Patent Law in India – Compliance with TRIPs Agreement
India became member of WTO on January 1st 1995. All, the member countries of WTO were required to sign the TRIPS Agreement mandatorily, which was the part of WTO Agreement as an Annexure thereto. Meaning thereby, the TRIPS Agreement was binding on all the WTO member countries. Further, the compliance with the provisions of TRIPs agreement was a prerequisite of joining the WTO and objective thereof, was to streamline the rules of trade between the member countries at the global level. The TRIPS agreement fundamentally applicable on the developed, developing and less developed countries. USA, UK, Canada being the developed countries has incorporated and complied most of the provisions of the TRIPS agreement; however, the developing countries like India, Singapore, and Bangladesh could not implement and complied with the same because of social and economic conditions. TRIPS Agreement became the first international instrument, which comprehensively focused on the trade related aspects of the intellectual property rights.
As per Article 27.1 of the TRIPS Agreement, the member countries were required to amend their intellectual property laws in consonance with the TRIPS Agreement, so that patents was available for all the inventions in the field of technology, whether it is a product or process and there should not be any discrimination, if it passes through the standard tests of novelty, inventiveness and industrial applicability.
Three exceptions were also included regarding patentability of any product or process. First, if any invention is against the morality or public policy, it cannot be patented. In this category, those inventions are included, which are hazardous to human life, animal life, or plant’s life and are harmful to the environment. The Second exception was that the methods of diagnosis, therapeutic and surgery for treating humans or animal may be excluded from the regime of palatability by the member countries. The third exception was that the Members countries may exclude the plants, animals other than micro-organisms from patentability. The countries which barred varieties of plant from patentability, were expected to provide a sui generis system of protection of plant varities. To comply with the TRIPS Agreement, India made an effective sui generis system for the protection of plant varieties and enacted the Protection of Plant Varieties and Farmers Rights Act, 2001, who contribute in conservation, improvement, and make available resources of plant genetics for the development of new plant varieties. This Act provides protection to trees and vines for eighteen years and fifteen years for extant varieties and other plants.
The provisions of the TRIPS Agreement were to be compiled by the member countries within a specific period, from the date of its enforcement i.e. January 1st 1995. Different timelines were given to the member countries to comply with the provision of the TRIPS. The developed member countries were to implement the provisions of TRIPS within 6 years i.e. before 31st December 2000 and 10 years’ by all the developing member countries i.e. 31st December 2004.
To comply with the provisions of TRIPS Agreement, India had to amend its Patents Act 1970 thrice. The first amendment took place in the year 1999 and second in the year of 2002 and the third in the year of 2005.
Patents Amendments Act 1999:
The objective of Patents Amendments Act 1999 was to exclude product patents in the segment of food, medicine and drugs. This amendment also provided stronger protection for foreign pharmaceuticals patents and to more focused environment for domestic research and enhanced competences therein. Indian pharmaceutical industries were given freedom to modernize its pharma industry so that it can compete with the pharma industry of developed countries. In compliance with TRIPS Agreement, the uniform term of patent protection of 20 years for all categories of invention prescribed.
Patent Amendment Act of 2002:
The Patent Amendment Act of 2002 made a number of significant changes, but most noteworthy was to extend the uniform expiry of patented tenure for 20 years from the date of filing, for all category of inventions. Before the amendment of 2002, in India, the patent term for the process was 5 years from the date of sealing or 7 years from the date of patent granted, and the term for all other category of patents was 14 years from the date of patent granted. Further, through this Amendment Act, India made other major changes into the Principle Act in accordance with TRIPS Agreement, such as inclusion of new definitions as to what is invention and what inventive step is and excluded business methods, algorithms and traditional knowledge from patentability.
Patent Amendment Act of 2005:
The Patents (Amendment) Act of 2005 passed by the Parliament, on December 26, 2004. The TRIPS Agreement mandated that all the WTO member countries should change their laws for product patent for an agrochemical and pharmaceutical compounds. By the amendment of 2005, India complied with the above requirement of TRIPS Agreement and adopted product patent system in lieu of process patent system. Before this amendment, the product patents for agrochemicals and pharmaceuticals were not patentable in India.
And due to this reason, the generic pharmaceutical industry grown tremendously, and generic medicines were available to the public at very low cost. The reason that Indian pharmaceutical companies could provide medicines and drugs at low cost because of the regulatory system of India was restricted to process patents and India was following a rigid price control of drugs. It is worth to mention that in the year 2002, India in terms of volume, was the largest producer of generic drugs in the world. Now we need to understand what is product patent? The grant of product patent means that once a product is granted patent, none can get patent for the same product and shall not be able to manufacture the product, even if the different process is used. So, technically, the drugs could not be produced by reverse engineering for the patented product. Further, a computer program per se was excluded from the scope of patentability by the amendment Act of 2005. The amendment act of 2005 also redefined the definition of ‘New Invention’, which includes novelty standard, non-obviousness or inventive step and its industrial applicability. If the product or process is at par with these three standards, then only it is eligible for granting patent. The new Section 11A (7) provides that the patent holder can claim damages for the infringement retrospectively from the publication date of the patent application. Through the amendment act of 2005, under Section 92 of the India Patents Act, the provisions for compulsory license was introduced under some circumstances such as, in case of national emergency, extreme situations, and crises related to public health. Under Section 100, under some circumstances, the Government of India is allowed to use the existing patent. However, it is to be noted that the act of 2005 provided significant protections to ensure that there is any compromise with the production of generic versions of drugs, which may impact the availability of drugs to the general public.
In view of the above, we can say that the latest amendments in Indian IP Laws are close in compliance of obligations under TRIPS Agreement, which were necessarily required to change the 40 years old patent system of India. Further, India is not signatory of TRIPS Agreement only, and the provisions of TRIPs Agreement cannot be complied in isolation, because India is a member of a number of other international organizations and signatory of international treaties, and the same also has to be taken into account before changing any law. These major amendments in the Indian Patent Laws were required to comply with the obligations of India under international agreements and treaties. The new amended Patents law has provided a stronger patent method in India, which stringently safeguards the rights of patentee.