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The monthly magazine, October 2026 · Science and Technology › Intellectual property and Geographical Indications

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India's Patent Office refuses a patent on BPaL, the six month regimen for drug resistant TB

LeadPrelims and Mains31 Oct 2026

Why in news

  • In October 2026 the Indian Patent Office refused the TB Alliance's application for a patent on BPaL, the combination of bedaquiline, pretomanid and linezolid for drug resistant tuberculosis.
  • The refusal followed two pre grant oppositions filed in 2020 by patient groups, with support from Médecins Sans Frontières and others.

Background

The bacterium _Mycobacterium tuberculosis_ causes tuberculosis, and standard treatment takes six months with four drugs

  • When the bacterium resists the two main drugs, rifampicin and isoniazid, doctors call the disease multidrug resistant TB
  • BPaL is a six month, all oral regimen that the World Health Organization recommends for certain drug resistant TB. The TB Alliance, a non profit, developed pretomanid, its new component.
  • India carries the world's largest TB burden. The National TB Elimination Programme runs diagnosis and free treatment, and drug resistant cases are its hardest and costliest part.
The old regimen against BPaL, and how a pre grant opposition works Drug resistant tuberculosis: what the regimen changed, and the route by which India refused the patent Older regimens for drug resistant TB 18 to 24 months of treatment Many drugs, often with painful daily injections High drop out, and further resistance when patients stop BPaL Six months, all oral Three drugs: bedaquiline, pretomanid, linezolid Recommended by the World Health Organization for certain drug resistant TB Application The TB Alliance applies for a patent on the three drug combination. Opposition In 2020 patient groups file pre grant oppositions: the combination was disclosed in trials from 2015. Hearing The Patent Office hears both sides. The Patents Act, 1970 bars a new use of known substances without enhanced efficacy. Refusal October 2026: the patent is refused. Generic makers may supply the regimen in India.
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How India's patent law came to refuse BPaL, 1970 to 2026 Blue: what Parliament and the Supreme Court decided. Teal: the Patent Office applying those rules to tuberculosis drugs 1970 2005 2013 2023 2026 Patents Act, 1970 Process patents only on medicines. Indian firms copy drugs by other routes. Amendment Product patents on medicines under WTO rules. New forms of known drugs need enhanced efficacy. Pre grant opposition open to anyone. Novartis judgment Novartis v. Union of India: the Supreme Court upholds the test. Efficacy means therapeutic efficacy. No patent on a new crystal form of imatinib. Bedaquiline The Patent Office refuses a secondary patent on the drug after a pre grant opposition. Generic makers step in. BPaL refused October: the three drug combination is nothing new. Trials had disclosed it from 2015. Generic supply of the regimen stays open. Each step kept generic supply alive: the law rewards a real inventive step and refuses a monopoly on a known drug in a new form, use or combination.
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What India's patent law says

  • The Patents Act, 1970 grants a patent only for an invention that is new, involves an inventive step and has industrial use.
  • The Act refuses a patent on a new form or a new use of a known substance unless it shows enhanced efficacy. The Act also refuses patents on methods of treating people. The timeline below shows how Parliament, the Supreme Court and the Patent Office built that position, from the 2005 amendment and Novartis v. Union of India (2013) to the bedaquiline refusal of 2023.

What the decision does

  • No company can hold a monopoly in India on the three drugs taken together. Generic makers can supply each drug and the combination to the national programme and to export markets.
  • Indian manufacturers already make bedaquiline and linezolid. Generic makers can now price a six month course for public programmes.
  • The decision binds only India. In countries that grant the patent, the regimen stays with one supplier.

Analysis

The regimen is valuable, but value is not novelty.

  • Patent law rewards an inventive step
  • Trials had already described the joint use of the three known drugs

The fight was over access, not price alone.

  • A single supplier can ration a drug by country and by volume
  • For a disease whose patients are poor and whose programmes are public, the right to buy from several makers decides whether the regimen reaches clinics at all

India's rules are policy, not accident.

  • The 2005 amendment that accepted product patents also sharpened the efficacy test and widened the opposition route
  • The BPaL refusal applies that design as intended

The innovation argument has limits here.

  • Developers say strict rules discourage research on neglected diseases
  • Pretomanid came from a donor funded non profit, not from a market monopoly

The way forward

  • Scale up BPaL in the National TB Elimination Programme with competitive generic supply, and track cure rates and adverse effects in the field.
  • Negotiate pooled procurement so that the six month course reaches high burden districts first.

Exam lens

  • Prelims:
    • BPaL: bedaquiline, pretomanid and linezolid, a six month all oral regimen for drug resistant TB
    • Patents Act, 1970: no patent on a new form or use of a known substance without enhanced efficacy, and none on methods of treatment
    • The Novartis v. Union of India (2013) judgment upheld the efficacy test
    • Pre grant opposition is open to any person
  • Mains: "India's patent law balances innovation against access to medicines." Examine with reference to the refusal of a patent on the BPaL regimen for drug resistant tuberculosis.

Asked before: Prelims 2019 · Mains 2024 GS3 · Prelims 2019

Show the questions
  1. Prelims 2019: Consider the following statements: 1. According to the Indian Patents Act, a biological process to create a seed can be patented in India. 2. In India, there is no Intellectual Property Appellate Board. 3. Plant varieties are not eligible to be patented in India. Which of the statements given above is/are correct?
  2. Mains 2024 GS3: What is the present world scenario of intellectual property rights with respect to life materials? Although, India is second in the world to file patents, still only a few have been commercialized. Explain the reasons behind this less commercialization.
  3. Prelims 2019: Which of the following are the reasons for the occurrence of multi-drug resistance in microbial pathogens in India? 1. Genetic predisposition of some people. 2. Taking incorrect doses of antibiotics to cure diseases. 3. Using antibiotics in livestock farming. 4. Multiple chronic diseases in some people. Select the correct answer using the code given below.

Connects to

Sources
  • The Hindu, 29 October 2026

Settled facts (dates of Acts, constitutional provisions, standing definitions) are from standard references.

Filed under: Intellectual property and Geographical Indications · The monthly magazine, October 2026