Make Medicines Affordable (MMA) campaign and its partner Vietnam’s Network of People Living With HIV (VNP+), are celebrating a partial invalidation of Janssen Pharmaceutical’s (J&J) attempts to extend its patent monopoly on the tuberculosis (TB) drug bedaquiline (BDQ) in Vietnam. On October 10, 2025, the Intellectual Property Office of Vietnam partially revoked the validity of Patent No. 12414, specifically its method-of-treatment claims, in its decision No. 228144/QD-SHTT.IP.
The Intellectual Property Office of Vietnam revoked claims 1-19, 21-23, and 25-32 by J&J, stating that J&J’s argument to patent BDQ “fails to satisfy the inventive step requirement,” stating that current TB treatment methods already involve the combination of several drugs and a person of average skill in the art could completely combine bedaquiline with other anti-TB compounds needed to form the drug. At the same time, the less significant claims 20 and 24 were maintained, as the patent office considered that the combination of bedaquiline and pyrazinamide demonstrated superior efficacy in pre-clinical studies.
“This decision is a good example of a strict application of inventive step requirements by the Vietnam Patent Office. If a similar approach is replicated when examining any other pharmaceutical patent applications, it will create more freedom-to-operate and will pave the way for generic manufacturers to produce or supply medicines at a lower cost, making them more affordable and accessible to patients. This decision affirms that attempts to evergreen patents by introducing non-inventive patents will not be accepted in Vietnam, setting a positive precedent in balancing intellectual property rights and public health rights,” said Dong Dang Do, Chairman of VNP+.
VNP+ has long advocated against J&J’s monopoly on bedaquiline, in line with MMA’s mission to remove intellectual barriers to keep drug costs low, to prevent millions of people from dying annually because life-saving medicines are overpriced. Globally, TB kills more people than any other infectious disease.
TB is curable in most cases, and most people must take medicine for at least six months to be cured. In 2012, bedaquiline became the first drug from a new class to be approved for tuberculosis in almost fifty years, and it has since become a key part of the standard treatment for multidrug-resistant tuberculosis (MDR-TB).
Those with MDR-TB have fewer treatment options, which are more expensive and require a longer treatment course, leading to higher death rates among people with drug-resistant forms of TB. Due to the unaffordably high price of bedaquiline, many LMICs have been forced to use less effective — and more toxic — drugs to treat MDR-TB.
Implications of this decision in Vietnam
The WHO recognizes Vietnam as a high-burden country for TB and MDR-TB. In 2024, the WHO estimated that TB led to approximately 227,000 deaths in the Western Pacific Region, which includes Vietnam, among other countries.
“J&J’s attempt to extend its patent monopoly on bedaquiline is an unethical barrier that directly threatens the lives of people with drug-resistant TB in Vietnam. The decision to partially revoke the patent is an important step to ensure that drug-resistant TB patients in Vietnam can receive the best medicine, without being hindered by monopoly prices,” said Dong Dang Do.
Both VNP+ and J&J have the opportunity to appeal the decision by the Intellectual Property Office of Vietnam within 90 days, giving them before January 3, 2026 to do so. An appeal “will only confirm that J&J is still putting profits over lives,” said Dong Dang Do. We urge J&J to accept this decision to reduce the burden on Vietnam’s public health system,” adding that if J&J appeals, VNP+ will strongly oppose it, as the majority of the company’s patent in this case have been confirmed to be uninventive.
Bedaquiline Fumarate Patent controversially upheld in force
At the same time, the Intellectual Property Office of Vietnam in another decision on 29 September 2025 No. 150091/TB-SHTT chose to uphold the part of J&J’s patent on bedaquiline fumarate salt No. 10953 that VNP+ also opposed. The recent decision by the Intellectual Property Office of Vietnam maintains the validity of Points 20 and 24 in J&J’s filing, which pertain to bedaquiline fumarate patent, stating that the combination containing compound (Ia) or (Ib) with pyrazinamide according to the invention has superior efficiency compared to the combination as suggested by D1. In its reasoning, the Office concluded that forming the fumarate salt from the base compound was not obvious, as that the fumarate form demonstrates greater stability, improved solubility, non-hygroscopic properties, and better bioavailability, and that these technical effects could not be predicted from prior art. These arguments were used to justify the inventive step and novelty of the retained claims. “Such approach of the patent office is controversial, as bedaquiline was known and technology of producing salts from various compounds was also well known before the priority date of the patent, thus there is nothing inventive in it and such approach is harmful to public interest,” said Dong Dang Do.
Public investments in the development of BQD
Leading health and humanitarian organizations including Médecins Sans Frontières/ Doctors Without Borders and the Global Tuberculosis Community Advisory Board (TB CAB) have consistently called out J&J for prioritizing profits over lives, given the company’s astronomical pricing of BDQ.
Public investments in the development of BDQ include direct funding of clinical trials and a donation program, and tax credits and deductions, among others. The total public investments are estimated to be US $455 – 747 million, compared to originator investments of an estimated US $90 – 240 million.
Despite these public investments and civil society groups’ demands for more affordable bedaquiline, J&J established multiple, worldwide patent monopolies worldwide on the drug. This sparked the filing of 20 patent oppositions against secondary patent applications or patents on bedaquiline in Belarus, Brazil, India, Kazakhstan, Kyrgyzstan, Moldova, Thailand, Ukraine, Vietnam.