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.

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New Delhi: 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. 

The groups that are opposing the proposed amendments include Medecins Sans Frontieres Access Campaign (a worldwide campaign for affordable medicines), Council for Social Development (a research and advocacy institution), and Third World Network (an international non-profit that works on issues relating to development, developing countries and North-South affairs), among others.

“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. 

Issues with draft amendments 

According to the groups, to prevent the abuse of patent rights, certain measures require patent holders to disclose how their patents are being worked by filing an annual working statement to the patent office.

“The draft amendments propose to extend the interval for submitting working statements from annually to once every three financial years,” they added. 

The new amendments also propose to remove the requirement to seek information on whether the patented product is manufactured in India or imported, and the prices of the patented products, the groups said. 

“This information in the past has been used to register patented medicines not available in India,” they added.

According to K.M. Gopakumar, legal advisor and senior researcher, Third World Network, the timely disclosure of the extent to which a patent has been worked in India is crucial to ensure that the patented product adequately meets the reasonable requirements of the public.

In the case of medicines, this determines if a patented medicine is available to the people in India at a reasonably affordable price substantiated by data, he said in the statement.

“Extending the interval for filing working statements to three years from the existing one year, and removing the requirements to disclose how it is worked — whether manufactured in India or imported — and the approximate prices of the patented products, could significantly impede the process of obtaining compulsory licences and making available essential medicines to the public at an affordable price,” he added. 

In the existing law under Section 8 of The Patents Act, patent applicants must periodically disclose foreign patent applications and related developments on their legal status, ensuring transparency. 

The proposed amendment to the rules could replace this ongoing periodic requirement with a one-time obligation, potentially hindering timely updates and critical information sharing, which could result in the grant of frivolous and unmerited patents, said the groups. 

(Edited by Richa Mishra)