The Indian Patent Office has rejected a patent application submitted by the US-based TB Alliance for the BPaL drug combination used in the treatment of multidrug-resistant tuberculosis (MDR-TB). The decision has implications for access to affordable TB medicines and India’s efforts to tackle drug-resistant disease.
What is the BPaL Regimen?
BPaL is a six-month, all-oral treatment regimen recommended by the World Health Organization for drug-resistant TB. It combines bedaquiline, pretomanid and linezolid.
A related BPaLM regimen adds moxifloxacin and has reported treatment success of around 89%, compared with lower success rates associated with older, longer treatment protocols that may involve injections.
Why Was the Patent Rejected?
Civil society organisations opposed the application under Section 25(1) of the Patents Act, 1970, arguing that earlier clinical research had already disclosed the combination.
The Patent Controller cited concerns relating to lack of novelty, absence of an inventive step and inadequate disclosure. The decision also considered key provisions of the Patents Act:
- Section 3(d): Prevents patenting new forms of known substances without enhanced therapeutic efficacy and helps check evergreening.
- Section 3(e): Excludes mere admixtures of known substances from patentability.
- Section 3(i): Excludes methods of treatment of human beings from patent protection.
Significance for TB Treatment in India
India carries a substantial share of the global TB burden, making affordable treatment particularly important. Removal of a patent barrier can potentially enable eligible generic manufacturers to enter the market, increasing competition and reducing medicine costs.
Lower procurement prices could allow public programmes such as the National Tuberculosis Elimination Programme (NTEP) to expand access within available resources.
Public Health and Regulatory Significance
The decision also relates to the broader Right to Health under Article 21. However, patent rejection does not automatically permit generic manufacturers to market the medicines.
Manufacturers must still obtain the necessary approvals from the Central Drugs Standard Control Organisation (CDSCO) and comply with applicable treatment guidelines, quality standards and regulatory requirements.
FAQs - BPaL regimen
What is the BPaL regimen?
BPaL is a six-month, all-oral regimen for certain forms of drug-resistant tuberculosis. It combines bedaquiline, pretomanid and linezolid.
What is the difference between BPaL and BPaLM?
BPaLM adds a fourth medicine, moxifloxacin, to the three drugs used in BPaL.
Why did India reject the BPaL patent application?
According to the article, earlier clinical research had already disclosed the combination. The Patent Controller cited lack of novelty, absence of an inventive step and inadequate disclosure.
How could the patent rejection affect access to TB medicines?
The rejection could make it easier for eligible generic manufacturers to enter the market. Greater competition could lower procurement costs and help the National Tuberculosis Elimination Programme expand access.
Can manufacturers sell generic BPaL medicines immediately after the rejection?
No. As the article explains, rejecting a patent application does not grant marketing approval. Manufacturers still need the applicable regulatory approvals and must meet drug quality standards.
