The Indian patent office will provide drug innovators a chance to explain their views before a decision to grant compulsory licences against their patented medicines is taken. The patent office's decision has, for the first time, set rules for examining compulsory licence 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 the patent office's move to seek the opinion of Pfizer before granting a compulsory licence to Natco. The application seeks granting a compulsory licence to manufacture and export generic version of Pfizer's patented cancer medicine, Sunitinib, to Nepal.
The application was made under Section 92 (A) of the Patent Act and the Patent Rules, 2006, which allows the government to permit or issue compulsory licence to local manufacturers to export patent medicines to the countries, which do not have the capability to manufacture such medicines.
Since such licences are meant to be issued at the time of public health crisis, the Patent Rules do not spell out in detail the modalities of issuing them.
Natco had argued that inviting patentee (Pfizer) to appear at the hearing to contest the grant of compulsory licence was not required under the patent law.
The patent office, however, felt that the arguments of the patentee shall be helpful in deciding the terms and conditions for granting such a licence and may also be helpful in avoiding the abuse of the provisions of Section 92 (A).
"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 of 92 (A) 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, said.
Natco is the first and the only Indian generic drug maker to seek the compulsory licence route to supply medicines to a least developing country.
Including the current one, Natco has two pending requests for compulsory licences to supply cancer medicines 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 licence application. Natco will be given time to respond to Pfizer's submission before the patent office takes up the case for final hearing.
By Ms.Bobby Aanand, Metropolitan Jury.
The patent office on July 4 dismissed a petition filed by Natco Pharma opposing the patent office's move to seek the opinion of Pfizer before granting a compulsory licence to Natco. The application seeks granting a compulsory licence to manufacture and export generic version of Pfizer's patented cancer medicine, Sunitinib, to Nepal.
The application was made under Section 92 (A) of the Patent Act and the Patent Rules, 2006, which allows the government to permit or issue compulsory licence to local manufacturers to export patent medicines to the countries, which do not have the capability to manufacture such medicines.
Since such licences are meant to be issued at the time of public health crisis, the Patent Rules do not spell out in detail the modalities of issuing them.
Natco had argued that inviting patentee (Pfizer) to appear at the hearing to contest the grant of compulsory licence was not required under the patent law.
The patent office, however, felt that the arguments of the patentee shall be helpful in deciding the terms and conditions for granting such a licence and may also be helpful in avoiding the abuse of the provisions of Section 92 (A).
"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 of 92 (A) 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, said.
Natco is the first and the only Indian generic drug maker to seek the compulsory licence route to supply medicines to a least developing country.
Including the current one, Natco has two pending requests for compulsory licences to supply cancer medicines 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 licence application. Natco will be given time to respond to Pfizer's submission before the patent office takes up the case for final hearing.
By Ms.Bobby Aanand, Metropolitan Jury.
