What is a Patent?
A patent is a form of intellectual property that gives an inventor exclusive rights to their invention for a set period, usually 20 years.
This allows the inventor to prevent others from making, selling, or using their invention without permission.
Current Law: Pre-Grant Opposition in India
As of now, India's Patents Act allows "any person" to file a pre-grant opposition.
This is a legal step where anyone can oppose the grant of a patent before it is issued.
The aim is to prevent unwarranted monopolies and protect public health.
The Proposal: Draft Patent Amendment Rules
The draft rules propose that the controller of patents will have the discretion to decide who can file a pre-grant opposition.
This change could make it more difficult for individuals and civil society organizations to oppose patents.
Why Change?
The official reason for the proposed changes is not clear, but critics argue it is to benefit big pharmaceutical companies by reducing the obstacles they face in obtaining patents.
Pros of Proposed Changes
Streamlined Process: Could make the patent approval process more efficient.
Industry Growth: May potentially encourage more innovation in the pharmaceutical sector.
Cons of Proposed Changes
Public Health Risk: Could lead to unjust monopolies and make essential medicines more expensive.
Reduced Transparency:May limit who can file an opposition, reducing public oversight.
Legal Uncertainty: Without clear guidelines, decisions about who can file pre-grant oppositions may become arbitrary.
Global Impact
The changes could affect not just India, but other countries that rely on India's generic pharmaceuticals, thereby raising global health concerns.
In the News
Activists like Nandita Venkatesh and Phumeza Tisile have been acknowledged for their efforts in preventing big pharma from extending patents on critical drugs like Bedaquiline.
Notable Cases
Bedaquiline: Used for treating multidrug-resistant TB; attempts to extend its patent were thwarted.
Tenofovir:Used for HIV treatment; patent extension based on "novel invention" was opposed and rejected.
Stakeholder Views
Stakeholders like patient groups and social organizations argue that the proposed changes could be disastrous for public health and access to affordable medicine.
The debate over the proposed amendment continues, with significant public interest in ensuring that the laws around patenting serve both innovation and public health.
