Big Blow: JnJ loses patent battle of key tuberculosis drug Bedaquiline in India

This landmark verdict will allow local companies to make cheaper generic versions, thereby, breaking the monopoly of the pharma major on the key anti-Tuberculosis drug. It comes at a time when India is setting ambitious targets to eradicate TB from the country by 2025.

Bedaquiline, sold under the brand name Sirturo, was approved for medicinal use in the United States in 2012, becoming the first new tuberculosis drug in 40 years to be given the green light.

Developed by Janssen, Johnson & Johnson’s (J&J) pharmaceutical division, in 2012, bedaquiline received conditional approval by the US Food and Drug Administration (FDA) for the treatment of multidrug resistant (MDR) TB. A 2018 WHO rapid communication on MDR-TB treatment guidelines prioritised bedaquiline among drugs for treatment and, in 2019, it was launched in India.

The company had filed a patent for Fumarate salt of bedaquiline in 2008 to extend its patent till the end of 2027. It was under review by the patent office. The strategy is called patent evergreening used by companies to keep the prices high as it would keep the affordably priced generic versions of the drug out of the market.

However, two TB survivors, Nandita Venkatesan from Mumbai and Phumeza Tisile from Khayelitsha in South Africa—had filed pre-grant opposition against the application at the Mumbai Patent Office in 2019, along with Médecins Sans Frontières (Doctors Without Borders, or MSF), urging to reject the secondary patent application filed by JnJ.

The survivors had launched their challenge as part of a campaign to make the drug more affordable.

Pronouncing her verdict, Latika Dawara Asst. Controller of Patents & Designs Patent Office on Thursday stated that the "instant application does not meet the requirements of section 2(1)(ja) and sections 3(d) & 3(e) of the Patents Act based on the findings from the investigation as well as from the matter presented by the opponents in the pre-grant opposition proceedings as discussed above".

"Therefore, it is hereby ordered that the invention disclosed and claimed in the instant application has been refused to proceed further under section 15 of the Act and simultaneously, I dispose both of the pre-grant oppositions as per the provision under Section 25(1) of the Act and corresponding Rules made there under, the order said.

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Commenting on the verdict, JnJ spokesperson in India told Money Control that 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 J&J’s API patent expired in India.

“We remain committed to supporting India’s efforts to end TB and look forward to participating in the TB high-level summit hosted by Prime Minister Modi later this week,” the statement further read.

In 2020, Johnson and Johnson announced it was cutting the price of bedaquiline tablets, made available to the Stop TB Partnership in around 135 low- and middle-income countries, to USD 340 from USD 400 for a six-month treatment course.

The medical charity Doctors Without Borders (MSF) welcomed that decision at the time but said the price should come down further and be extended to more countries.

Many such manufacturers have already expressed an interest in supplying the drug at more affordable prices under the WHO's pre-qualification programme.MSF welcomed the ruling.

"(We) urge generic manufacturers to use this opportunity to enter the market and produce and supply quality-assured generic versions of the lifesaving TB drug bedaquiline without the fear of litigation hanging over their heads," Ilaria Motta, tuberculosis medical adviser for the MSF Access Campaign, said in a statement.

Venkatesan told AFP in January bedaquiline had become the "backbone" of most tuberculosis treatments, especially for those suffering severe, drug-resistant cases.

India accounted for nearly 29 percent of 10.6 million tuberculosis cases worldwide, according to the World Health Organization's (WHO) 2022 Global TB report, a major public health problem as it struggles with drug-resistant strains.