HEALTH
Patients’ groups oppose changes to patent rules, say could hinder access to affordable medicines
- Admin
- Sep 16, 2023
Patients’ groups oppose changes to patent rules, say could hinder access to affordable medicines
The groups say Draft Patents (Amendment) Rules could make it harder to challenge patent applications, impede process of obtaining compulsory licences & effect transparency in system.
A number of patient rights groups, academics, and intellectual property and public health experts have opposed the proposed Draft Patents (Amendment) Rules, 2023, saying that they may be a result of the constant push from multinational pharmaceutical industry lobbies over the past year to remove essential safeguards from India’s patent laws.
The draft rules, made public on 23 August, are intended to streamline the operations of the patent office and expedite patent processing timelines.
“While these objectives are commendable, certain amendments could dilute critical protections, potentially affecting people’s right to file pre-grant opposition, the accessibility of compulsory licences, and transparency in the patent system,” said the groups in a joint statement Thursday.
Compulsory licence is a provision of Indian patent rules that may allow generic drug makers to produce a medicine, introduce competition, and lower costs.
The groups underlined that the pre-grant opposition procedure — through which an opponent can challenge a pending application prior to the grant of a patent — is one of the important public health safeguards against patent evergreening and unmerited monopolies, ensuring that quality-assured and affordable generics remain accessible.
However, the proposed draft amendments bring significant changes, they noted.
“The amendments introduce a dynamic and exorbitant fee for filing pre-grant oppositions, granting excessive authority to the Controller to determine the ‘maintainability of the representation’,” said the statement.
This, the statement added, marks a departure from the current practice of not charging any fees for pre-grant opposition filings and allowing any person to provide critical information to the patent office, aiding the Controller in examining patent applications. Apart from this, the groups highlighted several other issues with the proposed draft amendments.
ThePrint reached a spokesperson of the Union Ministry of Commerce and Industry via calls. This report will be updated if and when a response is received.
“While these objectives are commendable, certain amendments could dilute critical protections, potentially affecting people’s right to file pre-grant opposition, the accessibility of compulsory licences, and transparency in the patent system,” said the groups in a joint statement Thursday.
Compulsory licence is a provision of Indian patent rules that may allow generic drug makers to produce a medicine, introduce competition, and lower costs.
The groups underlined that the pre-grant opposition procedure — through which an opponent can challenge a pending application prior to the grant of a patent — is one of the important public health safeguards against patent evergreening and unmerited monopolies, ensuring that quality-assured and affordable generics remain accessible.
However, the proposed draft amendments bring significant changes, they noted.
“The amendments introduce a dynamic and exorbitant fee for filing pre-grant oppositions, granting excessive authority to the Controller to determine the ‘maintainability of the representation’,” said the statement.
This, the statement added, marks a departure from the current practice of not charging any fees for pre-grant opposition filings and allowing any person to provide critical information to the patent office, aiding the Controller in examining patent applications. Apart from this, the groups highlighted several other issues with the proposed draft amendments.
ThePrint reached a spokesperson of the Union Ministry of Commerce and Industry via calls. This report will be updated if and when a response is received.
