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 bodyof 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 balancebetween 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
Ever since the 2005-amendments to the Indian patent regime, MNCs and Western governments have lambasted India for a weak IP regime. This narrative gained momentum after two significant developments.
In Novartis vs Union of India, the Supreme Court invoked the Section 3(d) of the Indian Patent Act, thwarting the company's attempt at patent monopoly over anti-cancer drug Glivec whose active ingredient was therapeutically no better than the earlier variant. Earlier, Indias patent office granted a compulsory licence over Nexavar, Bayers anti-cancer drug (priced at R2.8 lakh a month), allowing a generic priced at R8,800 a month to enter the market. These decisions came after a rigorous judicial process and are arguably in compliance with WTO/TRIPS standards. Yet, Big Pharma remains peeved, repeatedly terming the Indian IP law weak and under-protecting of inventions. IP regimes are merely means to accessible innovation. If the IP regime was blindly ratcheted up, innovative output would reduce over time. Innovators as revered as the Wright brothers have used their patent monopoly to prevent superior technologies from entering the market, forcing the US government to step in with licensing provisions. Stronger IP protection does not necessarily guarantee more innovation. It is often the reverse. It is here that Section 3(d) assumes relevance, mandating that in order to merit a patent, a pharmaceutical patentee must demonstrate that the substance is therapeutically superior to the existing substance. While the US would treat this as a weak patent regime, it embodies a strong innovation filter. If the US looked in its own backyard, it would find patent rulings (viz. Pfizer vs Apotex) endorsing similar logic: trivial improvements, like enhanced solubility and heat stability, do not merit a 20-year monopoly.
Indias compulsory licensing regime is meant to prevent against patent abuse. IP regimes should grant not only private rights, but also ensure that innovations serve the public interest. Indias compulsory license regime is one of the very few that provide for a licence in cases where the patentee prevents the emergence of a superior technological improvement. US courts routinely deny injunctive relief to patentees on grounds of patent abuse and issue what are effectively de facto compulsory licenses. It may take a weak IP regime to generate a strong innovation ecosystem; one that not only generates a higher innovative yield, but also ensures that innovations remain accessible to the public.
The author, an intellectual property expert, is the founder of SpicyIP