This study describes and analyses the various legal regimes governing intellectual property rights in the protection of life forms, patent on life forms, plant varieties and sets forth regulatory options for national governments to protect plant varieties while achieving other public policy objectives relating to plant genetic resources.

A patent can be understood as an IPR relating to inventions and is the grant of exclusive right, for a limited period, provided by the Government to the patentee, in exchange for full disclosure of his invention, for excluding others, from making, using, selling, importing the patented product or process producing that product for those purposes. This study normative employed normative method to examine the legality of patent on the life forms.

Introduction:
Creations of the human brain are called intellect and if they have commercial value they can be classified as property. Intellectual Property thus refers to inventions, industrial designs for articles, literary and artistic work, symbols, etc. The word patent has been derived from the Latin word patent-em meaning open. The self-contradiction demands an explanation.

The widest possible dissemination of new knowledge makes the greatest economic efficiency. But if everybody is free to access new knowledge, the inventors have little incentive to commit resources to produce it. Intellectual Property Rights (IPRs) temporarily transform knowledge from a public good into a private good so that owners of intellectual property can recoup their expenditure in creating new knowledge[1]

A patent can be understood as an IPR relating to inventions and is the grant of exclusive right, for the limited period, provided by the Government to the patentee, in exchange for full disclosure of his invention, for excluding others, from making, using, selling, importing the patented product or process producing that product for those purposes.

Intellectual property is divided into two main categories: industrial property rights, which include patents, utility models, trademarks, industrial designs, trade secrets, new varieties of plants and geographical indications; and copyright and related rights, which relate to literary and artistic works.

India and TRIPS (Related Aspects of Intellectual Property Rights)

On 16 April 1994, India signed the General Agreement on Trade and Tariff (GATT) along with 116 other nations. The agreement also established the World Trade Organisation WTO) which succeeded GATT. Under WTO, no country has the option to choose what part that it likes and abstain from others. The Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement of WTO imposes some rules on member countries.

The TRIPS agreement ensures that patent protection is available for all the fields of technology including agriculture, energy and healthcare. Also, members can exclude certain inventions from patentability if the exploitation of the invention would be affecting the morality of the general public. TRIPS further focussed on patentable subject matter about biological material. [2]

For example:

1. Plants, animals, the essential biological process of production of plants and animals may be excluded from patenting.
2. Microorganisms per se and non-biological and microbiological processes are patentable.

Patents Act, 1970 and TRIPS Agreement

The Patent System in India is governed by the Patents Act, 1970 (No. 39 of 1970) as amended by the Patents (Amendment) Act, 2005 and the Patents Rules, 2003, as amended by the Patents (Amendment) Rules 2006 effective from 5 May 2006. The same is by the provisions of the TRIPS Agreement.

The recent conferment of 'product patent' along with the 'process patent' is an example of such compatibility. The TRIPS Agreement was formulated to bring basic level harmonisation in IPRs laws all over the world. The provisions of the TRIPS Agreement are the most extensive and rigorous. They protect all the forms of IPRs collectively.

Patents on life-forms and living processes

Patenting of Life Forms-The Indian Stand [3]

In India before 2002, amendment the understanding is that there is no patent protection for an invention relating to life forms. But in Dimminaco A.G v. Controller of patent and design,40 the Calcutta High Court held that a process for the preparation of vaccine containing the live virus is patentable since the term manufacture covers even living organisms.

So according to the Court even if the end product contains a live virus the process involved in bringing out the end product becomes an invention. It may be noted that there is no decision reported to date directly on the application of the inventive step standards to inventions relating to biotech patents in India.

In the light of Article 27 of TRIPS the Section 3 of the Patent Act, 1970 has been amended. The definition of "invention," "new invention," "inventive step" reflects a restrictive approach to the legal protection of living materials. In the absence of a definition for "plant," "animal," "microorganism" "essentially biological process," "non-biological process" and "plant variety" its interpretation by the patent office becomes crucial. Since the term micro-organism can have a variety of definitions that may not be exhaustive to include genetic material, it is argued that it is safer to place reliance upon the guiding provision in the TRIPS agreement.

Another concern is that if the "inventive step" is going to be interpreted by considering only technical advance or economic significance, then the standard of patentability gets lowered and the same should not be allowed. Because these factors have been used as secondary considerations and they never served as a basis for establishing "inventive step."

2008, the patent manual incorporates provisions that are used as guidance by the patent office to interpret various provisions in the Act. Standing Problem, Distance, Surprising Effect, Long Felt Need, Failure of Others, Complexity of Work, Commercial Success, Cheaper and more economical Product and simplicity of the proposed technological solution are considered as indicators of inventive step in 2008 draft Manual of Patent Practice and Procedure.

Patents in micro-organisms and their conceptual issues

Can microorganisms, for instance, be patented? Before 1980 the answer to this question was: NO. Microorganisms were clearly "products of nature" and as such were not considered patentable. However, the era of manoeuvring DNA between organisms changed that.

The Mashelkar Committee report has clearly stated that microorganisms are patentable subject matter in India. Inventions about Microorganisms and other Biological materials were subjected to product patent in India, unlike many developed countries. But with effect from 20.05.2003 India has started granting patents in respect of invention related to microorganisms, though India was not obliged to introduce laws for patenting microorganisms per se before 31.12.2004.

Microorganisms patenting per se being considered to be a product patent, the period of protection was 5 years from the date of grant or, 7 years from the date of filing of the patent application. Now grant of patents for microbiological inventions is for 20 years from the date of filing.

The most vital distinction between the legal practices of India and developed countries is that India (developing countries) does not allow patenting of microorganisms that already exist in nature as the same is considered to be a discovery as per the provisions of 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.

The grants of Patents in respect of Microorganisms depend upon the regulations concerning the requirements for the deposition of Microorganisms under the Budapest Treaty of which India has become a member and accessibility of that microorganism from the depositories. As per proviso (ii) to section 10(d) the Microorganism is not being described fully and particularly and is not available to the public, the said Microorganism is to be deposited before the International Depositary Authority under the Budapest Treaty. [4]

Conceptual issues
India has allowed patenting of microorganisms but the Patent Act does not define the term "Microorganisms". This has led to many debates regarding the patentability of microbes. In the absence of a clear definition of microorganism and microbiological process in the TRIPS agreement, the country needs to draw a distinctive line between the product of human intervention leading to novelty and those freely occurring in nature.

Dimminaco case:

A case in the point: Although the Indian Patent Act, 1970 does not permit patenting of microorganisms, per se, this particular case at Calcutta High Court is a case to understand the intricacies of patenting. Dimminaco Case 2 clarified the position relating to patentability of biotechnology inventions, particularly in a case where a process of manufacture of vaccine involving a living end product was involved. The main issue in contention between the parties was whether the phrase 'method of manufacture' used in section 2(1) (j) could be said to include a live organism.

The court, in its positive affirmation, has held that the dictionary meaning of 'manufacture' did not exclude from its purview the process of preparing a vendible commodity that contains a living organism. The application of microorganisms in food is a billion-dollar industry today. Since genetically modified microorganisms (criteria that lend the human intervention angle to satisfy one of the criteria to make the organism patentable) is not permitted to be used in the food industry, the only source for improving the textural and sensory properties of food is by isolation of new strains of bacteria that deliver these properties.

One need not mention the time, effort and money involved in this exercise. In the Dairy industry, lactic cultures are used for the preparation of fermented products and cheese whose consumption rates are increasing at a rate of 10% annually. Suppressing the growth of these fermented products is the growth of functional foods containing probiotic cultures. These are bacteria that when consumed in sufficient quantities confer some beneficial attributes to the host.

The probiotic strains used in these products have been isolated after decades of research work followed by clinical trials to prove their probiotic attributes. Most of these strains are patented in the European Union and the United States (where isolation of a new strain of bacteria is patentable). As a result, these companies are marketing these products containing these microorganisms. [5] However, the same protections for these bacteria is not available in India.

This is not encouraging enough for the academia and industry in India to isolate potential probiotic strains due to the absence of patent protection. Some of the probiotic products launched in India are by companies that use strains that are catalogued by leading international culture suppliers or by foreign companies that have these strains. One may also run the risk of being accused by other nations of being insensitive to the issues of promoting multilateral trade and hence of being subjected to sanctions which may prove to be more economically ruinous in the long run.

Patents on plants

Article 27 (3)(b) of the TRIPs agreement allows members to exclude from patent protection, plants and animals; and biological processes for the production of plants or animals. TRIPs provide options to member states protecting new plant varieties utilizing patent or sui generis system or both. India opted for sui generis protection and legislated Plant Varieties Protection and Farmers Right Act-2000 that enables the farmer to save, use, sow, re-sow, exchange, or share the seeds of a protected variety, besides offering protection on farmers' variety, extant variety and essentially derived variety.

Conceptual issues

Whereas plant variety protection could boost research in the area of plant biotechnology by both public and private bodies, it could also result in higher prices for seeds, thus naturally excluding the small and marginal farmers from accessing such new technologies.

Farmers and indigenous peoples in developing countries such as India are facing serious problems as plants that they developed and conserved are being appropriated by private entities leading to bio-piracy and exploitation of traditional knowledge claiming the exclusive right to produce and sell many 'modified' plants and animals.

This is a great matter of concern today that knowledge, innovation and efforts of these communities are neither acknowledged nor benefited when the legal 'intellectual property rights' systems grant patents on genetic and biological materials and living organisms to private corporations.

The following are the other reasons which have been laid down which object to life form patenting:

1. Farmers would be obliged to pay royalties on every generation of plants and livestock they buy and reproduce for production purposes
2. Breeders will no longer have free access to germplasm for developing new varieties of plants and animals.
3. Consumers will end up paying high prices for food, medicine and other biotechnological products.
4. In the end, public research which is paid for by all will be privatized by a few.
5. Food supply will be threatened by monopolistic control over genetic resources.
6. The concept of Human rights will be threatened as human beings, and parts of their bodies will become the exclusive property of the patent holders.

In 2000, CSIR found that almost 80 per cent of the 4,896 references to individual plant-based medicinal patents in the United States Patents Office that year related to just seven medicinal plants of Indian origin. Three years later, there were almost 15,000 patents on such medicines spread over the United States, UK, and other registers of patent offices. In 2005 this number had grown to 35,000, which demonstrates the interest of the developed world in the knowledge of the developing countries.

Whilst the corporations stand to make huge revenues from this process, the local communities are unrewarded and face the threat in future of having to buy the products of these companies at a high price. Hence such a system of IPR only benefits the private industries or multi-national corporations of industrially developed countries at the expense of the developing countries.

For instance, In Texas, a company called Rice Tec took out the patents on Basmati rice (which grows in the Indian and Pakistan regions) and have created genetically modified Basmati rice, while selling it as normal Basmati -- and it was not against the law, either. Four of the patients were withdrawn in June 2000, when the Indian government formally challenged the patent.

A US Patent Authority ruling did manage to prevent another company from using turmeric to create bi-products because their intentions were not novel and turmeric had been around for a long time. They also cancelled a patent on the Ayahuasca plant, a sacred plant for many indigenous people in Latin America.

Patenting of Transgenic Animals [6]

In 1988, a Harvard University biologist was granted a patent for a mouse that had been engineered for increased susceptibility to cancer. The Harvard Oncomouse became the first animal to be considered an invention by the U.S. Patent and Trademark Office. It established a precedent within patent procedures for patenting genetically modified animals. Although this research was intended to benefit human health, the question remains about the ethics of patenting complex living beings.

By 1997, over forty animals had been patented, including turkeys, nematodes, mice and rabbits. Hundreds of other patents are currently awaiting approval, including patents on pigs, cows, fish, sheep and monkeys.

Tracey the sheep have had human genes introduced into her mammary glands so that she produces a human blood-clotting agent called alpha-1-antitrypsin in her milk. The patent is held by Pharmaceutical Proteins Ltd. (PPL). Their spokesperson described sheep-like Tracey as "furry little factories walking around in fields." Tracey's success was said to provide "a strong impetus to the further exploitation of transgenic sheep as bioreactors for the production of large amounts of pharmacologically active proteins"

PPL has also applied for a broad patent covering all cloned mammals. Dolly the sheep was the first mammal to be successfully cloned, in February 1997: a nucleus taken from a cell from the udder of an adult sheep was implanted into an egg that had had its nucleus removed. This egg was then transferred into another sheep, where it developed into Dolly, who is genetically identical to the sheep from which the udder cells were taken. The Scottish research team who cloned her applied for a broad patent which would give them exclusive patent rights over all cloned animals.

Negative impacts of patenting of transgenic animals

The major concern that arises out of patenting of transgenic animals is that transferring genes from one species to another transgresses the natural barriers between them and affects the integrity of species. Species belonging to the same group, though they may slightly vary from one region to the other based on the environmental conditions, primarily have the same gene pool.

Ethical Issues
Some ethical issues stem from the patenting of animals. Most of them deal with the consequences that could arise after patenting animals while the other arguments focus on the religious, philosophical and spiritual grounds. The arguments which go against the patenting of animals are difficult to prove as many of them are factual assertions that are still to occur or to be proven.

The DNA is considered to be intimately related to the species identity and hence no part of it should be controlled for commercial interest. In the case of human beings, human DNA is unique and hence possesses the intrinsic value of a sacred kind. It can also be put as 'Human DNA bears the image of God' and to tamper with them and own them for commercial and economic interests would hurt the sentiments of the many.

The view that plants, animals and microorganisms comprising life on earth are part of the natural world into which we are born and hence the conversion of these species, their molecules, or parts into the corporate property through patent monopolies is counter to the interest of the people of the country and world, has been taken by many.

Patents on Human Life:

A most alarming aspect of patenting life is the patenting of human genes, cell lines and tissues. Corporate patent attorneys have lobbied the Patent office that these products of nature are patentable once they have been isolated to produce a form not found outside of a laboratory. For example, in 1976 a leukaemia patient named John Moore had surgery at the University of California to remove his cancerous spleen.

The University was later granted a patent for a cell line called Mo, removed from the spleen, which could be used for producing valuable proteins. The long term commercial value of the cell line was estimated at over one billion dollars. Mr Moore demanded the return of the cells and control over his body parts, but the California Supreme Court decided that he was not entitled to any rights to his cells after they had been removed from his body.

Patenting of Genes

Our Genes define us, as a species as well as individuals, and hence for human genes, there are strong oppositions both on the religious and secular front. Patents are being granted to genes despite there being many arguments for keeping the genes in the public domain. A patent cannot be granted on a gene as it naturally occurs.

Isolation of the gene is required for it to be patentable. The patent offices have treated genes as a new chemical compound and have granted composition of matter patents. Thus a patent granted on an isolated and purified DNA composition confers the right to exclude others from any method of using that DNA composition for up to 20 years from the date of filing. However, Human Beings are not patentable as human multicellular living organisms are not patentable.

Why are genes being patented?

Genes have been used for gene therapy though it is still in the early developmental stages. The technology used in each gene therapy will have huge commercial value in the coming future making patenting crucial. However, gene therapy is not a patentable subject matter in India.

Morality and Patents: Is there a connection?

Patents on living organisms are morally objectionable to many. Patenting organisms and their DNA promotes the concept that life is a commodity and the view that living beings are gene machines to be exploited for profit. If it is possible to consider a modified animal an invention, are patents and marketing of human reproductive cells far behind? Patents derive from concepts of individual innovation and ownership, which may be foreign to cultures that emphasize the sharing of community resources and the free exchange of seeds and knowledge.

Reason for non-acceptance of human gene patenting

Patents on living organisms are morally objectionable to many people. Patenting organisms and their DNA promotes the concept that life is a commodity and the view that living beings are "gene machines" to be exploited for profit. If it is possible to consider a modified animal an invention, are patents and human reproductive cells and their marketing far behind?

Patents derive from concepts of individual innovation and ownership, which may be foreign to cultures that emphasize the sharing of community resources and the free exchange of seeds and knowledge. Many disputes involving patent infringement cases emerged because of questions related to obviousness, enablement or the priority of invention that had to be decided by the courts.

More difficult were the questions about the ownership rights and privileges. For example, in the patent 'Unique T-lymphocyte line and products derived therefrom, the inventors used the spleen of a patient Mr John Moore who suffered from hairy cell leukaemia and came for treatment to Dr David Golde at UCLA. As part of the treatment, his spleen was removed and Dr Golde developed a cell line with enriched T-lymphocytes that produced large amounts of lymphocytes useful for cancer or AIDS treatment.

Without Mr Moore's initial knowledge or consent, but requiring his repeated visits to the hospital, Dr Golde and the University of California applied for a patent on the cell line derived from Mr Moore's spleen which was granted in 1984. Mr Moore subsequently sued Dr Golde and the University supreme Court. Both the Appeals Court and the Supreme Court recognized the novelty of Mr Moore's claim Mr Moore on the issue of conversion (unauthorized use of his body part) but recognized his right to be informed of what the physician was doing involving his health and well being. It's an irony that a person is not given any benefit of the substance which he had produced, and at the same time, others are minting money from the same substance.

What they say who are in favour:

That without patents society won't benefit from revelations about the molecular roots of disease. Moreover, the arguments that patenting DNA promotes the view that life is a commodity, cannot be accepted because it is not that the main aim of the DNA patenting is to earn profit or to use it for someone personal interest, on the contrary, the overall aim of the patent system is to promote the public interest and to provide a fair reward to inventors. The patents system is said to be justified because it provides an important incentive for the development of new products and technologies related to healthcare.

One of the most coveted arguments which are vociferously put forward against the patenting of life forms is that the First World patenting of Third World genetic resources represents a theft of community of biological resources. Patents held by the industrialized world on biological resources from the developing world will serve as a tool for the North to accumulate more wealth from the already impoverished south.

Microorganisms, plants, animals and even the genes of indigenous people have been patented for the production of pharmaceuticals and other products. Requiring developing nations to pay royalties to the wealthy industrial nations for products derived from their natural resources and innovation in the robbery.

Moreover, the developing world has never received compensation or recognition for these intellectual and technological contributions. Patenting life forms will exacerbate this inequality. This "bio-colonialism" will continue the pattern of a few transnational corporations profiting at the expense of genetic resources of the third world countries.

Conclusion
Patents on life forms hinder research, indigenous economies, and genetic diversity. No individual, institution or corporation should be able to claim ownership over species or varieties of living organisms.

In actuality, patents enable companies to create a monopoly on a product, permitting artificially high pricing. As a result, products such as drugs are often priced out of reach for many of those who need them.

Patents in science promote secrecy and hinder the exchange of information. By patenting products of research, the free flow of ideas and information necessary for cooperative scientific efforts are reduced. Scientific materials required for research will become more expensive and difficult to purchase if one corporation owns the rights to the material.

Patents exploit taxpayer-funded research. The development of biotechnology rests on 50 years of federally funded biomedical research. Corporations can make profits on their patented products by charging high prices to the citizens whose tax dollars supported the research and development of the products. Citizens are unfairly being asked to pay twice for medicines and other products. Patents promote unsustainable and inequitable agricultural policies.

A disastrous decline in genetic diversity could be the result of patenting of crop species. The genetic diversity inherent in living systems makes patent claims difficult to defend. The development of genetically uniform organisms would make it easier for corporations to maintain their patent claims.

Biotech companies holding broad spectrum patents on food crops will lure farmers to grow modified varieties with promises of greater yields and disease resistance. However, numerous examples worldwide show that improved crops have failed to hold up to corporate promises and led to the loss of the rich diversity of traditional crop varieties.

First World patenting of Third World genetic resources represents the theft of community resources. Patents held by the industrialized world on resources from the developing world will serve as a tool for the North to accumulate more wealth from the already economically impoverished South.

Microorganisms, plants, animals and even the genes of indigenous people have been patented for the production of pharmaceuticals and other products. Requiring developing nations to pay royalties to the wealthy industrial nations for products derived from their natural resources and innovation is robbery.

Patenting life forms bring with them overbearing issues of religious and ethical values. In today's competitive and globalized world, the biotechnology revolution is affecting industry and growth in a big way. It would, thus, be in our national interest to document, protect and modify new microorganisms isolated from various parts of our country and find their new and improved industrial uses. However, in the clash between socialist and capitalist centric ideologies, the betterment of society as the prime objective should be borne in mind before our regulatory bodies conclude.

End-Notes:

1. http://www.piperpat.com
2. http://www.wto.org
3. http://articles.manupatra.com article by Miss Ruthja, Title Conceptual issues in Biotic Patenting
4. http://www.slideshare.net article by Shradha Diwan, Title Patentability Of Microorganisms
5. http://www.ias.ac.in commentary by Suja Senan,M.J. Haridas,Prajapati
6. http://www.wpi. visited 26/12/2021

Written By: Ms Rukhsar Atayee, Student of LLM (IPR), Afghanistan