Indian civil society groups and public health experts have alleged the changes proposed in the Draft Patents (Amendment) Rules 2023 dilute the essential public interest safeguards provided by India’s current patent system.

Commenting on the draft rules put out by the Department for Promotion of Industry and Internal Trade for stakeholder response, the groups say that certain proposed amendments could dilute critical protections, potentially affecting people's right to file pre-grant opposition, the accessibility of compulsory licenses, and transparency in the patent system.

The ministry says the Draft Patents (Amendment) Rules, 2023, which were made public on August 23, 2023, aim to streamline the operations of the patent office and expedite patent processing timelines.

While the existing law under Section 8 of the Patents Act stipulates patent applicants must periodically disclose foreign patent applications and related developments on their legal status, ensuring transparency, the proposed amendment calls for a one-time obligation, which the civil society groups believe could potentially hinder timely updates and critical information sharing, resulting in the grant of frivolous and unmerited patents. "The present amendments present the most significant challenge to the Indian Patent System since 2005 and could have a disastrous impact on access to medicines, and they appear to be entering through a less conspicuous back door via the Rules,” Dr Biswajit Dhar, vice president, Council for Social Development says.

The current law also provides for pre-grant opposition of patents and is considered as important public health safeguard against patent evergreening and unmerited monopolies, ensuring that quality-assured and affordable generics remain accessible. However, the proposed draft amendments introduce a fee for filing pre-grant oppositions granting excessive authority to the controller to determine the “maintainability of the representation.” This makes 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 groups say.

“This proposed introduction of fees running into thousands of rupees for pre-grant oppositions could impose a significant financial burden on organizations such as ours, representing patients’ interests. At a time when our primary focus is allocating resources to treat our patients, securing funds for filing patent challenges becomes a daunting task, potentially affecting the timely access to essential medicines for those under our care” Eldred Tellis, Director, Sankalp Rehabilitation Trust, points out. 

He also adds that 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 organizations like theirs to file pre-grant oppositions. “This proposed amendment could potentially curtail our ability to file pre-grant oppositions to prevent the grant of unmerited patents on medicines to ensure timely availability of quality assured, affordable generic medicines.” 

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 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 means whether a patented medicine is available to the people in India at a reasonably affordable price substantiated by data. 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 licenses and making available essential medicines to the public at an affordable price", KM Gopakumar, legal advisor and senior researcher, Third World Network says.

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