“India misuses its own IP system to boost its domestic industries,” US Senator Orrin Hatch commented while introducing the 2014 report of the Global Intellectual Property Centre (GIPC) on ‘International Intellectual Property (IP) Index’. In this report, India featured at the bottom of a list of 25 countries, scoring only 6.95 out of 30.
The reasons for this low score, especially true in the case of the pharma sector, are the US view that India's patentability requirements are in violations of Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement, the non-availability of regulatory data protection, non-availability of patent term restoration and the use of compulsory licensing (CL) for commercial, non-emergency situations.
Given this, one could, erroneously though, assume that the Indian Patent Act is weak and not TRIPS-compliant.
However, the Indian Parliament amended the Patent Act in 2005, keeping the interest of public health at the centre. The Act provides safeguards, including checks on ever-greening of patents and broader framework for CL. All these conform to the Doha Declaration which states that “TRIPS Agreement does not and should not prevent WTO members from taking measures to protect public health". WTO holds that CL is an essential tool for governments to carry out public health policies in cases of extreme urgency or of public non-commercial use, as it facilitates the prevention of abuses of rights and encourages domestic capacities for manufacturing. Nothing in the TRIPS Agreement limits governments from issuing CL.
For similar reasons, the Indian Patent Act does not provide for ever-greening. The Supreme Court judgment on Glivec is a case in point. If the Indian patent regime is weak and not TRIPS-compliant, the aggrieved country should approach the dispute settlement body of the WTO for necessary action. Thus, it is intriguing if the US, which took India to WTO over the latter's solar power policy, is not doing the same for pharma IP. Is it really sure that the allegation that 'the Indian Patent Act is non-TRIPS compliant’ is a robust one?
There is no denying that innovation is the wheel of progress of any nation and needs to be rewarded and protected. However, there is an equally important need to strike the right balance between patent regimes and safeguarding public health interest. In that sense, the Indian Patents Act occupies a position of strength, not weakness.
Tapan J Ray
The author is an independent pharmaceutical industry analyst and consultant