By Ed Holt
BRATISLAVA, Jul 21 2023 – In a surprise move, pharma giant Johnson and Johnson (J&J) has agreed not to enforce some of its patents on a lifesaving TB drug, making generic versions available in many low- and middle-income countries (LMICs).

Although on the WHO’s list of essential medicines and a cornerstone of much TB treatment, bedaquiline had not been available in many countries in part because of its high cost.

A deal agreed between J&J and the Stop TB Partnership will allow the latter to procure and supply generic bedaquiline to 44 low- and middle-income countries through its Global Drug Facility (GDF). It is expected the price at which these countries will then be able to buy the drug under the deal will be significantly lower than currently, and some experts have suggested it may also reduce the price of the drug for those countries not covered in the deal.

But patient advocacy groups say that while it is good news that many countries will now get the drug more cheaply, there remain some serious problems with the new deal as countries with some of the highest TB burdens in the world
are excluded. They are also unhappy that it does not address the enforcement of secondary patents the company has on altered formulations of the drug, which are in place in scores of LMICs until 2027.

Critics have called on J&J to declare it will not enforce any secondary patents on bedaquiline in any country with a high burden of TB and withdraw and abandon all pending secondary patent applications for this lifesaving drug.

“We hope this deal will help drive down the price of this drug for all countries. But it doesn’t go far enough. What would have been best would have been for J&J to abandon and withdraw all the secondary patents it holds or has applied for everywhere,” Lindsay McKenna, TB Project Co-Director at the Treatment Action Group (TAG), told IPS.

Advocacy organisations have for years been pressing J&J to reduce the price of bedaquiline.

First approved in 2012, it was the first new TB drug in over 40 years and was hailed as revolutionary in the fight against drug-resistant TB, cutting out the need to use often very toxic, intravenously administered drugs. Its use in patient regimens also produced vastly improved treatment outcomes.

But its high cost – initially USD900 per course even in low-income countries – meant that it was available to relatively few people in many low- and middle-income countries, which have some of the highest TB burdens in the world.

Its price has now come down but remains too high in the eyes of many experts.

According to global health charity Medicins Sans Frontieres (MSF), J&J currently prices the drug at USD1.50/day for an adult treatment (USD272/six months). But with scale-up and unrestricted generic competition, it says the price of bedaquiline could get closer to USD0.50 per day.

This would make a huge difference to cash-strapped TB programmes in poorer countries.

“Any penny that can be saved [on bedaquiline] and which can be spent on something else related to TB, such as case identification, is of massive importance, especially in countries with high TB burdens,” Christophe Perrin, TB advocacy pharmacist at MSF, told IPS.

But even if the deal does bring the price down to that level, some of the countries which would benefit from purchasing the drug at a lower price will not be able to as they have been excluded from it.

Nine countries in the Eastern European and Central Asian region, which have some of the highest TB burdens in the world, are not covered by the deal because of an exclusive supply agreement J&J has with a Russian pharma firm.

“This deal is beneficial for those countries which can access it, but why are some countries excluded? Those that are excluded have some of the highest TB burdens in the world. It’s a real worry,” said Perrin.

The exclusion has infuriated senior health officials in some of the excluded countries. In a rare instance of its kind, the national tuberculosis (TB) programme (NTP) of Belarus sent an open letter to J&J demanding urgent action to improve equitable access to bedaquiline in Belarus, and all other countries with a high burden of TB.

“It is completely unfair that we will be excluded from this deal,” Dr Alena Skrahina, Deputy National TB Programme Manager, Belarus, told IPS.

Another high-burden country that will not be able to take advantage is South Africa. The country’s national procurement rules mean that it obtains bedaquiline directly from J&J.

Doctors and patient activists involved in the country’s fight against TB say South Africa’s inclusion in the deal would have been a huge boon to its efforts against the disease.

“Any money that can be saved could be used to expand diagnosis, public awareness, and use shorter TB treatment regimens, which is what we are looking to do here. Almost 95% of our patients are receiving bedaquiline, so a reduction in the price could have a massive effect. It would definitely benefit South Africa if it was included in this deal,” Dr Priashni Subrayen, TB technical director at the Johannesburg-based healthcare organisation Aurum Institute, told IPS.

Brenda Waning, head of the GDF, told IPS the deal was a good one for LMICs, but could also theoretically benefit countries not covered by it. It is widely expected that the competitive tenders in the deal will push the global price of the drug down as well.

“The deal is special in that usually when a company like J&J gives out licences it does so to a supplier, but this deal allows for multiple competitive buyers. We are expecting the price of bedaquiline to go down, although we won’t know by how much until the tenders happen. But a lower price is not the only benefit for countries. It will also mean more suppliers – the last thing you want to be doing is relying on a single supplier for a drug so there will be greater supply security – and whenever you have a price decrease, that frees up money which can be used for other things [to fight TB],” she said.

“We think the access price [for other countries] may come down through these tenders, so these countries could, theoretically, get it at a lower price than previously,” she added.

But even if that does happen, it will not be enough for critics who say J&J must abandon secondary patents it holds, or has applied for, in any country.

Unlike primary patents, which protect a completely new chemical entity, secondary patents cover modifications of, medical uses, and dose regimes of the new compound, among others. Critics argue they form part of a practice of “evergreening” which extends companies’ monopolies on existing products and, crucially, makes it difficult for generic manufacturers to enter the market with a generic drug after the original patent has expired

J&J has secondary patents for bedaquiline in 44 countries which are not due to expire until 2027, but under the new deal with StopTB, those countries will now be able to obtain a generic version of the drug.

But they remain in place in those states – “if J&J were to suddenly pull out of this deal, these countries would be back to square one,” noted Perrin – and the company continues to actively pursue their implementation elsewhere.

Phumeza Tisile, a South African TB survivor who lost her hearing because of side effects of treatment with older generation TB drugs, said J&J, and other pharma companies, should immediately withdraw secondary patents and commit to not applying for them anywhere in future.

“This provides affordable medicine to people who need the drug [and] helps people get generic versions of the relevant medicine at a very low cost,” she told IPS.

Pharmaceutical firms often argue that secondary patents are necessary to recoup the often very high costs associated with bringing a novel drug to the market and invest in the production of other new medicines.

J&J did not respond when contacted by IPS, but in a statement made as news of the deal broker last week, the company denied its patents had prevented people from accessing its drug and that the most significant barrier to treatment access for patients was the millions of undiagnosed TB cases every year.

Tisile, who works for advocacy group TB Proof, dismissed such claims, saying secondary patents may be denying people the drugs which they need to stop them dying.

“It’s greed,” she said. “Pharma companies make medicines to help people, but it never made sense to me that they make this medication so out of reach to people who actually need the medication the most, for them, it’s only profits. “This then can be very dangerous to millions of people who need the medication to survive. In this case, it should be patients before profits,” she said.

Others pointed out that the development of many new drugs is often funded by taxpayers – one study found that public investment into bedaquiline’s development was as much as five times that of J&J.

“It’s not a good faith argument to say that secondary patents are needed for a company to benefit from its investment in a drug. You could flip that round and say that the public needs to benefit from the investment they made into a drug,” said McKenna.

IPS UN Bureau Report

Follow @IPSNewsUNBureau
!function(d,s,id){var js,fjs=d.getElementsByTagName(s)[0],p=/^http:/.test(d.location)?’http’:’https’;if(!d.getElementById(id)){js=d.createElement(s);js.id=id;js.src=p+’://platform.twitter.com/widgets.js’;fjs.parentNode.insertBefore(js,fjs);}}(document, ‘script’, ‘twitter-wjs’);