After some years, one of the most popular and hyped-about patent cases took place last Thursday in India’s patent office. The giant company of America Johnson and Johnson has been rejected for extending their monopoly on making bedaquiline, the life-saving drug for TB. After July this year, they will no longer have the rights over it to manufacture.
Incidentally, this development was made public by India’s patent office on World Tuberculosis Day. The committee feels that after this decision, it is going to improve the access of the patients to that core drug. Bedaquiline also happens to be part of the TB regime by WHO. Its oral drug is recommended by WHO to patients.
While talking to the media some experts have shared that this move is also going to make a way for other domestic companies to enter the market and supply a much cheaper drug for the treatment of TB. Some domestic companies whom they are backing now are Macleods, and Lupin.
This decision is been seen as a landmark because it is a similar kind of historical decision that had been taken by some other company a decade ago. Previously, the Swiss MNC Novartis had lost to protect their patent over the most famous cancer drug. It had been ruled that the drug named Glivec lacks inventive steps and so it adds to more health hazards. Under that patent law, it has been stated that no other pharma company could make the use of a drug for other users until the results prove that it was suitable for other purposes.
With regards to this case of Johnson and Johnson the assistant controller for designs and patents of the Mumbai office, Latika Dawara has shared that due to a lack of initiative steps in combination with nonpatentability, this decision has been given.
This decision was made after the filing of pre-grant opposition which was filed in 2019 by Phumeza Tisile, and Nandita and Nandita Venkatesan, two survivors of Tuberculosis. They were supported by Medicines S Frontières. The global IP advisor for MSF, Leena Menghaney has said that it is a very seminal decision that a country has taken. More countries need to come forward because TB is a global issue. It is very important that alternate manufacturers are given an opportunity to make TB medicines and sell them at a much lower price.
This measurement needs to be scaled because the medication extends for at least six months for every patient in general for every TB program which is been carried out throughout the world. When the media approached Johnson and Johnson for a view, a spokesperson shared that this is an ongoing case that had been filed in India more than a decade back. He said that it is the norm for giving other manufacturers a chance to come forward which they agree. He too has confirmed that in July 2023, their patent over API in India is expiring.