This report documents efforts by civil society organizations (CSOs) in various countries,
including Brazil, Ukraine and Thailand, to make Bedaquiline more accessible by using the
flexibilities provided in the Agreement on Trade-Related Aspects of Intellectual Property
Rights (TRIPS) – the safeguards in the intellectual property system that take into account
public health needs. The case study was undertaken during 2023-2024.

Tuberculosis remains a major global health crisis, with drug-resistant forms requiring
newer more effective treatments like Bedaquiline which offers shorter treatment times
and fewer side effects than older regimens. The report offers an overview of global and
country-specific efforts by CSOs to challenge patents held by Johnson & Johnson on the
tuberculosis (TB) drug bedaquiline (BDQ) to improve patient access and affordability.

CSOs primarily focused on opposing “evergreening” secondary patents that extend
Johnson & Johnson’s monopoly beyond the original patent expiration, arguing that these
patents lack inventive merit and artificially inflate prices. Successful actions, such as
patent rejections in India and Thailand and Johnson & Johnson’s agreement not to
enforce patents in 134 low- and middle-income countries (LMICs), are discussed
alongside challenges, including judicial difficulties, insufficient political will, and the
strategic importance of pursuing pre-grant patent oppositions.