Health NGOs have hailed the agreement reached between the Competition Commission and Johnson and Johnson (J&J) and its subsidiary Janssen Pharmaceuticals over the termination of the patent for a key TB medication.
Under the agreement, J&J will not enforce its patent over Bedaquiline – used for drug-resistant TB in 134 low- and middle-income countries – and will slash the price it charges the National Department of Health for the drug by about 40%.
Not enforcing its patent will open the market to generic suppliers and reduce the price, reports Business Day.
The terms of the deal include that the commission will not prosecute a complaint of alleged anti-competitive behaviour and abuse of dominance against J&J and Janssen – initiated in September 2023 and based on their application for the secondary patent for Bedaquiline.
Doctors Without Borders (MSF) and the Health Justice Initiative (HJI) said J&J’s secondary patent would have enabled an extension of the corporation’s monopoly on Bedaquiline in SA until 2027, using the tactic known as ever-greening. This would have blocked cheaper, generic Bedaquiline from entering the country.
MSF’s access campaign advocacy adviser Candice Sehoma said the two organisations welcomed the Competition Commission’s efforts “in recognising J&J’s tactic of patent ever-greening as a blatant attempt by a pharmaceutical corporation to extend its monopoly and put its profits before people, and we applaud it for prioritising the tackling of similar issues”.
HJI founder Fatima Hassan commended the commission for taking health product patent ever-greening seriously.
“Hopefully, its investigation will also be a warning sign to other corporations that are benefiting from an indefensibly lax patenting regime in SA and elsewhere in Africa… that must now be interrogated and investigated for pricing and ever-greening patenting strategies for several key medicines needed to prevent and treat HIV, cancer, cystic fibrosis, TB and other diseases,” she said.
Under the new agreement, J&J and its subsidiary have slashed the NDoH price for Bedaquiline by about 40%, from R5 577.12 to R3 148 inclusive of VAT and logistics.
According to MSF and HJI, J&J charged the Global Drug Facility, the world’s largest procurer of TB medicines and diagnostics from which SA cannot procure, R2 446 for a six-month course per person (without potential local charges, for example VAT).
J&J has agreed not to enforce its secondary patents in SA as well as in 134 low- and middle-income countries.
Being granted a secondary patent for Bedaquiline would have prolonged the lifespan of the patent to 2027.
“This conduct effectively restricted the entry of generic medication, and allegedly enabled these companies to charge excessive prices to the national department of health,” the commission said.
“The conduct was assessed as a possible contravention of the Competition Act. The commission will continue to prioritise work in secondary patents and act particularly where secondary patents have failed in other jurisdictions with more rigorous assessments.”
BusinessDay PressReader article – J&J cuts TB drug prices (Open access)
See more from MedicalBrief archives:
J&J probed for high TB drug prices and patent law ‘abuse’
J&J patent deal allows for cheaper generic TB drugs, but SA may lose out
TB drug costs to drop after J&J loses patent extension bid
WHO may promote bedaquiline after SA brokers deal with J&J