Patenting Of Biotechnological Inventions Under The Trips Standards
Written By: Meghna Prusty
In India, there is a wide range of subjects that are eligible. In India, any product or process, regardless of technology, is a patentable subject matter. However, a Section of the Patents Act lists a large list of inventions that are not patentable subject matter, including biotechnology inventions. In India, the discovery of any living entity that occurs naturally is not a patentable subject matter. Plants and animals, in whole or in part, are also prohibited biotech subjects, as are seeds, varieties, species, and essentially biological procedures for the production or multiplication of plants and animals. Microorganisms and microbiological processes, on the other hand, are patentable subject matter. Plants, animals, humans, and their parts, as well as genetically modified multicellular organisms, are not patentable in India. In India, gene sequences and DNA sequences with disclosed functions are patentable. Human beings and embryonic stem cells, on the other hand, are not patentable. Furthermore, patentability is disallowed in India for medical treatment procedures.
• There are no clear restrictions in the Patents Act regarding the uniqueness of biotechnological inventions. Because most biotechnology inventions are natural products found in living creatures, they may be considered discoveries rather than patentable. However, according to the 2008 Draft Manual of Patent Practice and Procedure, biological materials such as recombinant DNA, Plasmids, and manufacturing techniques are patentable if they are made with substantial human intervention. Because there are no precedents in the area, Manual’s interpretation is being utilized to assess the uniqueness of biotechnology inventions. Isolate has been granted several patents.
• In India, it is necessary to demonstrate that innovation can be developed, employed in at least one field of activity, and replicated with the same qualities as many times as necessary for it to be industrially relevant. Because the legislation makes no specific reference to the industrial applicability of biotechnology patents, it is appropriate to apply conventional industrial applicability standards to biotechnology inventions. Biotechnology ideas that can be developed and used in an industry, as well as replicated as many times as needed, will meet India’s Industrial Applicability criteria.
•The approach to inventive steps with relation to biotechnology inventions in India is not apparent because of a lack of case law. In light of their naturally existing counterparts, isolated gene sequences and protein sequences will be deemed to have an inventive step, according to the 2008 Draft Manual. Furthermore, because of their numerous uses in the pharmaceutical and diagnostics industries, the economic importance requirement for biotechnology inventions is extremely straightforward to meet. In India, principles such as the reasonable expectation of success, predictability of the field, and others are used to determine creative steps, and they will be used in biotechnology inventions as well.
•The approach to inventive steps with relation to biotechnology inventions in India is not apparent because of a lack of case law. In light of their naturally existing counterparts, isolated gene sequences and protein sequences will be deemed to have an inventive step, according to the 2008 Draft Manual. Furthermore, because of their numerous uses in the pharmaceutical and diagnostics industries, the economic importance requirement for biotechnology inventions is extremely straightforward to meet. In India, principles such as the reasonable expectation of success, predictability of the field, and others are used to determine creative steps, and they will be used to biotechnology inventions as well.
In Trips Standard
The Punta del Este declaration of September 1986 launched the Uruguay Round of multilateral trade negotiations under the auspices of GATT. The so-called Trade-Related Aspects of Intellectual Property Rights (TRIPs) were part of the negotiating mandate. Between 1987 and 1989, developing countries were successful installing discussion on norms and standards of Intellectual Property Rights (IPRs). But in April 1989, developing countries agreed to discuss norms and standards of IPRs. The Uruguay Round concluded with the adoption of the final act in April 1994 at the Marakkesh ministerial meeting.
The most contentious of the issues in the TRIPs Agreement was that relating to patents. Within this, Article 27 attracted the most attention because it stipulates the technology fields to be covered and exceptions to patentability. A close look at Article 27 (3) (b), which deals with nio-technology patents, is necessary. This article has given rise to many apprehensions for developing countries. In this paper, we will analyze Article 27 (3) (b) of the TRIPs Agreement and look at the genesis of this article.
The Paris Convention does not require biotechnology to be accorded patent protection. But at the same time, it does not prohibit it, leaving it for individual countries to decide whether or not to accord protection to biotechnology.
Article 1 (3) of the Paris Convention states, “ Industrial property shall be understood in the broadest sense and shall apply not only to industry and commence proper, but likewise to agricultural and extractive industries and to all manufactured or natural products, for example, wines, grain, tobacco leaf, fruit, cattle, minerals, mineral waters, beer, flowers, and flour”.
For various reasons, including ethical reasons, living organisms were generally regarded as being outside the patent system.
The work at WIPO on the patentability of biotechnology inventions started with the setting up of a committee of experts on biotechnological inventions and industrial property. This committee met four times between 1984 and 1988, and it did not complete its work. The participation of developing countries in this committee left much to be desired. Although the committee did important work and clarified many problems it could not reach any consensus.
The discussion on Article 27 (3) (b) in the “negotiating group on trade-related aspects of intellectual property rights including trade in counterfeit goods” was not exhaustive. According to Grevais (1998), the initial draft proposed by developed countries got through and the amendments proposed by developing countries were not accepted. The question that arises is, why did the developing countries accept a formulation taken directly from the European Patent Convention?
Article 27 (3) (b) of the TRIPs Agreement provides for the protection of plant biotechnology inventions. This is a very confusing provision, which includes exceptions within exceptions. Article 27 (3) (b) states, members may also exclude from patentability: (b) plants and animals other than micro-organisms, and essentially biological processes for the production of plants or animals other than non-biological and microbiological processes. The provisions of this subparagraph shall be reviewed four years after the entry into force of the agreement establishing the WTO.
This provision may be deciphered in the following way:
- Plants need not be patentable (means that product patents need not be granted but process patents can be granted)
- Animals need not be patentable (means that product patents need not be granted but process patents can be granted)
- Micro-organisms are patentable
- Essentially biological processes for the production of plants are patentable
- Essentially biological processes for the production of animals are not patentable
- Non-biological processes for the production of plants are patentable
- Non-biological processes for the production of animals are patentable
- Microbiological process for the production of plants is patentable
- Microbiological process for the production of animals is patentable
Article 27 (3) (b) has its roots in the Strasbourg Convention on the ‘unification of certain points of substantive law on patents for inventions’ of 1963 of the Council of Europe. Article 2 (b) of the Strasbourg Convention states:
The contracting states shall not be bound to provide the grant of patents in respect of… for plant or animal varieties or for essentially biological processes for the production of plants or animals; this provision does not apply to microbiological processes or the products thereof.
The intersection of biotechnology and intellectual property rights (IPR) has significant legal and societal ramifications. Intellectual property regulations enacted during the Industrial Revolution have proven ineffective in the Information Age. Existing patent laws are being challenged by new genetic inventions, which differ significantly from the mechanical and chemical inventions that have hitherto been the subject of patents. In comparison to their physical features, modern biotechnology inventions, particularly genetic inventions, have grown more valuable as an embodiment of information.
Bioinformatics and genetic databases have necessitated a new patent method, one that is more in line with the current information era. Although it is impossible to create a new IPR every time a new technology arises, it is also difficult to integrate all types of inventions within a single set of laws.
Student at The Law College, Utkal University