Bedaquiline for TB

Why in news?

Johnson & Johnson’s patent on bedaquiline expired recently which will allow generic manufacturers to supply this crucial drug for Tuberculosis.

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Transmission - TB bacteria spread through the air from one person to another
It spreads through the air when infected people cough, sneeze or spit.
Treatment - Tuberculosis is preventable and curable.
Globally, DR-TB is a major contributor to antimicrobial resistance.

Each year, nearly half a million people develop drug-resistant TB and nearly 10.4 million people develop drug-sensitive TB.

Bedaquiline is the core drug for the treatment of drug-resistant TB (DR-TB).
Bedaquiline is a crucial drug in the treatment of multi-drug resistant TB (MDR-TB) patients for whom the first-line drug treatment has stopped working.
It is also an oral medicine with minimal side-effects as compared to other such medicines like Kanamycin.
Janssen Pharmaceutical (a subsidiary of J&J) made bedaquiline around 2002 and was approved in 2012.
So far, J&J has claimed sole ownership of bedaquiline.

J&J has filed secondary patents over bedaquiline till 2027, which were granted in 66 low-and middle-income countries.
It includes 34 countries with high burden of TB, multidrug-resistant TB (MDR-TB) and TB/HIV.
J&J is maintaining its monopoly over the bedaquiline market through this patents.
J&J is planning a deal with Global Drug Facility (GDF), a non-profit distribution agency, which could expand access to the drug.
J&J has sought to extend its patent on bedaquiline and is facing has faced public outrage for it.
In India - The Indian Patent Office rejected J&J’s secondary patent which would have extended its monopoly for 4 more years.
Indian measures against evergreening of patents -
- Section 3(d) of the Patents Act of 1970 does not allow ‘evergreening’ of patents to ensure that the monopoly does not exist.
- This section prevents innovator pharma companies from extending the patent beyond the stipulated period of 20 years.

On the expiry of Bedaquiline patent, the drug makers can make the generic versions as per the law.
Generic competition of drug manufacturing will decrease the prices of the drugs.
In India - National TB programmes will benefit from the generic supply of bedaquiline from Indian manufacturers to reduce prices.
With patent inforce, the drug was procured only through the government and costs about Rs.21,000 for a 6-month course.
The government has restricted the supply of the drug, in view of the cost.
With the advent of generics at a lower price, the reach of the drug to the drug-resistant TB patients in the country will expand in due course of time.

Some of the countries hardest hit by DR-TB will not benefit from this deal.
Eastern European countries and China with high burden of TB are out of the agreement.
Countries like South Africa are not purchasing from GDF so far.
South Africa cannot access generic Bedaquiline until 2047 as the ever-greening patent is still inforce.

Quick Facts

A primary patent protects directly an active ingredient.
A secondary patent protects a range of chemicals related to an active ingredient such as crystalline forms of the original compound, methods of use, formulations, dosages, etc.
Ever-greening of patents - To extend the patent period when companies make slight changes to the formulation.
The Global Drug Facility (GDF) for tuberculosis (TB) was launched by the Stop TB Partnership.
It aims to provide equitable access to affordable high-quality anti-tuberculous drugs and diagnostics.

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