INDIA dealt a fresh blow to the international pharmaceutical industry on Friday (November 2) as its patents appeal board revoked a patent granted six years ago on Roche’s hepatitis C drug Pegasys.
The Intellectual Property Appellate Board (IPAB) cited a lack of evidence that the drug was any better than existing treatments and its high price as reasons for the decision.
Pegasys was the first medicine to win protection in 2006 under India’s new patent regime and the revocation will rekindle tensions between New Delhi and global drugmakers worried by the country’s tough stance.
The decision follows another high-profile setback for the industry in March, when India granted the first ever compulsory licence to domestic drugmaker Natco to sell cheap copies of Bayer’s cancer drug Nexavar.
Multinational drug manufacturers see India’s $12bn (£7.48bn) drug market as a huge opportunity, but are wary of what they see as lax protection for intellectual property in a country where generic medicines account for more than 90 per cent of sales.
Indian generic companies, which do not need to plough money back into future research, can produce drugs at a fraction of the cost of originator firms like Roche or Bayer.
Sankalp Rehabilitation Trust, an advocacy group for cheaper medicines, had challenged the Pegasys patent with the IPAB, saying the drug was costly and gave the Swiss company a monopoly in the market for the drug.
The market price of Pegasys is Rs436,000 ($8100/£5054) for 48 weeks of treatment, although it is also available at a discounted price of Rs314,496 ($5842/£3646), Sankalp said in a statement.
Pegasys is given in combination with another drug, ribavirin, which costs Rs47,160 ($876.17/£546.73) for the same period, Sankalp added.
The appeals board on Friday termed Sankalp’s plea “valid.”
Roche, which can appeal the decision to the Supreme Court, said it was reviewing the IPAB decision and could not comment on it in detail. But it said a solid system of patent protection was essential to ensure research into new treatments.
