UPDATE: Natco Pharma Seeks 'Compulsory License' For Copy Of Pfizer Drug
January 05 2011 - 6:33AM
Dow Jones News
Natco Pharma Ltd. (524816.BY) said Wednesday it has informed
Pfizer Inc. (PFE) that it wants to make and sell a low-cost generic
version of the U.S. company's maraviroc for treating the HIV
infection under a so-called "compulsory license."
Natco Pharma's move is significant because, if successful, the
Indian generic drug maker will set a precedent for other Indian
companies to override multinational drug makers' patents for the
treatments of diseases ranging from cancer to hypertension.
Natco Pharma wants to sell its generic version of maraviroc in
India at INR15,000 for a month's supply, compared with the
INR65,000 price tag for Pfizer's branded version, a spokesman for
the Indian drug maker told Dow Jones Newswires.
Indian patent laws allow applications for the grant of a
"compulsory license" three years from the date a patent has been
given.
According to an Economic Times newspaper report earlier
Wednesday, Pfizer got the patent for maraviroc in January 2007.
Pfizer wasn't immediately available to comment.
Natco Pharma could get permission to make and sell a low-cost
copy of maraviroc in India under a "compulsory license" for the
remaining term of the patent if it can be established that the
patented product isn't available to the public in the country at an
affordable price.
Ranjit Kapadia, vice president of institutional research at HDFC
Securities, said that obtaining this compulsory license could be a
long, drawn-out process, given the lack of clarity on various
aspects of this provision in the Indian patent laws.
This isn't the first time the Hyderabad-based drug maker has
sought such a licence.
Natco Pharma in 2008 sought permission under the "compulsory
license" provision to make the generic versions of two cancer
drugs, namely Pfizer's Sutent and Roche Holding AG's (ROG.VX)
Tarceva, to export to Nepal.
But the Natco Pharma spokesman said the company didn't pursue
these applications with the Indian patent office after Nepal showed
disinterest in the move.
Several multinational drug makers have found fault with India's
application of patent laws, despite amendments introduced in 2005
to bring the country in line with standards approved by the World
Trade Organization.
The multinational drug industry relies on the protection of
intellectual property for innovation to fund the high cost of
research, but India's patent office and courts have been less
inclined to defend patents on a number of occasions, contending
that prices have to be kept low so the country's vast, and mostly
poor, population can afford medicines.
Some multinational drug companies have retaliated by cutting off
investments into India.
-By Rumman Ahmed, Dow Jones Newswires; 91-9845104173;
rumman.ahmed@dowjones.com