known process results in a new product or employs at least one new reactant, methods for agriculture or horticulture and any process for treatment of human beings, plants or animals to render them free of disease or to enhance their economic value. Inventions relating to atomic energy are also not patentable.
What are the contentious issues in the Patent (Third) Amendment Bill?
One of the contentious issues is the ??patentability?? criteria - what makes an innovation patentable. While some lobbies want the criteria to include incremental innovation in the list of patentable innovations, others do not.
The domestic industry lobby has emphasised that it wants a tighter definition of patentability and does not want different salts, esters, ethers, isomers, mixtures of isomers, complexes or derivatives of an active substance to be patentable.
The section relating to opposition is also being debated, the mechanism through which a patent application can be challenged. The MNC lobby is pushing for a post-grant opposition, whereas the domestic lobby is asking for a pre-grant opposition.
NGOs and the domestic industry are also urging the government to simplify procedures for compulsory licensing, in the event of a public health emergency.
According to these groups, the present procedure for issue of compulsory licences for commercial purpose is unduly elaborate and very time consuming and defeats the very purpose of compulsory licensing for urgently required Drugs.
