India’s patent office has decided that drugmakers should be able to have their say before the country grants compulsory licenses, which allow domestic generics makers to export copies of patented medicines to countries that don’t have the ability to make the drugs needed to combat a public health crisis.
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).
Source:The Business Standard