For over five years, the Thai Network of People Living with HIV/AIDS (TNP+) and AIDS Access Foundation have been advocating to remove barriers to access to multidrug-resistant tuberculosis (MDR TB) drugs by filing oppositions to patent applications for a MDR TB medicine known as “Bedaquiline” in Thailand. After long efforts, patent applications are rejected and there is now no patent barrier to Bedaquiline in Thailand. It allows the country to import generic Bedaquiline at affordable price and provide it to patients under the national heatlh insurance schemes at no cost.
Chalermsak Kittitrakul, TNP+’s Project Manager for Access to Medicines, said, “The civil society’s movement on opposing the patent applications for Bedaquiline started at the 50th Union World Conference on Lung Health in Hyderabad, India in 2019. Civil society representatives from various countries met and agreed to join hands in campaigning for access to the drug for multidrug-resistant tuberculosis called “Bedaquiline” by filing oppositions to the patent applications related to Bedaquiline. In the following years, oppositions began to be filed in India, Brazil, Thailand, Ukraine, Belarus, Moldova, Kyrgyzstan, Vietnam, and Indonesia.”
Janssen Pharmaceuticals N.V., which is Johnson & Johnson (J&J), filed five patent applications for Bedaquiline in Thailand. The first of which is for the base compound, which was granted and expired in June 2023. The other four are ever-greening patent applications.
In 2020, AIDS Access Foundation and the Thai Network of People Living with HIV/AIDS (TNP+) filed information with the Department of Intellectual Property (DIP) to oppose and request that all of the four patent applications should be rejected.
In June 2023, the Department of Intellectual Property had decision to reject (not accept) two patent applications, which were applications filed for the use of Bedaquiline for the treatment of multidrug-resistant TB and latent TB. In September 2023, J&J appealed the decision. And, the Department ruled on the appeal in February 2024, upholding the first ruling and dismissing the both applications because they were not qualified to be patented under the Thai law. This ruling is final. If J&J disagrees, the company may file a lawsuit with the Intellectual Property Court.
In April 2024, J&J decided to drop the other two applications which were related to the fumarate salt and the pediatric formulation of Bedaquiline.
- TNP+ and AIDS Access Foundation filed an opposition to the patent application for Bedaquiline at the office of the Intellectual Property Department in March 2020.
Mr. Chalermsak said, “The Intellectual Property Department’s ruling indicated that the both applications did not violate Section 9(4) of the Patent Act, which does not grant patents to inventions on methods of diagnosis, treatment or cure of human and animal diseases. It was one of the main arguments that civil society used to cite in order to reject the applications. But the Department rejected the both applications, citing that they violated Sections 5(1) and (2) because they were not “new inventions” and were not “inventions with an inventive step”. The chemicals referred to in the applications were chemicals that had been previously disclosed. The treatments of drug-resistant TB and latent TB with the same group of drugs had also been disclosed before. This invention is still a process of using the same compounds to produce drugs to treat tuberculosis as before, and it is still a composition of drugs with the same compounds to treat new diseases only. The Department’s ruling is consistent with the information and reference documents that civil society submitted to consider rejecting the applications.”
“Although Bedaquiline is not patented in the country and we can import or manufacture it, we found that J&J filed an additional application in late 2024 for the long-acting formulation of Bedaquiline. TNP+ submitted a letter and information to the Department of Intellectual Property, asking the Department to consider rejecting the patent application because it is an application against the Thai patent law and does not qualify for patent protection.”
“Evergreening has always been used as a common trick by multinational pharmaceutical companies to extend their monopolies, that hinders the public’s access to essential medicines. This tactic also causes heavy and unnecessary workload on the DIP’s patent examiners. The case of Bedaquiline is just one example, where a single drug has mulitple patent applications to extend the unjustified monopolies. Many of these evergreening patent applications seek patent protection on the therapeutic methods, which is clearly against our law. However, the applications are written deceptively in a way that makes it look like they are not for therapeutic use. And they also include claims of chemical compounds and manufacturing processes that were previously stated in other applications already filed or publicly disclosed. That is just for making it confusing and waste time to examine. These disqualified patent applications should be rejected from the earliest stages of consideration, and not allowed to remain in the process.”
“The current patent system has been abused repeatedly and does not truly promote innovation and access to medicines, but rather allows multinational pharmaceutical industry to exploit it to increase their monopoly and make profit on people’s lives and health. This system creates and extends inequalities in access to medicines and should be reformed by taking public health interests before trade benefits.”
Bedaquiline has been approved on the National List of Essential Medicines for the treatment of multidrug-resistant tuberculosis since 2019. From 2020 to 2024, Thailand’s natioanl health insurance systems purchased and imported the orginal Bedaquiline from J&J at an average cost of 35,672 baht per six-month treatment (about USD 1,100) for 724 patients per year in average. In 2024 to 2025, J&J reduced the price to 11,734 baht per treatment. And, in 2025 to 2026, Thailand was able to purchase generic Bedaquiline from India for only 5,348 baht per treatment (about USD 160), increasing access to treatment in Thailand to almost 1,000 cases per year.
You can learn more about the ever-greening drug patents here.
- Feature image: International protest against Johnson & Johnson, the patent holder for Bedaquiline, at the 50th Union World Conference on Lung Health in Hyderabad, India, in 2019.
