Johnson & Johnson to let go of patent for DR TB drug

This will benefit drug-resistant TB patients in 134 low and middle-income countries; generic manufacturers will be able to create it

In a ray of hope for TB patients after months of shortage of medicines, Johnson & Johnson has decided to let go its patent on bedaquiline, the less toxic drug used to treat drug-resistant TB patients, in 134 low and middle-income countries, paving the way for generic manufacturers.

The move comes after decades of pressure by TB advocacy groups from countries like India, on the US-based drug giant to give up its secondary patent, which is intended to provide an additional layer of protection to a company. Notably, the company’s primary patent was set to expire this year, and India’s patent office had rejected its application for a secondary patent earlier this year.

In a press statement, the company said, “The decision is intended to assure current and future generic manufacturers that they may manufacture and sell high-quality generic versions of SIRTURO® without concern that the Company will enforce its bedaquiline patents, provided the generic versions of SIRTURO® produced or supplied by generic manufacturers are of good quality, medically acceptable, and are used only in the 134 low and middle-income countries.”

Docs want partnerships

The decision is welcomed by TB elimination advocacy groups in the city as well as in the country. As of now, private medical practitioners can prescribe the medicine, but patients need to visit a public facility like DOTS centres to access the drug. The medicine is made available largely in public hospitals and DOTS centres. “Hopefully, the government will look at a Public-Private Mix (PPM) to make the drug widely accessible,” said Dr Lancelot Pinto, a pulmonologist with P D Hinduja Hospital. Such a partnership has been running at the hospital for the past three years.

Dr Preeti Meshram, pulmonologist at JJ Hospital, said, “Partnerships allow hospitals to provide medicines to patients living in the area surrounding a hospital. There are TB treatment centres in every ward and patients can access them either in a public-private partnership centre or a public facility.”

There are four PPM centres in Mumbai but health officials are in talks with more hospitals to expand. Dr Pinto also added that J&J’s move is a great victory for the fight against TB. “Hopefully, it will set a precedent for patients and activists in the future, every time a pharma company tries to use evergreening as a way to extend a patent,” said Dr Pinto.

TB survivor and activist Ganesh Acharya took a sigh looking back at decades of struggle. “Affordability is a major barrier to access such life-saving medicines. Bedaquiline is much more effective with fewer side effects, and one company had a monopoly over it, making it expensive. Now, this medicine will soon be available everywhere at a low cost,” he said.

Haphazard use

BMC’s health department head, Dr Daksha Shah, was instrumental in starting the medicine on an OPD basis in the city. Expressing concerns over its arbitrary or haphazard use, she said, “We are already supplying medicines to private patients through our programme, this is the most effective drug so far. Now the recent development will open it up in the private market, but it should be used by private practitioners with precaution in accordance with the government’s current protocol.”

Doctors Without Borders said in a statement, “We now want to see Japanese pharmaceutical corporation Otsuka follow suit and publicly announce that they will not enforce any secondary patents in low and middle-income countries for the other critical newer TB drug delamanid, especially as the corporation’s primary patent is set to expire in 10 days in India and other countries.”

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