New Delhi: In what can be termed a huge development for drug-resistant TB (DR-TB) patients across large parts of the world, bedaquiline maker Johnson and Johnson said on September 30 (Saturday) that it would drop its patent over the drug in 134 low- and middle-income countries (LMICs).
Bedaquiline is one of the most important components of the drug regimen prescribed for DR-TB patients. These are those patients on whom the first line of TB drugs fail to produce the desired result, and so they require an advanced level of treatment regimen.
Globally, there are 4,50,000 DR-TB patients, a vast majority of whom are in the LMICs, including India.
In a press release issued on September 30, the American drugmaker said, “The decision is intended to assure current and future generic manufacturers that they may manufacture and sell high quality generic versions of Sirturo [brand name of bedaquiline] without a concern that the Company will enforce its bedaquiline patents.”
This development comes after decades of public pressure and efforts of TB advocates who have been demanding that the company must give up its call for what is called a ‘secondary patent’ – or the extension of its primary patent. J&J’s patent over the base compound of the drug was set to expire in most countries in 2023. However, it had applied for a secondary patent to extend what the activists termed a ‘monopoly’ over the drug.
India’s patent office had rejected J&J’s application for a secondary patent in April 2023. This was hailed as a major victory as far as access to this key drug was concerned. India has the largest number of DR-TB patients across the world.
Recently, the South African Competition Commission had announced an ‘unprecedented’ investigation into exorbitant prices of bedaquiline that the country’s government had to pay to buy the drug for its patients.
Reacting to J&J’s move, Médecins Sans Frontières (MSF) said, “While India was saved from granting unmerited secondary patents [another patent after expiry of primary patent] due to provisions such as PreGrant Opposition filed by patients/ patient groups, this non enforcement [of patent] in all other countries will mean that Indian generic [makers] can now enter all these markets without the fear of litigation.”
The entry of more manufacturers would ensure competition, which may help in bringing down the prices of this very important drug in TB management, explained Ganesh Acharya, a Mumbai-based TB activist, to The Wire.
He added, “I expect the cost of the six-month course [180 tablets over 180 days per patient] to come down to $80, and [this] can come as a huge relief to the governments [who procure the drug for patients].” Till 2020, it was $400 for the six-month regimen for every patient, which the company kept further reducing over the period of time. However, it was still considered unaffordable for many governments.
In August this year, the drugmaker had entered a deal with ‘Stop TB Partnership’, a UN-hosted coalition of TB advocates, to reduce the price of its drug by half, and to sell the six-month course [per person] at the price of $130, to it.
The ‘Stop TB Partnership’, through its ‘Global Drug Facility (GDF)’, supplies DR-TB drugs to several countries, or fulfils a part of their requirements.
Two days ago, Unitaid, a WHO-hosted agency, wrote an open letter to J&J terming the company’s deal with ‘Stop TB partnership’ an “incomplete solution”. It demanded that the firm must drop its secondary patent.
“Unitaid is calling on J&J to remove secondary patents or provide a comprehensive license to generics and allow all countries to purchase bedaquiline at the negotiated rates, including those excluded from the agreement or not procuring through GDF,” it wrote.
Blessina Kumar of the Global Coalition of TB Activists sounded a more cautionary note. “The drug going off patent now is a big cause for celebration but we have to see that the results of this development don’t remain confined to paper but translate into actual relief for patients,” she told The Wire.
“There is a lot for the governments to do hereon,” she said, adding, “The governments will have to properly map their needs, give assistance to manufacturers, if necessary, and most importantly, work on their supply chains.”
She explained that supply chains were one of the most important parts of the pyramid, referring to India’s current crisis of stock-outs of DR-TB drugs. “Even if there are doses manufactured at affordable prices for the governments, if they are not able to forecast their needs properly, we would again see a crisis…leaving patients running from pillar to post [to get access to drugs].”
