IPR ISSUES IN BIOTECHNOLOGY

Abstract:

In this fast facing world, inventions and variations in the technology is a common trend. Intellectual Property Rights aims to protect the rights of those who create this innovation or variations. Biotechnology is one of the field which is also growing at fast rate. This Article deals with basic introduction , types of biotechnology, IPR available in biotechnology, issues regarding IPR,  International perspective, Indian perspective. The main aim is to clear the concept of biotechnology in relation to IPR.

INTRODUCTION

Intellectual property is a product of human intellect and the rights granted on it allow its owner to benefit from the fruits of this intellectual endeavor by creating a monopoly over it. Such benefit is not always a natural right but requires recognition by a statute. Intellectual property rights (IPRs) play a key role in every sector and have become the basis for crucial investment decisions. IPRs are exclusive rights and therefore there is always a challenge to strike a balance between the interests of innovators and the interests of the society at large. Another important factor is having an adequate legal framework to protect the interests of innovators and inspire confidence that their intellectual property will be protected, in turn triggering further innovation.

Biotechnology is a science concerning evolution in living organisms or their components. It usually deals with modification and manipulation within the living organism or their components for specific applications. It aims at improving health and livelihood of the society. Biotechnology can be used in any field whether it is medical or agricultural or environmental or Industrial. Biotechnology includes molecular biology, biochemistry, genetics or cell biology. It trade in vaccines, antibiotics, pest resistance crops, fermentation, biocatalysts, bioremediation.

KINDS OF BIOTECHNOLOGY

Biotechnology can be differentiated on the basis of  nature and area of study. They are as  following:

  1. Medical Biotechnology:  This include use of living cells and others materials to improvise the health conditions. It aims at creating cures for disease and to prevent them. It is basically study of DNA structure for better functioning of humans and production of pharmaceutical drugs. Vaccines and Antibiotics are great examples of medical biotechnology. Vaccines are chemicals released in the body that helps the immune system to fight pathogens like Hepatitis B vaccines. Antibiotics are chemicals helping human body to fight against antigen like sulfa, penicillin.
  2. Agricultural Biotechnology:It is concerned with increase in the crop yield or manipulating plants to deal with regional problems like climate, fertility. It involves modification of genetics of plant. One good trait of a plant is fused with another plant to produce a better and advantageous plant. Examples of this are Pest Resistance crops          ( Fungus Bacillus thuringiensis), plant and animal breeding( flower production).
  3. Environment Biotechnology(Grey biotechnology): This branch tackles with problems of pollution and waste. It envisages on developing technology to clean up waste and reduce dependency on conventional land based disposal methods. Bioremediation is a technique used to develop enzyme bioreactors that pretreat industrial and food waste as well as allows their removal via sewage system.
  4. Industrial Biotechnology (White biotechnology): It is exercised for industrial purpose by using modern molecular biology. It improves efficiency and lessen the environmental impacts of industrial processes. It comprises the practice of using micro-organism, enzymes to produce useful industrial products. Genetically modified organisms are being created to enhance applicability and economic viability of industrial technology. Biocatalysts such as enzymes are used to synthesize chemical as well s fermentation is also done. Micro-organisms are also utilized for production of new textiles or plastics or biofuels.

IPR AVAILABLE IN BIOTECHNOLOGY

The Trade Related Intellectual Property Rights signed by members of World Trade Organisation includes various types of Intellectual Property Rights available in Biodiversity. These rights are:

  1. Trademark(medical devices, graphical designs, computer icons, words/name)
  2. Patents(enzymes, microorganisms, vaccines, antibiotics, peptides, polypeptides)
  3. Registered(Industrial) Designs(biochemical, biophysical, bio-electrochemical apparatus)
  4. Trade Secret( laboratory notebooks, clinical data, design workbooks)
  5. Copyrights
  6. Plant Varieties Rights

In present time, mostly used are Patents and Plant varieties rights as they provide exclusive as well  as time limited rights.

ISSUES RELATING TO BIOTECHNOLOGY

The issues before the various countries regarding IPR in Biotechnology is what stand they should take on:

  • distinction between discoveries and invention in biological area.
  • The definitions and the scope of patentable microorganisms
  • The scope or protection of living beings like the plants and animals
  • The conditions of deposition connected with the patentable inventions involving living entities like Bacteria, fungi, genes etc.

INTERNATIONAL PERSPECTIVE:

Plant Varieties Rights:  Previously in mid 1960s, only few countries provided intellectual protectionto plant varieties. This created a pressure on other countries leading to formation of International Union for the Protection of New Varieties of plants (UPOV) signed by 10 European countries. Many countries have signed this convention from time to time.

It requires that member countries must adopt national legislation to give at least 24 species protection within the eight years of signing as mentioned in the convention. To protect a plant variety it should be distinct, uniform, stable and satisfies novelty requirement.

In March , 1991 a diplomat conference was held and substantially UPOV was revised. It applies the convention to all the species and also includes exclusive rights of harvested material. It allows enforcement against farmed saved seed.

Patents: patents are time limited exclusive rights for new invention. Only a few countries provide for patent protection for biotechnology. These countries are  Australia, Bulgaria, Canada, Czechoslovakia, Hungary, Romania, Japan, the Soviet Union and the parties to the European Patent Convention. The general time limit of patent is 20 years .

In Diamond v. Chakrabarty , US Supreme Court held that a particular genetically engineered bacterium was statutory subject matter for a utility patent.

There are various treaties for protection of biotechnology:

  • The Paris Convention for the Protection of Industrial Property (the Paris Convention);
  • The Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure (the Deposit Treaty) and
  • The Patent Cooperation Treaty (PCT)

INDIAN PERSPECTIVE

The present Indian patents act does not allow the patenting of any life, of products, plants and plants varieties. Biocon ltd. established in 1978 was India’s first biotechnology company. It aims at building technology platforms based on fermentation process. With the development of Syngene(drug discovery) and Clinigene(clinical development) Biocon became global bio-pharmaceutical.

CONCLUSION

Biotechnology is emerging vogue in the era. Various manipulations and innovations are being made in this field by different countries. IPR  tends to protect this rights and innovations by various modes such as patents, trade secret etc. Different countries has different meaning of inventions which are posing a great threat. Countries adopt their policies according to one’s own benefit and welfare. There is a dire need of reforms in the field of biotechnology.

REFERENCES

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