Roche Holding AG has decided not to pursue a patent application for its breast cancer drug Herceptin in India, the Swiss company said on Friday, as Western drugmakers come under pressure over high prices in the fast-growing market.
The Kolkata Patent Office said earlier this month that it had dismissed certain patent applications filed by Roche, because the company had failed to submit the applications for Herceptin correctly.
“Roche has come to the conclusion not to pursue Indian Patent No. 205534 (the secondary patent) and the related divisional applications,” a Roche spokesman said in an emailed statement. “This decision takes into account the strength of the particular rights and the IP (intellectual property) environment in India in general.”
Western pharmaceutical companies are keen to tap into India’s $13 billion drug market, but there are concerns about the level of protection for intellectual property in the country, where generic medicines account for more than 90 per cent of drug sales.
Herceptin, a treatment for a particularly aggressive form of breast cancer, is Roche’s third-biggest seller and notched up global revenues of 3.08 billion Swiss francs in the first half of the year.
India’s government has considered issuing a compulsory licence on Herceptin, which would allow local drugmakers to sell far cheaper, generic copies. The government has so far held off from a decision.
In 2012, India issued the first ever compulsory licence to domestic drugmaker Natco Pharma (NATP.NS) on a kidney and liver cancer drug, Nexavar, patented by Germany’s Bayer.
Roche’s decision not to pursue a patent for Herceptin could pave the way for generic drugmakers to produce cheaper copies, known as biosimilars, because they are not identical replicas of the original drug.
However, Roche said there are no approved versions in India of a biosimilar version of Herceptin, also known as Trastuzumab.
Roche said it would continue to enforce other patents covering its drugs in India.