US Government’s Interference in India’s Tenofovir Proceedings

9 Dec 2010

Perhaps not quite the stuff of WikiLeaks’ US Embassy Cables, but C.H Unnikrishnan of Livemint has revealed how the US Commerce Secretary, Gary Locke, has effectively lobbied India’s Commerce Minister on Gilead receiving ‘fair consideration’ in its appeal over its tenofovir applications. Thanks to SpicyIP, a copy of the letter can be read here.

Readers may recall that Gilead’s patent applications for tenofovir disoproxil (2076/DEL/1997) and tenofovir disoproxil fumarate (896/DEL/2002) were rejected following various pre-grant oppositions. The decisions of the Indian Patent Office (IPO) as relating to Cipla’s and Intermed Lab’s oppositions can be read here and here. Gilead has since filed an appeal to the Intellectual Property Appellate Board (IPAB). For an insight into the politics of how members of the IPAB are selected, see Spicy IP’s views  here.

On the contents of the letter, one reading is that the US Commerce Secretary is simply asking that Gilead’s applications get a fair and transparent hearing — to ensure that India’s IP laws provide the requisite business climate for spurring innovation and advancing the US-India bilateral commercial relationship. Nothing wrong with that, right?

That would be a overly generous reading of the letter. Firstly, why is Mr Locke ‘particularly concerned’ about Gilead’s patents? Is this usual diplomatic practice to involve oneself in the patent application of a particular company? As D.G Shah, secretary general of the Indian Pharmaceutical Alliance has rightly said, the US would certainly not tolerate the Indian Government taking up such issues for a company and meddling in the affairs of the USPTO.

Second, Mr Locke mentions Gilead’s ‘innovative’ business model, a so-called ‘no-profit pricing approach’ which entails technology transfer licenses to Indian companies who can then provide HIV/AIDS drugs to 95 of the world’s poorest countries. This part of the letter is eerily similar to some of the press documents that Gilead itself has put out. Mr Locke conveniently forgets to mention Gilead does not have patents in any of the 95 countries, that it maintains control over the tenofovir API market through it’s ‘innovative’ licensing model and continues to prevent the sale of finished products by licensees to middle income countries like Brazil.

Last but not least, Mr Locke feels it’s acceptable to suggest that the IPO’s decisions are not fair, not timely (considering it takes the USPTO around 6 years to examine an application to grant) and contrary to those of other patent offices, including the USPTO. Basically this means that India is not toeing the line that the US (and others like Japan and the EU) and their corporations want. In case he has forgotten, patents are national rights and countries have discretion on how to grant them.

The fact is, this isn’t the first time that Gilead has attempted to influence the appeal of its patent applications. The last attempt we know of was its involvement in the George Washington University India project, where one of its employees gave a presentation in front of the head of the IPO and other government officials, on why tenofovir disoproxil and its fumarate salt meet the efficacy standard of s3d. The worrying part is that the US Government is now directly involved.

It is often considered conspiratorial to say that the politics of intellectual property is imperialistic, with western governments and corporations leaning on developing countries who are trying to set their own patent standards within the boundaries of TRIPS. In the light of this episode and the revelations coming out of WikiLeaks, it would seem that this is how business has been conducted all along. If that is the case, then it’s all the more reason for stronger transparency and public opposition mechanisms within the patent system.

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