India’s IPR regime, never in the background, has come under sharp focus recently for a variety of reasons.
It is ten years since India amended the Indian Patents Act, 1970 to bring its laws in line with the agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The most important of those amendments related to the introduction of product patents for 20 years, including for pharmaceutical products. Significant safeguards were built into the legislation. These included debarring of ever greening patents, a process by which the patent holder seeks to extend the life of patents by some minor tinkering with the products. The amended legislation also expanded the scope of compulsory licensing and introduced for the first time post grant opposition to patents (Provisions relating to pre-grant opposition were retained).The legislation raised the bar for what constitutes an invention and what cannot be patented in India.
The above provisions served Indian consumers well by keeping the price of some important drugs dealing with critical illnesses such as cancer under check. The Patent office’s rulings have by and large been upheld by the highest courts. Inevitably big pharma have lobbied with their governments to force India to dilute the provisions.
The new government under pressure
The NDA government’s approach to the IPR issues has been a subject of intense discussion, especially in the context of repeated attempts by the US Trade Representative (USTR) to put India and some other countries on the mat over the alleged weaknesses in their IPR regime. The Office of the USTR is part of the executive office of the American President and apart from being the chief trade negotiator of the U.S. government has enormous clout over the conduct of trade across the world.
On April 30, the office of the USTR named India and China among 13 countries, which were placed on a priority list, requiring close scrutiny for their alleged IPR weaknesses in diverse areas including pharma, IT and publishing.
The report called upon these governments to plug what it thinks are the lacunae in their IPR regimes so as to align them with global standards. For India the USTR action has been a persistent thorn. As soon as the NDA government took office it had to face a similar report. In fact out of last year’s inclusion in the priority list, India faced a mid-term appraisal.
However, the U.S. authorities noted some improvement — a conclusion no doubt arising out of improving relations between the two countries at the highest levels.
There has been one saving grace on both occasions: India while being on the priority list was not designated a priority watch country, which might have led to penal action against India. In practical terms that means being able to stand up to influential lobbies such as seen spectacularly in pharma. The consolation prize of avoiding punitive action by the developed countries is simply not enough.
Draft of a new policy
India needs to fashion a policy that will be in tune with global standards and at the same time protect special Indian strengths. Prime Minister Narendra Modi has said as much: “India should align its IPR laws with global standards.” Commerce Minister Nirmala Sitharaman remarked earlier that “We need an integrated policy,” While nothing significant can be inferred from these statements the government has done well to release a draft IPR policy in the public domain. Taking a balanced approach, it says that existing laws — that seek to protect the rights and incentives of innovators on the one hand and public interest on the other — would remain. However it also calls for legislative changes to keep pace with economic and technological developments.
A challenging task
It is going to be an extremely challenging task to stick to that position. Of special concern have been the developments in the pharma industry where India is facing maximum pressures from extremely well funded lobbies set up by big pharma from the U.S. and other developed countries (although it must be reiterated that pharma is not the only area).
IPR challenges have to be met increasingly through political action and diplomacy. The government needs to strengthen its decision-making process and boost the skills of its negotiators. In this connection an important initiative of the NDA government has been the setting up of an IPR think tank which among other tasks, will help in the formulation of a National Intellectual Property Rights policy for the first. The draft paper is the first step. The government has called for feedbacks before it finalises a new IPR policy.
The domestic constituency of the NDA government also cannot obviously be ignored. Already there have been rumblings over the composition of the technical committee that will advise the government.
To reiterate, the main challenge is to eradicate even the faintest of suspicions that the government is acting under external pressure. India does not have an IPR policy but it has a strong legal foundation. Important precedents have been set especially in pharma-related matters. Besides, there is a well functioning Patents office with sufficient experience to grant patents and uphold consumer interests. From here a new, well balanced policy should not be too difficult. Resisting the big lobbies which have the support of the political establishments of developed countries is an entirely different matter.
It is ten years since India amended the Indian Patents Act, 1970 to bring its laws in line with the agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The most important of those amendments related to the introduction of product patents for 20 years, including for pharmaceutical products. Significant safeguards were built into the legislation. These included debarring of ever greening patents, a process by which the patent holder seeks to extend the life of patents by some minor tinkering with the products. The amended legislation also expanded the scope of compulsory licensing and introduced for the first time post grant opposition to patents (Provisions relating to pre-grant opposition were retained).The legislation raised the bar for what constitutes an invention and what cannot be patented in India.
The above provisions served Indian consumers well by keeping the price of some important drugs dealing with critical illnesses such as cancer under check. The Patent office’s rulings have by and large been upheld by the highest courts. Inevitably big pharma have lobbied with their governments to force India to dilute the provisions.
The new government under pressure
The NDA government’s approach to the IPR issues has been a subject of intense discussion, especially in the context of repeated attempts by the US Trade Representative (USTR) to put India and some other countries on the mat over the alleged weaknesses in their IPR regime. The Office of the USTR is part of the executive office of the American President and apart from being the chief trade negotiator of the U.S. government has enormous clout over the conduct of trade across the world.
On April 30, the office of the USTR named India and China among 13 countries, which were placed on a priority list, requiring close scrutiny for their alleged IPR weaknesses in diverse areas including pharma, IT and publishing.
The report called upon these governments to plug what it thinks are the lacunae in their IPR regimes so as to align them with global standards. For India the USTR action has been a persistent thorn. As soon as the NDA government took office it had to face a similar report. In fact out of last year’s inclusion in the priority list, India faced a mid-term appraisal.
However, the U.S. authorities noted some improvement — a conclusion no doubt arising out of improving relations between the two countries at the highest levels.
There has been one saving grace on both occasions: India while being on the priority list was not designated a priority watch country, which might have led to penal action against India. In practical terms that means being able to stand up to influential lobbies such as seen spectacularly in pharma. The consolation prize of avoiding punitive action by the developed countries is simply not enough.
Draft of a new policy
India needs to fashion a policy that will be in tune with global standards and at the same time protect special Indian strengths. Prime Minister Narendra Modi has said as much: “India should align its IPR laws with global standards.” Commerce Minister Nirmala Sitharaman remarked earlier that “We need an integrated policy,” While nothing significant can be inferred from these statements the government has done well to release a draft IPR policy in the public domain. Taking a balanced approach, it says that existing laws — that seek to protect the rights and incentives of innovators on the one hand and public interest on the other — would remain. However it also calls for legislative changes to keep pace with economic and technological developments.
A challenging task
It is going to be an extremely challenging task to stick to that position. Of special concern have been the developments in the pharma industry where India is facing maximum pressures from extremely well funded lobbies set up by big pharma from the U.S. and other developed countries (although it must be reiterated that pharma is not the only area).
IPR challenges have to be met increasingly through political action and diplomacy. The government needs to strengthen its decision-making process and boost the skills of its negotiators. In this connection an important initiative of the NDA government has been the setting up of an IPR think tank which among other tasks, will help in the formulation of a National Intellectual Property Rights policy for the first. The draft paper is the first step. The government has called for feedbacks before it finalises a new IPR policy.
The domestic constituency of the NDA government also cannot obviously be ignored. Already there have been rumblings over the composition of the technical committee that will advise the government.
To reiterate, the main challenge is to eradicate even the faintest of suspicions that the government is acting under external pressure. India does not have an IPR policy but it has a strong legal foundation. Important precedents have been set especially in pharma-related matters. Besides, there is a well functioning Patents office with sufficient experience to grant patents and uphold consumer interests. From here a new, well balanced policy should not be too difficult. Resisting the big lobbies which have the support of the political establishments of developed countries is an entirely different matter.
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