Biotechnology Patenting through Indian Perspective

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Overview

Biotechnology basically refers to the technology that has been based on biology. It usually involves the category of recombinant DNA, antigens, antibodies, novel microorganisms, and artificial organisms, etc. It has been emerging as a potential technology in the field of agriculture, pharmaceutical, plant varied and environmental field which focusses on intellectual property rights globally. The most recent development in this field has seen a major transformation in human activities in order to make them more sustainable for growth and development and fit into the regimes of intellectual property rights.

How patent is granted in India?

In India, the issue of the patent is governed by the Indian Patent Act of 1856. Since its enactment, it has been modified several times as per the technological developments of the era and the advancements that followed. A major amendment took place in 1970 which essentially dealt with making patenting in India more like the norms issued by International authorities. It laid down three basic requirements for patenting a particular invention or technology, which were:

  1. Novelty: Any invention that is to be patented should be something new and not done before.
  2. Inventive step: The invention should be non-obvious in nature.
  3. Industrial Application: The invention should be fit for industrial application that too in a positive and ethical manner.

The 1970 amendment did not include anything about biological or biotechnological patents. Further, an amendment was brought in 2002 complying with the norms of the International Organization which included provisions for biotechnological, microbiological, and biochemical patents. It also laid down the process to patent these inventions.

The TRIPS agreement

The TRIPS agreement was signed by the member countries of WTO in 1995. It laid down the minimum requirements for grant and substantiation of patents and other intellectual property rights. The member countries of the agreement have to comply with the rules laid down in the agreement.

Section 27 of the agreement talks about biotechnological patents. Firstly, it says that the product has to be innovative as in new. Secondly, it should be modern and innovative in its processes and should be industrial in its application. A subsection of this also ensures that all the member states have to provide patents for the plant and animal plant and non-biological microorganisms and non-biology processes.

The governments (of member countries) may however exempt from the development of patents through plants, animals, and other biological processes to ensure their healthy development. However, there are no specific definitions laid down for the above-mentioned terms that give the space to the governments to mould it to their benefit. The TRIPS agreement also mentions that the grant of a patent should not be done when the invention is against public morality or ethics and harmful for mankind as a whole.  

Biotechnological patents in India

The Indian Patent Act of 1970 lays down a proper definition of the term invention. It says that the invention means “an innovative phase that is ideal for the industry”. The novelty or newness specifically means it should be distinct from the prior art. Anything of such sort should not have been made or brought up before the public in the past. The skilled individual who is trying to register the patent should not be contradicting the principles of science and also be ethical in his approach.

The most difficult task in registering the biotechnological patents is the inventive phase. To ease it down and make it more comprehensive a detailed information on the patent has to be covered while making the disclosure. The patents though cannot be described in words easily, but it has to be comprehensive enough to show that it is new and innovative. The Indian Patent Act prohibits patenting of such biotechnological inventions which have life as well as non-living substances.

In addition, the Act also specifically states that no authorized process has to be patented for the medical treatment of human beings or any surgical, curative prophylactic, or diagnostic treatment of animals. The act also prohibits patenting of seeds, animals, plants, or any such variety thereof. These restrictions existing do not stop or pose a huddle in new biotechnological developments. The inventions of these biotechnological products, especially the conventional ones like fermentation, formation of yeast, etc. have been rising.

 No special reference was made to the processes or methods of processing the bio-conversion of biologically active substances in the Patent Act of 1970, so considering this loophole the patentability of live types such as micro-organisms and gene cell lines are being exempted from the spirit of patent law.

In the case of “Monsanto Technology LLC vs. Controller of Patents and Design[i] Monsanto Technology applied for patenting a method of development of a transgenic plant that was capable of surviving the harsh environmental conditions. The company claimed that in this process there was a substantial human intervention in inserting rDNA molecule that made the plant capable of surviving such harsh environmental conditions. The IPO argued that this process involved a biological process of regeneration and selection which was excluded from the Patent Act. It was finally held that the method used by Monsanto Technology came under the human intervention part and hence excluded from the regeneration process that could not be granted patent. Hence the patent was granted to the company.

Conclusion

The biotechnological field though tough to organize and group into patents has a lot of potential in itself which can take mankind to new heights. It can be used as a method of sustainable development at many stages and hence needs to be promoted. This article has dealt with the patenting of biotechnological technology in a detail. The processes are somewhat different in different countries but the International Agreement binds them together. 


[i] Monsanto Technology LLC vs. Controller of Patents and Design, 2407 DELNP 2006.

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