Patentability of Micro-organisms

Dr. Swaranjit Singh Cameotra Deputy Director in Institute of Microbial Technology, Chandigarh Email: ssc@imtech.res.in

Bindu Sharma Founder and CEO Origiin IP Solutions LLP, Bangalore Email: bindu@origiin.com

 A patent is a form of intellectual property, consisting of a set of exclusive rights granted by a Government to an inventor or its assignee for a limited period of time in exchange for the public disclosure of an invention. In order to get patent rights, the invention shall fulfil three fundamental statutory conditions of patentability, such as, novelty, inventiveness and industrially usefulness. Often, subject matter of a patent, that is claimed is either a product or a process to prepare a product or both. However, more precisely, as per Indian Patents Act, 1970, the invention means a new product or process involving an inventive step and capable of industrial application. Further, the inventive step means a feature of an invention that involves technical advance as compared to the existing knowledge or having economic significance or both and that makes the invention non-obvious to a person skilled in the art.

The micro organisms as a subject matter of a patent have always been fascinating, primarily for their being a living form. Conventionally a micro-organism is considered as an organism that is microscopic or too small to be seen by the naked human eye though there are various algae and fungi that are visible by naked eye. Micro-organisms include bacteria, fungi, virus, protists and other prokaryotes as well as some microscopic plants (phytoplankton) and animals (zooplankton).

In order to understand patentability of micro organism, it is important to know that Article 27(3) (b) of TRIPS Agreement, that allows member states to exclude from patentability “plants and animals, other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes.” This clearly indicates that TRIPS makes it obligatory for all its member states to extend patents for micro-organisms, non-biological, and microbiological processes. However, the plant and animals have clearly been indicated to be not patentable.

As far as Indian patent laws are concerned, in order to be compliant with TRIPS agreement, the third amendment to the Patents Act, 1970 was introduced through the Patents (Amendment) Ordinance, 2004 w.e.f. 1st January, 2005 that extended product patents to all fields of technology including food, drugs, chemicals and micro organisms provided such inventions fulfil statutory conditions of patentability. It is worth noting here that micro organism that exists in nature is products of nature and mere identification of micro organisms cannot amount to invention but a discovery which is not patentable. Therefore, a naturally occurring micro organism fails to fulfil the critical conditions of patentability, i.e., novelty and inventive step.

What differentiates an invention from a discovery is human intervention, thereby, the most critical issue regarding patentability of micro organisms is assessment of human intervention that draws line between discovery and invention. However, Genetically Modified Micro organisms (GEMs), creation of which involves human effort, resulting in enhancement of its known efficacies compared to state of the art, are patentable. Section 3 j of Indian patent act 1970 states that micro organisms are patentable but it doesn’t categorically mention that only GEMs are patentable. However, relating patentability of micro organism to the statutory definition of an invention depicts that micro organism shall be a new product that involves an inventive step and is capable of industrial application.

The most discussed and landmark case on micro organism is Diamond vs Chakrabarty. A genetic engineer Ananda Mohan Chakrabarty, working for General Electric, developed a bacterium (derived from the Pseudomonas genus) that is capable of breaking down crude oil and hence was used in treating oil spills. Chakrabarty filed for a patent for the bacterium in the United States.. There were three main claims in the patent specification that related to inoculums, bacterium itself and the process to prepare the genetically modied bacterium. Examiner had no problems granting rights over claims related to inoculums and the process but as the law dictated that living things were not patentable, rights were refused for the bacterium as a product. The Board of Patent Appeals and Interferences agreed with the original decision of patent examiner. However, the United States Court of Customs and Patent Appeals overturned the case in Chakrabarty's favor, stating that "the fact that micro organisms are alive is without legal significance for purposes of the patent law." Sidney A. Diamond, Commissioner of Patents and Trademarks, appealed to the Supreme Court. The Supreme Court case was argued on March 17, 1980 and decided on June 16, 1980.

Drawing line between discovery and invention is extremely critical to assess patentability in case of micro organisms. Extent of human intervention is one of the most critical factors to determine patentability. In Dimminaco A.G v. Controller of Patents & Designs, the issue was the patenting of the process for preparation of infectious bursitis vaccine, which was invented for protecting poultry against infectious bursitis. The Controller held that the process of separation of the vaccine which has living entity cannot be considered a manufacture and hence not patentable. He also held that since the vaccine contains living organism it cannot be patented. The court held that the matter involved is of a new process of preparation of vaccine under specific scientific conditions and the said vaccine is useful for protecting poultry against contagious bursitis infection and there is no statuary bar to accept a manner of manufacture as a patentable even if the end products contain living organism.

Apart from basic criteria of patentability, i.e., novelty, inventiveness and industrial use, sufficiency of disclosure of the invention is extremely important and the subject-matter of the invention shall be described in a manner sufficiently clear and complete to be carried out by the person skilled in the art. In case of an invention, claiming micro organism as a product, completely describing the invention in the description to enable a person skilled in the art to carry it out is usually impossible. This is why, in the particular case of inventions involving micro-organisms, where such micro organism is not available in public, a deposition of such micro organism material has been made necessary in the institute recognised by Budapest Treaty.

In India, an essential requirement for filing an application for patent wherein the invention is based on a microorganism, deposition of microbial sample is necessary in the International Depository Authorities (Institute of Microbial Technology, Chandigarh) formed under Article-7 of the Budapest Treaty and accessibility of that micro-organism from the depositories. As per section 10(4) (d) (ii) of the Indian Patent Act, 1970, the micro-organism if not being described fully and is not available to public, it to be deposited before the IDA under the Budapest Treaty before filing of application in India. All the characteristics of the micro-organisms and details of depositary institutions along with accession number shall be mentioned in specification for correctly identifying the same.

Due to short life cycle, rapid growth, easy to culture, micro organisms have been used widely in industry today for producing high value compounds such as enzymes, hormones, polymers, organic acids etc. Various industries like brewery, dairy products are primarily based on various micro organisms. However, microbes are also well known for their vital role in degradation of toxic compounds by transforming them into less toxic forms. It is interesting to note that more than half of the world’s oxygen is produced by the activity of the micro-organisms. Many algae and cyanobacterial strains produce and release oxygen in the atmosphere by means of oxygenic photosynthesis.

Thus, there is a changing trend in the research on the microbial world around the globe and many more new ways to use the power of the single celled micro-organisms will come up in different fields like medicine, drugs, high value compounds production and in removal of toxic pollutants from the environment. In India, we have an IDA in IMTECH, Chandigarh and good progress is made in the conservation of microbial diversity. The IDA also has a Patent Depository where the facility can be availed as per the norms. In India there are two ‘Hotspots’ of Biodiversity, the Western Ghats and the seven states in the Indo-Burma Region. Thus, it is all the more important to have a well defined system for the conservation of the important biodiversity. In Pune a culture collection and an IDA (MCC: Microbial Culture Collection) has been set up so that the rich and new microbial diversity that is isolated is properly maintained. The strains are identified for supply to users in academic institutes and industries. The MCC was recognized by the World Intellectual Property Organization (WIPO), Geneva, Switzerland as an International Depository Authority (IDA) on April, 2011. Setting up of two IDAs in India demonstrates that conservation of microbial diversity isolated from different environmental niches and its detailed study for products and processes is a very important activity.

Further reading:

1 Indian Patent Act 1970

2 Manual of Indian Patent Office, 2008

3 Preservation of micro-organisms as deposits in Patent Applications. Swaranjit Singh Cameotra. BBRC 353(4): 849-850, 2007.

4  Can Microbes be patented. Swaranjit Singh Cameotra. BBRC, Online November 2012.