The countdown to the USTR for 2017 Special 301 Review has begun. This is the United States Trade Representative (USTR)’s annual round up of countries with poor protection of intellectual property rights (IPR) or unfair market access to IP-dependent US enterprises . The hearing for this year’s Special 301 Review is slated for February 28 and organisations have been asked to submit their views.
Leading the charge on behalf of India’s pharma sector is the Indian Pharmaceutical Alliance (IPA) which argues the case for removal of India from the Priority Watch List.
Besides highlighting several steps taken by the Government of India to improve the IPR ecosystem, the most significant part of the IPA’s submission is equating Section 3(d) of India’s Patent Act with US Hatch-Waxman provisions. Arguing that Section 3(d) is merely an appropriate alternative in the Indian context to the Hatch-Waxman provisions, IPA points out that Section 3(d) is simpler, less litigious, patient friendly, and has potential to avoid “unjust enrichment” of the right holders.
As DG Shah, Secretary General, IPA argues, ‘The legal framework in the US mitigates the problem of non-meritorious, secondary medicinal patents by providing the incentive of exclusivity to successful generic challengers but India does not have a comparable provision in its law. Nor is it feasible to have one as India does not have mandatory generic substitution (and the consequent rapid substitution of generics) as in the US. To make the incentive meaningful. Section 3(d) in India’s Patents Act provides an alternative. It is perhaps a more efficient way than to grant weak patents in the first instance and then impose the burden of litigation to set matters right.’
In other words, Section 3(d) seeks to prevent weak patents rather than taking corrective action later.
Taking a diametrically opposing stance, the Global Intellectual Property Center (GIPC) of the US Chamber of Commerce recently released its International IP Index which ranks 45 countries by the ‘strength’ of their IP standards. Its submission to the USTR recommends India’s continuance on the Priority Watch List and subjecting it to an out-of-cycle review to ratchet up the pressure. The GIPC International IP Index ranks India ranks 42nd out of 45 countries, followed only by Pakistan and Venezuela. The highest ranked country is the US followed by the UK, Germany and Japan.
The GIPC specifically refers to India’s poor record of protecting biopharma patents. The report also cited 2016 statistics, that 98 per cent of patents granted in India in 2015 were for applications
over five years old, with one case stretching 19 years to prosecute and grant a patent.
It’s ironic that US President Donald Trump’s first executive action in office was to withdraw from the Trans-Pacific Partnership (TPP) Agreement to fulfill his election promise of putting America First. But when the Indian government takes all precautions to put India First, by including provisions in our patent law to prevent evergreening and monopolies, we’re named and shamed.
There’s no doubt that India’s IP ecosystem is at a nascent stage but each country has the right to choose its own path. Just as President Trump chooses his own.