Source: CropBiotech Update

A third amendment has been made to India's Patents Act, this time extending the country's patent protections to include agro-chemicals, food, and biotechnology products, apart from drugs and pharmaceuticals.

This was made in order to meet with the World Trade Organization (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement, to which India is committed.

The TRIPS agreement has stipulated three criteria for patent rights, namely novelty, inventive step, and utility; however, it has not defined microorganisms and microbiological processes. Thus, the new patent regime will cover seeds created by novel means, including transgenic seeds; and claims in gene patent applications may pertain to genes or partial DNA sequences, proteins encoded by these genes, vectors used for transfer of genes, genetically modified micro-organisms, cells, plants, and animals, and the process of developing a transgenic product.

The amendment went into effect on January 1, 2005.

Access the patent ordinance at http://www.isaaa.org/kc.

New amendments to Patents Act, 1970 to affect farm sector

Ashok B Sharma
Financial Express via CropBiotech Update

The new Ordinance, issued by the government for amending the Patents Act, 1970, is likely to affect the farm sector as it extends the product patent regime to agro-chemicals, food and biotechnology products, apart from drugs and pharmaceuticals.

This is the third amendment to the patent law, in succession. This was done to fulfill the country’s commitment to TRIPs and WTO. The amended patent law came into effect from January 1, this year.

The new amendment has not categorically excluded seeds developed by novel means. Though India had earlier opted for the sui generis system for protection of plant varieties and had subsequently put in place, the Plant Varieties Protection & Farmers’ Right Act, lack of clarity in the amended patent law will lead to a situation of patenting of seeds developed by novel means, particularly the transgenic seeds.

The seed industry, engaged in developing transgenic seeds, is eager to seek such a protection, citing Article 27 of the TRIPS agreement.

The TRIPS agreement has stipulated three criteria for patent rights, namely novelty, inventive step and utility.

Though the second amendment to the Patent Act had excluded plants from the patent regime, it said that the bio-technological processes, to develop unique plants, can be covered under patents.

The third amendment, which has extended the product patent regime, has not categorically excluded such seeds from being patented. It has done little to restrict the scope of patentability.

Several experts like Dr KV Swaminathan, chairman of Waterfalls Institute of Technology Transfer and BK Keayla, convener, National Working Group on Patent Laws had earlier criticised the liberal ways in which patent rights are granted, citing minor changes as ‘innovation’. They had suggested granting of patent rights over basic invention.

The third amendment has limited the scope of pre-grant opposition to patent rights to mere filing of representation before the controller of patents, while at the post-grant stage, objections can be filed before the board constituted for the purpose.

This amendment failed to define the emergency clause, where the government can step in and intervene in public interest. It mentions only the national emergency and circumstances of extreme urgency, without stating specific emergencies, relating to health and environment.

The third amendment, though, has a clause for dealing with abuse of patent rights, it fell short in defining the terms for commercial use. Such terms for commercial use are in vogue in Argentina, China, UK and France.

Defining terms for commercial use is necessary to check monopolies and encourage competition and this finds mention in Article 31 (b) of the TRIPS agreement.

The TRIPS agreement has not defined micro-organisms and microbiological processes.

Here, the question is whether the microganisms, existing freely, are patentable or their mere isolation in pure form are patentable or human intervention, in establishing a level of novelty in the discovered micro-organism, is needed for patenting. The USPTO verdict of the case Diamond vs Chakraborty in 1980 establishes that human intervention, leading to a novelty in expression, can be patented.

It says: “the respondent’s micro-organism plainly qualifies as patentable subject matter. His claims is not to a hitherto unknown natural phenomenon, but to a non-naturally occurring manufacture or composition of matter - a product of human ingenuity having a distinctive name, character and use...... His discovery is not nature’s handiwork, but his own...”

Th next question is whether a product produced by a micro-organism, which is known, can be patentable or the process is patentable. In absence of clear definition of micro-organism and micro-biological process in the TRIPS agreement, the country’s policymakers need to draw a distinctive line between the the product of human intervention, leading to novelty and those freely occurring in nature.

In the absence of clarity in the third amendment, claims in gene patent applications may pertain to genes or partial DNA sequences, proteins encoded by these genes, vectors used for transfer of genes, genetically modified micro-organisms, cells, plants and animals and the process of developing a transgenic product.

These may lead to multiple rights owned by multiple actors, called patent thickets over a final product. Hence, there are problems of not only patent thickets, but also of royalty stacking and reach-through claims.

The food sector in India will also have to face new challenges in the new patent regime. Different processes and products will become patentable.

There is, therefore, a need to document all the traditional processes as well as products, with a view to reduce the number of controversies over claims for patent rights.