In the intricate dance between groundbreaking pharmaceutical innovation and the urgent demands of public health, India has recently showcased a compelling move that underscores the delicate equilibrium required for a nation grappling with a critical health crisis.
India is home to the world’s highest prevalence of tuberculosis (TB) and drug-resistant tuberculosis (DR-TB), a nation where nearly 1,000 lives are claimed by the disease daily. The formidable Bedaquiline, a linchpin in the fight against multidrug-resistant tuberculosis, stands as a beacon of hope. Marketed as Sirturo, it was a game-changer, the first novel medicine for TB in four decades when it earned its license in 2012.
However, the plot thickens as Johnson & Johnson (J&J) endeavours to extend its monopoly on Bedaquiline through a secondary set of patent applications worldwide. This manoeuvre seeks to safeguard modified compounds, specifically the bedaquiline fumarate salt, effectively stretching the availability of affordable generic alternatives beyond the standard 20-year patent protection period—a period set to conclude in 2023.
India Rejected The Application
India, a proactive player in this high-stakes narrative, has rejected this application, employing a robust set of domestic intellectual property laws. Section 3D of the Indian Patent Act is a crucial weapon in the country’s arsenal, designed to thwart pharmaceutical giants’ “evergreening” tactics. This section prevents corporations from making negligible changes to drug compositions merely to extend patent life—a stance consistent with international agreements such as the Trade-Related Aspects of Intellectual Property Rights (TRIPS).
This evergreening patent application rejection is not an isolated incident but a manifestation of India’s commitment to public health. The nation has successfully contested and denied patent renewals founded on marginal modifications, adhering to the TRIPS agreement, which allows countries to take public health measures without compromising innovation.
India’s approach echoes beyond its borders, setting a precedent for other nations facing similar challenges. Argentina, in 2012, mirrored India’s Section 3(d) in its guidelines for patent examiners, while in 2004, the industrial property offices of Bolivia, Colombia, Ecuador, Peru, and Venezuela followed suit.
It’s not merely about saying “no” to patent extensions; it’s about crafting a nuanced framework that navigates the intricate dance between fostering innovation and ensuring access to critical medications. India strives to strike this delicate balance by meticulously tailoring its intellectual property laws. The nation’s commitment resonates globally, influencing pharmaceutical landscapes and encouraging a discourse that transcends borders.
In this saga, patent offices worldwide are challenged to adapt, train examiners rigorously, and fortify their infrastructure. This ensures that the delicate balance India strives for becomes a universal aspiration—a harmonious symphony of innovation and accessibility for the greater good.