Biotechnology is where cellular, biological, molecular processes are applied in flora, fauna or microorganisms. This field is useful in the following places: industries, health facilities, agriculture, projects related to environment. Next, the word ‘patent’ is the legal right which the creator/owner of an intellectual property possesses exclusively and stops anyone other than him from getting advantage from the product for which he is the owner. This short article discusses about various aspects of Biotechnology Patents, its role and purpose and how it can be a success in near future. Agreement on Trade Related aspects of Intellectual Property Rights gives protections for all fields of technology but is clear in the field of microorganism patenting. There are basically two sides that are being debated:
1) That they cannot be patented because they are just discoveries from already existing microorganisms.
2) That they are definitely inventions because alterations to the existing microorganisms are made if man with normal prudence cannot understand how it is invented.
- There are issues that arise if these inventions are patented. If rights are granted, exceptions and limitation to these rights have to be specified. For that, the claim that is given in the patent application should be specified and the right should be clear and unambiguously claim. For that, the claim that is given in the patent application should be specified and the right should be clear and unambiguously claim. This is to avoid future claim of right in further development of the invention that prevailed during the application for patent. There is a possibility for such organisms to reproduce themselves and this leads to production of the patented organism for which there is high possibility for the owner to claim further rights over reproduced ones.
- Initially there was no express provision that authorized biotechnology processes to be patentable in Patents Act, 1856. After 2002 Amendment, there came a hope for patenting these processes expressed in the Act. Section 3 of the Act enumerates the list of those that cannot be patented. Clauses (b), (c), (j), (h), (i), (h), (p) indirectly makes a loophole for people against patenting these processes to prevent the patenting. Yet, there are contrasting provisions of the Act in Section 10 and Rule 13(8) which talks about depositing the microorganism with the Depository maintained which validates its patenting. Such deposits are based on Budapest Treaty which India adheres. These Depositories are in Pune and Chandigarh.
- Moving on to the most important part of Biotechnology Patents, this may affect religious beliefs and moral principles. For example, organ transplants which may even lead to trafficking of mass. There is a high risk of production of Bio-weapons for which serious legal steps have to be taken before something wrong happens. One other important issue is, there may be copy of same inventions with few modifications, yet clearing the three essential requirements needed for patenting. Reference has to be made to Diamond v Chakraborty which held a very basic principle to determine patentability of a process, i.e., “anything under sun made by a man” is patentable. Thus, it means mere survival of the organism before the invention will not amount to rejection of a patent. The changes that are brought forth by humans matter and the patentability depends on that.
- Hence, it is clear that India is still at its phase of making clear cut laws to avoid confusions in the process of patenting. Because what may seem to be right for one, may not be the same to the other. Instead of making it the discretion of authority to decide, it is better to frame definite principles to be followed by the authorities without application of their own views over the issues. Thus, in order to arrive at uniformity in the process of biotechnology patenting, our country has to go a long way. Yet, we are at a correct pace and following International treaties and other countries’ successful laws for protection of biotechnology patents will help us frame perfect provisions for the same.