BPaL Patent application rejection by the Indian Patent Office has brought attention to access to treatment for drug-resistant tuberculosis (TB). On 27 October 2026, the Patent Office rejected an application filed by the US-based Global Alliance for TB Drug Development, commonly known as TB Alliance. The application concerned BPaL, a combination of three medicines used to treat certain forms of drug-resistant tuberculosis through a six-month, all-oral treatment regimen.

The decision followed objections from civil society organisations, which argued that the combination and its use had already been disclosed in earlier scientific research and clinical trials. The Patent Office cited several reasons for rejecting the application, including lack of novelty, absence of an inventive step and provisions of Indian patent law that restrict patents on certain known medicines and treatment methods.

The decision means that this particular application did not result in a patent grant in India. It does not automatically cancel other patents or remove all regulatory requirements related to the medicines.

What Is BPaL Treatment?

BPaL is a combination of three medicines: bedaquiline, pretomanid and linezolid. It is used in the treatment of certain forms of drug-resistant tuberculosis.

Tuberculosis is an infectious disease caused by bacteria that usually affects the lungs, although it can also affect other parts of the body. Drug-resistant TB develops when the bacteria do not respond to one or more medicines normally used to treat the disease.

Drug-resistant tuberculosis can be difficult to treat because some standard medicines may no longer work effectively. Treatment depends on the type of resistance, the patient’s medical condition and the recommendations of healthcare professionals.

BPaL offers a shorter, all-oral treatment option for eligible patients with particular forms of drug-resistant TB. An all-oral regimen uses medicines taken by mouth rather than relying on injectable drugs.

The combination is important because effective treatment can help patients recover and reduce the spread of tuberculosis. However, the medicines must be prescribed and monitored by qualified healthcare professionals according to the applicable treatment guidelines.

Difference Between BPaL and BPaLM

BPaL and BPaLM are related treatment combinations, but they contain different medicines.

BPaL includes bedaquiline, pretomanid and linezolid. BPaLM adds moxifloxacin to these three medicines.

Moxifloxacin is an antibiotic that may be included in treatment regimens for eligible patients, depending on the type of tuberculosis and the patient’s clinical circumstances. The appropriate regimen is determined by medical professionals under the relevant treatment guidelines.

India has been using BPaLM under its tuberculosis control efforts. According to the information provided, more than 15,000 patients in India have received BPaLM through the National Tuberculosis Elimination Programme (NTEP).

The Patent Office’s decision concerned TB Alliance’s specific BPaL patent application. It should not be interpreted as a decision that automatically removes every patent relating to the medicines or their combinations.

Why Did the Indian Patent Office Reject the Application?

The Indian Patent Office rejected the application on 27 October 2026 after considering patentability concerns and objections to the proposed patent.

The reasons cited included lack of novelty, absence of an inventive step, non-patentability under the Patents Act, 1970, and insufficient disclosure.

Novelty means that an invention must contain something new that was not already disclosed in earlier information available to the public. An inventive step requires more than a change or development that would be obvious to a person skilled in the relevant field.

In this case, opponents argued that scientific research and clinical trials dating from 2015 had already disclosed the medicines in combination and their use in a shorter treatment regimen.

The Patent Office also referred to Sections 3(d), 3(e) and 3(i) of the Patents Act, 1970. These provisions establish limits on what can be patented in India, including certain changes to known medicines, simple mixtures of known substances and methods of treating human beings.

Role of Section 3(d) of the Patents Act, 1970

Section 3(d) is an important provision of Indian patent law. It restricts patents on certain new forms of known substances unless the required improvement in efficacy is demonstrated.

The provision aims to prevent patents from being granted merely because a known substance has been presented in a different form without meeting the legal requirements.

In the pharmaceutical sector, this rule is relevant when a patent application concerns a new form or modification of an existing medicine. The applicant must satisfy the applicable legal standards rather than relying only on the fact that the product has been changed.

The provision is part of India’s broader approach to balancing pharmaceutical innovation with access to medicines.

What Do Sections 3(e) and 3(i) Mean?

Section 3(e) of the Patents Act, 1970 excludes a mere admixture of known substances when the combination only brings together the properties of its ingredients without the required qualifying result.

In pharmaceutical patent applications, this provision can become relevant when an applicant seeks a patent for a combination of medicines that are already known. The specific facts and evidence of each application must be assessed under the law.

Section 3(i) excludes methods of treating human beings from patentability. It addresses treatment methods rather than automatically making every medicine used in a treatment regimen unpatentable.

The Patent Office cited these provisions among its reasons for rejecting the BPaL application. Its decision was based on the specific application and should not be treated as a blanket ruling on every patent involving bedaquiline, pretomanid or linezolid.

Civil Society Groups Opposed the Patent Application

Several civil society organisations filed pre-grant oppositions against the application in July 2020. They included the Delhi Network of Positive People, Sankalp Rehabilitation Trust, Third World Network, Lawyers’ Collective and Médecins Sans Frontières Access Campaign.

These organisations raised concerns about whether the proposed combination met the requirements for patent protection. They argued that earlier research and clinical trials had already disclosed the combination and its use in a shorter treatment regimen.

A pre-grant opposition is a legal process that allows a person to challenge a patent application after it has been published but before the patent is granted.

Section 25(1) of the Patents Act, 1970 provides the legal basis for this process. It allows objections to be submitted on specified grounds, helping the Patent Office examine whether an application meets the requirements of Indian patent law.

Civil society organisations have also urged TB Alliance to withdraw related patent claims in other countries and surrender patents that have already been granted where applicable.

Tuberculosis Burden in India

Tuberculosis remains a major public health challenge in India. According to the figures provided, an estimated 2.71 million people developed TB in India in 2024, representing approximately one-quarter of global cases.

Drug-resistant TB presents additional difficulties because treatment can require specialised medicines, careful monitoring and longer or more complex medical management, depending on the type of resistance.

India’s National Tuberculosis Elimination Programme works to improve TB prevention, diagnosis, treatment and reporting. Access to effective medicines is an important part of these efforts.

The availability and affordability of treatment can affect whether patients are able to complete the recommended course of medicines. Patent decisions may influence market competition and the conditions under which pharmaceutical products can be supplied, although actual prices and availability depend on several legal, regulatory and commercial factors.

Why the BPaL Patent Decision Matters

The rejection has drawn attention to the relationship between patent protection, medical innovation and access to essential treatment.

Patents can provide incentives for developing new medicines by giving applicants certain exclusive rights for a limited period when legal requirements are met. At the same time, patent law establishes conditions intended to prevent protection from being granted to inventions that do not meet the required standards.

In India, provisions such as Sections 3(d) and 3(e) are particularly relevant to certain pharmaceutical applications involving known substances and combinations.

The Patent Office’s decision means that TB Alliance’s specific application did not secure a patent grant in India. It does not, by itself, establish that all other patent rights relating to the medicines have ended or that every version of the treatment can be produced and sold without further legal or regulatory checks.

The decision is relevant to ongoing discussions about affordable healthcare, pharmaceutical patents and treatment access for drug-resistant tuberculosis. It also highlights the role of pre-grant opposition in allowing interested parties to raise concerns before a patent is granted.