Even as the data protection committee constituted by the Chemicals Ministry is struggling to find a way to recommend limited period of "data protection" without causing major harm to the domestic industry, "market exclusivity" through "data protection" could be the only way left for global pharmaceutical majors if they have to do handsome business with most of their patented molecules in India. A compilation on drug patent expiry dates in US carried out by New Delhi based Centre for Trade and Development (CENTAD) has given credibility to this view.

According to CENTAD compilation, not many molecules that have patent protection in the US will get patent-protected market exclusivity in India.

Of the new drug molecules mentioned in the Orange Book of the US, majority has been found to be moving towards patent expiry in the near future. CENTAD has suggested that in cases where the companies have not given details of patent expiry date in Orange Book, the obvious reason is the nearing patent expiry. CENTAD has analyzed the first patent expiry dates of 327 new chemical entities that have found place in the US Orange Book during 1995-2005. Of the 327, only 29 drugs have a patent life beyond 2014. The patent expiry dates of another 75 NCEs have not been mentioned. It is clear that all 223 NCEs whose first patent expiry as per US Orange Book comes before 2015 must have been received their patents before 1995. None of the pre-1995 molecules can be patented in India. Of the 75 NCEs where patent expiry dates have not been mentioned, 46 NCEs were registered before 2003. If one considers the 8 - 10 years time frame needed to bring a patented new molecule into the market, all Orange Book submissions before 2003 must be of molecules developed prior to 1995. Thus, only 29 of the post 2003 drugs will be having any chance for patent protection in India. Adding that to the first list of 29 NCEs, the total number of molecules that might be patentable in India would come up to 58. If the government sticks to its decision to allow data exclusivity to only NCEs, only these 58 NCEs will be eligible for data protection. This seems to be the main reason why multinational companies want to see data protection happening for all derivates of the drugs in India.

Meanwhile, the Chemicals Ministry has decided to call for another meeting to take decisions upon granting "data protection" on pharmaceuticals. A compensatory model, projected by the CSIR Chief is under active consideration, it is learnt. While the committee is convinced that "non-reliability of test data for regulatory purposes" is not mandated under TRIPS, it may try to provide some protection to safeguard the commercial interests of larger companies in the form of limited data protection.
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