When a drug giant ties up with a non-profit

Public pressure across the world may have prompted one of the world’s biggest pharma multinationals to enter into an agreement with a non-profit
organisation that will source and supply generic versions of its topline tuberculosis (TB) drug in dozens of low- and middle-income countries (LMIC) fighting this disease that kills two million people annually.

It is a new kind of pact that Johnson & Johnson (J&J) has finally concluded with the UN-backed Stop TB Partnership, whose Global Drug Facility (GDF) purchases and makes TB drugs available at more affordable rates to a host of countries struggling with a heavy load of TB.

This is a significant development, because J&J’s bedaquiline—it is on the World Health Organization (WHO)’s list of essential medicines—combats the lethal multidrug-resistant TB (MDR TB), which afflicts more of the poor and those with HIV than others.

Over the past two years, close to half a million new cases have been registered annually. So there was a celebration of sorts when the deal was announced on July 13, allowing GDF “to tender, procure, and supply generic versions of sirturo® (bedaquiline) for the majority of low- and middle-income countries, including countries where patents remain in effect.”

But, this deal is not the best way to fight the scourge of TB, because it excludes far too many countries.

All bedaquiline suppliers that meet GDF's quality criteria are eligible to participate in the tender and have been briefed on its goals, processes and timelines, says a spokesperson for Stop TB.

Two Indian companies, Lupin and Macleods, which reportedly have generic versions of the drug in the works, are eligible to bid for the tender that will also see the participation of J&J.

All of this sounds good in a world where innovator drug companies have routinely used their patent monopolies to set high prices for life-saving drugs, ignoring the desperate need of patients.

In the high-profile campaigns conducted by public health lobbies, humanitarian organisations and individuals under rubric of patents versus patients, the J&J agreement would appear to be a major victory against pharma greed.

There are, however, some curious aspects to the bedaquiline agreement which has come about after protracted negotiations spread over two years, according to the two sides.

To start with, there is the absence of patents. J&J’s primary patent on the drug, which was developed by its subsidiary Janssen and approved by the US Food and Drug Administration (FDA) in 2012, expired on July 18 everywhere.

In as many as 52 lmics that GDF supplies to, there is no question of a patent obstacle. Why, then, is there such a hullabaloo over J&J’s pact with Stop TB when any generic company, for instance, Lupin and Macleods that are already making the drug, was free to supply to these markets?

The reason is that in the other 44 countries supplied to by GDF, J&J holds secondary patents that are valid till 2027 and could have blocked exports by generic makers.

So as of July 19, under this agreement, the generics will also be supplied to these countries, says the GDF chief, who calls the deal “a massive advancement” in promoting access to life-saving medicines.

Secondary patents are tweaks that cover the various forms of salts and esters of the original base compound, and the ways in which the drug is administered.

It is a system that allows the innovator companies to extend the patent term indefinitely, sometimes by almost double the original period of 20 years, and is denounced as patent evergreening by critics.

India is one of those rare countries which has tried to pre-empt such practices by including a specific section in the country’s Patents Act that debars new patents on existing inventions.

That is the reason for J&J’s secondary patent on bedaquiline being rejected by the Indian Patent Office in March this year. So far, J&J has not challenged the decision, but it still has the option to approach the courts.

Did the India setback push J&J into signing the deal with Stop TB, as some campaigners have claimed? It seems highly unlikely. The famous Section 3d of the Patents Act that sometimes, but not always, stops the grant of secondary patents is a one-of-a-kind law.

Other countries have not incorporated such a provision in their regulations, and as such, a revocation of secondary bedaquiline patents would have been unlikely in LMICs where these are registered.

There is much speculation as to what prompted J&J to agree to the deal. Was it the sustained campaign against the company over the past two years? Possibly.

Whatever the spur, it would seem that J&J has pulled off a public relations coup by permitting generic bedaquiline in most of the countries where such patents have been registered. Millions of TB patients will get access to cheaper versions of bedaquiline, which is no small deal.

According to Médecins Sans Frontières, which is the largest NGO provider of TB treatment worldwide, bedaquiline is the most expensive of the TB regimens, as J&J currently charges US $1.50 per day for an adult treatment.

Once a global tender is floated, experts say the price would come down to $0.50 per day and may dip further.

But not all countries with a heavy burden of TB will benefit from this agreement. Millions of patients remain excluded because of gaps in the deal between J&J and Stop TB. A big chunk are patients in the central Asian and European states.

Under a 2018 licensing agreement that J&J signed with Russian pharmaceutical company Pharmstandard, sirturo® is being manufactured under contract for supply to 17 countries, starting with Russia itself.

These countries, although burdened with high rates of MDR TB, are excluded from accessing the generic version, and ironically are being charged a much higher rate than the GDF-supplied price.

There are other similarly burdened nations which will not also benefit from generics, such as South Africa and Indonesia, because they do not procure drugs through GDF.

Most health activists are, therefore, not too buoyed by the deal. They contend that until J&J withdraws its secondary patents, the battle against the disease will not be won.

Secondary patents, however, are a larger issue involving patent law reform on pharmaceuticals. Till that happens, the stopgap accord on TB drugs is the best, it appears, we can hope for.

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