The Indian patent office will provide brand-name drugmakers a chance to explain their views before a decision to grant compulsory licenses against their patented medicines is taken,The Business Standard reports. In doing so, the patent office is, for the first time, setting rules for examining compulsory license applications from local companies against multinational drug majors like Pfizer and Roche.
The patent office on July 4 dismissed a petition filed by Natco Pharma opposing its move to seek Pfizer's opinion before granting a compulsory license to Natco, which wants to make and export a generic version of Pfizer's patented cancer med, Sunitinib, to Nepal. The application was made under a provision of the patent law that allows the government to issue compulsory licenses to local generic drugmakers to export patented meds to countries that don't have the capability to make drugs.
Since such licenses are meant to be issued at the time of public health crisis, India's patent law don't spell out the specifics. Natco had argued that inviting Pfizer to appear at the hearing to contest the grant of compulsory license was not required under the patent law. The patent office, however, felt that the arguments of the patent holder would be helpful in deciding the terms and conditions for granting such a license, and avoiding abuse of patent laws.
"I think Natco's application itself is a weak one as they did not submit proof to suggest that there is a public health emergency in Nepal due to lack of availability of the drug. The patent controller, therefore, states in his order that one of the reasons for the ‘hearing' is to ensure that the provisions...are not ‘abused'. This is a sound order and helps the patent office take a better decision on a complicated area of law," Shamnad Basheer, a patent expert, tells the paper.
Natco is the first and the only Indian generic drugmaker to seek a compulsory license to supply meds to a least-developing country. Natco has two pending requests for compulsory licenses to supply cancer meds to Nepal; the other request is for permission to export Roche's cancer medicine, Erlotinib.
The patent office decision will enable Pfizer to express its views on the compulsory license application. Natco will be given time to respond to Pfizer's submission before the patent office takes up the case for final hearing.
Source: The Business Standard