On March 23, 2023, the Indian Patent Office (IPO) rejected pharma company Janssen’s application for an extension of its patent on bedaquiline, a drug used in the treatment of tuberculosis patients. The verdict that came just a day ahead of World Tuberculosis Day was celebrated by health activists and tuberculosis survivors in India.
Janssen, owned by multinational Johnson and Johnson, applied for an extension of their original patent on bedaquiline on the basis of having discovered a new formulation. According to Indian law, in order to be granted a patent extension in such a situation, the manufacturer has to show that the new formulation leads to an enhanced therapeutic effect. Janssen repeatedly failed to prove that in the case of bedaquiline salt formulation.
If the patent on bedaquiline had been extended, public and family budgets would have remained burdened by unjustifiable high costs of the drug. Bedaquiline is an important drug for TB patients on many counts. The older TB drugs include injectables such as kanamycin, which have severe side effects including permanent hearing loss. On the other hand, bedaquiline is an oral drug with much higher safety and efficacy profile.
Bedaquiline was the first new tuberculosis drug in forty years when it was approved by the US Food and Drug Administration in 2012. According to the most recent Global Tuberculosis Report, in 2021, India recorded 119,000 cases of multidrug resistant tuberculosis and over half a million deaths caused by the disease.
Priyam Lizmary Cherian, an intellectual property lawyer who argued the case at the IPO, said that the decision should ease the generic production of bedaquiline, making safe and effective treatment more accessible. “India, being a generic production hub, can count on companies being able to pick up production after the original patent expires in July 2023,” she said.
Widely recognized as a disease of the poor, tuberculosis is generally not a prominent field in Big Pharma research and development, although it affects the lives of hundreds of thousands in the Global South. In 2021, the money invested in this field globally was not even half of what a UN High Level Meeting identified as a target.