[Ip-health] Economic Times: Natco seeks Pfizer nod for drug clone

Thiru Balasubramaniam thiru at keionline.org
Wed Jan 5 05:53:54 PST 2011


Natco seeks Pfizer nod for drug clone

5 JAN, 2011, 06.31AM IST, KHOMBA SINGH,Economic times

NEW DELHI: Natco Pharma has sought a voluntary licence from Pfizer to  
make and sell copies of the US company's HIV medicine in India, a  
first step to a provision that permits firms to legally make patented  
drugs of other companies.

Natco sent a notice to the US drugmaker in November saying Pfizer's  
drug was too expensive for HIV patients in India, and that Natco can  
sell its own product at about one-fifth the price, two people with  
direct knowledge of the development told ET.

This is the first step in what is known in pharma industry as  
Compulsory Licensing(CL), a provision that allows generic drugmakers  
to make and sell low-cost version of a patented drug under certain  
conditions. Natco is the first company to initiate the process for CL  
in the country and this will be a big test case for application of the  
provision in India.

In all probability, Pfizer will reject Natco's request saying that it  
has spent huge amount of money to develop the drug, the first person  
said, asking not to be named. "This will be the acid test and set a  
precedent for the use for CL to make medicines affordable for masses  
in India," he said. Natco executives declined to comment while Pfizer  
did not reply to an e-mail query. The Hyderabad-based Indian company  
has also informed the government about its notice to Pfizer, a senior  
commerce ministry official who has seen a copy of the notice said.

Pfizer has time till May to reply, as Indian patent law allows an  
innovator company to respond within six months of receiving a notice  
for voluntary license. If it does not allow Natco to make cheap drugs,  
the Indian pharma company can approach the government for CL, that  
will allow it to sell a lowpriced version of the drug after paying  
royalty to Pfizer.

The government can invoke the provision after three years of the grant  
of the patent under certain conditions such as the product is not  
available at an affordable price for public or the patent holder fails  
to launch the product within a stipulated time.

Pfizer's HIV drug maraviroc sold under the brand Celsentri costs  
about . 65,000 for a month dosage, said Natco in its notice to the  
world's largest drugmaker. The Indian company has said it can make a  
copy that will cost . 15,000 a month to HIV patients, the commerce  
ministry official said. Pfizer got the patent for maraviroc in January  
2007, one of the first HIV drugs to be patented in India. The  
country's drug regulator had given marketing approval for maraviroc  
tablets (150mg & 300mg) in November 2009, its website said. According  
to Jayanti Patel a Mumbai based stockist for Pfizer and vice president  
of the city's Wholesalers' Association, the drugmaker had imported a  
few samples of Celsentri mainly for clinical trials and is not  
currently available with stockists.

The fate of the case this year and the government's response could  
shake up foreign drugmakers' ability to sell high priced patented  
products in India. Global innovator companies have been opposed to the  
CL provision . "Proposals to promote the use of CL could inhibit  
technological development in the sector in India and thereby undermine  
efforts to make medicines and other products widely available to  
patients," Tapan Ray , director general of Organisation of  
pharmaceutical producers of India , had said in its response to a  
government's discussion note regarding the use of CL in last  
September. OPPI, the lobby body of innovator companies in India, said  
that sales of patented products account for much less than 1% of the  
Indian Pharmaceutical market.

Although four years ago, Natco had unsuccessfully tried to seek CL for  
Pfizer's cancer drug to be sold in Nepal no local drugmaker has tried  
to invoke the provision in India as they say the process is not well  
crafted. India adopted a new patent regime in 2005 that introduced the  
provision of CL but has various loose ends.

C M Gulati, editor, of monthly medical journal MIMS said that CL can  
be given for several patented drugs in India but most of the local  
companies with the expertise to make such complicated drugs cannot  
apply. Half of the leading companies have been taken over by foreign  
firms while the others have marketing alliance with global innovators,  
he said. "The remaining lot have a secret desire to be taken over and  
want to avoid any confrontation with a potential buyer," Mr Gulati said.

The provision of CL has been used in countries such as Thailand,  
Brazil and South Africa. In all these nations the provision was used  
for HIV medicines, the commerce ministry has said in its discussion  
note. India has an estimated 2.3 million people living with HIV.


Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International (KEI)
thiru at keionline.org

Tel: +41 22 791 6727
Mobile: +41 76 508 0997

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