Janssen’s tuberculosis drug patent application gets rejected; Generics to be available soon

Reportedly, the oral drug has lesser-known harmful effects than injectable drugs. (File)

In a landmark decision today, the Controller of Patents office in Mumbai has rejected a Janssen Pharmaceuticals application for the patent of bedaquiline drug, used for treating the disease. Janssen Pharmaceuticals is a pharmaceutical company headquartered in Beerse, Belgium, and wholly-owned by Johnson & Johnson.

This move will allow pharmaceutical companies to launch generics after the main patent expires in July. According to industry experts, this move will help in bringing down the price of bedaquline.

The drug is used along with other medicines to treat tuberculosis patients when the first line of treatment fails to kill the bacteria.

According to the World Health Organization, in 2021, India has an incidence of 25.90 lakh tuberculosis cases. Data from the Ministry of Health and Family Welfare figures show tuberculosis patients notified in 2021 stood at 19.33 lakhs, up from 16.2 lakh in 2020. Of the cases notified in 2021, the number of drug-resistant cases was 48,232.

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Reportedly, the oral drug has lesser-known harmful effects than injectable drugs. According to media reports, the treatment cost for a six-month course is around Rs 65,000.

In 2009, Janssen Pharmaceuticals had published the patent for its bedaquiline medicine. After the patent is published, the public can raise opposition under the The Indian Patents Act, 1970. Later, several TB and HIV patients had challenged granting of the patent under Section 25(1)(h) of the Indian Patents Act, 1970.

Last year, TB survivor Nandita Venkatesan and Phumeza Tisile, filed a second pre-grant opposition application against Janssen’s move to get the patent extended for the drug. On Thursday, the patent controller decided to allow the patent till July 2023 but rejected the pharmaceutical firm’s request for patent extension.

Charity organisation Médecins Sans Frontières, also called Doctors, in a statement today said that the decision was a significant step toward increasing access to the lifesaving drug.

“Moving forward, J&J must not block the supply of more affordable generic versions of bedaquiline to high TB burden countries and stand by its 2019 statement from the Managing Director in India of Janssen [J&J’s pharmaceutical division], that generic manufacturers will be able to make generic versions of bedaquiline starting in 2023,” it said in a statement.

According to industry experts, the increase in competition in the market after the patent loss will also ensure a price drop.

Tuberculosis is a serious infectious bacterial disease that mainly affects the lungs. It is caused by a bacterium called Mycobacterium tuberculosis. When symptoms do occur, they usually include a cough (sometimes blood-tinged), weight loss, night sweats and fever. Sometimes, patients with active symptoms will require a long course of treatment involving multiple antibiotics.

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