മരുന്ന് പ്രതിരോധശേഷിയുള്ള ക്ഷയരോഗ ചികിത്സ: ഇന്ത്യ പേറ്റന്റ് അപേക്ഷ തള്ളിയത് എന്തുകൊണ്ട്?

The story so far: The Indian Patent Office has rejected a patent application filed by the U.S.-based Global Alliance for TB Drug Development (TB Alliance) for the combination of bedaquiline, pretomanid and linezolid, known as BPaL. The six-month, all-oral regimen is recommended by the World Health Organisation (WHO) for eligible patients with certain forms of drug-resistant tuberculosis.

BPaL — bedaquiline, pretomanid and linezolid — provides a shorter, more effective treatment for people with highly drug-resistant tuberculosis, for whom older regimens could involve 18–24 months of treatment, multiple medicines and, in some cases, painful injections.

The development is also central to the debate over intellectual property and access to medicines, because the treatment combines existing drugs with pretomanid, a newer anti-TB medicine developed by the non-profit TB Alliance.

Opposition to the patent application

India’s recent decision to reject the patent application follows two pre-grant oppositions filed in 2020. One was filed by Eldred Tellis of Sankalp Rehabilitation Trust and Ganesh Acharya, with support from the Lawyers’ Collective and the Médecins Sans Frontières Access Campaign. The other was filed by the Delhi Network of Positive People (DNP+), with support from the Third World Network (TWN).

The organisations have now welcomed the decision, arguing that the application sought patent protection for a combination of medicines and a treatment approach already disclosed in earlier scientific research and clinical trials.

“India’s latest decision will help facilitate generic competition and improve access to treatment,’’ said the group.

Why did Indian Patent Office decide to reject the application?

At the core of the dispute is the question — whether combining three existing medicines into a treatment regimen qualifies for a new patent. Health experts in their statement noted that research and clinical trials dating back to 2015 had already disclosed the combination of bedaquiline, pretomanid and linezolid, as well as its use in a shorter treatment course. They noted that the application now did not establish an inventive step sufficient to justify granting a new monopoly and patent.

Their challenge invoked three provisions of India’s Patents Act. Section 3(d) restricts patents on certain new forms or uses of known substances that do not demonstrate the required enhancement in efficacy. Section 3(e) excludes substances that do not result in enhanced efficacy. Section 3(i) excludes methods of medical treatment from patentability.

The opponents also argued that the application did not sufficiently disclose the claimed invention. Patent Office upheld all grounds of opposition.

What is the extent of TB in India?

India continues to carry the world’s largest tuberculosis burden. According to the WHO’s Global Tuberculosis Report 2025, an estimated 2.71 million people developed TB in India in 2024, accounting for about 25% of global cases. The estimated incidence rate was 187 cases per 100,000 people.

Drug-resistant TB adds to the challenge because the disease can require specialised treatment, careful monitoring and prolonged engagement with health services. High treatment costs can place pressure on households, particularly when illness affects a person’s ability to work and earn an income.

India’s national TB programme provides free diagnosis and treatment through public health services. However, access to medicines alone does not resolve all the challenges faced by patients, including treatment-related adverse effects, loss of income, travel costs and the need for nutritional and social support.

Comment | India needs innovative strategies to eliminate TB

Why is this important, and how could it help patients?

BPaL offers a shorter, all-oral treatment option for eligible patients than older regimens that could require treatment for much longer periods and, in some cases, painful injections. WHO recommends the six-month regimen for specified groups of patients with multidrug- or rifampicin-resistant TB, including those with additional fluoroquinolone resistance, subject to eligibility criteria.

For patients, a shorter course can mean fewer months of treatment, less disruption to work and family life, and a reduced burden of attending health facilities. However, outcomes depend on appropriate patient selection, clinical supervision, adherence and management of adverse effects.

Loon Gangte of DNP+ said: “Only those who have been treated for TB know what it feels like to go through more than a year of antibiotics with painful injections. Access to a shorter, oral and effective treatment can mean returning to work, caring for their families and rebuilding their lives.”

The patent rejection could make it easier for manufacturers to compete to supply the combination, potentially placing downward pressure on prices.

However, actual savings will depend on whether generic manufacturers can enter the market, whether they can obtain the necessary regulatory approvals, and how procurement and distribution are organised.

What is the national and international background to the issue at hand?

India introduced the National TB Elimination Programme (NTEP) in 2020, setting an ambition to eliminate TB by 2025 — five years ahead of the global Sustainable Development Goal target of 2030. The government approved the introduction of the BPaLM regimen, which adds moxifloxacin to BPaL, under the national programme in 2024. The programme can use BPaL without moxifloxacin in appropriate clinical circumstances.

According to the organisations, patents on the BPaL combination have been granted in 11 countries, including South Africa, Indonesia and Russia, and are due to expire in 2036. They have also called for the publication of pretomanid licensing agreements to improve transparency.

Prathibha Sivasubramanian of TWN said the Indian decision should prompt the TB Alliance to surrender granted patents and withdraw corresponding pending applications elsewhere.

Where does India stand on TB elimination?

India has made progress in finding and treating TB cases, but the scale of the epidemic remains substantial.

“The patent rejection is therefore one part of a much larger effort. Faster diagnosis, effective treatment, access to affordable medicines, prevention, nutrition support and sustained public investment remain essential. Ultimately, the decision’s public-health significance will depend on whether it translates into greater competition, lower treatment costs and reliable access to shorter regimens for patients who need them,’’ the group said.