Indian government ‘considers extending’ data exclusivity term
The Indian government is “seriously considering” extending the term of data exclusivity protection for agrochemical inventions from three to five years, it has been claimed.
A lawyer, who asked not to be named, told LSIPR that the Indian cabinet is set to consider including a stronger data exclusivity regime for agrochemical products in the Pesticides Management Bill, 2008.
Last Friday (March 27), Dilip Shah, secretary general of the Indian Pharmaceutical Alliance, told the Spicy IP blog that the government plans to introduce the amended bill to the current Indian parliament session, which started on February 23 and runs until May 8.
If approve, the amendment would also pave the way for a similar provision for pharmaceutical products.
A data exclusivity provision for pharma products would delay entry of follow-on drugs to the market, as generic drug makers would have to run their own clinical trials to prove safety and efficacy.
The World Trade Organization-administered TRIPS Agreement does not require countries to adopt data exclusivity—and has designated it as a “TRIPS-plus” measure.
Data exclusivity lasts about five to 10 years in countries that adopt the provision.
As trade relations between the US and India deepen, Indian Prime Minister Narendra Modi has reportedly been under increasing pressure to bring India’s IP regime more in line with that of developed countries, which generally have data exclusivity provisions, to make the country more business-friendly.
However, Shah warned that the amended bill would “eliminate competition and create a legal monopoly for agrochemicals and pesticides, making them unaffordable to small farmers”.
He added that despite data exclusivity proponents arguing that it attracts greater foreign direct investment, available data from other countries suggest that introducing data exclusivity does not result in greater research and development spending.
He continued: “If India were to go TRIPS-plus and introduce data exclusivity for agrochemicals, pesticides and medicines, not only the small farmers and poor patients will be denied access to affordable, competitively priced products, but the domestic industry will suffer irreparable loss as its ability to export these products will be severely compromised.”
The Office for the Controller General of Patents, Designs and Trademarks did not respond to a request for comment.
