Author- Mannat Gaind
Introduction
Economic expansion and growth have had a major impact on technology and fuelled competition in all industries. As a result, the global economy and business environment have witnessed rapid technological progress.
The development of biotechnology in highly industrialized countries has three aspects: the research and technology that underpins it, the companies active in this field, and government regulations. One of the fastest growing technological areas is biotechnology. The practice of biotechnology involves the modification or creation of new goods and processes through the manipulation of biological systems and living organisms.
The end result of biotechnology is neither naturally occurring in living organisms nor produced by nature. However, if it shows an innovative step, can be used industrially, and meets the patent requirements, it can be identified as an invention.
Companies need to obtain biotechnology patents to make life-related products, etc. A patent allows a company to develop a patented idea by granting intellectual property rights for a limited time, introducing a new product to the market, or licensing or transferring the rights to another company. You can get your investment back.
Evolution of biotechnology patenting in India
After its first amendment in 1999, the Indian Patents Act, 1970 was amended again in 2002. This Second Amendment made a big difference by allowing the patenting of products derived from chemical, biochemical, biotechnological, and microbiological processes.
Criteria for grant of Patent
Patentable subject matter must meet several criteria.
The first requirement is that there is something new. The invention must be original and distinct from “prior art” as defined in Section 2(1) (j) of the Indian Patent Act. Inventions that have already been published elsewhere in some way cease to be considered new before a patent application is filed.
Section 2(I) (j) of the Patent Act deals with non-obviousness. It describes an innovation that is not obvious to those skilled in the art because it involves a technical breakthrough beyond conventional knowledge, is of commercial importance, or both. In theory, there are specific genes with specific nucleotide sequences, but it is debatable whether finding and isolating them would be trivial for those knowledgeable in the field.
A patent should be useful. Certain types of jobs must be performed by the product. The invention should be applicable to related industries. Technical processes that are not immediately apparent to those skilled in the art must be included in innovation. Inventive step is the process of giving originality to an invention.
Conceptual framework
The Department of Biotechnology, established by the Government of India within the Ministry of Science and Technology, has established the Biotechnology Patent Facilitation Cell (BPFC) to facilitate research and development in the biotechnology sector. There is little funding for biotechnology research and development. Only state laboratories are funded. His lab Reddy, Biocon India, Bharat Biotech, Biological Evans and others are currently funding biotechnology research and development in the country.
Ethics in patenting biotechnological invention
Morals and ethics play an important role in society, because in India it is recognized and upheld on a par with the law. Morality refers to the belief that certain behaviours are morally acceptable and others are not. This belief is backed by accepted standards embedded in our culture. Plants and animals are revered and worshiped as deities in Indian culture.
Many people are against the concept of patenting life. They expressed concern that biotechnology would lead to structural changes in the agricultural sector. Especially when large companies are given legal rights to ongoing developments.
India has long opposed private ownership of natural objects and living things, but owning living things is frowned upon. However, as a signatory to the TRIPs agreement, India is bound by it in terms of patenting inventions such as microorganisms and other items produced by microbiological, non-biological or biotechnological processes.
The amendment states that an invention cannot be patented if it violates moral or social norms, endangers human or animal health, or harms the environment. For moral reasons, it has become clear that biological processes for reproduction of plants and animals cannot be patented.
Suggestions
Ethical concerns regarding biotechnology patents are controversial and vary from country to country, but local laws need to be changed to make ethical concerns more explicit. The patent grant period should be shortened. Biotechnology is a rapidly developing technology, so some inventions may already exist.
A specialized committee on biotechnology patents should be established to support determine and sustain innovation. Strict laws are required and licenses should only be granted if the necessary conditions are met. Biosafety measures should be taken to ensure safe production, use, storage, transfer and recovery. BPFC needs to improve the effectiveness of its policy framework while ensuring sound governance.
Conclusion
It is undeniable that the patent system has stimulated creativity and brought great benefits to human society. Developments in the biotechnology patent field can affect the entire human society, so individuals, organizations, or companies must decide together whether they should have private ownership of life.
Biotechnology is becoming more and more important for the growth and development of emerging countries like India. The unexpected development of biotechnology has been accompanied by a protracted struggle for reward and recognition. It wasn’t easy, as the ascent had its ups and downs. Undoubtedly, any biological product or compound that is made in a laboratory but not found in nature is entitled to a patent.
As a result, biotechnology patents have been introduced in India to protect the rights and interests of innovators. Biotechnology inventions resulting from the combination of human ingenuity and biological processes must be patentable. However, it is important to ensure that the invention does not violate moral principles or be immoral.
