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The Patent (Amendment) Rules 2024 are likely to increase the possibility of litigation and could impact the health safety of the Global South, according to experts.
Addressing a roundtable on Nuances of the Patent (Amendment) Rules 2024 organised by All India Drugs Control Officers’ Confederation (AIDCOC) Training Academy here on Saturday, Udaya Bhaskar Director-General, AIDCOC Training Academy and former DG of Pharmexcil said many issues pertaining to patent laws could significantly impact timelines of the drug discovery and global health security.
He further said the changes would significantly undermine India’s ability to ensure access to affordable medicines.
Dr .Ranga Reddy Burri, President, Infection Control Academy of India, said the evolving patent landscape had far-reaching implications for public health and access to medicines. The recent amendments to the Indian Patent Rules could significantly impact global health security, particularly for the Global South, he added.
The group of countries located in the Southern Hemisphere are generally called Global South and are seen as less developed, or developing than those in the Global North. They include Africa, Latin America and the Caribbean, Asia (excluding Israel, Japan, and South Korea), and Oceania (excluding Australia and New Zealand).
“As the world continues to reel from the aftermath of COVID-19, which exposed deep fractures in health equity—not only in India and other low- and middle-income countries but also in the Global North—it is imperative to view these regulatory shifts through a public health lens,’‘ he said.
“Recent changes in the Act that potentially delay generic competition or limit opposition to unjust patents could exacerbate existing health inequities. Indian patients are already burdened by high out-of-pocket health expenditures, and any increase in the cost of pharmaceuticals and medical devices—especially under growing private equity influence and rising private healthcare costs—will affect the middle class and uninsured populations,’‘ Burri said.
Other experts from the industry and regulatory fraternity, who did not want to be named, said as per the amendments of the Patent (Amendment) Rules, 2024, the controller General of patents can decide who can file the pre-grant opposition to a patent which was contrary to previous law which allowed any person to file a pre-grant opposition.
“After the amendments and empowering of the controller, there is a possibility of increased litigation if one prefers to challenge the controller’s decision on pre-grant opposition in a court of law,’‘ said Mr Roshan John ,Regional Advisor,Asia and Oceania,MSF .While there was no fee for filing a pre-grant opposition, financial barriers were now put in place with fees ranging from Rs 4,000 to Rs 2000, he added.
The experts in the roundtable also said the amendments could potentially delay the process of compulsory licensing by about a period of five years.
Published on April 19, 2025
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