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Analysis of Section 3(J) of the Patents Act, 1970

Issued: June 01 2009
In India, a new product or process involving an inventive step and capable of industrial application is an invention under section 2(j) of the Patents Act, 1970 as amended in 2005. However, there are certain limitations imposed by Section 3 of the Indian Patents Act under 15 clauses that define what are not inventions.

Section 3 (j) of the Indian Patents Act as based on Article 27.3 (b) of the TRIPS agreement is one such limiting provision that states as follows: “[P]lants and animals in whole or any parts thereof other than micro-organisms but including seeds, varieties and species and essentially biological processes for production and propagation of plants and animals.”

The section excludes as invention plants and animals in whole or parts thereof, including seeds, varieties and species, as well as essentially biological processes for their production or propagation. However, the term “essentially biological process” has not been defined in the Act unlike the European Patent Convention (EPC) which under rule 23b(5) states that “process for the production of plants or animals is essentially biological if it consists entirely of natural phenomena such as crossing or selection.”

There are various patents granted for the process of producing transgenic plants or animals, as a process consisting of technical or human intervention may not be regarded as essentially biological process. Therefore, the transgenic plants and animals may not be considered as patentable subject matter but the process for producing the same may be considered as patentable. However, in India plants and varieties are provided protection under the provisions of the Protection of Plants Varieties and Farmers Right Act, 2002.

With respect to the inventions relating to microorganism, the section specifically excludes micro organisms from the group of non-patentable invention. Micro-organisms modified by human intervention are considered as a patentable subject matter provided they meet the other prescribed patentability criteria. Whereas, naturally occurring micro-organisms are specifically excluded from being patented under section 3(c) of the Indian Patents Act under which “discovery of any living thing or non-living substance occurring in nature” is not an invention.

However, the term micro-organism has not been defined in the Indian Patents Act or the Manual of Patent Practice and Procedure, 2008 unlike the EPC. The Guidelines for Examination in the European Patent Office states that the term “microorganism” includes bacteria and other generally unicellular organisms with dimensions beneath the limits of vision which can be propagated and manipulated in a laboratory, including plasmids and viruses and unicellular fungi (including yeasts), algae, protozoa and, moreover, human, animal and plant cells.

In India, there is no clarity as to whether human, animal and plant cells – though microscopic in size – would be considered as micro-organisms or the parts of plants and animals.

Therefore, in wake of any definition and explanation of the term “micro-organism” in the Indian Patents Act or the Manual of patent practice and procedure, 2008, what constitutes a micro-organism in the Indian patent system is still a debatable issue.
 
 
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About the Author

Madhuri Tawri is a patent agent and an associate with the chemical and life sciences department of Krishna & Saurastri. She holds a Bachelor’s degree in law and a postgraduate degree in microbiology. Her practice area includes patent drafting, prosecution, prior art searches, oppositions, providing opinions relating to patentability, infringement and freedom to operate in the field of biotechnology, pharmaceutical chemistry, biochemistry, and microbiology. Tawri’s prior experience includes working with a US patent attorney and as a patent specialist in a pharmaceutical company in India. She is registered to practice before the Indian Patent Offices.

 

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