The department, a wing of the commerce ministry, which also looks at intellectual property-related issues, has sought details regarding prices, efficacy levels and size of the patient pool in need of such treatment from the health ministry, a government official said.
The proposal, initially mooted by a panel formed under the health ministry, recommends invoking the compulsory licence rule for three drugs— trastuzumab, ixabepilone and dasatinib — sold by multinational companies. While trastuzumab is manufactured and patented by Roche, ixabepilone and dasatinib are patented products of Bristol-Myers Squibb.
“We have written back to the health ministry, seeking more details on these drugs…We have sent a list of around 21 queries,” the official, privy to the developments, told Business Standard. “It is important to have these details before we move forward because such decisions can be challenged in a court of law. So, we have to be prepared to face the outcomes and sustain the decision.”
The panel, chaired by R K Jain, additional secretary in the health ministry, suggested invoking Section 92 of the patent law for these three medicines. This section allows the government to grant a compulsory licence “in circumstances of national emergency or in circumstances of extreme urgency or in case of public non-commercial use”. Once the government invokes this section, generic drug manufacturing companies can directly apply to the patent controller for permission to manufacture and sell these drugs at a lower price.
The health ministry’s move is prompted by concerns over the prices of the three drugs. According to trade sources, each of the three costs over Rs 1 lakh for a month’s dose. A vial (of 40 mg) of Trastuzumab costs Rs 1.24 lakh and 60 tablets of 20 mg each of Dasatinib are priced at Rs 1.17 lakh.
The key queries from DIPP include the number of cancer patients in India that can be treated through these medicines, prices of these three products in the domestic and international markets, whether there are alternative medicines or treatment for these drugs and the potential generic manufacturing companies, the official said.
If allowed, this would be a major step of the government towards encouraging compulsory licensing in India for making essential medicines affordable. However, the move is bound to upset multinational pharmaceutical companies, which claim spending billions of dollars on research and development of innovative medicines. A patent period of 20 years allows such innovator companies a monopoly in the market, while the price of the drug remains high in the absence of generic competition. Though a compulsory licence would not disrupt the patent period of the original drug, even entry of select generic players in the market with a significant price differential is bound to hurt the revenues and margins of the innovator company.
This is the second instance when India is considering issuing a compulsory licence to make an anti-cancer drug affordable. Last year, the patent controller granted a compulsory licence to Hyderabad-based Natco Pharma against Bayer’s patented anti-cancer drug, Nexavar. The German firm appealed against the patent controller’s order at the Intellectual Property Appellate Board but the latter agreed with the compulsory licence. While Bayer’s Nexavar was priced at Rs 280,000 a month, the compulsory licence is allowed to Natco Pharma on the condition that it will sell the medicine at Rs 8,800 for a month’s therapy and pay seven per cent royalty to Bayer on the total sales.
- Cost of a month’s dose of each of the three drugs — trastuzumab, ixabepilone and dasatinib — is Rs 1 lakh
- Government is actively considering invoking compulsory licence for these patented drugs
- Trastuzumab is manufactured and patented by Roche as Herceptin; ixabepilone and dasatinib are patented products of Bristol-Myers Squibb under brands Ixempra and Sprycel, respectively
- Last year, Natco was granted a licence for Bayer AG’s Nexavar
- Natco will sell generic Nexavar at Rs 8,800 for a month’s therapy, as against Bayer’s price of Rs 2,80,000 a month