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Patenting Of Life Forms

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.

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.

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

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 it likes and forgo from others. The Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement of WTO puts several rules on member countries.

The TRIPS agreement ensures that patent protection is available for all the fields of technology which includes agriculture, energy and healthcare. Also, members can eliminate 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.

For example:
  1. Plants, animals, essential biological processes of production of plants and animals may be eliminated from patenting.
  2. Microorganisms per se and non-biological and microbiological processes are patentable.

Patenting of life forms

To begin with the most obviously contentious subject, should life forms be patentable? Logically, the answer is straightforward if the criteria as they now stand are followed accurately. A life form as it occurs in nature is not patentable because there is no inventive step. A captured life form is also not patentable, because the concept of caging is not novel (though a new and ingenious design of cage might be). A modified life form is patentable, but only as far as the actual modification is concerned.

This view is intermediate between current patent practice, which has allowed excessively broad claims on the strength of a limited modification (cotton, for example), and the vitalist position that nothing to do with life should be patentable. Neither of these extremes makes sense. To think about this wide gap of opinion, helps to project forward to the time (probably sometime during this century) when new life forms will be synthesised from scratch.

Such life forms will surely be inventions, and therefore patentable. We shall understand them fully, so the mystical element will be gone (incidentally, that's not to say there should be no sense of wonder at such an accomplishment). Before that point, it will be commonplace to modify life forms so extensively that their origins are unclear. These projections warn us that appeals to morality to prohibit the patenting of life forms will not in the end be sustainable. But that is not to say that the issue is trivial, just that it cannot be dealt with at the level of patent claims.

Conflicts arise because under the current exclusive-rights system, possession of a patent confers too much power. We therefore need to institute stricter controls on use. Until that has been done, it is better to retain an illogical but precautionary position on claims.

Patents on life forms and living processes

In India before the 2002, amendment the understanding was that there was no patent protection for inventions 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 a vaccine containing live virus is patentable since the term manufacture covers even living organism. Even if the end product contains a live virus the process involved in bringing out the end product becomes an invention according to the court 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 Section 3 of the Patent Act, 1970 has been amended. The definition of the invention, new invention, and 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 processes, 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 which 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 never served as a basis for establishing inventive step.

The 2008, patent manual incorporates provisions which is used as a direction by the patent office to interpret various provisions in the Act. Standing Problems, 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 indicators of inventive steps 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 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 material were subjected to product patents in India, unlike many developed countries. But with effect from 20.05.2003 India has started granting patents in respect of inventions related to microorganisms, though India was not obliged to introduce laws for patenting microorganisms per se before 31.12.2004. Microorganism patenting per se is 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 an 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 the 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 Patent 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 the 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.

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, they primarily have the same gene pool.

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 is 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.

The First World patenting of Third World genetic resources represents a 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 wealthy industrial nations for products derived from their own 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 significantly. 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.

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