The patent withdrawal is a result of an unprecedented investigation by South Africa’s Competition Commission into J&J
“In particular, we welcome the Competition Commission’s efforts in recognising J&J’s tactic of patent evergreening as a blatant attempt by a pharmaceutical corporation to extend its monopoly and put its profits before people, and we applaud the Competition Commission prioritising the tackling of similar issues.
“We hope that this significant step will increase access to affordable bedaquiline for people living with TB in South Africa, as the country will now be able to purchase more affordable, generic versions of bedaquiline and could see more generic producers enter the market to bring the price of bedaquiline even lower, and ultimately, save more lives from TB.”
Background:
Last year, on 23 March 2023, a patent challenge initiated in 2019 in India by two tuberculosis (TB) survivors, Nandita Venkatesan from India, and Phumeza Tisile, a TB treatment activist from South Africa, was successful and resulted in the Indian Patent Office rejecting the US pharmaceutical corporation Johnson & Johnson’s (J&J) attempt to extend its monopoly in India on the TB drug bedaquiline, beyond the primary patent’s expiry of July 2023. This was a significant step towards opening up generic competition for this lifesaving TB drug. However, at the time, South Africa would not have been able to benefit from generic competition as J&J’s secondary patent would have enabled an extension of the corporation’s monopoly on bedaquiline in South Africa until 2027 – a tactic known as evergreening. The result of such “evergreening” would have blocked less expensive, generic bedaquiline from entering the country.
Since June 2023, South Africa was buying bedaquiline directly from J&J at 5577 rand (US$306) for a 6-month course per person, while countries procuring through the GDF (which South Africa cannot procure through) were paying less than half this price, at 2,446 rand ($134) for a 6-month course (without potential local charges, e.g. VAT).
On 15 September 2023, the South African Competition Commission launched an investigation into J&J’s evergreening patenting practices and anti-competitive pricing conduct. Almost immediately in September 2023, J&J announced that it would not enforce its secondary patents in 134 LMICs, including South Africa. Now, following the result of the Competition Commission’s investigation initiation, J&J is not just lowering its price, but will withdraw the related secondary patents in South Africa, a move which Médecins Sans Frontières/Doctors Without Borders (MSF) and the Health Justice Initiative (HJI) welcomed as a significant step to increase access to affordable bedaquiline in South Africa, a benefit to the hundreds of thousands of people affected by TB in South Africa.
