INTRODUCTION

A patent is an intellectual property right relating to inventions and is the grant of exclusive rights, for limited period, provided by the Government to the patentee, in exchange of full disclosure of his invention, for excluding others, from making, using, selling, importing the patented product or process producing that product for those purpose.1

A patent is a bunch of exclusive rights granted by the state to an inventor or his assignee on 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 the composition of matter. The objective of patent law is to encourage inventions by promoting their protection and utilization for the development of industries, promotion of technological innovation, and transfer and dissemination of technology. It stimulates new inventions of commercial utility. The patent is granted for a limited period to the inventor and after the period of expiry of the patent, the monopoly goes into public domain. Patent right is territorial in nature and patent obtained in one country cannot be enforced in other country.

The premise of intellectual property (IP) law is that by recognizing and rewarding the innovator, it fosters industrial and technical progress paving way for a vibrant socio-economic structure. Since invention is the life breath of growth and development, it is pertinent that the same must be protected against unnecessary encroachment. This has become more evident in context of huge strides being made in the field of biotechnology and information technology. With advancements in biotechnological research and pharmaceutical industry, pressure started mounting on policymakers to allow patenting of basic life forms so as to encourage research and development initiatives, which can contribute to exploring the unrecognized commercial utility of such life forms. New techniques have been developed to create novel life forms like genetically modified plants and animal species, genes, cell lines and so on, which can be patented as ‘bio-patents’.2 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 the nations, which are being brought under the umbrella provisions of the World Trade Organization (WTO).

However, the debate revolves around the limits of such protection. One strand of this mystery is the patentability of microorganisms, which requires a critical analysis of the present position of law and a further rumination with regard to its future prospects. Section 27 of TRIPS recognizes microorganisms as a patentable subject matter and therefore many nations have now started patenting of microorganism through their domestic patent laws.

BASIC PATENTABILITY CRITERIA

A patent is an exclusive privilege in the form of a monopoly right, granted by the State to the inventor or an assignee for a certain period of time in return of the full disclosure of the invention. A patent is thus a right to exclude others from making, using, selling, offering for sale or importing the patented invention for the term of the patent, which is usually 20 years from the filing date. As it is a monopoly right, the grant of a patent must fulfill the essential criteria of novelty, non-obviousness and usefulness.

The threefold requirements of patentability are set out in the European Patent Convention (EPC) in Article 52:3

That the invention must be new; that it must involve an inventive step; and that it must be capable of industrial application. The same three requirements are met with in one form or another in the USA, Japan, and indeed in practically all the countries that have a patent system.

The Trade-related Aspects of Intellectual Property Rights (TRIPS) agreement aims at reducing the distortions and impediments in the international trade by an efficacious protection of IP rights. It specifies certain minimum standards to be followed by the member countries. Article 27 of the TRIPS stipulates that patents shall be available for any invention, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application. TRIPS do not define the terms ‘new’, ‘inventive step’ or ‘capable of industrial application’. In patent terms, ‘novel’ means not previously ‘made available to the public’.4

Members can exclude from patentability, commercial exploitation that is necessary to protect human, animal or plant life, or health or to avoid serious prejudice to the environment. Patents shall be available and patent rights can be made enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced. Therefore, this provision is resonant of the triple criteria of novelty, non-obviousness and usefulness. However, the essence lies in non-discrimination, as patents shall be available for any invention, unrestrained by the field of technology.

Focusing on the general patentability criteria in the United States, the provision of the US Patent Act determines as to what is patentable subject matter. ‘Whoever invents or discovers any new and useful process, machine, manufacture or composition of matter, or any new and useful improvement’ may obtain a patent.5 By perforating through the various International Treaties and legal provisions in major jurisdictions, it becomes amply clear that the triple test for patentability is the basic and immutable standard.

PATENTABILITY OF MICROORGANISMS

Bacteria, fungi and viruses constitute the major group of microorganisms that have been exploited extensively by biotechnologists. The genetic material of these microorganisms serving as raw materials are tailored by the biotechnologists with the scissors of restriction endonucleases, stitched with ligases and converted into desirable form using sophisticated techniques of genetic engineering. The field of application of genetic engineering is broad and covers vast areas, for example, the use of fungi in bakery, wine and antibiotic industry, bacteria for the manufacture of vaccines, modification of plants/insects genome (transgenic plants) and the like. For over 200 years living organisms have been excluded from patent laws; life forms were considered a ‘product of nature’ and not a human invention.

Before 1980, Patents were given for inventions based on microbiological processes. No patent was given for the living entities per se, which were considered to be the products of nature. Although patent laws were originally framed for mechanical and chemical inventions the patenting of life forms was also included.6 First patent based on microorganisms was made by Louis Pasteur on 28 January 1873, for the process of fermenting beer.7 The claim made by him was: … invention produces a better quality and greater quantity of beer from the same quantity and quality of wort (the boiled extract of malt or other material) … the yeast or pure ferment is added to provoke or induce fermentation.

In countries across the world the so-called products of nature doctrine excluded living matter from patentability. The products of nature doctrine prohibited patentability of materials existing in nature, including living matter. Under this doctrine, one could secure patents for fermentation processes and purification of 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 of living materials – microorganisms. The non-patentable status of living organisms changed with the landmark decision of the Supreme Court, USA, in Diamond v. Chakraborty in 1980, when the genetically modified bacterium was granted a patent.

BUDAPEST TREATY: DEPOSITION OF MICROORGANISMS

The Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure, or Budapest Treaty, is an international treaty signed in Budapest, Hungary, on 28 April 1977. It was enforced on 9 August 1980, and was later amended on 26 September 1980. The treaty is administered by the World Intellectual Property Organization.8 As of December 2008, 72 countries were party to the Budapest Treaty. The accession to the Treaty is open to States party to the Paris Convention for the Protection of Industrial Property of 1883. The African Regional Industrial Property Organization,9 the Eurasian Patent Organization (EAPO)10 and the European Patent Organization (EPO) have filed a declaration of acceptance under Article 9(1)(a) of the Treaty.11

The treaty allows ‘deposits of microorganisms at an international depositary authority to be recognized for the purposes of patent procedure’.12 Usually, in order to meet the legal requirement of sufficiency of disclosure, patent applications and patents must disclose in their description the subject-matter of the invention in a manner sufficiently clear and complete to be carried out by the person skilled in the art. Regarding any invention involving a microorganism, it is impossible to describe it completely. This is why, in the particular case of inventions involving microorganisms, a deposit of biological material must be made in a recognized institution. The Budapest Treaty ensures that an applicant, that is a person who applies for a patent, need not deposit the biological material in all countries where he/she wants to obtain a patent. The applicant needs to only deposit the biological material at one recognized institution and this deposit will be recognized in all countries party to the Budapest Treaty.

INTERNATIONAL DEPOSITARY AUTHORITY (IDA)

The deposition of patents of microorganisms in a culture collection recognized as an IDA might be necessary in the realm of IP rights. It is likely that IDAs will transform into ‘biological resource centers’ and further into ‘global common genetic resources’, with an internationally agreed legal basis for benefit sharing.13 The deposits are made at an IDA in accordance with the rules of the Treaty on or before the filing date of the complete patent application. Article 7 of the Budapest Treaty outlines the requirements for a facility to become an IDA.12 As of 1 March 2008, there were 37 IDAs in approximately 20 countries worldwide.

DEPOSITABLE MATTER TO THE IDA

IDAs have accepted deposits for biological materials, which do not fall within a literal interpretation of ‘microorganism’. The Treaty does not define what is meant by microorganism. It is not necessary for the entity being deposited to be a microorganism – it should only be required for the purposes of disclosure and must be acceptable to the IDA.

The range of materials able to be deposited under the Budapest Treaty includes: cells, for example, bacteria, fungi, eucaryotic cell lines, spores; genetic vectors (such as plasmids or bacteriophage vectors or viruses) containing a gene or DNA fragments;14 organisms used for expression of a gene (making the protein from the DNA).

TRIPS AGREEMENT: PATENTING MICROORGANISMS

The agreement on TRIPS is an international agreement administered by the WTO,15 which sets down minimum standards for many forms of IP regulation as applied to other WTO members. It was negotiated at the end of the Uruguay Round of the General Agreement on Tariffs and Trade16 in 1994. Apart from setting the basic minimum standard for patentability, TRIPS obliges member states to patent microorganisms.17 Therefore, an understanding as to what constitutes a microorganism is essential. However, the term lacks a precise scientific definition because of which there are inherent anomalies in patenting these life forms. Although the TRIPS agreement is mandatory for patent production of microorganisms, yet it does not define microorganisms; thus there is no yardstick definition for member nations to follow in this regard. There is no clarity whether the term would include only genetically modified organisms or naturally occurring substances also.

However, the term microorganism will be understood in its widest sense to include any biological material that is self-replicable or replicable via a host organism. Sub-cellular material like genes, gene sequences, plasmids, replicons and so on will come under the definition of a microorganism. Some of the patentable micro-biological inventions according to the TRIPS agreement are: (i) process of producing a new microorganism; (ii) new microorganism as produced by the defined process; (iii) new microorganism per se; and (iv) process of cultivation or otherwise using a known or new microorganism to: (a) a form of multiplied microorganism itself, for example vaccine or edible biomass, and (b) a by-product of microbial growth, for example an antibiotic, enzyme, toxin or an otherwise useful industrial product. However, it becomes obligatory to provide patents for ‘microorganism’ and ‘micro-biological’ processes. Neither microorganism is defined in the TRIPS agreement nor does the agreement specify any parameters concerning the scope of its protection.18

MICROORGANISMS: MEANING AND DEFINITION

A general definition of a microorganism is an organism that is microscopic (too small to be seen by the naked human eye) and which can be seen only under a microscope, usually, an ordinary light microscope. Microorganisms are incredibly diverse and include bacteria, fungi, archaea and protists as well as some microscopic plants such as planktons and organisms such as amoeba. Thus, it may consist of a single cell or a cell cluster.

The European Commission (EC)19, 20 directives on microorganisms define it as any microbiological entity, cellular or non-cellular, capable of replication or transferring genetic material. EC directives have also defined biological material as any material containing genetic information and capable of reproducing itself or being reproduced in a biological system. Various definitions of microorganisms could be quoted as follows:

  • Any of various microscopic organisms, including algae, bacteria, fungi, protozoa and viruses (The Concise Oxford Dictionary).

  • Any organism, such as a virus, of microscopic size (Collins English Dictionary).

  • Microorganisms are microscopic life forms including microscopic fungi, protista, prokaryotes and viruses.21

  • A microscopic organism consisting of a single cell or cell cluster, including the viruses.22

Hence a quotation from an English dictionary would not be sufficient to provide a definition of the term ‘microorganism’. A more precise and scientific definition is required for the purposes of providing a clear definition of the scope of exceptions to patentability set out in Article 27.3(b) of TRIPS agreement. Hence TRIPS agreement produces an ambiguity in defining microorganisms. The more authentic decisions regarding the patentability of microorganisms were made by the US Supreme Court in 1980 (Diamond v. Chakrabarty case), when the genetically modified bacterium was granted a patent.31

CRITERIA OF NOVELTY FOR PATENTING MICROORGANISMS

A microorganism exists as a part of the Nature; hence its discovery is NOT an invention. If it is an invention, logic of treating scientific theories and principles as non-patentable inventions gets defeated. If microorganisms isolated from the nature for the first time are considered patentable, then minerals and ores discovered from the interior of earth and deep seabed would qualify for patenting. Thus, microorganisms can be considered as an invention only if the microorganism has not been described in the literature and there is an element of human intervention with the discovery.23

The general notion is that the patent system encourages the creation of new, previously unforeseen inventions. Therefore, even though Chakrabarty simply shuffled genes, changing bacteria that already existed, the widest interpretation by the court lent the broadest amplitude to patentability to the living subject matter. Thus, the US position could be summarized as: once the basic patentability criteria are met, as for any other technological invention, living matter can be patented. The relation between invention and products of nature does not correspond to the relation between living and non-living things, but between products of nature and man-made inventions.24 There is a wide spread controversy regarding the consideration of microorganisms as ‘invention’ or ‘discovery’.25

Extensively interpreted, therefore, the invention concept would also encompass the kinds of subject matter that require human intervention in order to make them available in a useful form by way of isolating or purifying naturally occurring products. The TRIPS agreement nowhere defines the term microorganism, and the lack of a commonly accepted scientific definition poses the risk of inherently chaotic interpretations by different jurisdictions. As far as the question of compliance with TRIPS is concerned, most patent laws do not deal specifically with the question of whether or not a new living strain of microorganism is itself patentable, but the EPC26 does not exclude the possibility.27 The EPO does grant patents for microorganisms, as the patentability is not explicitly excluded. The present position is thus: microorganisms are patentable not only in the United States, but also Europe, Japan and all major jurisdictions under the TRIPS obligation.

DIAMOND v. CHAKRABARTY: OPENING A NEW AVENUE FOR PATENTING SYSTEMS

The patenting of inventions per se seems to be interwoven with the doctrine of product of nature. This doctrine specifies that potentially patentable subject matter must be created through human intervention. Patents are not available for the handiwork of nature. Thus a newly discovered mineral or plant found in the wild is not patentable subject matter under 35 U.S.C S.101.28, 29, 30 In contrast, the so-called purified forms of natural products may be patentable if they are sufficiently different from the non-purified (natural) forms so as to be novel and non-obvious. The non-patentable status of living organisms changed with the landmark decision of the Supreme Court, USA, in Diamond v. Chakrabarty in 1980, when the genetically modified bacterium was granted a patent.31 In 1972, Ananda Mohan Chakrabarty, a genetic engineer and a researcher of the General Electric Company, filed a patent application in relation to a bacterium that was intended to consume petroleum (oil) spills (superbug). Chakrabarty claimed that: A bacterium from the genus Pseudomonas containing therein at least two stable energy-generating plasmids, each of said plasmids providing a separate hydrocarbon degradative pathway: Salicylate – an aromatic hydrocarbon, and, Naphthalene – a polynuclear aromatic hydrocarbon, 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 not possessed by any naturally occurring bacteria, the invention could treat oil spills. The versatility of these ‘novel’ microorganisms was demonstrated by the substantial extent to which degradation of complex hydrocarbons – such as crude oil – was achieved. Hence Chakrabarty requested a patent for the bacterium in the United States but was turned down by a patent examiner, because the law dictated that living things were not patentable.

The Board of Patent Appeals and Interferences agreed with the original decision; however, the United States Court of Customs and Patent Appeals overturned the case in Chakrabarty's favor, writing that ‘the fact that microorganisms 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. In the Supreme Court the case was argued on 17 March 1980 and decided on 16 June 1980.32

CHAKRABARTY’S PATENT CLAIMS

The patent claims made by Chakrabarthy were of three types:

  • First, process claims for the method of producing the bacteria.

  • Second, claims for an inoculum comprised of a carrier material floating on water, such as straw, and the new bacteria.

  • Third, 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. 1

    that microorganisms are products of nature, and

  2. 2

    that as living things they are not patentable subject matter under 35 U. S. C. 101.33

The Patent Office Board of Appeals reiterated the examiners decision on the ground that microorganisms do not fall within the ambit of 35 U. S. C. 101, as they are living things.

DECISION AND RULING

In a 5–4 ruling, the court ruled in favor of Chakrabarty, and upheld the patent, holding that: A live, human-made microorganism is patentable subject matter under [Title 35 U.S.C.] 101. Respondent's microorganism constitutes a ‘manufacture’ or ‘composition of matter’ within that statute.

Chief Justice Warren E. Burger wrote the decision, and was joined by Potter Stewart, Harry Blackmun, William Rehnquist and John Paul Stevens. Burger wrote the interpretation of 35 U.S.C. 101, which says:

Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title.

SUPERBUG: DISCOVERY OR INVENTION

The Court of Customs and Patent Appeals emphasized that the issue was not whether the claimed bacterium was living or inanimate, but whether it constituted an invention made by human intervention. In the court's view, the fact that Chakrabarty's bacterium was alive was without legal significance. On the question as to in which category would the invention fall, the Supreme Court held that the genetically engineered petroleum-consuming bacterium could be categorized either as a composition of matter or a manufacture. The court read the term manufacture in S.101 in accordance with its dictionary definition to mean the production of articles for use from raw or prepared materials by giving to these materials new forms, qualities, properties or combinations, whether by hand labor or by machinery. In a landmark decision, the US Supreme Court reaffirmed that the bacterium was not a handiwork of nature; rather it was Chakrabarty's own invention, hence satisfies the criteria for being patented.

PATENTING MICROORGANISMS: POSITION IN INDIA

Patent Act of India, 1970, Section 2(1)(j)34 defines an invention as a new and useful manner of manufacture or a substance produced by manufacture. No definitions of manner of manufacture or substances were given in the Act. Hence the Patent Office adopted the practice of interpreting a manner of manufacture as a patentable subject matter only if it results in a tangible nonliving substance.

The 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. India joined the Budapest Treaty on 17 December 2001, and Microbial Type Culture Collection (MTCC) and Gene Bank of the Institute of Microbial Technology, Chandigarh (IMTECH) acquired the status of an IDA on 4 October 2002 marking the amendment of existing systems in India. The position was made more clear after the 2002 amendment of the Indian Patents Act, 1970 whereby microorganisms can be patented provided they satisfy the other requirements.35

THE PATENT AMENDMENT ACTS

The Patent Amendment Act 2002 came into force in May 2003, bringing microorganisms within the realm of patentability. Section 3(j) was couched in terms of Article 27(3) (b). It states that: plants and animals in whole or any part thereof other than microorganisms but including seeds, varieties and species and essentially biological processes for production or propagation of plants and animals are not inventions within the meaning of this Act. It excluded microorganisms from the exceptions to patent protection and allowed patenting of processes pertaining to microorganisms as well as non-biological and microbiological processes.

Subsequently, The Patents Act, 1970 was once again amended in the year 2005, so as to establish congruence with TRIPS. The amendment deleted Section 5 of the Act, which provided for only process patents. The provision included inventions where only methods or processes of manufacture were patentable. Therefore, the deletion of this section paves way for product patents, which is in stark opposition to US approach that argues patenting of life forms has tremendous advantages.36

Despite concerns against the patenting of microorganisms, this position may augur well for the biotechnology industry as it is growing at an inexorable pace.

DIMMINACO A G v. CONTROLLER OF PATENTS AND DESIGNS

Patentability of biotechnological process with living end product was ascertained by Calcutta High Court decision in the case of Dimminaco A G v. Controller of Patents (2002).37 The facts of this case are that – Dimminaco A.G., a Swiss Company applied for patenting the process for preparation of a live vaccine for Bursitis. Bursitis is an infectious poultry disease and the invention involved a live (attenuated) vaccine to combat the disease.

The Controller of Patents refused to allow application on the ground that as the vaccine involved processing of certain micro-organic substances, this was only a natural process devoid of any manufacturing activities and hence not patentable under S.2(1)(j). This was in consonance with the prevailing practice that granted patents only to non-living and tangible inventions that fulfilled the patentability criteria, 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 that a vaccine with a living organism is not an article, substance or manufacture.38 The Controller had claimed that the dictionary meaning of article is a ‘material thing, item, a thing of a particular class or kind as distinguished from a thing of any class of kind’. The Controller said the definition does not cover living things. 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.

Through creative judicial exposition, the Calcutta High Court held that: ‘The Indian statute on patents does not put any fetters on patentability of microorganisms developed in a controlled environment in the laboratories’.

Taking recourse to the normal dictionary meaning of manufacture, the court observed that manufacture is where ‘the material in question after going through the process of manufacture has undergone any change by the inventive process and it becomes a material which is different from the starting material’.39 The court held that this meaning of manufacture does not exclude the process of preparing a product that contains a living substance from patentability.

Court also held that the process for creating a vaccine leads to a vendible product even if the end product contains living material.40 The court said that if the invention results in the production of some vendible items or improves or restores formal conditions of vendible item or its effect in preservations and prevention from deterioration of some vendible product, then such an invention would pass the vendibility test. Therefore, as 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 synchronous with the position in the United States, most of the European countries as well as Japan, as 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 thriving biotechnology industry.

CONCLUSION

Patenting of life forms may have many dimensions that relate to the use of intellectual property rights concept in the industrialized world and its appropriateness in the aspect of rights on knowledge, their ownership, use, transfer and dissemination. In the global scenario, the TRIPS agreement makes it mandatory to provide patent protection to microorganisms 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 microorganism is concerned, TRIPS does not provide a definition of microorganism. The national rule-makers must define microorganism in such a way as to include the following: bacteria, virus, and fungus and algae.

Another important limitation in the scope of patent protection to biological materials is the lack of defining the concept of invention and discovery. Microorganisms as such occur in nature and their discovery cannot be called invention. Microorganism when genetically modified falls in the category of invention because of human input. Genetically modified microorganism may perform any number of activities, hence patenting of this genetically modified microorganism will result in blocking of further research on that microorganism.

The numerous concerns raised against patentability of microorganisms can be addressed by defining the term microorganism in a precise and scientific manner; substantiating the differences between discovery and invention; by granting patents to only those inventions, which involve substantial human intervention (for example, genetic engineering).

From Diamond v. Chakrabarty to TRIPS and beyond, manifests huge interest of biotech industry for constant innovation and endeavor, paving way for increased inventions that aim at human welfare. The criterion of utility is deeply embedded behind the rationale of patenting microorganisms, whether it is the usefulness of those microorganisms in treating oil spills, preventing an infectious disease or the creation of new drugs to combat life-threatening diseases. Without an efficacious patent protection, the vast reservoir of such information may remain a trade secret, without being brought into public domain. This proves the need for a sheltered and substantial patent system for the protection of the research concerning microorganisms.