‘Patients’ rights and access to drugs could be hurt by proposed amendments in patent rules’

Draft amendments are a result of multinational pharma industry lobbying, say public health experts and activists; proposed changes include ‘exorbitant’ fees for filing pre-grant opposition, fewer disclosures

A patient receives medicines at a clinic in New Delhi. File image used for representational purpose only. | Photo Credit: PTI

Some clauses in the draft Patents (Amendment) Rules, 2023 have triggered fears that important public health safeguards against patent evergreening and unmerited monopolies will be diluted. Civil society organisations, academics, and intellectual property and public health experts have voiced their concern that the Rules — released last month by the Department for Promotion of Industry and Internal Trade for stakeholder comments — will hurt people’s rights to file pre-grant opposition to patents.

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The proposal comes after persistent lobbying from the multinational pharmaceutical industry over the last year to remove essential safeguards from India’s patent laws, the group said. It has caused significant concerns among patient groups working to ensure access to affordable medicines, diagnostics, and vaccines for patients in India and other developing countries. 

According to the government, the draft Rules aim to streamline the operations of the patent office and expedite patent processing timelines.

Exorbitant fees

Experts argue that pre-grant opposition is a key safeguard against patent evergreening and unmerited monopolies, ensuring that quality-assured and affordable generics remain accessible. However, the proposed draft amendments would bring significant changes.

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. This 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. 

The proposed introduction of fees running into thousands of rupees for pre-grant oppositions could impose a significant financial burden on organisations representing patients’ interest, said Eldred Tellis, director of the Sankalp Rehabilitation Trust. He was participating in a discussion organised on Thursday by the Third World Network and Medecins Sans Frontieres, Access Campaign to talk about the recently proposed amendments and their impact on patients’ rights.

Diluting safeguards

“Also, granting the Controller discretionary authority to determine who may file pre-grant oppositions is beyond the scope of the Patents Act and contradicts prior judicial rulings, which clearly allowed organisations like ours, as well as anyone, to file pre-grant oppositions,” Mr. Tellis added.

The group said that to prevent 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. 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. This information in the past have been used to register patented medicines not available in India,” explained K.M. Gopakumar, legal advisor and senior researcher, Third World Network. He added that the proposed deletions could significantly impede the process of obtaining compulsory licenses and making available essential medicines to the public at an affordable price.”

Transparency concerns

A release issued by the group noted that under Section 8 of the existing 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,” the group said.

Patients’ groups, civil society organizations, and public health experts are calling on the government to carefully consider these concerns and revise the proposed draft amendment rules to ensure that the safeguards enshrined in India’s patent system are protected to ensure public health and access to affordable medicines.