MNCs fail to launch patented drugs in India

With no global blockbuster drug finding an exclusive market on the strength of a product patent in India during the first 21 months of the country's product patent regime, the apprehensions of a negative impact due to the regime change are fast fading away.

Apart from Roche's hepatitis medicine Pegasys, which received a patent in March 2005, there have been no major announcements on grant of product patents.

None of the major multinational companies have introduced any patented products in the Indian market during this period.

For instance, Pfizer launched five new products during March 2005-December 2006. Eli Lilly introduced two. However, none of them were patented products and were the original brands of already existing Indian generic versions.

Multinational pharmaceutical industry representatives said that they are hopeful of receiving more patents in the coming years. "Indian patent offices are yet to be fully functional. Lack of procedural clarity, delay in the finalisation of patent inspectors' guidelines and a series of pre-grant opposition on key products are the key reasons," they said.

Indian patent offices have already granted dozens of product patents in pharmaceuticals. In Mumbai alone, the patent office is known to have granted 31 product patents in pharmaceuticals during the last one year. The same could be the case with Delhi and Kolkata patent offices, said experts. According to them, these patents were all non-controversial.

The patent experts are of the opinion that pre-grant opposition could not be a major reason for the delay in grant.

"There are over 100 pre-grant oppositions on pharmaceuticals filed in patent offices across the country. The actual number of products questioned will be much less as several of these pre-grant opposition applications are on the same product. The patent examiner can treat all similar oppositions as one," Dr Gopakumar G Nair, an IPR consultant, said.

However, patent examiners may have to work overtime in 2007 to clear approximately 25,000 pharmaceutical patent applications that are known to have reached Indian patent offices.

This includes the 9,000 odd applications that were in the mailbox and all subsequent applications for product and process patents on pharmaceuticals and medical items filed during the last two years.