India Patent Office Rejects TB Drug Patent, Raising Hopes for Affordable Treatment

NEW DELHI, Oct 30: In a significant development for patients battling drug-resistant tuberculosis (TB), India’s Patent Office has rejected a patent application filed by the US-based Global Alliance for TB Drug Development, commonly known as TB Alliance, for the BPaL combination treatment, opening the possibility of greater competition in the supply of medicines used against the disease.

The decision, issued on October 27 and reported on October 29, concerns a combination of three medicines — bedaquiline, pretomanid and linezolid  used in shorter, all oral treatment regimens for eligible patients with drug-resistant tuberculosis.

The ruling has drawn attention from public health advocates and TB survivors, who have long argued that affordable access to effective medicines is essential to controlling the disease. However, healthcare experts have cautioned that the rejection of the patent application does not automatically guarantee cheaper medicines or immediate availability of generic alternatives.

The Patent Office refused the application under Section 15 of the Patents Act, 1970, after considering objections raised through two pre-grant oppositions filed in July 2020. The Controller found that the application did not satisfy key requirements relating to novelty, inventive step, patentability and sufficient disclosure.

The application, filed in April 2018, had been challenged by individuals and organisations working on affordable access to TB treatment. The objections questioned whether the combination of existing medicines qualified for fresh patent protection and whether the claimed invention met the legal standards prescribed under Indian patent law.

The two oppositions were filed jointly by TB survivor and activist Ganesh Acharya and Eldred Tellis, and separately by the Delhi Network of Positive People (DNP+).

Acharya described the decision as an important victory for people affected by drug-resistant tuberculosis, maintaining that access to life-saving medicines should not be restricted by unnecessary commercial barriers.

The development is particularly important for India, which continues to carry one of the world’s largest tuberculosis burdens. According to estimates cited by the World Health Organisation, approximately 2.71 million people developed TB in India in 2024, accounting for nearly a quarter of the global total.

Importance of the BPaL combination

BPaL combines bedaquiline, pretomanid and linezolid and offers an alternative to lengthy treatment courses for certain categories of drug-resistant TB patients.

Traditionally, treatment for drug-resistant tuberculosis has involved prolonged medication, sometimes extending over 18 to 24 months. Such lengthy treatment can place considerable physical, emotional and financial pressure on patients and their families.

Shorter treatment options have therefore emerged as an important development in TB management. They can reduce the duration of medication, help patients return to their regular activities sooner and ease the burden on healthcare facilities.

India has also adopted the six-month BPaLM regimen for eligible patients under its National Tuberculosis Elimination Programme. BPaLM includes the three medicines used in BPaL, along with moxifloxacin.

The shorter regimen has strengthened treatment options for people diagnosed with multidrug-resistant or rifampicin-resistant tuberculosis who meet the prescribed eligibility criteria.

However, specialists emphasise that these medicines cannot be prescribed indiscriminately. Treatment decisions must be based on drug-sensitivity results, medical history, clinical assessment and established national treatment protocols.

Patent rejection does not guarantee immediate price relief

While public health advocates have welcomed the Patent Office’s decision, the next challenge will be ensuring that the ruling translates into tangible benefits for patients.

The rejection removes one potential patent barrier to generic competition in India. It does not, however, automatically approve generic versions of the medicines, determine their market prices or guarantee uninterrupted supplies.

Manufacturers must still meet applicable regulatory requirements, while government procurement agencies and healthcare institutions will have to ensure that quality-assured medicines reach eligible patients without delays.

Public health experts believe that effective coordination between the central government, state health departments, pharmaceutical manufacturers and treatment centres will be essential.

Reliable procurement systems, transparent distribution and proper monitoring will also be necessary to prevent shortages and ensure that patients are not forced to discontinue treatment.

The availability of affordable medicines is particularly important for people from economically weaker backgrounds, who often face difficulties managing the costs associated with prolonged treatment, travel to hospitals and loss of income.

For many families, shorter treatment courses can mean reduced disruption to employment, education and household responsibilities.

Doctors stress the need for controlled access

Even as the patent rejection has generated optimism, doctors have called for caution regarding the distribution and use of the combination medicines.

Pulmonologists have pointed out that not every patient with drug-resistant TB is eligible for BPaL or BPaLM treatment. Certain medical conditions, previous exposure to the medicines, age-related factors and pregnancy status may influence treatment decisions.

Doctors have also highlighted the importance of monitoring possible adverse effects, particularly those associated with linezolid, which can cause blood-related and neurological complications.

Regular medical supervision and appropriate laboratory investigations are therefore essential during treatment.

Healthcare specialists have warned that unrestricted or inappropriate use of the medicines could undermine efforts to control drug resistance. Improper prescribing, incomplete treatment and inadequate monitoring can contribute to the development of further resistance, making future treatment more difficult.

The existing system of providing these medicines through designated tuberculosis treatment centres is intended to ensure that prescriptions and diagnoses are verified before patients receive the drugs.

In Mumbai, civic health officials have indicated that a substantial proportion of drug-resistant TB patients may not qualify for the shorter regimen because of clinical and other eligibility requirements.

This highlights the need to balance affordable access with responsible medical supervision.

A wider challenge for India’s TB elimination programme

The patent decision comes at a time when India is working to strengthen its tuberculosis detection, treatment and prevention programmes.

The National Tuberculosis Elimination Programme has expanded diagnostic services, treatment facilities and community-based support to improve patient outcomes.

Early diagnosis remains a major priority because delayed identification of infection can increase the risk of transmission and complicate treatment.

Public health workers also play an important role in encouraging patients to complete prescribed treatment and attend follow-up appointments.

The availability of shorter treatment options can support these efforts, but experts say medicines alone cannot eliminate the disease.

Improved nutrition, awareness, timely diagnosis, infection control and sustained financial support for patients are equally important.

TB survivors and advocacy organisations have also called for greater involvement of affected communities in decisions concerning treatment access, drug procurement and healthcare policy.

The Patent Office’s decision has therefore renewed the debate over the relationship between intellectual property protection and public health requirements, particularly in countries carrying a substantial burden of infectious diseases.

For India, the immediate priority will be to ensure that the legal development leads to practical improvements in treatment affordability and availability while maintaining strict standards of medical safety.

The coming months will be important in determining whether the ruling encourages greater generic competition and helps expand access to quality-assured medicines for eligible drug-resistant TB patients.