In a significant win for children suffering from tuberculosis (TB), more affordable versions of a crucial TB drug will soon be available in India.
On July 5, the country’s patent office rejected Johnson & Johnson’s (J&J) patent application for the pediatric formulation of Bedaquiline.
This decision is especially important as Bedaquiline is a second-line treatment recommended by the World Health Organization (WHO) for multi-drug resistant TB (MDR-TB). MDR-TB affects patients who do not respond to the first-line TB drugs and need stronger medications.
MDR-TB (Multi-Drug Resistant Tuberculosis) is a type of tuberculosis that doesn’t respond to first line TB treatment drugs. Thus, makes it harder to treat and requires more complex, longer, and often more expensive medication regimens.
This victory for affordable medicine has a backstory. Last year, J&J also lost a patent case for the adult version of Bedaquiline in India.
This was the result of a challenge started in 2019 by two TB survivors, Nandita Venkatesan from India and Phumeza Tisile, a South African TB advocate. Their efforts prevented J&J from extending their monopoly on the drug for an additional four years.
The activists won, and in parallel, South African activists pushed their competition commission to investigate Bedaquiline’s pricing.
The concept of “evergreening” patents played a crucial role in these cases. Pharmaceutical companies often try to extend the life of their patents by making minor changes to existing drugs, thereby maintaining their monopoly and profits. However, Indian patent law, especially Section 3(d), prevents this practice by not allowing patents on new forms of known substances unless they significantly enhance efficacy.
The patent office found that the pediatric formulation of Bedaquiline lacked inventive steps since its components and preparation methods were already known. Additionally, J&J’s lack of response to the opposition further contributed to the rejection of their patent application.
This decision is particularly impactful given that an estimated 3.33 lakh children in India fall ill with TB each year, representing 28% of the global childhood TB burden. However, many cases remain undiagnosed, suggesting this number might be an underestimation.
By rejecting the patent, India is paving the way for more accessible and affordable treatment options, offering hope to thousands of children and TB patients across the country.
After this decision, Indian pharmaceutical companies can make the generic version of this drug in India which will reduce the price of the drug significantly.
Many TB patients who are living poor and developing countries or someone who are not able to afford expensive treatment can take the benefit of this move.