The ever-present threat of evergreening

Apart from lenacapavir, other crucial medicines have also been the target of patent evergreening by Big Pharma. Kanaga Raja looks at the case of the tuberculosis drug bedaquiline in Thailand.

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THE practice of evergreening 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 (MDR 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: ‘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 [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, TNP+ and the AIDS Access Foundation have been advocating for the removal of barriers to access to MDR TB drugs by filing oppositions to patent applications for bedaquiline in Thailand. It said that after lengthy efforts, the patent applications have been rejected and there is now no patent barrier to bedaquiline in Thailand, allowing the country to import generic versions at an affordable price and provide them 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, which was for the base compound, was granted and later expired in June 2023, while the other four were evergreening applications. In 2020, the AIDS Access Foundation and TNP+ filed information with the DIP to oppose and request that all four patent applications be rejected.

In June 2023, the DIP decided to reject two applications, which were applications filed for the use of bedaquiline for the treatment of MDR TB and latent TB. However, in September 2023, J&J appealed the decision. 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. This ruling is final and 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 paediatric formulation of bedaquiline.

MMA pointed out that bedaquiline has been approved for inclusion in Thailand’s National List of Essential Medicines for the treatment of MDR TB since 2019. From 2020 to 2024, the 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 $1,100) for 724 patients per year on average. From 2024 to 2025, J&J reduced the price to 11,734 baht per treatment.

However, from 2025 to 2026, Thailand is able to purchase generic bedaquiline from India for only 5,348 baht per treatment (about $160), increasing access to treatment in Thailand to almost 1,000 cases per year.

In its post, MMA quoted 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 … bedaquiline by filing oppositions to the patent applications related to bedaquiline.’

Kittitrakul noted that in the following years, oppositions began to be filed in India, Brazil, Thailand, Ukraine, Belarus, Moldova, Kyrgyzstan, Vietnam and Indonesia.

Of the Thai DIP’s ruling on the two patent applications, he said it indicated that both applications did not violate Section 9(4) of the country’s Patent Act, which does not grant patents to inventions on methods of diagnosis, treatment or cure of human and animal diseases. This had been one of the main arguments cited by civil society to reject the applications.

Instead, the DIP rejected both the applications on the grounds that they violated Sections 5(1) and (2) because the inventions concerned 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,’ said Kittitrakul. ‘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 DIP’s ruling was consistent with the information and reference documents that civil society had submitted to consider rejecting the applications, Kittitrakul pointed out.

However, he noted 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 DIP asking the Department to consider rejecting the application because the application is against the Thai patent law and the subject matter does not qualify for patent protection.

‘Many of these evergreening patent applications seek patent protection on the therapeutic methods, which is clearly against our law,’ said Kittitrakul. ‘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 on chemical compounds and manufacturing processes that were previously stated in other applications already filed or publicly disclosed.’

Such patent applications, Kittitrakul suggested, should be rejected from the earliest stages of consideration and not be allowed to remain in the process.

He said the current patent system has been repeatedly abused and does not truly promote innovation and access to medicines, but rather is exploited by the multinational pharmaceutical industry to increase monopoly and profit on people's lives and health.

‘This system creates and extends inequalities in access to medicines and should be reformed by [putting] public health interests before trade benefits,’ said Kittitrakul.                                                                            

Kanaga Raja is the Editor of SUNS (South-North Development Monitor), which is published by the Third World Network. This article first appeared in SUNS (No. 10237, 9 June 2025).

*Third World Resurgence No. 363, 2025/2, pp 32-33