Civil society files lawsuit against Thai Department of Intellectual Property as “failure to reject TB patent is unlawful”

Translated from the original press release published in Thai, by The Standard and Prachathai.

  • On 2 February 2021, a civil society network, comprising of the AIDS Access Foundation and the Thai Network of People Living with HIV/AIDS (TNP+), filed a lawsuit at the Central Intellectual Property and International Trade Court, against Thailand’s Department of Intellectual Property (DIP), Ministry of Commerce and the Director General.
  • The desired outcome is for a court order to be issued to the DIP, legally ordering it to reject Janssen Pharmaceutica N.V’s patent application on bedaquiline, a drug essential in the treatment of drug-resistant TB.
  • Janssen Pharmaceutica N.V is a Johnson & Johnson company.

Nimit Tienudom, director of the AIDS Access Foundation said:
“Bedaquiline is essential in treating drug-resistant TB and greatly shortens the treatment period for patients. Civil society groups have demanded the rejection of this patent request in many countries. The rejection of the patent request will allow more TB patients to access the drug. The DIP has the authority to reject the request without further examination, as the application is in relation to a treatment method. This means that the request does not meet patentability requirements and therefore is against the Patent Act 1979… the question is why the department hasn’t carried out their job?”

“The DIP is responsible for keeping a balance between protecting patent holders’ rights and people’s interest. If they see that a patent application is obviously ineligible, they should exercise their authority to protect the right of people in a stricter manner. The court ruling will establish a norm for the DIP, indicating that they have to strictly adhere to the laws in examining patent applications.”

“Drug-resistant TB is becoming a more and more severe problem. Treatment using traditional TB drugs requires 1-2 years of treatment. Bedaquiline can reduce this to 6-9 months. The World Health Organization has ranked Thailand among the 14 countries with the highest burden of TB, including many cases of drug-resistant tuberculosis. The DIP must reject Janssen’s patent request so that Thailand can be in a better position to manage TB. Currently the price charged by Janssen is very expensive, and the Thai health insurance system cannot afford this drug for all patients.”

Apiwat Kwangkeaw, president of TNP+ said:
“The older TB drugs currently being used in Thailand today have severe side effects. A TB survivor, and one of the co-plaintiffs, was treated with a less optimal drug for a period of 23 months. During this time she experienced various side-effects, including depression, insomnia, fatigue, dizziness, nausea, and difficulty concentrating, which she believes was a key cause of a car accident she was involved in. Many patients cannot tolerate the side-effects and quit the medication before the treatment is complete. She does not want other TB patients to face this prolonged treatment with negative impacts.”

“Bedaquiline has been included in the Thailand’s Universal Health Coverage Scheme (UHC) for 2021. However at current prices, approximately 36,000 baht for 6 months of treatment ($1,200 USD) the budget can only extend to around 100 patients per year. In South Africa the same treatment would costs 12,000 baht, a third of the price. If the DIP rejects Janssen’s patent request, the price of the drug will reduce and access will increase.”

2 February 2021. Civil society files a lawsuit at the Central Intellectual Property and International Trade Court, against Thailand’s Department of Intellectual Property (DIP) for causing a delay to essential TB treatment by failing to reject an unlawful patent application submitted by Janssen (Johnson & Johnson) © AIDS Access Foundation/TNP+

More detail:

Janssen Pharmaceutica N.V. filed its patent request (no. 0501002434) to the Department of Intellectual Property on 27 November 2005. The civil society organizations assessed the application and found that is against Article 9(4) of the Patent Act and therefore the DIP is authorized to reject the request in accordance with Article 28 and 30. However, the DIP did not apply the law and instead accepted Janssen’s request for further examination.

In March 2020, the AIDS Access Foundation sent a letter to the DIP, demanding that the Department reject the patent application filed by Janssen Pharmaceutica N.V.. They received a response stating that the patent application is not against the law.  AIDS Access Foundation, TNP+ and a TB survivor have therefore filed a lawsuit to ensure justice is enacted within the intellectual property system.