Recently, the Indian Patent Office rejected an application by pharmaceutical giant Johnson & Johnson (J&J) to extend its patent on the drug bedaquiline. 

What is Bedaquiline?

Bedaquiline is a drug in tablet form used to treat drug-resistant tuberculosis (TB).

What is drug-resistant TB?

  • As of 2017, India accounted for around one-fourth of the world’s burden of multi-drug-resistant (MDR) TB and of extensively-drug-resistant (XDR) TB.
  • MDR TB resists treatment by at least two frontline drugs in TB treatment, isoniazid and rifampicin.
  • XDR TB resists these two drugs as well as fluoroquinolones and any second-line injectable drug.
  • XDR TB is rarer than MDR TB.
  • TB incidence in India has been on the decline, but MDR TB and XDR TB endanger initiatives to locally eradicate the disease.

How is drug-resistant TB treated?

  • TB is an infection of the bacterium Mycobacterium tuberculosis in the lungs, but often in other organs as well.
  • It can be treated by strictly adhering to the doses and frequencies of drugs prescribed by a physician.
  • Deviations from this schedule can lead the bacteria to become drug-resistant.
  • The drugs often have side effects that diminish the quality of life and/or because patients haven’t been afforded access to the requisite drugs on time.
  • Drug-resistant TB is harder to treat.


Significance of bedaquiline:

  • One important option for those diagnosed with pulmonary MDR TB is bedaquiline.
  • In 2018, the World Health Organization replaced two injectable drugs for MDR TB with an oral regimen that included bedaquiline.
  • Bedaquiline hadn’t completed phase III trials.
  • Studies until 2018 found that it could be toxic to the heart and the liver.
  • Hence it is recommended only as a treatment of last resort.
  • India’s Health Ministry has guidelines for bedaquiline use as part of the Programmatic Management of MDR TB under the National TB Elimination Programme.

Why was the patent application rejected?

  • J&J’s patent application was for a fumarate salt of a compound to produce bedaquiline tablets.
  • It was argued that J&J’s method to produce a solid pharmaceutical composition of bedaquiline is obvious, known in the art and doesn’t require an inventive step.
  • According to the Indian Patent Act 1970, an ‘inventive step’ is an invention that is not obvious to a person skilled in the art.

Significance of the rejection:

  • India has the largest population of people living with drug-resistant TB.
  • J&J’s patent on bedaquiline meant the drug cost $340 per person, plus the cost of other drugs.
  • The rejection is expected to lower the cost of bedaquiline by up to 80%.
  • So far, the Indian government has directly procured the drug and distributed it through State-level TB programmes.
  • After July 2023, manufacturers of generic drugs will be able to produce generic versions of bedaquiline.


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