India Rejects TB Drug Patent for Affordable Care

INDIA REJECTS TB DRUG PATENT TO IMPROVE AFFORDABILITY

WHY IN THE NEWS ?

The Indian Patent Office has rejected a patent application for the BPaL tuberculosis drug combination, potentially encouraging generic competition, reducing treatment costs and improving access to shorter treatment for patients suffering from drug-resistant tuberculosis.

PATENT REJECTION AND KEY FEATURES OF BPaL TREATMENT:

• Patent Rejection: The Indian Patent Office rejected a patent application filed by the US-based TB Alliance (Global Alliance for TB Drug Development) for the combination of three TB medicines.
• Drug Composition: BPaL combines three medicines: Bedaquiline, Pretomanid and Linezolid, offering an effective treatment option for eligible patients with drug-resistant TB.
• Shorter Treatment: It is a six-month, all-oral treatment regimen recommended by the World Health Organization (WHO), reducing dependence on prolonged antibiotic courses and painful injections.
• BPaLM Regimen: A related treatment, BPaLM, includes an additional antibiotic called Moxifloxacin and has recorded a treatment success rate of approximately 89%.
• Patent Opposition: The application faced two pre-grant oppositions filed in 2020 by patient groups and public health organisations, challenging the possibility of extending exclusive patent rights.
• Generic Competition: Patent rejection removes one potential legal barrier to other manufacturers producing the drug combination in India, subject to applicable regulatory requirements.

SIGNIFICANCE FOR TB PATIENTS AND INDIA’S HEALTHCARE SYSTEM

• Affordable Treatment: Increased generic competition could reduce medicine prices and allow the government to purchase more treatment courses within the same healthcare budget.
• Patient Benefits: Shorter oral treatment can reduce physical suffering, financial pressure and treatment interruptions, helping patients return to normal life sooner.
• Public Healthcare: Since drug-resistant TB medicines are provided free through the public health system, lower procurement costs could benefit the government’s National TB Elimination Programme (NTEP).
• Regulatory Safeguards: Patent rejection does not automatically authorise marketing. CDSCO approval, quality standards and applicable regulatory permissions remain necessary.
• Implementation Challenge: The government must expand access to BPaL/BPaLM, ensure uninterrupted supplies and maintain quality checks for generic medicines.