Milind Antani, Partner in charge of pharma-life sciences and healthcare practice, Nishith Desai Associates, Ajay Chandru and Aarushi Jain, Senior Members, IP team, Nishith Desai Associates elaborate on whether Indian IPR laws need to comply with international standards
PM Modi recently stated that India needs to align with international IPR laws, but his Commerce Ministry head Nirmala Seetharaman says that India is in line with TRIPS. There are indications that the the mother organisation of PM Modi’s BJP party, the RSS, too are not in favour of changing India’s IPR laws.
Although PM Modi made a statement that Indian IPR laws need to comply with international standards, the question to consider is: what exactly are these international standards? As such, there is only one international standard for protecting IPR, i.e the TRIPS Agreement, which India is a member of in any case. India’s IPR laws are complaint with the TRIPS Agreement.
Seetharaman has also emphasised in her statement that India is complaint with TRIPS. Thus, if, any member country including the US believes that Indian laws are not complaint with TRIPS they have recourse to the WTO Dispute Settlement Body (DSB), being the relevant body having jurisdiction to determine if country’s laws are complaint with TRIPS or not. Making generic statements about India’s IPR laws not being up to the mark is unwarranted in that sense.
It is no secret that Big Pharma believes that Section 3 (d) and compulsory licensing provision in the Indian Patent Act is not in complaint with the TRIPS Agreement. At the same time, India has taken a stand that Section 3 (d) of the Indian Patents Act and compulsory licensing provisions are TRIPS compliant and are in line with the flexibilities provided in the TRIPS agreement. Validity of these provisions is again a question for the WTO DSB to decide. There are certain other provisions such as data exclusivity and patent linkage provisions which are TRIPS plus provisions that have been heavily advocated by the Big Pharma lobby and US to be adopted by India. Adoption of these provisions is solely at India’s discretion.
India is already on a reformation track in relation to its IPR laws with the constitution of an IPR think tank last year which has created the draft National IPR Policy. The draft National IPR Policy has been heavily criticised by various stakeholders especially the public health advocates. This has reignited the debate on whether do we need a reformation of the IPR laws, when we are complaint with the TRIPS Agreement. This has also raised concerns that the reformation in IPR laws is being initiated at the behest of Big Pharma through the US Government and India might make certain concession in their IPR Laws and incorporate certain TRIPS Plus flexibilities to attract foreign investment. Any kind of reformation especially in patent laws, which will have an adverse effect on the public health (by raising the prices of the life-saving drugs, for instance) is going to result in a huge public outcry. Further, any such changes to the patent law not only affect the people in India but also other developing and least developing countries to which the Indian generic industry exports these lifesaving drugs. Thus, the government should tread on this path very carefully.
What then is the way forward for India on IPR policy, given that other pacts like the TPP, etc are also being negotiated?
India and US are in the process of negotiating and inking a Bilateral Investment Treaty (BIT) and there is a possibility that BIT may require India to adhere to certain TRIPS Plus flexible standards. In the past US has used such regional and bi-lateral trade agreement to force countries to enact TRIPS Plus standards. A BIT unlike a trade agreement also gives recourse to an individual investor to the dispute resolution mechanism as envisaged in the BIT, if the terms of BIT have not been implemented and the same has affected the investor’s investment in India whereas in case of most trade agreement it’s the member country, which has the recourse to the dispute resolution mechanism. However, it is pre-mature to comment on the effect of BIT in relation to the IPR until the draft of the treaty is released.
The best way to move forward on IPR Policy is first to make improvements in the government infrastructure that implement the IPR laws, which is the patent and trademark office. As a priority, government should focus on improving the existing functioning and efficiency of patent and trademark offices, since these offices are understaffed and lack essential resources to dispense their duties because of which there is a huge of pendency of patent applications and trademark applications.