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BIOTECH ISSUES IN PATENT LAW

  1. INTRODUCTION

‘It is the Biotech Issues in Patent Law where the language of science meets the language of the law’.

Biotech issues in patent law emerge from the techniques of basic genetic engineering[1]. It represents the fascinating interface between science and law. Due to the belief system that living organisms and cells were nonpatentable products of nature, patent protection for biological material was for many years restricted.

Under the rational that living organisms were not new, assumptions appeared that it cannot be patented. The distinction between what is technical and what his life has provoked tension in society and that tension is still with us.

Making exclusions of nature, from the public domain which is for all men and women, it creates disharmony and insecurity because of unethical and uncontrolled possibility for commercial use in society and in nature.

By using these technologies it is possible for the researchers and industries to exploit the biological resources and to produce in large-scale commercially viable products in the field of pharmaceuticals, agriculture etc. without caring for the nature , and subsequently posing questions of   moral , ethical ,  legal , and economic realms of humans.

 The growing R&D of biotechnology[2] has added new pages to the Intellectual Property regime. Because of the commercial potential that lies from the use of biotechnology the question of patenting of life forms emerged as a crucial issue.

 Concept of patent law –

A patent is a form of industrial or intellectual property that grants exclusive and monopoly rights to a person who has invented a new and useful article or an improvement of an existing article or a new process of making an article.

A patent is granted for some article or for some process of making some article applying the idea, having its essential components novelty, inventive step, lack of obviousness, and sufficiency of description. After the expiry of the patent, anybody can make use of the invention. This system has been evolved to encourage and develop new technology.

Also read the study between Trade secret and Patent

  • HISTORY OF THE PATENT IN BIOTECHNOLGY

Born in the heart of the poet, flowers as it were in the actor and bears fruit in the spectator .all there in the serene contemplations of the work from in reality a single knowing object fused together   – Bharata natya Shastra .The concept of patent system was developed in the late nineteenth century, in response to the problem of protecting mechanical inventions. Patent system initially was not modeled for from the perspective of living products.


[1] To produce organisms to produce artificial organisms with artificial genomes.

[2] Biotechnology is the application of industry of manmade techniques and instruments of research in biological manner.

The prevailing international patent regulation system was developed under the idea of lifeless organism and plants and animals

Historically, patent was given for improvements in the process of making beer and improvement in the Agreement on the Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement), patents is available for any invention in any and all fields of technology.[1]

(3) Discussions & Analysis –

Even though , good amount work is in progress in this area and the law is also settling, confusion still persists about the grant of patents and their treatment. There is a need to bring clarity among the business houses and researches about the application of standard tests for granting patents and valuation of patents for fixing royalties. This issue extends to the transgenic plants and transgenic animals too.

 Many companies and universities are engaged in research to identify genes that are associated with specific diseases and will wish to patent any such genes that are found under the guidelines of EPC &TRIPS[2].

Opponents think that there should be some control over human by playing them God. In a case of RELAXIN[3], the claim was for patenting human gene encodes for relaxin. It was held patenting of one single human gene has nothing to do with human life.

Examples –

  • The Mormon Church, for its own religious reasons, has accumulated what is probably the world’s most extensive collection of genealogical data and access to these data helped Myriad Genetics of Salt Lake City to identify the BRCA1 gene associated with an increased risk of breast cancer.[4]

  • In some states of USA and in some other countries, DNA databases are kept based on samples compulsorily collected from convicted criminals, even nonviolent ones, or even from suspects who were never charged or convicted. It is not difficult to imagine a scenario in which certain gene is found to be associated with violent behavior and all persons who carry the gene are made liable to police surveillance.   These are the areas in which the real ethical problems are to be found and arguments about whether or not one should patent a gene are completely irrelevant to these issues.

  • PARKE –DAVIS V HK MULFORD decided by the Us COURT OF APEALS. In the modern world of genomics that logic is s distinction without a difference ,If you accept that argument  then would it not follow that you could paten , human heart you removed and preserved it ? a human gene is created first in nature, the same way other parts of human bodies are and the fact that it is may be isolated, cloned and purified does not change the roots of origin’[5]

  • But in 1980 Diamond V Chakraborty, US Supreme Court granted patent to genetically modified bacteria useful for oil spill cleanup. Court held that this bacteria is very markedly different from those bacteria found in the nature therefore patentee should be grant patent anything which is made-up by man under the sun.

[1] Law of Intellectual Property Rights, S.R Meynemi

[2] European Patent Convention & Trade Related Aspects of Intellectual Property

[3] 1995 OJEPO 588

[4] WIPO magazine, 2006.

[5]   Barbara A Caulfield – why we hate gene patents ‘.when this was written Ms Caulfield  was executive  vice president  and general counsel at Affymetrix, a leading US biotechnology company that has been active in providing apparatus for genetic testing .

Issue of Patenting Life forms –

Patenting of life forms (which is an output of biotech industry) emerged as an important issue only after 1970’s when there was a boom in biotechnology by the emergence of Recombinant DNA Technology, Tissue culturing, etc.

By using these technologies it is possible for the researchers and industries to exploit the biological resources and to produce in large-scale commercially viable products in the field of pharmaceuticals, agriculture etc., under the realm of biotechnology.

Analysis –

The patent system has come into focus as never before, as its opponents often rest their case on feelings that patenting biological material is unethical. There are many issues concerning biotechnology  that must be considered, but rather than by opposing patents, those purposes can perhaps be better achieved by adopting specific laws that regulate the different matters, e.g. by prohibiting human cloning, regulating the use of research animals so as to spare them suffering, making provision for environmental considerations etc. The law is complex.

Genetic R & D in Biotechnological subject   ranges from ethics governing research and use of biotechnological matter to governmental regulatory rules, professional rules etc. all of which to some extent reflect changes of social policy in the light of scientific developments. The patent system has itself been challenged with respect to biotechnological inventions because of obstacles to free research.

The biotech inventions suffer from increased number of litigations on the grounds of unacceptable subject matter of the patent, obviousness, insufficiency of specifications and claims and application of standard tests.

Conclusion –

Modern Biotechnology aims to exploit the genetic information present in living organisms. During the development of this field, many process and related products have arisen, enabling the skilled person to process further with the exploitation of genetic information.

This article is written by Chitra Rana and edited by Rupreet Kaur Dhariwal.

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