Biotechnology and Intellectual Property Rights
Authored by Shubhangi Sahu
Keywords: Biotechnology, Patents, Inventions, Biotech Patents Biodiversity, Sustainable Development.
This article gives an insight about the biotechnological industry its meaning, its scope, importance and why it needs to get patented. It will also focus on various policies, laws and initiatives taken by the government and how there is still a need for the more technically sound laws to deal with the present era.
Biotechnology means discoveries and inventions through resources available in our biodiversity. Biodiversity is a growing sector and aims at eco-friendly society by making products which are more natural and less chemical. However, such discoveries involve very intensive research and costs thus need patents to protect themselves and cover all costs which in incurred upon. It is notable that India is ranked in top 12 destinations of Biotechnology worldwide and is number 3 in Asia-Pacific and also estimated to be worth USD 100 billion by 2025.[i] Thus, India has a huge scope in biotechnology industry and government should take major steps to help this industry grow and lead to a sustainable society.
Meaning of Biotechnology
The development of genetic resources of biodiversity is known as biotechnology. Any technique that uses a living organism or its part to develop or modify a product for improving plants and animals or microorganisms or for any other specific uses is biotechnology.[ii] WHO defined biotechnology as “biological processes that have been engineered”.[iii] Biotechnology is said to be the building block for healthcare and pharmaceutical sciences.
Biotechnology has been classified into three broad sectors, namely, healthcare biotechnology which is also known as red biotechnology and includes techniques and inventions related to medicines, drug discovery etc., the second is agricultural biotechnology known as green biotechnology which includes techniques involved for making plants resilient to environmental conditions, for high yielding and all other advanced techniques and methods involved for producing better farm outputs. The last sector is industrial biotechnology also known as white biotechnology which involves bioprocessing, manufacturing of bio-based products etc., the main aim of this sector is to discover environment friendly products and processes.[iv]
Why biotechnology needs to be patented?
Biotechnology is very important for the human society firstly because it insists upon the environmentally friendly methods and products which is the need of the hour. But one of the biggest impacts of biotechnology is in the health sector, through genetic engineering scientists have been able to create so may medicines such as interferon for cancer patients, synthetic human growth hormones, methods of genetic engineering for correcting inherent conditions and so on. [v] Use of biotechnology help industries in becoming efficient and eco-friendly thus contributing in making these industries sustainable.[vi] It also helps agricultural industry in high yielding crop with minimum inputs and lowering the chemical usage.[vii]
Biotechnology has a lot to offer and has the potential to change the face of the society, thus they need to be protected so that such inventions can come at a larger scale and help in making an eco-friendly society which will help towards making a sustainable place to live. Since biotechnology involves discoveries and inventions which brings the Intellectual Property Rights especially patents in the picture.
The need for the patent in biotechnology becomes important because these inventions, discoveries are very research intensive i.e. companies have to spend their lot of time to discover or innovate some new ideas, on an average company involved in biotech industry have to spend their 40 to 50 percent of their revenue in research and development which is comparatively very higher than the other industries. This intensive research comes with a huge cost making these industries very expensive; thus, they need to be protected by the patents so that they can secure their inventions and also cover the cost and time spent on such products.
When such products are made by the small enterprises, they need investors and big companies to make their products as they cannot bear such high costs thus when they get patents for their products, it secures their innovations and further they can seek investors and make their product successful. Thus, patents help small enterprises and their ideas. Patenting helps industry grow and also and increases competition, as when such products are patented, they inspire others to make such innovations through biodiversity and thus will make the industry larger and better, and this industry is very important as it promotes sustainable development.[viii]
Govt. Initiatives for Biotechnology
· The most important legislation is Patent Act, 1970 under which every invention has to pass a two step test in order to get a patent; firstly it must not fall in any of the categories specifically excluded in Section 3 of the Act [includes (b)- invention contrary to public morality; (c) discoveries, things isolated from nature, plants and animals; (d) new forms or uses of known substances; (e) mere admixture; (i) methods of treatment and diagnosis]. Secondly, invention should clear the three-pronged test of novelty, inventive step and industrial applicability.[ix]
· Govt of India set up a Department of Biotechnology (DBT) within the Ministry of Science and Technology to promote research and development in the field of biotechnology. The DBT established a “Biotechnology and Patent Facilitation Cell” which is an awareness cum facilitation mechanism aimed at creating awareness and understanding about IPRs among scientists and researchers.[x] [xi]
· Council of Scientific and Industrial Research (CSIR) has also been set up by the government to focus on science and technology, technology development, generation and management of intellectual property and many more.
· Ministry of Science and Technology has also issued guidelines “Instructions of Technology Transfer and Intellectual Property Rights” where govt has given guidelines regarding ownership of Intellectual property, Royalty to investors, patent facilitating fund, norms for private industry and so on.[xii]
· Recombinant DNA Safety Guidelines by Department of Biotechnology which covers areas of research involving genetically engineered organism.
· Guidelines for Research in Transgenic Plants & Guidelines for Toxicity and Allergenicity Evaluation of Transgenic Seeds, Plants and Plant Parts, 1998 which is also given by the Department of Biotechnology covers areas of research on recombinant DNA on plants including transgenic plants and their growth in soil.
· Various legislations and policies of the Govt deal with biotechnology such as Environment Protection Act, 1986; EXIM Policy; National Seed Policy, 2002; Seeds Act, 1966; Drugs and Cosmetics Act,1940; Biodiversity Act, 2005 and many more.
Challenges for Biotech Patents
Despite having so many legislations and policies biotechnology faces lot of challenges because IPR laws were made when technology was not very much advanced and thus it faces problems to cope up with the prevalent technological advances. Even though the traditional doctrines have extended to the subject matters like genes, proteins and other unicellular and multi-cellular organisms, some of the common problems faced by biotechnology are; the traditional doctrines deal with novelty, non-obviousness, utility and the written description struggles whereas the biotech inventions deal especially with the genetic inventions, which is a controversial subject-matter, also, genes are natural occurring entities which can only be discovered and not invented, meanwhile, there is a thin line between discovery and invention which leads to confusion a problems. Thus, the present laws of IPR and traditional doctrines dealing with it needs to be broadened up and enhanced to meet up with the technological advances. [xiii]
Biotechnology industry has a lot to offer and yet it is appreciable and welcoming as it aims at sustainable development. Though we looked at various laws and policies made by the government with regards to this industry there is still a need for advancement and broadening up of these laws and doctrines to make them better so that they can easily cope up with the technological advances. There is also a duty of the government to create awareness abut these laws and protections among the inventors, scientists so that they can work on new inventions and get their products and discoveries protected.
Foot notes: [i] www.makeinindia.com [ii] www.ciesin.org [iii] www.who.int [iv] Kafarski, Pawel. (2012). Rainbow code of biotechnology. Chemik. 66. 814-816. available at https://www.researchgate.net/publication/287253802_Rainbow_code_of_biotechnology. [v] clas.wayne.edu [vi] p-bio.org [vii] www.atlasbiyo.com [viii] healthcaremba.gwu.edu [ix] www.iam-media.com [x] www.dbtindia.nic.in [xi] patentbusinesslawyer.com [xii] www.pfc.org.in [xiii] Conjunction of Biotechnology and Patent Law: Challenges Posed by Biotechnology Before The Existing Patent System By Vaishali Singh, (2018) PL (IPR) February 100