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Data Exclusivity in India — and Beyond


Last year, when the government of India adopted its patent amendments as required by the TRIPS Agreement, health activists carried out concerted campaigns to try to avert what they characterized as a "public health disaster in the making."

Well, the law has been in effect since January 1, 2005, and so far there is no evidence it created a catastrophe in pricing, availability or access to essential medicines in India, or in developing countries importing from India.

Indeed, the law has fueled a continuing boom in investment in R&D and is creating a brain-gain, as Indian scientists return home to pursue innovation in their own country. As a result, India grows richer.

Patent law isn’t a social panacea, but neither is it a "public health threat" — a title that would better describe many of the activists.

Now the same groups are at it again with their tired, false arguments, both misrepresenting the Indian government’s obligations to provide
basic protection for commercially valuable test data (i.e., data exclusivity, which protects the test data submitted to authorities by
innovator companies from being used by their competitors for a set period of time) under TRIPS, and decrying the policy as harmful to
public health.

In fact, it is uniformly the case that developing countries with appropriate data exclusivity provisions enjoy better access to more innovative products sooner. And not having data exclusivity in India has not been a panacea for public health.

Nevertheless, activists have successfully gotten the World Health Organization (WHO) to "interpret" the TRIPS Agreement so as to read out the explicit obligations detailed in Article 39.3 that nearly all developing and developed countries interpret as requiring data exclusivity. Then they push the WHO’s false conclusions onto the government of India.

How often have we seen ideologically drive, anti-IP campaigns that conjure up catastrophic, fear-mongering scenarios that are based on the fiction that IP is a barrier to public health? They have always been proven wrong, yet here they go again.

Fortunately, it looks like the Indian government has the confidence of its convictions and won’t be sidetracked on data exclusivity any more than it was on patent protection. And, like patent protection, data exclusivity will be good for both product innovation and Indian economic development.