Patenting of Microorganisms

Author : Prashant R Dahat

A patent is a bunch of exclusive rights granted by the state to an inventor or his assignee upon satisfying certain conditions. The inventor is given a monopoly right over the product for a fixed number of years in exchange for the public disclosure of certain details of a machine, method or composition of matter. The object of patent law is to encourage scientific research, new technology and industrial progress. It stimulates new inventions of commercial utility. The patent is granted for a limited period to the inventor. After the period of expiry of the patent the monopoly goes into public domain. Lately patent regimes around the globe have recognized the utility and innovative prospects of patenting of microorganisms.

In initial days of development of patent mechanisms there was an over burden of Ethical and Moral firewalls surrounding the idea of resting the right of commercial exploitation of certain substances and resources in the hands of a selected few. Patenting by many was opined as a capitalist centric idea. The taboos were even more incasing of patenting life forms, considering the religious, moral and notional values attached. With advancements in Pharmaceutical Industry and increasing stress on biotechnological research, pressure started mounting on policy makers to allow such patenting of basic life forms so as to encourage research and development [R&D] initiatives in the field which can contribute in exploring the unrecognized commercial utility of such life forms.

Thus with the landmark decision of the U.S Supreme Court in the case of Diamond v Chkrabarty flood gates were open for patenting of microorganism not just in Unites States but as a subsequent after effect , in various legal regimes around the globe. Section 27 of TRIPS recognize ‘Microorganisms’ as a patentable subject matter and thus incompliance of the same many nations4 have now allowed patenting of microorganism through their domestic patent laws.
In today’s world, genetic experimentation has become an international commonplace. Developments in genetic research have already provided society with dynamic technological advances. The revolution in biotechnology is one of the most important developments affecting industry in the twentieth century. Biotechnology has captured the attention of all nations. Every country is prepared to spend large funds to promote research and development in biotechnology. New techniques have been developed to create novel life forms. But, the laws regulating and protecting these experiments and their subsequent innovations continue, however, to sputter at an inchoate stage. One reason for the situation can be the different economical and ethical standings of nations which are being tried to be brought under the umbrella provisions of the WTO.This paper makes an attempt to analyze all these legal and ethical issues involving patenting of microorganisms. Apart from throwing light over the evolution of laws governing the field in various nations, the paper also tries to bring to picture, present day status of these legal provisions in light of the new technological advancements. After discussing the status quo around the globe, Domestic provisions in India have been looked into and significant case laws have been discussed. In the last part of the paper the researcher comes up with his conclusion on the issue and put froths his own relevant propositions.
In countries across the world the so called “products of nature doctrine” excluded living matter from patentability. The products of nature doctrine precluded patentability of materials existing in nature, including living matter. Under this doctrine, one could secure patents for fermentation processes and purified, naturally occurring chemical or biological compounds, as well as patents for microorganisms as a culture or in combination with a carrier. The product claims for the microorganisms, however, were not patentable because they comprised living material – microorganisms.
In U.S.A however the case of Diamond v. Chakrabarty only that opened new vistas of bringing forms of life, specifically microorganisms under the preview of patenting, in the case Supreme Court of the United States considered the question of whether a microorganism is patentable subject matter under the United States patent laws. Chakrabarty, a microbiologist, sought to patent a genetically engineered bacterium which degrades crude oil; a characteristic which makes it extremely valuable for controlling oil spills. The patent examiner denied Chakrabarty’s patent claim for the bacteria itself, but allowed his claims for products and processes involving the bacteria. The examiner denied the bacteria patent, finding that a micro-organism is a “product of nature” which, as a living thing, and thus cannot be patented. However when the case reached the Supreme Court, in a 5-4 ruling, the Court held that a live, human-made micro-organism is patentable subject matter under section as a” manufacture’ or “composition of matter.”
In addition to the Chakrabarty decision, revisions in Federal patent policy encouraged increased patenting of living organisms and related processes. Prior to 1980, no single patent policy existed for government-supported research, despite the Federal Government’s preeminence in biotechnology related research funding. Instead, each Federal agency developed its own rules, resulting in 26 different patent policies. Under this system, only about 4 percent of some 30,000 government-owned patents were licensed. Furthermore, the government policy of granting nonexclusive licenses discouraged private investment, since a company lacking an exclusive license was unlikely to pay the cost of developing, producing, and marketing a product. Thus, potentially valuable research remained unexploited.
To resolve this problem, Congress passed the Patent and Trademark Amendments of 1980 (Public Law 96-517) as amended in 1984 (Public Law 98-260) to promote efforts to develop a uniform patent policy that would encourage cooperative relationships and to commercialize government funded inventions. From 1980 through 1984 patent applications by universities and hospitals for inventions containing human biological increased more than 300 percent as compared to the previous 5-year period. The policies adopted by Congress in 1980 and 1984, which gave statutory preference to small businesses and nonprofit organizations, were extended to larger businesses (with some exceptions) in 1983. The Technology Transfer Act of 1986 (Public Law 99-502) granted Federal authority to form consortia with private concerns. Executive Order 12591, issued in 1987, further encouraged technology transfer programs, including the transfer of patent rights to government grantees. In combination with the Chakrabarty decision, these actions helped spur patent activity.
After 10 years of debate, the EU adopted Directive on the legal protection of biotechnological inventions in 1998 (Directive). In contrast to the situation in the US, the Directive has clear provisions stating that certain inventions will not be patentable because their commercial exploitation would offend against “order public” and morality. The European Union in the European Patent Convention has defined “’biological material” instead of “micro-organism”, as – “Biological material means any material containing genetic information and capable of reproducing itself or being reproduced in a biological system” The Directive was incorporated into the European Patent Convention (EPC) in June 1999 and therefore impacts the EPO’s examination of European patent applications relating to biotechnology inventions.
The Directive directly addresses patenting life forms. Under the Directive (and the EPC and EPC Rules amended as a result of the Directive), plants or animals may be patentable if the technical feasibility of he invention is not technically confined to a single plant or animal variety. This changed the EPC’s prior wording that explicitly excluded plant and animal varieties from patentability. The Directive states at Article 6 that the human body at the various stages of its formation (including the embryo and sequences or partial sequences of genes) is not patentable.
However, the Directive states that an element of the human body (including the sequence or partial sequence of a gene) that has been isolated from the body by means of a technical process may be patented even if the structure of the element is identical to that of a natural element. To be patentable under the Directive, as was previously true in the EU, the isolated element must still be novel, involve an inventive step and be capable of industrial application.
The Australian patent law defines invention as “any new manner of manufacture.”18 The question of patents for living organisms was considered at length in the case of Ranks Hovis v McDougall Ltd.’s Application and the Court held that- “No objection can be taken to a claim to a new organism on the ground that it is something living. Any new variants claimed must have improved or altered useful properties and not merely have changed morphological characteristics which have no effect on the working of the organism; and Naturally occurring micro-organisms per se are not patentable as they represent a discovery and not an invention, but a claim to a pure culture in the presence of some specified ingredients would satisfy the requirement of a technical intervention. The guidelines for a micro-organism in Australian Patent Law states, “What is discovered in nature without any practical application, is a mere chemical curiosity and is not patentable. However, isolated micro-organisms are considered patentable.
In 1997, the Japanese Patent Office (JPO) published its ‘Implementing Guidelines for Inventions in Specific Fields’. Inventions in the biotechnology field in the Guidelines are divided into four types: genetic engineering, micro-organisms, plants and animals. Inventions relating to genetic engineering include those of a gene, a vector, a recombinant vector, a transformant, a fused cell, a recombinant protein, and a monoclonal antibody. Inventions relating to micro-organisms include micro-organisms per se as well as those relating to the use of micro-organisms.
In Japan, micro-organism means yeast, molds, mushrooms, bacteria, actinomycetes, unicellular algae, viruses, protozoa, etc. and further includes undifferentiated animal or plant cells as well as animal or plant tissue cultures.
In India, the position was made clear after the 2002 amendment to the Indian Patents Act. Before the amendment, the unamended Section 3(j) of the Act stated that plants and animals in whole or in part thereof including seeds, varieties and essentially biological process for the production of plants and animals are excluded. However in India after the 2002 amendment micro-organisms can be patented provided they satisfy the other requirements.
Sadly there is dearth of judicial dicta with respect to patenting of microorganisms in India. However an unreported Kolkata HC decision throws some light on this aspect. In Dimminaco AG v Controller of Patents & Design, The applicant, Dimminaco AG, had applied for a process patent involving the manufacture of a live vaccine for protecting poultry against infectious bursitis. However, the application was rejected by the Indian Patent Office stating that the definition of “invention” in the Patents Act did not include a “living organism” thus any process that resulted in a “live vaccine” would not qualify as a “manner of manufacture”.
The Kolkata High Court, rejected the findings of the Indian Patent Office and held that the dictionary meaning of the word ‘manufacture’ does not exclude the process of preparing a commodity which contains a living substance”. Following this decision process patent was issued to the applicant from the patent office. Apart from the above case, another former case is Vandana Shiva and Ors v. Union of India which briefly touches upon the issue of patenting of microorganisms in the general light of patenting of all living forms. In the above case, Four petitioners had sought a writ of mandamus restraining the Union of India from signing/ratifying the existing version of GATT Treaty,’ or to restrained the Union of India from, agreeing to sign and signing Art. 27.5.3 (b) of the TRIPs Agreement.
They also seek a direction for exclusion of patents on life-forms including plants, animals, human beings produced through biological or microbiological processes, whether natural or modified on grounds of public morality and public order. They seek a further direction against Union of India from violating the fundamental rights and ensuring their protection while signing the Treaty, the right to health and nutrition ensured by the existing Indian intellectual property regime and patent system which had ensured the exclusion of patents on life forms and patents on products in the area of health and. agriculture on grounds of morality and public order and also in respect of rights of farmers including the right to seed as owners, producers, breeders and innovators etc.
The High Court of Delhi however took the view that the signing of any treaty, in this case the GATT treaty cannot be challenged if there is no infringement of fundamental rights of the citizens. The Court was of the view that it was a matter of policy which was best left to the executive. While citing British and American sources it concluded it was best to a non-interfering policy in this regard. The point to note here is the reluctance of the courts to interfere with “a matter of policy” of the executive even if the challenge is based on the grounds of public morality and public order. Since now the matter is some what settled after the decision of the Calcutta High Court, still a binding decision of the Supreme Court is still awaited to give a final verdict on the issue.
Patenting of life forms may have at least two dimensions. Firstly, there is the ethical question of the extent of private ownership that could be extended to life forms. The second dimension relates to the use of IPRs’ concept as understood in the industrialized world and its appropriateness in the face of the larger dimension of rights on knowledge, their ownership, use, transfer and dissemination. The TRIPS Agreement makes it mandatory to provide patent protection to micro-organisms and non-biological and microbiological production of plants and animals. This makes it difficult for the developing countries to exclude inventions within this category altogether. Hence, the strategy should be how to limit the scope of these provisions. As far as the patent protection of micro-organism is concerned, TRIPS does not provide a definition of micro-organism. The national rule-makers must define micro-organism in such a way as to include the following: bacteria, virus, and fungus and algas space.
Another important way to limit the scope of patent protection to biological materials is to make a difference between the concept of invention and discovery Micro organisms as such occur in nature. If any micro-organism is discovered it cannot be called invention, it falls in the category of discovery. Micro-organism when genetically modified falls in the category of invention because of human input. Genetically modified micro-organism may perform any number of activities. If a researcher is able to research upon a particular activity, and he is allowed patenting of his genetically modified micro organism this will result in blocking of further research on that micro-organism.. Also since only inventions are qualified for patenting, naturally found micro-organisms, DNA structure, genes, blood cells, etc., can be excluded from patent protection. Nations can also exclude certain inventions in biotechnology by relying on the exclusion provision available under the TRIPS Agreement which permits the state parties to exclude certain inventions which are injurious to health and environment of human and animals. Using this exception a member state can exclude terminator type technologies from patent protection.
The most important difference between the patent law of the India and developed countries is that India do not allow patenting of microorganisms that already exist in nature as the same is considered to be a discovery as per the provisions of the section 3(d) and therefore not patentable. But genetically modified versions of the same microorganisms that result in enhancement of its known efficacies are patentable. European and Australia/US or some other approach better suits the needs of its emerging economy rather Indian approaches in relation to patenting of biotechnological product and processes. Companies and investors venturing into the biotech sector need to fully realize the significant role intellectual property plays in the commercialization process for Biotechnological innovation.

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