Secondary patent for Johnson & Johnson TB drug rejected: How this will help in India’s fight against tuberculosis

What is bedaquiline and why is it the need of the hour?

At the time of receiving an approval from US Food and Drug Administration in 2012, bedaquiline became the first new TB therapy to become available after a period of 40 years.

But the novelty of the drug is not the only reason why there is a need for increased access.

Bedaquiline is considered to be one of the most effective treatments available for drug resistant tuberculosis, with minimal side-effects as compared to the existing drugs such as Kanamycin that can lead to kidney damage and permanent hearing loss.

The drug also prompted development of shorter-courses of treatment for such resistant TB – more than halving it from two years to nine month to one year course. It is also an oral medicine unlike Kanamycin or Streptomycin. A shorter-course, all-oral medicine is likely to increase odds of people completing their treatment and preventing more cases of drug resistant TB.

This is the reason the World Health Organisation updated its treatment protocol for rifampicin-resistant or multi-drug resistant TB to include bedaquiline as the core drug. With severe side-effects, the guidelines also recommended limiting the use of the injectable drugs. However, the higher costs and limited availability of the medicine was a challenge for use of the drug for the treatment of a larger number of people.

The drug first became available in India under the government’s TB programme in 2015, but with a six-month course – which is the minimum required – costing Rs 21,000 per person, availability remained an issue. Although the drug is more widely available now, there are still issues in accessing the treatment in smaller cities and towns, said Nandita Venkatesan, a TB survivor and one of the persons who filed a petition against the secondary patent by Johnson and Johnson’s subsidiary Janssen. Kanamycin used for her treatment resulted in permanent hearing impairment and kidney damage.

On what claim did Janssen apply for a secondary patent?

The primary patent of bedaquiline and “its salts, isomers and enantiomers” expires on July 18 this year. The company had, however, filed for a secondary patent for the fumerate salt and a wetting agent of the same active pharmaceutical ingredient. This would have extended the monopoly of the company on the drug for over four years till December 2027.

This is what is known as ever-greening of patents – when companies make slight changes to the formulation to extend the patent period, guaranteeing their monopoly over the drug.

With India being one of the biggest manufacturers of generics, the country’s patent law has a specific section that disallows ever-greening of patents. It says that a drug cannot be termed as an invention if a new form of the same substance is developed without any significant improvement in efficacy.

Initially, the secondary patent filed by Johnson and Johnson was based only on the fumerate salt and was changed to fumerate salt along with a wetting agent after opposition submitted by the Network of Maharashtra People Living with HIV (NMP+) in 2013. The drug is essential for those living with HIV who are likely to develop more resistant forms of TB.

The current opposition, which resulted in the secondary patent being rejected, came from two TB survivors – Indian Nandita Venkatesan and South African Phumeza Tisle. The opposition was based on two points – the primary patent already disclosed the fumerate salt and the wetting agent used as the additional salts of the active ingredient and the company hadn’t demonstrated an enhanced efficacy of the medicine in its patent application.

What will be the implication of the drug coming off the patent?

With companies being allowed to manufacture generic versions of the medicine after July 2023, not only would there be an increased availability of the medicine but the prices are also expected to drop by up to 80 per cent.

At present, the lowest price of the medicine stands at around USD 45 per person per month, which could reduce to USD 8 to 17 per person per month, according to MSF (Doctors Without Borders). Similar significant price drops were seen with a couple of diabetes medicines that also came off patent over the last two years.

Venkatesan added that it will become cheaper for the government to procure the medicine for the national programme, improve access to it in tier 2 and tier 3 cities, and could also be allowed at private hospitals with good TB centres.

Why is it important for India’s TB goal of 2025?

India has taken up the challenge of eliminating TB by 2025, five years ahead of the global target. While the government is focusing on increasing access to molecular diagnostics, improving nutrition through community engagement, and the whole of government working towards the goal, there is a need for better treatment options.

There are also vaccines in the pipeline. However, experts say the most important intervention – after accurate detecting TB cases and drug resistance through molecular screening – will be to actively find the cases and ensure that they complete the treatment.

An all-oral shorter course of treatment with bedaquiline along with other drugs is likely to improve adherence. The government is already moving towards all-oral regimen with bedaquiline, phasing out kanamycin.

“The fear of the side-effects is enough to put someone off from taking the treatment. This comes on top of the fact that they have to take so many drugs for nearly two years during which life has to be put on hold. This is why bedaquiline is necessary,” said Venkatesan.

What will be the global impact?

With the patent ending in July, generic manufacturers in India will not only be able to supply the medicines at a lower cost to India but to other high-burden countries in the world. The Prime Minister Narendra Modi earlier this month said that 80 per cent of the global TB medicines are manufactured in India and had promised help to other countries who are working towards elimination.

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MSF called for the company to withdraw similar secondary patents filed in other countries as well. “It is high time that we have alternate manufacturers supplying bedaquiline at lower prices, especially as the scale-up of the all-oral, shorter, six-month drug-resistant TB regimens by TB programmes is being planned around the world,” said Leena Menghaney, Global IP Advisor, MSF Access Campaign.