Pharma Jogot
Swiss giant Roche says it has decided not to pursue an Indian patent for the top-selling breast cancer drug Herceptin, paving the way for local generic drugmakers to make a cheaper version.
The announcement comes after a health ministry committee earlier this year urged the government to issue a “compulsory license” that would have obliged Roche to license a generic company to make a more affordable copy.
“Roche has come to the conclusion not to pursue” the patent, the company said in a statement emailed to the news agency late Friday, taking “into account the strength of the particular rights and the IP (intellectual property) environment in India in general”.
A Roche spokesman could not be reached for further comment.
India’s patent laws are tougher than those in many other countries as part of its attempt to make medicines more affordable for its hundreds of millions of poor.
This has led to a string of setbacks in India for Western drugmakers whose patents are accepted in other nations but not by New Delhi.
India, known as the “pharmacy to the world”, has a huge generics industry that turns out cheaper copycat versions of life-saving branded drugs for the South Asian nation and other emerging markets and developed countries.
Herceptin’s active ingredient was discovered before 1995 when India did not recognize patents.
After joining the World Trade Organisation (WTO), India had to change its law.
But it did not start granting patents on drugs until 2005, and even then, its laws only applied to drugs discovered after 1995.
Roche obtained an Indian patent for Herceptin that involved a different composition but that patent had been challenged by patient rights activists as insufficiently innovative.
Indian law refuses to allow patents for tweaks to drugs — so-called evergreening — and only grants a new patent on an existing drug if changes make it “significantly more therapeutic”.
“They (Roche) had seen the writing on the wall, they knew the Herceptin patent had been granted on very shaky legal grounds,” Kalyani Menon Das, one of the leading activists in a campaign for a generic version of Herceptin in India, told the news agency.
Earlier this year, India said in a ruling on Novartis’s breakthrough leukemia drug Glivec that no new patents for reformulations of old medicines could be granted unless there was a “significant therapeutic improvement”.
Like Roche’s Herceptin, Glivec was discovered before 1995.
Western drugmakers are seeking to win a larger part of India’s rapidly expanding drugs market to compensate for slowing sales in advanced markets.
India’s drug market sales are forecast to balloon to $74 billion in 2020 from $12 billion in 2010, consultancy PwC estimates.
But Western firms complain India’s patent laws offer insufficient protection for their drugs and have had a number of legal tussles with Indian authorities. (Source: The Financial Express)