[Ip-health] A compensatory model for data protection under consideration as most drugs face patent expiry

[Gopa Kumar]

A compensatory model for data protection under consideration as most
drugs face patent expiry
Thursday, August 24, 2006 08:00 IST
Joe C Mathew, New Delhi

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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