Patenting of life forms in India for many years has been perplexing for the stakeholders. The Indian Patent Office has evolved over time to come up with various initiatives to address the issues surrounding patenting of life forms. Even though the initiatives have helped in addressing the confusions to an extent there still needs some work to be done to provide a clarity for the stakeholders.

A life form could be a unit or a being that is alive in nature. As an example, it may be anything from plant or an animal or a virus to a human being. This provokes a question whether living beings can be patented?

The Indian government's stance on patenting life forms has gradually changed over time. Couple of decades earlier, India was against granting patents to life forms. The same is apparent based on India's demand on review of Article 27.3 of TRIPS and support for the African group proposal on review of Article 27.3 presented in 1999, which suggested that patents on life should be prohibited, including those on microbiological processes. However, TRIPS had directed the member countries to allow patents to all technologies and microorganisms as well. To comply with the direction of TRIPS, amendments to the Indian Patents Act, 1970 were made between the years 1999-2005 in order to suit India's international commitments under TRIPS. Particularly, an amendment to the Act was made in the year 2002 which allowed patents on microorganism. The amendment opened up new possibilities to secure patent rights for new microorganisms and other areas involving microorganisms.

In order to patent a living form in India, the invention must meet the requirements stipulated by the Act. The requirements include sufficient disclosure of the invention, the invention is new, non-obvious and useful, the invention meets the vendibility test, and the invention is in the public interest. Since, the Patents Act does not grant patent for the discovery of "any living thing or non-living substance occurring in nature," the product or process that is to be patented is ought to be secluded from nature by application of human intervention.

The judgment by the Calcutta High court in the case Dimminaco A G v/s Controller of Patent Designs & Ors" on January 2001 completely flipped the panorama of patenting life forms in India. Dimminaco A G, a Swiss company approached the Hon'ble High Court of Calcutta upon getting a refusal on its process patent that pertained to preparation of a live vaccine for Bursitis. The company got denial on the grounds that, the invention containing a living organism was not patentable as under section 2(1)(j). The Controller of Patents determined that the process was not an invention, since the end product produced by the corresponding process contained a living organism, thereby making it not patentable. On the contrary, the High Court applied the vendibility test to the invention and deemed that the process results in a vendible item that is new and useful. Since the process resulted in a vendible item, patent was granted for the process and there was no discussion about the end product containing living material in reaching this conclusion. The conclusion which could be drawn from the instant case is that, patent rights are granted to a process rather than a product provided that the product produced using the process is a vendible item.

Further, the Act was amended in the year 2002, to include Section 3(j) which does not allow patenting biological processes for production of plants and animals, or plants and animals in whole or in part other than microorganisms. This amendment opened gates for patenting living forms (microorganisms) and not just the processes of producing the life form. It is still uncertain how far Section 3(j) would aid in patenting of microorganisms as there is an ambiguity in defining what constitutes a microorganism. Therefore, it is vital to have a clear working definition for "microorganism" as a legislative amendment in India.

However, there is a clarity in the matter of patenting Genetically Modified Organisms (GMOs). GMOs are also categorized under life forms, and even though GMOs are living beings, they do not occur naturally in nature. A significant human intervention is necessary for the development of GMOs. Hence, the Act provides more leeway for patenting GMOs.

It is to be noted that biotech companies make huge investments in the research and development to come with new improved microorganisms. Considering the huge money that is invested and the risk that is taken by these companies it is virtuous that these companies are rewarded for their work. Denying patents for microorganisms that are developed as a result of intensive research and huge investment is highly demoralizing to the companies. It is also to be considered that genetic engineering and biotechnology is an important player in the development of a country. The developed nations such as USA, Japan and European countries recognized this and have framed the legislation that makes it easier to patent life forms. The Indian government over the time has made necessary amendments to address the issues surrounding the patenting of life forms. However, it is not sufficient and there is scope for improvement. Considering all of the above, it is imperative for the Indian government to come up with legislations to clear the ambiguities clouding the patenting of life forms.

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