In India for the first time disputed patent for bedaquiline

On February 7 two activists - Nandita Venkatesan (Mumbai, India) and Fumeza Tisile (Khaelitsha, South Africa) - applied to the Indian patent office with a request to revoke Johnson & Johnson's drug for the treatment of drug-resistant tuberculosis (TB) Bedaquilin. The statement of the plaintiffs has already been supported by the international organization Doctors Without Borders (MSF).

According to the MSF portal, both activists - who have been treated for MDR-TB in the past - have been deafened by the strong side effects of therapy, which in most countries are forced to use because of the high cost of Bedaquiline.

It was the tragic circumstances that young people faced that made them fight for affordable and inexpensive treatment for tuberculosis.

According to Doctors Without Borders, in 2017, the prevalence of MDR-TB in the world was 558 thousand people, and only a quarter of them received proper treatment. At the same time, the standard treatment regimen for such patients, as mentioned earlier, includes extremely dangerous injecting drugs. Their use is associated with severe adverse reactions, and complete cure of MDR-TB is possible only in 55% of patients.

According to the latest WHO guidelines, bedaquiline is the main drug for the treatment of drug-resistant tuberculosis, noted in MSF, while an international organization recommended to refuse from drugs that are dangerous to use.

However, according to MSF, by the end of last fall, less than 29 thousand people underwent bedaquiline treatment in the world. The main reason for this is the extremely high cost of the drug. Even though Johnson & Johnson offered to reduce the price for a six-month course to $ 400 in South Africa, this did not change the situation. Experts say that you need to radically change the cost of the drug so that it becomes available in most countries with a high burden of MDR-TB.

“Data on improvements in cure rates and saved lives are clearly evidence of the need for Bedaquiline for patients with DR-TB,” said Anya Reuter, MSF doctor for the treatment of drug-resistant tuberculosis in Khayelitsha (South Africa). - It is important that bedaquiline gives patients a chance to recover without the use of toxic injectable drugs with severe side effects. This is a revolution in the treatment of tuberculosis, and it has already occurred in South Africa. However, in many other countries, bedaquiline is needed at an affordable price to treat LU-TB patients. If the patent is withdrawn, considerably more affordable bedaquiline generics will appear rather quickly. This will save hundreds of thousands of lives and save many people around the world from suffering. ”

Note that in India, an objection has been filed against the issuance of the Johnson & Johnson patent for the release of a drug in powder form. Activists believe that the company's claim does not meet the requirements of "novelty." However, if the agency agrees with the arguments of the pharmaceutical giant, Bedaquilina generics will not enter the Indian market until at least 2027.

Otherwise - if the patent is still revoked - the Indian manufacturers of anti-tuberculosis drugs will be able to enter the market with generics and supply bedaquiline at discounted prices both domestically and abroad.