30 September 2023, Geneva
Christophe Perrin, TB Advocacy Pharmacist, MSF Access Campaign:
“We welcome Johnson & Johnson’s (J&J) announcement finally paving the way for unfettered access to affordable generic versions of bedaquiline for all people living with drug-resistant tuberculosis (DR-TB) who need the drug in low- and middle-income countries.
We need all newer TB innovations to be as affordable as absolutely possible, so governments can scale up prevention, testing and treatment to beat back this curable disease
“This huge success is a testament to the persistent efforts of TB activists, civil society and also countries prioritising public health over corporations’ interests.
“The initial crack in J&J's patent shield occurred when the Indian Patent Office rejected the corporation’s secondary patent application for the fumarate salt of bedaquiline – a cynical attempt by J&J to lengthen their monopoly beyond the already given 20 years. Two women who had survived TB and had to endure the older, more toxic drugs, had filed this successful challenge to J&J’s additional patent in India – Nandita Venkatesan of India and Phumeza Tisile of South Africa.
“After J&J lost its attempt to extend its monopoly in India, national TB treatment programmes from Ukraine and Belarus requested J&J to drop its secondary patents in their countries and others heavily affected by TB. The recent investigation by the South African Competition Commission undoubtedly added significant pressure on J&J, ahead of their announcement.
“We now want to see Japanese pharmaceutical corporation Otsuka follow suit and publicly announce that they will not enforce any secondary patents in low- and middle-income countries for the other critical newer TB drug delamanid, especially as the corporation’s primary patent is set to expire in 10 days in India and other countries. Delamanid is another key DR-TB drug used in combination with bedaquiline, and is particularly important for children.
“The last 10 weeks have marked a sea change in TB – we have seen J&J back down on the price and its patents for bedaquiline; we have seen Cepheid and Danaher finally after over 10 years of pressure reduce the price of the most important TB test by 20%; and we’ve had a declaration by governments at the UN pledging to scale up these new and improved TB tools to people who need them. We need all newer TB innovations to be as affordable as absolutely possible, so governments can scale up prevention, testing and treatment to beat back this curable disease that continues to kill 1.6 million people every year. People with TB literally cannot afford to wait any longer.”