Key Takeaways
- The Indian Patent Office has rejected a patent application for the BPaL treatment regimen
- The rejection of the patent application will increase access to the treatment for patients in India
- Civil society groups are calling on the TB Alliance to waive patents in other countries
What is the BPaL treatment regimen?
The BPaL treatment regimen is a six-month, all-oral treatment for drug-resistant tuberculosis, recommended by the World Health Organization (WHO) for eligible people.
It offers a shorter course of treatment than older, longer regimens, reducing the burden of treatment on patients and their families.
Who is affected by the patent rejection?
India has the worldโs largest tuberculosis burden, with approximately 2.71 million people developing TB in the country in 2024, accounting for a quarter of global cases.
Civil society groups, including the Delhi Network of Positive People (DNP+) and the Third World Network (TWN), have welcomed the patent rejection.
By the numbers
- 2.71 million: The number of people who developed TB in India in 2024.
- 187: The incidence rate of TB per 1,00,000 people in India.
- 11: The number of countries where patents on the BPaL combination have been granted.
- 2036: The year when patents on the BPaL combination are set to expire.
What led to the patent rejection?
The patent rejection follows two pre-grant oppositions filed in 2020, one by Eldred Tellis and Ganesh Acharya, with support from the Lawyersโ Collective and Mรฉdรฉcins Sans Frontiรจres Access Campaign, and the other by the Delhi Network of Positive People (DNP+), with support from TWN.
The opponents challenged the patent application on the grounds that the combination of bedaquiline, pretomanid, and linezolid, as well as its use in a shorter treatment regimen, had already been disclosed in scientific research and clinical trials dating back to 2015.
What are the implications of the patent rejection?
The patent rejection means that the BPaL treatment regimen will not be proprietary, allowing for greater access to the treatment for patients in India.
Civil society groups are also demanding that the TB Alliance stop the pursuit of proprietary rights over BPaL in other countries.
What do experts say about the patent rejection?
Loon Gangte of DNP+ explained that access to a shorter, oral, and effective treatment can mean returning to work, caring for their families, and rebuilding their lives for patients who have been treated for TB.
Prathibha Sivasubramanian, senior researcher at TWN, endorsed the call for the waiving of patents, saying that the Indian Patent Officeโs decision should serve as a clear signal to the TB Alliance to voluntarily surrender granted patents and to withdraw all corresponding pending applications in other jurisdictions.
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What are the next steps for the TB Alliance?
The TB Alliance should consider the Indian Patent Officeโs decision and voluntarily surrender granted patents and withdraw all corresponding pending applications in other jurisdictions.
The TB Alliance should also publish its pretomanid licence agreements, as demanded by civil society groups.
How will this decision impact TB treatment in India?
The rejection of the patent application is expected to increase access to the BPaL treatment regimen for patients in India, who will no longer have to rely on expensive and proprietary treatments.
This decision may also set a precedent for other countries to reject similar patent applications, increasing global access to affordable TB treatments.
What are the global implications of the patent rejection?
The rejection of the patent application may have global implications, as it could lead to increased access to affordable TB treatments in other countries where patents have been granted.
Civil society groups are calling on the TB Alliance to waive patents in other countries, which could lead to a significant increase in access to TB treatments globally.
Frequently Asked Questions
What is the BPaL treatment regimen?
The BPaL treatment regimen is a six-month, all-oral treatment for drug-resistant tuberculosis.
Why was the patent application rejected?
The patent application was rejected because the combination of bedaquiline, pretomanid, and linezolid had already been disclosed in scientific research and clinical trials dating back to 2015.
What are the implications of the patent rejection?
The patent rejection means that the BPaL treatment regimen will not be proprietary, allowing for greater access to the treatment for patients in India.
