India's product patent regime for drugs, which is now five years old, is set to enter a phase in which there will be a distinct change in the kind of patents sought as well as patent challenges, say officials and industry experts.
This is because all pending 'mailbox' applications have already been cleared and there are specialised groups in place to analyse sector-specific applications.
"We have cleared all mailbox applications (received until 2005). Now, we are looking at the 2005-06 applications, which are better than the earlier ones. The quality will improve further," said Patent Controller PH Kurian.
The pre-1995 inventions are not eligible for patenting in India. All patent applications received during 1995-2005 were categorised as 'mailbox' applications and scrutinised after India changed laws to permit product patents in medicines from January 1, 2005.
India received approximately 11,000 applications in the mailbox during the 1995-2005 period.
"Last five years have seen our patent examiners scrutinising the applications that were submitted from 1995 onwards. A good number of these were challenged as they did not merit patent protection. The backlog is almost over. The new patent applications are of better quality and hence will face less pre-grant oppositions," said Mumbai-based patent expert Gopakumar G Nair.
In last five years, there have been over 470 pre-grant oppositions and 200 post-grant oppositions. "The second phase of India's patent regime will be marked by less pre-grant oppositions and more post-grant oppositions", said Nair.
Kurian expects pre-grant oppositions to reduce once the quality of patent applications improves, though he does not see a sudden reversal in the pattern.
There has, meanwhile, been an improvement in the quality of patent examination due to the specialised systems that are in place now, according to Kurien.
"We have specialised groups looking into each category of patent applications today. The scrutiny is rigorous and may even result in the number of patent grants slowing during the current year. Yet, credibility and transparency of the decisions are on the rise," he said.
The next phase of the patent regime is also likely to see better enforcement, according to the head of medical affairs, Asia Pacific Region of US drug major Merck & Co Naveen Rao.
"The industry has more clarity on patent laws and the country will gradually move towards a better system", he said.
Over 80 per cent of India's patent applications are from foreign firms. Of the 6,000 plus applications that reached patent offices in 2008-09, only 17 per cent were Indian filings, said Kurian.
Civil society groups, spearheading pre-grant oppositions during the last five years, had claimed that a majority of these mailbox applications were not eligible for patents anyway.
