In the aftermath of this year’s USTR Special 301 Report, which retained India on the Priority Watch List, industry leaders comment on the Report’s result, as well as the overall IPR scenario in India. By Viveka Roychowdhury
‘OPPI welcomes the continued focus on strengthening IPR in India’
The Draft intellectual property rights (IPR) Policy is a positive step towards an IP regime that has the potential to support and drive a number of economic and socio-cultural benefits. Our country already has the elements required to realise the PM’s ‘Make in India’ vision: consistent growth, a highly educated workforce and established science-based research institutions. We can extend ‘Make in India’ to ‘Develop in India’ and ‘Innovate in India’, if we develop a robust, predictabl, and enforceable legal framework for the protection of IPR.
Our PM was pretty categorical in his view that India’s patent laws should be brought on par with global standards, to make Asia’s third largest economy a hub for outsourced creative services. He has been quoted on April 24, 2015 as saying, “If we don’t work towards bringing our IPR at par with global parameters, then the world will not keep relations with us. If we give confidence to the world on IPR, then we can become a destination globally for their creative work, when he spoke at the first Global Exhibition on Services (GES).
– Ranjana Smetacek, Director General, Organisation of Pharmaceutical Producers of India
‘We should not agree to anything that is TRIPS Plus’
India is already well aligned with all the requirements of TRIPS. India’s Patent Act 1970 as amended, is recognised as a breakthrough regulation which is also adopted and followed by many other leading countries in the world.
Special mention should be made of the Section 3(d) of our Patent Act which only allows genuine innovation and blocks evergreening of patents by minor improvements. A patent is granted only if there is a significant therapeutic improvement or advantage. This is also commended by leading international organisations like WHO, UN and leading global NGOs like MSF, PEPFAR, Clinton Foundation etc. I would strongly recommend that we do not tamper with the provisions of our landmark Patents Law which is fairly balanced and pro-people. I would like to reiterate that we should not agree to anything that is TRIPS Plus!
– Daara Patel, Secretary-General, IDMA
‘Relevance of 3(d) in its present form may be opened for a debate and deliberation’
India has positioned itself as a “Pharmacy of the World”. India is emerging or poised to emerge as a superpower. Divergence of views including in IPR and patents is only naturally expected, given the past, present and future of global economy and economies and current status of member nations or regions governing global treaties and trade in the past, treaties such as WTO and TRIPS emerged from extensive discussions, deliberations, debates and negotiations.
Negotiations and the discussion process and the exchange of views associated with bilateral or multilateral negotiations help resolve distances and differences in positions and perceptions of issues and policies. Having successfully negotiated the WTO and TRIPS nearly 20 to 25 years ago, India needs to be prepared to discuss and deliberate on all contentious subject matters of mutual interest. Having faced the new product patent regime and surfed through the early turbulent waters, India should gain in self- confidence and move on from a highly defensive position and posture to one that befits a global leader of tomorrow.
Extreme positions and views on IPR as in other areas, is not the order of the day. Over the past two to three decades, the institution and instrument of IPR especially patents have been monopolistically extended by the Big Pharma and the government supporting their views, so much so that the delicate balance which is so sacrosanct to the statute of patents between the rights of the users (patients) and the rights of the patentees (assignees/ licencees) have been unduly tilted in favour of extremely monopolistic interests. With the advent of WTO/ TRIPS, the balanced views of developing countries such as BRICS and India in particular, has come to be heard and debated globally.
Unfortunately, examples such as that of Gleevec has been unduly and unfairly highlighted against India, even though Gleevec being a pre -95 molecule did not deserve absolute monopoly in India.
The most contentious subject matter of S.3(d) in its present form was most essential to prevent undue evergreening, especially in the transition phase. S. 3(d) has done its job and the international community has taken note of its contribution. Relevance of 3(d) in its present form may be opened for a debate and deliberation, even though it is India’s position that it is equally useful and adversely impacting incremental innovations of MNCs as well as research based Indian companies.
Data protection and data exclusivity though not directly related to TRIPS, may continue to be discussed and the implications as well the extent of implementation be debated. These being related primarily to the regulatory framework of DCGI and CDSCO, the current initiatives to join as an observer on Pharma Inspection Council and Co-operations (PIC or PICS), may cover these subjects also on the regulatory front.
The threat of TPP and other non-multilateral and deliberately secret treaty negotiations, excluding India are on the anvil. Though such restrictive and non tariff barrier (NTB) blockades are as much detrimental to the people and patents of those negotiating members, being the ‘Pharmacy of the World’, India has equal responsibility and obligation to keep India’s generic medicines affordably accessible to patients of these developing as well as developed countries. To that extent, India must continue the dialogue and remove apprehensions that India’s IPR regime is not globally compliant to TRIPS or WTO.
It is in this context that we at IDMA believe that there are common elements and threads between the PMO’s and the Commerce Ministry’s positions. India should do what is in the best interest of India. This will and should include the interests (including export –based, research-based, and also “Make in India” –based) of the Indian pharma industry.
– Gopakumar G Nair, As IPR Sub Committee Chairman, IDMA
‘Need to look at IPR as an opportunity, not impediment’
The PM is absolutely right in saying “India needs to work on IPR guidelines matching global standards”. Bringing India’s IP regime in line with international agreements and practice will establish India as a destination for innovation. While we commend the progress India has made in advancing IPRs and the positive steps taken toward complying with the TRIPS Agreement, more needs to be done to align this increasingly important industrial country with international standards. We need to have a predictable and transparent system in place.
For the research-based pharma industry, some areas of the law—patentability standards, lack of data protection, local working requirements—undermine India’s ability to capitalise on the benefits of strong intellectual property rights protection. Effective patent systems help patients because incentives stimulate long-term research and development efforts needed to develop better medicines. We believe that changes in the patent law will also help India’s pharma companies. India is an emerging economy with a potentially world-class pharma industry. With additional improvements in its intellectual property regime, India is poised to make significant contributions to public health through innovation, not only within India, but around the globe.
In the TPP, countries are seeking to establish a comprehensive framework that will encourage trade liberalisation and economic growth. In the life sciences area, the TPP, through ensuring that partner countries adopt strong IP policies, will foster economic conditions that will provide proper incentives for innovative pharma companies to continue to make the investments required to bring new therapies to market that improve the quality of patient care. Barriers, such as those I have outlined, discourage pharma innovation and impede investment and ultimately limit economic growth and access and are against our shared interest of delivering the most effective healthcare possible.
Looking to weaken IP protection will certainly not resolve the many challenges that healthcare faces in India. Pro-innovation policies and increased access to medicines are not mutually exclusive; rather they are two sides of the same coin and together are in the interests of the patient. It is about time that we as a country look at world class IPR as an opportunity rather than an impediment.
– Ranjit Shahani, Vice Chairman and Managing Director, Novartis India
‘Industry should not get unduly concerned about the USTR report’
USTR has essentially has been a mouthpiece of PhRMA and BIO. Joseph Stiglitz, Nobel Prize Winner in Economics, while talking to the TPP negotiators about IPR and medicines in New York had recently said that the USTR does not reflect the views of the American society.
It is the only discordant voice in an otherwise growing friendly economic relationship between the two countries.
The USTR blindly reiterates in its reports what a section of the US pharma and biotech industry writes to protect their narrow and short term commercial interests.
The Government of India is mindful of this and it appears that it has decided to focus on other sectors of the economy such as defense procurement and local production, smart cities, nuclear reactors, energy, etc. to neutralise the USTR.
The industry should also not get unduly concerned of these reports of the USTR. They are biased, lack objectivity and (are) without evidence.
– D G Shah, Secretary General of Indian Pharmaceutical Alliance (IPA) and CEO, Vision Consulting Group
‘Confusion on IPR policy prevents investment’
I think what the discussion within India shows is that on the one hand India can just about defend its IP stance in court, but everyone knows that India’s IP regime provides uncertainty to investors (foreign and domestic) and this is what PM Modi was getting at.
The spirit of TRIPS may not have been upheld with the Novartis Gleevec decision, but one can say that the letter of the law, as the Supreme Court was asked to interpret, was applied, but that doesn’t mean the decision was fair, or the best for investment or even patients.
India needs to decide whether it really wants to encourage investment in domestic research or just maintain a copycat drug industry. Right now everyone is confused and confusion prevents investment.
– Roger Bate, Economist, Resident Fellow of the American Enterprise Institute
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