By Ashok B Sharma
Financial Express via Checkbiotech

India is set to amend its Patent Act, 1970 for the third time with a view to meet its commitments to WTO by January 1, 2005. The amendments are proposed to be consistent to the agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS - 1994).

Patent Act, 1970 was amended for the first time in 1999 and for the second time in 2002 which came into effect from May 20, 2003. The third amendment is slated to provide patent product regime in pharmaceuticals, food and chemicals, including agro-chemicals. Granting patent rights over micro-organisms, microbiological and non-biological processes for production of plants and animals are also likely to be covered under the third amendment.

Though India opted for sui generis system for protection of varieties and enacted a law for the purpose, it is likely that the transgenic seeds developed through human intervention may be covered under the new patent regime. The biotech industry in the country 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. In tune with Article 27, the second amendment to the Patent Act effected from May 20, 2003 has inserted a new definition of ‘invention’ which reads : “invention means new product or process involving an inventive step and capable of industrial applications.” Though the second amendment has excluded plants from the patent regime, it says that biotechnological processes to develop unique plants can be covered under patents.

Keeping in view the past events and likely developments in the near future, the upcoming third amendment to the Patent Act may, therefore, pose new challenges before the farm sector. In this context, the policymakers has a duty to ensure that several protections given to farmers like for saving seeds for the next season under the Plant Varieties Protection & Farmers’ Rights Act are not diluted. Similarly the community rights ensured under National Biodiversity Act should not be ignored. The challenge, therefore, before the government is to develop a holistic view of the entire intellectual property rights (IPR) regime in the country. The second amendment to the Patent Act has a provision for disclosure of the geographical origin of the biological material and notifying certain depositories for biological inventions.

The TRIPS agreement has not defined micro-organisms and microbiological processes. Here the question is whether the micro-organisms 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 : “respondent’s mico-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...”

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 drawn a distinctive line between the the product of human intervention leading to novelty and those freely occurring in nature.

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-trough claims. Reach-through claims are research tool patents such as patents on markers, assays, receptors, transgenic animals. Reach-trough claims results in royalty stacking. These complexities need to be resolved so that the farmers does not end up paying heavy sum in royalty.

The food sector in the country 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.

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