India revokes Roche patent;
questions high price of drug
India dealt a fresh blow to the international pharmaceutical industry on
Friday 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 $12 billion 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 percent 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 436,000 rupees for 48 weeks of treatment,
although it is also available at a discounted price of 314,496 rupees, Sankalp
said in a statement.
Pegasys is given in combination with another drug, ribavirin, which costs
Rs 47,160 for the same period, Sankalp added.
The appeals board on Friday termed Sankalp’s plea “valid.”
PAYING FOR INNOVATION
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.
“Many of the generic drugs today used in India were once patent-protected
and are only available to society because companies such as Roche were willing
to take a risk by investing in new innovative drugs,” a company spokesman said.
He added that Roche was assessing a number of different ways to make drugs
accessible to patients in poorer countries, including volume discounts, rebates
and price capping.
Campaigners for greater healthcare access contend that the best way to
ensure low drug prices is to maximise generic competition by challenging
unjustified patents.
Leena Menghaney, a manager in New Delhi for Medecins Sans Frontieres
(MSF), said this was particularly important in a disease area like hepatitis C,
which is a growing problem in many Asian countries and often hits the most
vulnerable in society.
“This case shows that if people choose to use different public health
safeguards in Indian law to check abuse of the patent system, then indeed they
do work,” she said.
Another case involving drug patents is currently in front of India’s the
Supreme Court, with Novartis battling against an earlier decision refusing it a
patent on cancer drug Glivec.
India is also taking a tougher line on drug pricing more generally, with
plans to increase dramatically the number of essential drugs subject to price
regulation.
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