From ages human beings have been trying to master the art of Biotechnology, but the 21st century has been seeing something different. The work in the field of Biotechnology has seen a rapid growth and this rapid growth and fierce competition have pushed the limits of intellectual rights and patent laws. With the advancement of technology and research more and more efforts are being put to patent life forms, organisms and Human parts in specific. This is an area which involves not only technology, Law, ethics and morality but also religion. Involvement of religious beliefs and practices around the world and the question of morality many a times lead to controversies and law suits.
Change in the basic nature of Humanity, conception of pseudo-human life forms and negativity associated with Humans "Playing God" are undoubtedly a cause of apprehension are real and a very problematic issue. This needs to be addressed with each and every improvement in the field of Biotechnology and assertion of patent rights on resulting innovation.
HISTORY OF LIFE FORM PATENT
Thomas Jefferson the man behind the first Patent Act did not have even slightest idea that the life forms can ever become a subject of Patent protection. The most famous case of Diamond v Anand Chakrabarty where a biochemist at GE developed a genetically modified organism that had the ability to decompose crude oil. At first his patent application was rejected which on further appeal was granted by the court with order stating "His claim is not to a hitherto unknown natural phenomenon, but to a nonnaturally occurring manufacture or composition of matter-a product of human ingenuity".
BIOTECHNOLOGY PATENT AND INDIA
Patent Act in India was enacted in 1856 from then it has been modified several times, one such major amendment was done in 1970 which satisfied the international norms of patentability such as Novelty, Inventive step and industrial application. The patent act 1970 had nothing specific concerning the Biotechnology invention and protection. At the same time patent offices and courts in US and EU were seeing increasing number of biotech inventions and patent application, as a result demand of amendment of Indian patent act to introduce biotech patentability gained significance in India. The amendment came in 2002 to explicitly include biochemical, biotechnological and microbiological processes within the definition of potentially patentable process.
OPPORTUNITY OF BIOTECHNOLOGY PATENT IN INDIA:
The practices prevalent in India in this regard, and are quite nascent and the Topic of Biotechnology Patent is not as clear and tidy as it is in other fields of intellectual property. There are several outstanding deficiencies within the substantive law that needs addressing. Apart from narrow standards of patentability, biotech products are faced with certain additional hurdles like mandatory disclosure of biological material, prior approval from the Biodiversity Board and access & benefit issues under the Indian Patent regime.
The Indian Patents Act does not define, in an comprehensive manner, what is patentable. Relatively, Section 3 includes a list of inventions considered not patentable. In respect of biotechnology inventions, the Indian Patents Act 1970 as amended till date postulates under Section 3(a) to 3(e), 3(h) to 3(j) and 3(p), inventions that will not be considered as a patentable subject matter in India. Though, Clauses 3(c) to 3(d), 3(i) to 3(j) and 3(p) are imperative in the context of patentability of biotechnological inventions. Clause 3(c) states that "The mere discovery of a scientific principle or the formulation of an abstract theory or discovery of any living thing or nonliving substances occurring in nature" will not be considered as patentable invention.
This provision of non-patentability is common to patent laws of other countries. The Clause 3(j) states that "Plants and animals in whole or any part thereof other than microorganisms including seeds, varieties and species and essential biological processes for production or propagation of plants and animals as non-patentable invention".
WHAT IS NOT PATENTABLE IN INDIA
- Section 3 (b) - . As per the section an invention
- would not be patentable if it is immoral or against public order, harmful to human, animal or plant life or harmful to environment
- Discovery of living things or non living substances in nature - Section 3 (c)
- Plants and animals in whole or any parts thereof other than micro-organisms but including seeds, varieties and species - Section 3 (j)
- Essentially biological processes for the production or propagation of plants and animals– Section 3 (j)
- Any Process for the medicinal, surgical, curative, prophylactic, diagnostic or therapeutic or other treatment of human beings or animals to render them free of disease or to increase their economic value or that of their products – Section 3(i)
- Methods of agriculture or horticulture – Section 3(h)
- Traditional knowledge – Section 3(p)1
WHAT IS PATENTABLE IN INDIA
- The MPPP regards claims to 'genetically modified Gene Sequence/Amino Acid Sequence, a method of expressing the sequence, an antibody against the protein/ sequence, a kit containing such antibody/ sequence as having a single inventive concept and capable of being granted a patent
- Gene sequences, DNA sequences without having disclosed their functions are not patentable for lack of inventive step and industrial application
- Living entities of artificial origin such as microorganism, vaccines are patentable
- Biological material such as rDNA, plasmids are patentable provided they are produced by substantive human intervention
- Processes for producing chemical and biological substances using microorganisms including lower plants and animals are patentable
- Modified Microorganism & process therefor
- Process for modification/ isolation of microbes.
- Isolated nucleic acids encoding gene, first time isolation of a molecule; novel peptides, novel peptide analogs, proteins, vaccines, antibodies, recombinant: DNA, RNA, Amino Acids, antibodies, primers, recombinant oligonucleotides and primers, genes and process therefor; DNA related inventions such as preparing plasmids, vectors etc.; composition/formulation thereof.
- Cell lines-A cell line is patentable if artificially produced.
- Hybridoma technology: patents are also allowed on hybridoma technology, but not on protoplast fusion.
- rDNA, cDNA, r-RNA, r-antibodies
- Expressed sequence tag's, or ESTs, are small fragments of genetic material
- obtained by reverse transcriptions of messenger RNA (mRNA) from expressed
- Genes. The gene sequence, or expressed sequence tags (ESTs), can be Patented if it
- has a use, such as if it works as a probe.2
It can be seen that the Biotechnology and life form patentability is a subject of exploration in India. With more and more research and innovation going around in this field and keeping in view the rich Bio-Diversity that India enjoy, there is a true need to protect the interest of inventors. India needs to enable its inventors and inventions to compete in the global scenario, although few claims are do considered but they are more case to case basis and there is a lack of tidy guidelines.
1. Indian Patent act ,1970
2. Biotechnology Patenting In India and Related Issues - Rajashree Sharma
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