PATENTABILITY OF MICROORGANISMS IN INDIA

Conventionally a micro-organism is considered as an organism that is microscopic, i.e., too small to be seen by the naked human eye and can be viewed only under a microscope, usually, an ordinary light microscope. Micro-organisms include bacteria, fungi, virus, protists and other prokaryotes as well as some microscopic plants (phytoplankton) and animals (zooplankton). The European Commission (EC) Directive (Directive 98/44/EC of the European Parliament and of the Council of 6th July,1998 on the legal protection of biotechnological invention made under the provision of the Treaties of Rome, 1957) on microorganisms define it as any micro-biological entity, cellular or non-cellular, capable of replication or transferring genetic material. Artcile-2(1)(a) of the EC directive have also defined "biological material" as any material containing genetic information and capable of reproducing itself or being reproduced in a biological system. There is a compulsory provision as to submit the microorganisms or biological material to the International Depository Authority established under Article-13(1)(a) of the Directive..

Ever since the US Supreme Court allowed the patenting of microorganisms in 1980 (Diamond v. Chakrabarty case, where US Supreme Court allowed patenting of crude oil spilling bacterium)  and this subject has been drawing a great deal of attention all over the world. As microorganisms are important constituents of biodiversity, issues like the origin of a microorganism and its patentability and ownership have gained importance. Inventions pertaining to microorganisms and other biological material are subjected to product patent in India. The most significant distinction between the legal practices of the India and developed countries is that India does not allow patenting of naturally occurring microorganisms as the same is considered to be a discovery as per the provisions of the section 3(c) of the Indian Patent Act, 1970 and therefore not patentable. But Genetically Modified Microorganisms (GEMs) that result in enhancement of its known efficacies are patentable. However, the patentability of naturally occurring microorganism is till today a debatable issue in India, as section 3(j) of the Indian Patent Act also grants  microorganism as a patentable subject matter, as it doesn’t categorically mention that only GEMs are patentable. Recommendations provided in the recently submitted report of the Technical Expert Group on Patent Law Issues constituted by the GoI, are expected to bridge the understanding of this complex issue of microorganism patentability. However under Indian Patent Act, 1970 and Rules, 2003 a sample of the biological material or GEMs is to be submitted to Microbial Type Culture Collection and Gene Bank (MTCC), Institute of Microbial Technology, Chandigarh, India.

The grant of patents relating to microorganisms depends upon the regulations regarding the requirements for the deposition of microorganisms in recognized International Depository Authorities (IDA) formed under Article-7  of the Budapest Treaty and accessibility of that microorganism from the depositories. As per section 10(4) (d) (ii) of the Indian Patent Act, 1970 , the microorganism if not being described fully and is not available to public the said microorganism is to be deposited before the IDA under the Budapest Treaty before filing of application in India. All the characteristics of the microorganisms and details of depositary institutions along with accession number shall be mentioned in specification for correctly identifying the same.

Apart from setting the basic minimum standard for patentability, TRIPs obliges member states to patent micro-organisms (Article-27 (3) (b)). However, the term microorganism lacks a precise scientific definition because of which there are inherent anomalies in patenting these life forms. Though the TRIPs agreement mandates patent protection for micro-organisms, it does not define micro-organisms; thus there is no standard definition for member nations to follow. TRIPs facilitate the provision for the member country to adopt a sui generis (adoption of national laws and regulation) system to protect the GEMs and invented biological material.   It is not clear whether, the term would include only genetically modified organisms or naturally occurring substances also.

In regard to the patenting of these life forms, a landmark decision of US Supreme Court i.e., Diamond v. Chakravarty, 1980 is worth mention here. In 1972, Ananda Chakrabarty, a microbiologist, and a researcher in the General Electric Company, filed a patent application in relation to a bacterium that was intended to consume petroleum spills. He claimed that a bacterium from the genus Pseudomonas containing at least two stable energy-generating plasmids, each providing a separate hydrocarbon degradative pathway was a human-made, genetically engineered bacterium capable of breaking down multiple components of crude oil. It was asserted that because of this property, which is possessed by no naturally occurring bacteria, the invention could treat oil spills.

Chakrabarty’s patent claims were of three types viz., process claims for the method of producing the bacteria;

Claims for an inoculum comprised of a carrier material floating on water, such as straw, and the new bacteria; and Claims to the bacteria themselves. The patent examiner allowed the claims falling into the first two categories, but rejected claims for the bacteria. The decision rested on two grounds, 1. that micro-organisms are products of nature, and 2. that as living things they are not patentable subject matter. The Patent Office Board of Appeals reiterated the examiners decision on the same grounds. The Court of Customs and Patent Appeals emphasized whether it constituted an invention made by human intervention. In the courts view, the fact that Chakrabarty’s bacterium was alive was without legal significance. In a landmark decision, the US Supreme Court reaffirmed that the bacterium was not a naturally occurring; rather it was Chakrabarty’s invention. As a result of the Supreme Court’s decision, the US biotechnology industry flourished and many US patents have been granted on human-made higher life forms such as transgenic mice, fish etc. Before the TRIPs come into existence, the US had allowed patenting of micro-organisms. Only plants and animals and essentially biological processes for the production of plants and animals are excluded from patent protection as these are not inventions, while micro-organisms and non-biological and microbiological processes are patentable under TRIPs.

Similarly, the Calcutta High Court decision in Dimminaco AG v. Controllerof Patents and Designs, 2002 relating to patentability of biotechnological process with living end product is another milestone decision in Indian context.

Dimminaco A.G., a Swiss company applied for patenting the process for preparation of a live vaccine for Bursitis, an infectious poultry disease and the invention involved a live (attenuated) vaccine to combat the disease.

The Controller of Patents refused to allow the application on the ground that the vaccine involved processing of certain microbial substances; this was only a natural process devoid of any manufacturing activities and hence not patentable. This was in consonance with the prevailing practice that grants patents only to non-living and tangible inventions, even though the Patent Act imposed no such limitation. However, on appeal, the Calcutta High Court diverted from the above position. It rejected the contention of the controller that a patent is given only for a process that results either in an article, substance, or manufacture and a vaccine with a living organism is not an article, substance, or manufacture. Law does not bar processes where the end-product is living. No statutory bar in the Act to accept a manner of manufacture as patentable even if the end product contains a living organism.

The Calcutta High Court held that, the Indian statute on patents does not put any restraints on patentability of micro-organisms developed in a controlled environment in the laboratories.  The Court also held that the process for creating a vaccine leads to a vendible product even if the end product contains live material. The court said that if the invention results in the production of some vendible items or improves or restores formal conditions of vendible item. Therefore since the claim process for patent leads to a vendible product, it is certainly a substance after going through the process of manufacture.

The court concluded that a new and useful art or process is an invention, and where the end product is a new article, the process leading to its manufacture is an invention. This decision on the Calcutta High Court was in line with the position in US, most of the European countries as well as Japan, since most processes in the biotechnology field will be patentable, irrespective of whether resultant product is living or non-living. After the Dimminaco decision, the Indian law kept pace with the needs of flourishing biotechnology industry.