The Indian Patent Office has rejected Mumbai-based BDR Pharmaceuticals'application for a compulsory licence to make a generic version of US drug maker Bristol-Myers Squibb's anti-cancer drug Dasatinib, said media reports today. The development comes as a disappointment to millions of patients suffering from chronic myeloid leukemia as the drug won't be accessible to many because of its high price.
In India, a month's dose of the drug costs about Rs 1 lakh. BDR had applied for the licence in March and said it would sell the drug for Rs 8,100 a month.
A compulsory licenceis a right granted by the government that allows parties other than the patent holder to produce and sell a patented product or use a patented process, without the consent of the patent holder.
While rejecting the plea for licence, the Indian Patent Office said that BDR failed to make out a prima facie case for the grant of compulsory licence, under Section 87 of the Patents Act, reported TheTimes of India.
"The application did not make efforts to obtain a licence from the patentee on reasonable terms and conditions," TOI quoted Chaitanya Prasad, the Controller General of Patents, as saying.
Justifying the need for a compulsory licence such as affordability, shortage of supply or a medical emergency in the local market and also completion of other formalities such as seeking a voluntary licence from the patentee are the threshold requirements to be satisfied before engaging the patent office for hearing a compulsory licence application, notes Mint in this article.
BDR Pharma's application was India's second compulsory licence application after it issued its first compulsory licence to Natco Pharma last year to manufacture generic version of German drugmaker Bayer's kidney cancer drug Nexavar.
The first licence was granted seven years after amendment to the Patents Act 1970 was passed in April 2005.The order paved the way for reduction in the prices of costly life saving drugs.
The Intellectual Property Appellate Board (IPAB) directed Natco to pay 7 percent royalty to Bayer from the sales of generic drug Nexavar. The IPAB also imposed Rs 50,000 cost on Natco for some "misinformation" in its affidavit.
Bayer obtained a patent in India in 2008 for Nexavar which cost Rs 2.8 lakh for a pack of 120 tablets, equivalent to a month's dosage.Natco had said it will supply the same quantity for Rs 8,880, a reduction of almost 97% in the price.
India's move was criticised by the global pharmaceutical majors, generally referred to as the Big Pharma. They charged that the move adversely impactdrug companies' willingness to innovate and to provide access to the drugs they release in other countries. The US, home for many power pharma firms, had also flayed the Indian decision.
In fact, the Deputy Director of the US Patent and Trademark Office (USPTO) said that India was wrong to issue a compulsory license for Nexavar. She also asserted that drug companies will not market their products in countries like India or China if they persist in issuing licenses. In particular, she noted the Indian public would suffer as they will not get access to these new drugs.
India, however, has held that the move was very much in compliance with the trade-related intellectual property rights of the World Trade Organisation. These norms permitted granting such a licence in larger public interest, if the price of a drug is not affordable.
While the rejection of licence to BDR comes as a major disappointment to patients, it also shows that India is not blindly granting rights to produce generic version of patented drugs to every other pharma companies. The development should help India hold its ground in its fight for cheaper healthcare.
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Updated Date: Dec 20, 2014 23:43:47 IST