The draft patent amendment rules made public on August 23 this year could hugely benefit big pharma but turn out to be disastrous for patients in India and in countries in the global South, which rely on generic drugs manufactured in India, in accessing affordable drugs and vaccines.
The draft rules released by the Department for Promotion of Industry and Internal Trade for stakeholder comments have made a few significant changes that will create needless hurdles in pre-grant opposition of patents. First, the draft amendment rules have introduced a variable fee for filing pre-grant oppositions. The proposed introduction of fees can run into thousands of rupees and thus impose a significant financial burden on civil society organisations and patients’ groups filing pre-grant opposition.
The most important change is about granting the controller the power to determine the maintainability of representation by individuals or civil society organisations to file pre-grant oppositions.
