- 1 Patent Legislation – Introduction
- 2 India’s Pre-TRIPS Era
- 3 TRIPS Agreement in India
- 4 Effects Of The TRIPS Agreement On India
- 4.0.1 This is in stark contrast to what the condition was prior to the TRIPS Agreement.
- 4.0.2 The ultimate objective of adding the provision of compulsory licensing in the 2005 Revised Act was to provide such a license if
- 4.0.3 The Revised Act has further added some provisions to shape the future of India’s pharmaceutical industry. These provisions are
Patent Legislation – Introduction
Patent legislation is the part of the Intellectual Property(IP) law that consists of laws regarding the new inventions. Earlier the patent laws protect only tangible scientific inventions (circuit boards, heating coils, zippers etc). However, over time patents protects a variety of inventions such as coding algorithms, business practices, or genetically modified organisms.
In general, the patent is granted to those inventions which are:-
● not a natural object or process
● useful and
● not obvious.
In this article, we will be discussing the evolution of the patent legislation over a period of time.
India’s Pre-TRIPS Era
The TRIPS Agreement is the most comprehensive multilateral agreement on intellectual property which came into existence on1 January 1995.
In the colonial area, British initiates the concept of issuing pharmaceutical patents. Over time, the system and laws of issuing patents evolved. After the next few decades, there was a sharp fall in the productions of patents on medicines in India. Although, one of the most famous legislation that followed was the Patents Act, 1970. This act comes to overcome the backdrop of firms who charge very high prices for something which the common people could not afford to buy. It includes the firms on pharmaceutical products. The foreign pharmaceutical firm controls almost 70% of the local market which was the result of continuance dominance.
This, therefore, enabled India to change and form itself into one of the more useful pharmaceutical businesses on the worldwide scale. This made space for the neighborhood pharmaceutical organizations to jump into the nearby market, and increase their share of the Indian Market. This brought about the decreasing of shares of foreign firms, who were presently held in their means. Accordingly, Indian firms turned out to be all the more technically sound and sophisticated realizing that they could avoid consideration from the foreign firms. They began developing new procedures for medicate generation and furthermore skilled in reverse-engineering.
TRIPS Agreement in India
India added another dimension to its International IP Law when it turned into a member of the WTO and acknowledged The TRIPS Agreement. This agreement came into a drive in 1995. The TRIPS Agreement spun around the possibility that the supremacy and the stability of the developed countries, Such as the USA, Japan, Europe. It depends on them guaranteeing the protection of IP rights outside their domains, particularly in the developing nations. The TRIPS Convention likewise guaranteed that for the nations to be a part of the WTO, they must be a part of the TRIPS agreement. This, particularly, underlined the “single undertaking” nature of the WTO.
Article 31 of this Agreement was a slight deviation from this general rule. It allows the issuance of compulsory licenses by the government to third parties under four conditions:
- Situations of National Emergency
- Situations involving the commercial non-public use
- Where there is an inherent need to correct anti-competitive practices
- Involving dependent patents.
Effects Of The TRIPS Agreement On India
Between the time of 1995-2005, as an immediate reaction to the inevitable risk that was approaching, that is the loss of the local market, because of the increase in costs of the pharmaceutical items, the local firms turned their consideration outside India. They turned towards exports and R&D(Research and Development) in the developed countries. This was suitably brought up by the Organization of Pharmaceutical Producers of India (OPPI).
Indian organizations, however, couldn’t figure out how to enter the American Market in view of their stringent administrative hindrances. This, however, was temporary, as the Indian firms improve their skills in navigating patents and soon they were to hold 20% to 50% of the considerable number of applications of drug approval in the US. This huge turnover has brought about India in gaining the advantage in the trade activities. “It has turned out to be one of the biggest providers of pharmaceuticals formulations in the world”.
This is in stark contrast to what the condition was prior to the TRIPS Agreement.
- Foreign exports currently form the main part of the income of the local firms, at that point the local sales. By utilizing India’s third world patent framework in accordance with that of the Western nations, India gains authenticity and positive consideration. The R&D Sector likewise enhanced drastically under the TRIPS Agreement.
- Economic development brought the total and utter disregard for general wellbeing to the front, as public health activists raised the issue of the conflict between the two sections. TRIPS enabled the issuance of necessary licenses to those nations which did not have the assets to make their own pharmaceutical items. The Doha Convention went far in lightening the troubling conditions in the underdeveloped nations.
The ultimate objective of adding the provision of compulsory licensing in the 2005 Revised Act was to provide such a license if
- ”A patent is not worked in India [for] three years after its grant”
- ”Reasonable requirements of the public’ are not satisfied”
- ”The patented invention is not available to the public at a ‘reasonably affordable price’
The Revised Act has further added some provisions to shape the future of India’s pharmaceutical industry. These provisions are
- The recognition of product patents, not just process patents
- A twenty-year term from the filing date of applications
- The availability of patents for industrial application.”
On close examination of the Indian context, we can find many anomalies in the Revised Act. Many undefined and vague terms, such as the requirement to involve in “reasonable” efforts to negotiate with the patent-holders is lost completely in relation to the Indian perspective. Such ambiguities have given rise to many flexibilities, which are of relevance with respect to the developing countries, and their access to pharmaceuticals.
Such a wide analysis of the flexibilities is beyond the scope of this paper. Despite these ambiguities, India has gone on to implement the TRIPS Agreements, as this allows a vast scope of expansive development and flexibility in the area of pharmaceuticals that no other legislation had ever provided before in the international dominions, remains one of the more go-to topics to research on.