 "Patient Groups raise concerns over proposed draft of patent rules")
Concerns emerged from patient advocacy groups after the Draft Patents (Amendment) Rules, 2023 were made public last month by the Department for Promotion of Industry and Internal Trade. This release has raised concerns among civil society organisations, academics, and intellectual property and public health experts.
The draft amendments to the Patents Rules, 2023, introduce changes such as a fee for filing pre-grant oppositions, giving sole authority to the controller, an exit 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. They also propose an extension of the interval for submitting working statements from annually to once every three financial years, and the removal of the requirement to disclose whether patented products are manufactured in India or imported, along with the prices of those products.
Patient groups and public health experts argue that these changes would weaken the safeguards in India's patent system. They are calling on the government to revise the proposed amendments to ensure that access to affordable medicines is not compromised.
"This proposed introduction of fees running into thousands of rupees for pre-grant oppositions could impose a significant financial burden on organisations such as ours, representing patients' interests. 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, as well as anyone, to file pre-grant oppositions," sharing his concerns, Eldred Tellis, Director, Sankalp Rehabilitation Trust stated. "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," Tellis further added.
Echoing the sentiment, K M Gopakumar, Legal Advisor and Senior Researcher, Third World Network stated, "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."
Commenting on the same, Biswajit Dhar, Vice President, Council for Social Development stated, "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; they appear to be entering through a less conspicuous back door via the Rules."
Patient groups and public health experts are urging the government to reconsider the proposed amendments to the Patents Rules, 2023. They say that these changes would have a devastating impact on access to essential medicines in India.