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TWN
Info Service on Health Issues (Jun25/04) Penang, 6 Jun (Kanaga Raja) — The practice of “ever-greening” patents has always been a “common trick” used by multinational pharmaceutical companies to extend their monopolies, with the case of Bedaquiline, a key drug in treating multi-drug-resistant tuberculosis (TB) in Thailand, being just one such example, according to the Thai Network of People Living with HIV/AIDS (TNP+). In a post on its website on 27 May, the Make Medicines Affordable (MMA) campaign, led by the International Treatment Preparedness Coalition (ITPC) and partners, quoted Chalermsak Kittitrakul, TNP+’s Project Manager for Access to Medicines, as saying: “Ever-greening 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 [Thai Department of Intellectual Property] patent examiners,” he said. “The case of Bedaquiline is just one example, where a single drug has multiple patent applications to extend the unjustified monopolies,” Kittitrakul pointed out. [Filing multiple patent applications is a common strategy used by pharmaceutical companies to block generic competition. In the absence of opposition and weak examination by patent offices, 20-year patent monopolies are often granted for each application.] According to MMA, for over five years, the Thai Network of People Living with HIV/AIDS (TNP+) and AIDS Access Foundation have been advocating for the removal of barriers to access to multi-drug-resistant tuberculosis (MDR TB) drugs by filing oppositions to patent applications for a MDR TB medicine known as “Bedaquiline” in Thailand. It said that after long efforts, patent applications have been rejected and there is now no patent barrier to the drug Bedaquiline in Thailand, allowing the country to import generic versions at an affordable price and provide it to patients under the national health insurance schemes at no cost. Providing some background, MMA said Janssen Pharmaceuticals N.V., wholly owned by Johnson & Johnson (J&J), filed five patent applications for Bedaquiline in Thailand, the first of which was for the base compound, which was granted and later expired in June 2023, while the other four were “ever-greening” patent applications. It said in 2020, AIDS Access Foundation and TNP+ filed information with the Thai Department of Intellectual Property (DIP) to oppose and request that all four patent applications be rejected. In June 2023, the Department of Intellectual Property decided to reject (thus not accept) two patent applications, which were applications filed for the use of Bedaquiline for the treatment of multi-drug-resistant TB and latent TB. However, in September 2023, J&J appealed the decision, according to the MMA post. The DIP ruled on the appeal in February 2024, upholding the first ruling and dismissing both applications as they did not qualify for patents under Thai law. According to MMA, this ruling is final and if J&J disagrees, the company may file a lawsuit with the Intellectual Property Court. It said 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. MMA pointed out that the drug Bedaquiline has been approved for inclusion in the National List of Essential Medicines for the treatment of multi-drug-resistant TB since 2019. It said that from 2020 to 2024, Thailand’s national health insurance systems purchased and imported the original 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 on average. However, from 2024 to 2025, J&J reduced the price to 11,734 baht per treatment. It said from 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. In its post, MMA has quoted Mr Kittitrakul of TNP+ as saying: “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 multi-drug-resistant tuberculosis called “Bedaquiline” by filing oppositions to the patent applications related to Bedaquiline,” he added. Kittitrakul noted that in the following years, oppositions began to be filed in India, Brazil, Thailand, Ukraine, Belarus, Moldova, Kyrgyzstan, Vietnam, and Indonesia. “The Intellectual Property Department’s ruling indicated that 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,” he said. He said: “It was one of the main arguments that civil society used to cite in order to reject the applications. But the Department rejected both the 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,” he noted. “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,” said Kittitrakul. The Department’s ruling is consistent with the information and reference documents that civil society submitted to consider rejecting the applications, the social activist pointed out. “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,” said Kittitrakul. 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, he added. “Ever-greening 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 multiple patent applications to extend the unjustified monopolies,” Kittitrakul stressed. “Many of these ever-greening patent applications seek patent protection on the therapeutic methods, which is clearly against our law,” he further said. “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,” Kittitrakul explained in the MMA post. According to Kittitrakul, this is just to make it “confusing” and a waste of time to examine. “These disqualified patent applications should be rejected from the earliest stages of consideration, and not allowed to remain in the process,” Kittitrakul suggested. He said the current patent system has been abused repeatedly and does not truly promote innovation and access to medicines, but rather allows the multinational pharmaceutical industry to exploit it to increase their monopoly and make a 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,” said Kittitrakul in the MMA post. +
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