Why India rejected a patent application for shorter drug-resistant TB treatment | Explained

BPaL is the name for a treatment regimen combining three medicines: bedaquiline, pretomanid and linezolid. It is used for eligible people with certain forms of drug-resistant tuberculosis. The regimen is important because it can replace older, longer treatment approaches with six months of oral medicines.

Pretomanid is the newer anti-TB medicine in the combination. The non-profit TB Alliance developed it. Bedaquiline and linezolid were already known medicines, while the application sought protection for using all three together as BPaL and for the shorter treatment course.

The Indian Patent Office rejected that application. Opponents argued that earlier research and clinical trials, including work dating back to 2015, had already disclosed the combination and its use in a shorter course. WHO recommends six-month BPaL treatment for specified eligible patients with multidrug- or rifampicin-resistant TB, including some with fluoroquinolone resistance.

India’s Patent Office decided that the application did not show enough new invention to justify another patent monopoly. Health experts and opposition groups said research and clinical trials dating back to 2015 had already disclosed BPaL and its use in a shorter treatment course.

The challengers relied on Sections 3(d), 3(e) and 3(i) of India’s Patents Act. These provisions restrict certain new forms or uses of known substances without enhanced efficacy, exclude substances lacking enhanced efficacy, and exclude methods of medical treatment from patentability. They also argued that the application did not sufficiently disclose the invention.

The Patent Office upheld all grounds of opposition. This means the decision rejected the application’s claims on each of the stated grounds, rather than accepting the combination as a sufficiently inventive, adequately disclosed patentable invention. The ruling could therefore help generic manufacturers compete.

The six-month BPaL course is dramatically shorter than older regimens for highly drug-resistant tuberculosis. Those older treatments could last 18–24 months. Compared with them, BPaL reduces the stated treatment period by 12 to 18 months.

For example, someone previously facing an 18-month regimen could complete BPaL 12 months sooner. Against a 24-month regimen, the difference would be 18 months. The newer course is also all-oral, whereas some older regimens involved painful injections and multiple medicines.

The shorter duration can reduce disruption to work and family life and lessen the burden of repeated health-facility visits. It does not apply automatically to every patient. WHO recommends BPaL for specified eligible groups, and outcomes still depend on appropriate selection, supervision, adherence and management of adverse effects.

Rejecting the patent application could open more room for generic manufacturers to compete in supplying the BPaL combination. Competition may place downward pressure on medicine prices. That matters because drug-resistant TB can require specialised care, prolonged treatment and costly medicines, creating financial pressure for households.

For patients, lower prices could make the six-month oral regimen easier to obtain. The shorter course may also reduce treatment disruption, travel to health facilities and time away from work or family. India’s public TB programme already provides free diagnosis and treatment, but patients still face adverse effects, lost income, travel costs and nutritional or social needs.

The rejection does not automatically guarantee lower prices or universal access. The article notes that actual savings will depend on factors not specified in the provided text. Treatment also remains limited to eligible patients and requires clinical supervision, adherence and adverse-effect management.

Two pre-grant oppositions challenged the BPaL application in 2020. Eldred Tellis of Sankalp Rehabilitation Trust and Ganesh Acharya filed one, with support from the Lawyers’ Collective and the Médecins Sans Frontières Access Campaign. The Delhi Network of Positive People filed the other, supported by the Third World Network.

In India’s patent system, a pre-grant opposition is a formal challenge made while a patent application is still under examination and before a patent is granted. It gives opponents an opportunity to present reasons why the application should not receive protection. Here, the challenges questioned novelty, inventive step, efficacy, medical-treatment patentability and disclosure.

The Patent Office upheld all grounds of opposition and rejected the application. The organisations welcomed the decision because they argued that earlier scientific research and clinical trials had already disclosed the combination and shorter treatment approach. They said the ruling could facilitate generic competition and improve access.

Drug-resistant tuberculosis is harder to treat because medicines that normally control TB may no longer work effectively against the resistant disease. Clinicians therefore need different or specialised drug combinations. Treatment decisions must account for the patient’s resistance pattern and eligibility for a regimen such as BPaL.

The article describes drug-resistant TB as requiring specialised treatment, careful monitoring and prolonged engagement with health services. Monitoring helps clinicians supervise response, support adherence and manage adverse effects. Older regimens could involve multiple medicines, 18–24 months of treatment and, in some cases, painful injections.

BPaL changes the burden for eligible patients by offering six months of oral treatment. Yet it does not remove the need for supervision. The article stresses that outcomes depend on appropriate patient selection, clinical oversight, adherence and management of adverse effects. Costs, travel, lost income and nutritional needs can still affect care.

A patent is a legal right that can give an inventor exclusive control over a claimed invention for a limited period. To qualify, an application generally must describe the invention adequately and show that it is new and inventive, rather than an obvious or previously disclosed idea. This is why patentability can affect medicine access and generic competition.

Prior disclosure matters because earlier research or clinical trials may show that the claimed invention was already known. An inventive step asks whether the claimed advance is sufficiently new and non-obvious. In this case, opponents said studies dating to 2015 had already disclosed BPaL and its shorter course, so the application did not establish enough inventive step.

India’s Sections 3(d) and 3(e) address certain known substances or combinations without enhanced efficacy. Section 3(i) excludes methods of medical treatment. The opponents also challenged disclosure, and the Patent Office upheld every stated ground.