INTRODUCTION

Scientific progress in genetic engineering and other biological sciences has been exponential since the 1953 discovery of the double-helix structure of DNA. This has led to the thousands of patents being granted for rights pertaining to DNA sequences, coinciding with an increase in the commercialization of research. However, patenting life forms and Genetically Modified Organisms (GMOs) is the current area of controversy.

There are several reasons why the patenting of life forms is unique. Firstly, the creation itself is live. In other words, the invention has the ability to reproduce in certain circumstances. Furthermore, the invention may not always be sufficiently described for the purposes of a patent specification. This has resulted in circumstances where parties have been made to submit their inventions for patent purposes.

PATENTING LIFE FORMS –SCOPE AND CHALLENGES

A unit or a living thing found in the natural world might be considered a life form. For instance, it could be a virus, an animal, a plant or even a human being. This raises the question of whether patents can be granted for life forms?

Over time, in India the position on life forms patenting has progressively evolved. A few decades ago, India was strongly against patenting of life forms. The same is evident from India’s demand for a review of Trade – Related Aspects of Intellectual Property Rights (TRIPS) Article 27.3 and support for the African group proposal for a review of Article 27.3 of TRIPS, which was presented in 1999 and urged that patents on life forms and microbiological processes, be prohibited. TRIPS, on the other hand, required member countries to grant patents on all technologies and microorganisms. Between 1999 and 2005, changes were made to the Indian Patents Act, 1970 (Act) to bring it into compliance with TRIPS and meet India’s international obligations under the agreement. More specifically, in 2002, the Act was amended to grant patent on microorganisms. The amendment made it possible to obtain patent rights for novel microorganisms and other fields that involving microorganisms.

An invention must fulfil the Act’s requirements in order to be granted a patent in India for living form. The invention must meet certain criteria, such as being new, useful, and non-obvious; it must also pass the vendibility test and be in the public interest. The product or method that is to be patented must be secluded from nature by the use of human intervention, as the Patents Act does not give patent for the discovery of “any living thing or non-living substance occurring in nature.”

In January 2001, the Calcutta High Court rendered a decision in the Dimminaco A G v. Controller of Patent & Design Ors. case, which fundamentally altered the context of life form patenting in India. A Swiss business named Dimminaco A.G. filed an appeal with the Hon’ble High with the Hon’ble High Court of Calcutta after their process patent for creating a live vaccine against bursitis was denied. The invention including a living organism was not patentable under section 2(1)(j) of the Act, according to the refusal letter sent to the company. Because the associated procedure’s final result contained a living organism and was therefore not patentable, the Controller of Patents concluded that the process was not inventive. Instead, the High Court determined that the technique produced a novel and beneficial vendible product after applying the vendibility test to the invention. Because the procedure produced a vendible product, a patent was awarded for the process, and no consideration was given to the end product including living material in reaching this determination. The present case suggests patent rights are awarded to processes rather than products, so long as the result created by the process is marketable good.

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Furthermore, in 2002 the Act was revised to include Section 3(j), which prohibits the patenting of biological processes used in the production of plants, animals, or any combination of plants and animals – aside from microorganisms – for commercial purposes. This change made it possible to patent living things, such as microorganisms, rather than only the methods involved in creating them. The extent to which Section 3(j) would facilitate the patenting of microorganisms is unclear due to the lack of clarity surrounding the definition of microorganism. Thus, as a legislative amendment in India, it is imperative to have a precise working definition for the term “microorganism.”

PATENTING GENITICALLY MODIFIED ORGANISMS (GMOs)

GMOs fall under the category of life forms. Despite being life forms, GMOs are not found in nature. The development of genetically modified organisms requires significant human intervention. Therefore, the Act gives additional room for GMO patenting.

It should be emphasized that biotech organizations make significant efforts in research and development to create new, improved microorganisms. Considering the substantial sums of money invested and risks undertaken by these organizations, it is right that they receive recognition for their efforts. Refusing to grant patents for these microorganisms created through extensive study and substantial financial expenditure is extremely discouraging for the involved firms.

Besides that, biotechnology and genetic engineering should be considered as significant factors in a nation’s development. Developed nations, including the United States, Japan, and Europe, have acknowledged this and implemented laws that facilitate the patenting of life forms. The Indian government has gradually made changes to address the problems with life form patenting.

CONCLUSION

Life sciences and genetic engineering could potentially be very important in the near future. But there will always be a need to strike a balance and some moral and legal challenges needs to be addressed. That is, we must find a mechanism to adequately compensate and incentivize the producers of unique GMOs while ensuring that the product remains accessible to the general public. Lastly, an organized structure must be constructed to ensure that the law does not contain any loopholes.

Author : Batchu Varshini, a student at Symbiosis Law School, Nagpur, in case of any query, contact us at Global Patent Filing or write back us via email at support@globalpatentfiling.com.