MC Explains I Why Bedaquiline going off patent in India in July may be a giant leap in the fight against TB

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On March 23, the Indian patent office rejected an application by US-based pharma giant Johnson & Johnson (J&J) to extend its monopoly on manufacturing key tuberculosis drug Bedaquiline in India beyond July 2023.

This paves the way for the manufacture and availability of generic versions of the drug, which may slash its cost by 30-70 percent starting July this year.

As of now, Bedaquiline costs about $45 (approximately Rs 3,700) per month per patient while its generic version is expected to cost just about $8- $16 (Rs 658-1,316) in comparison.

MC explains the significance of this development and what it means for India in its fight against the infectious disease.

Also read: World Tuberculosis Day 2023: This AI tool can detect active TB cases in seconds

Why is the rise in drug-resistant tuberculosis a concern?

India has the highest burden of TB and multiple drug resistant-TB (MDR-TB) globally — disproportionately high even for the country’s population.

The annual TB report released last year showed that the country had a total of 19,33,381 new and relapsed tuberculosis patients in 2021.

This also included nearly 1,20,000 multiple drug resistant or MDR TB patients, who are resistant to at least isoniazid and rifampin, the two most potent TB drugs used to treat the bacterial disease.

Within this pool, nearly 20 percent or about 24,000 patients are further identified as XDR (extremely drug-resistant) TB patients, who, apart from being resistant to isoniazid and rifampin, are also resistant to fluoroquinolone and at least one of three injectable second-line drugs: amikacin, kanamycin and capreomycin.

It has been estimated that the risk of death due to MDR TB maybe 7.5 to 8.5 times higher compared to TB, and in 2020, the bacterial disease had caused 4.93 lakh deaths in India, which was 13 percent higher than the previous year.

MDR, pre-XDR and XDR TB, on top of the more benign form of the ailment, spell trouble for a country that targets eliminating the infectious disease by 2025.

Why is the availability of Bedaquiline important for the fight against MDR TB?

Bedaquiline,which was launched in the Indian market at a whopping Rs 7 lakh per vial, is purchased by the Union health ministry’s National TB Elimination programme and provided free of cost to nearly 60,000 MDR TB patients who reach out to authorised centres for treatment.

This drug has gained popularity by raising the treatment success rate of MDR TB from around 50 percent to 93 percent and cutting the treatment duration by 75 percent, from 2 years to 6 months.

Also read I India will soon roll out a new drug regimen for drug-resistant TB: Director, ICMR- National Institute for Research in Tuberculosis

But considering that there are nearly 1,20,000 MDR TB patients in India every year but the government is purchasing just half the number of courses, it is estimated that half of those who need the treatment cannot access it.

Why did the Indian Patent Office reject the evergreening of J&J’s Bedaquiline patent?

On March 23, the 2019 patent challenge by two TB survivors, Nandita Venkatesan and Phumeza Tisile, supported by Médecins Sans Frontières or Doctors Without Borders (MSF), was successful and the Indian Patent Office rejected J&J’s attempt to extend its monopoly over the drug in India beyond the primary patent’s expiry this July.

Indian patent law does not allow the evergreening of patents — an extension of a patent on new forms of medicine without a proven change in efficacy — and prevents pharma companies from abusing the patent system by making minor changes that can extend their 20-year drug monopolies, said MSF.

On its part, J&J said that it has been a long-standing partner in India’s efforts to combat TB, providing access to SIRTURO (bedaquiline), improving diagnostic capacity, training health workers on the clinical management of TB and DR-TB, and raising awareness about TB at the community level.

“The patent application in question — for a formulation of bedaquiline — was filed in India over a decade ago, as part of standard procedures when developing new medicines,” said a company spokesperson. “Whether this patent was granted or not, a formulation patent would not have prevented generic manufacturers from developing the active pharmaceutical ingredient (API) in their own formulations after July 2023, when our API patent expires in India.”