India Rejects Patent Application for BPaL Tuberculosis Treatment
The Indian Patent Office denies monopoly rights for the BPaL drug regimen.
1Patent Rejection in India
The Indian Patent Office officially rejected the application filed by the U.S.-based TB Alliance for the BPaL regimen. This treatment combines bedaquiline, pretomanid, and linezolid into a six-month, all-oral course for drug-resistant tuberculosis. The decision prevents the establishment of a new patent monopoly for this specific medical combination within the country.
2Opposition Grounds and Arguments
Two pre-grant oppositions filed in 2020 successfully challenged the application. Opponents argued that the combination and its use in shorter regimens were already disclosed in research dating back to 2015. They contended that combining these known medicines fails to constitute an inventive step, which is a fundamental requirement for granting patents.
3Legal Framework and Safeguards
The Indian Patent Office upheld four specific grounds for rejection based on the Patents Act. These include Section 3(d), which restricts patents on new uses of known substances, Section 3(e) regarding mere admixtures, and Section 3(i) which excludes methods of medical treatment. The application also failed to sufficiently disclose the claimed invention.
4Public Health Context in India
India currently carries the world's largest tuberculosis burden, with approximately 2.71 million new cases in 2024. This figure represents one-quarter of all global tuberculosis infections, with an incidence rate of 187 per 100,000 people. Access to shorter, oral treatments is critical for patients to return to work and rebuild their lives.
5Activist and Stakeholder Response
Groups including the Delhi Network of Positive People and the Sankalp Rehabilitation Trust welcomed the rejection. Activists argue that the TB Alliance received significant public and philanthropic support for developing pretomanid. Consequently, they believe the organization should not pursue proprietary rights or secondary patents on combinations involving already known, essential medical components.
6Global Patent Landscape Status
While India has rejected the application, patents for the BPaL combination have already been granted in 11 other countries. These jurisdictions include Russia, South Africa, Indonesia, and several Central Asian nations. These existing patents are currently scheduled to expire in 2036, creating a complex international landscape for access to this treatment.
7Calls for Voluntary Surrender
Civil society groups are now demanding that the TB Alliance voluntarily surrender granted patents in other jurisdictions. Researchers from the Third World Network have urged the organization to withdraw all pending applications globally. Furthermore, there is a strong call for the TB Alliance to publish its existing pretomanid licence agreements for transparency.
8Implications for Future Access
The rejection in India serves as a significant precedent for drug-resistant tuberculosis treatment accessibility. By denying the patent, the Indian government prioritizes public health needs over proprietary claims for known substance combinations. This development forces a re-evaluation of how international organizations manage intellectual property rights for essential, publicly-funded medical innovations.