BY INVITATION. ‘PM Modi must firmly rebuff US pressure to dilute India’s robust patent law’

In September 2014, the Prime Minister will undertake his maiden visit to the US. On the Obama administration’s agenda is likely to be its long list of complaints about India’s intellectual property regime documented in the annual Special 301 Watch List issued by the US government to name and shame countries whose IP policies do not match the aspirations of US IP-intensive industries, especially Big Pharma.

For the past 25 years, India has been front and centre in the Special 301 report. This year was no exception as India was designated a Priority Watch List Country, meaning it faces intensive engagement by the US government over its IP policies. The US also announced that it will undertake an out-of-cycle review of India’s IP policies and engage in an even more strenuous cycle of behind-the-scenes “constructive” consultations. Members of PM Modi’s delegation are likely to face considerable pressure from the US administration to engage in such consultations.

Big Pharma and the US are most concerned by Section 3(d) of India’s Patents Act, which weeds out the plethora of secondary patents that pharmaceutical companies file to extend their monopoly control over medicines, guaranteeing them even more supra-competitive profits.

Section 3(d) disallows patents on new forms of medicines unless they demonstrate significantly increased therapeutic efficacy. It also disallows secondary patents on new uses of existing products. In other words, Big Pharma gets just one monopoly, lasting 20 years instead of a series of overlapping monopolies that can last decades longer.

The US, at the behest of Big Pharma, also objects to pre- and post-grant opposition procedures, which have been used to successfully oppose many unwarranted patents, including on life-saving HIV medicines.

A third major concern focuses on India’s use of compulsory licensing. Contrary to the tone of the US complaint, compulsory licenses have been and still are widely issued globally. The US, in fact, is the most widespread user of government licences. By contrast, India has issued only one compulsory license so far.

While ignoring the complete legality of compulsory licences, the US alleges that India’s compulsory licences are protectionist if they are based on a failure to manufacture locally when such manufacture is economically feasible. But the global IP think tank, the Max Planck Institute, has stated unequivocally that compulsory licensing to promote local production is allowable under international law.

Finally, the US states its intentions to pursue Big Pharma’s long-term goal of expanding monopoly control over medicines through the imposition of rules that go beyond those mandated by the WTO. The US-led Trans-Pacific Partnership Agreement negotiations represent the most aggressive provisions for a new IP monopoly regime and suggestions abound for the US to bring India into these negotiations.

Big Pharma and the US are concerned that India’s smart IP policies are now being considered in Brazil, South Africa, the Philippines and other countries. They want to nip that possibility in the bud. Every time monopoly control over medicines is extended, patients in India and throughout the world face life threatening diseases without the medical technologies that might improve, extend, and even save their lives.

India watchers can only hope that PM Modi will remain firm in his defense of India’s lawful, pro-health patent law regime and reject any attempt by the Obama administration to win concessions on IP issues. Any concessions will disarm India and many other countries in their pursuit of the right to health for their citizens.