On 23 March, the Indian Patent Office in Mumbai rejected the application of J&J subsidiary Janssen Pharmaceuticals to extend the patent.
Published Mar 25, 2023 | 10:00 AM ⚊ Updated Mar 25, 2023 | 10:00 AM
Bedaquiline is protected by patents till July 2023, which means that J&J has exclusive rights to manufacture and sell it. (Creative Commons)
As World Tuberculosis Day was being celebrated across the globe on Friday, 24 March, there was some good news for millions of tuberculosis patients in the country.
The Indian Patent Office rejected an attempt by US pharmaceutical corporation Johnson & Johnson (J&J) to renew its patent for the TB drug Bedaquiline as the primary patent expires in July.
On Thursday, the Indian Patent Office in Mumbai rejected the application of Janssen Pharmaceuticals, a subsidiary of J&J, to extend its patent.
The drug is considered a key medication against multidrug-resistant (MDR) tuberculosis (TB). Its original patent was filed in India in 2003 and granted in 2008.
But why is this good news?
The patent renewal would have allowed the US-based pharma company a monopoly on the drug in India till 2027.
The rejection will now enable Indian pharmaceutical companies to manufacture the same drug and sell it to the government — as well as patients — at a much cheaper rate, subject to regulatory approval.
As of now, once the patent is granted, the chosen drug company can market and sell the drug exclusively for a certain period of time, typically 20 years from the date of filing of the patent application.
The patent office in Mumbai delivered the judgement after two TB survivors — Nandita Venkatesan, a two-time TB survivor, and Phumeza Tisile, a TB survivor from South Africa — filed a plea in 2019, along with Médecins Sans Frontières/Doctors Without Borders (MSF).
The petitioners requested the rejection of the secondary patent application filed by J&J. MSF also called on the pharmaceutical corporation to withdraw the patent application in India and other countries where equivalent patents remain. They called for generic versions being made available in 2023.
“I had to battle this deadly disease for nearly eight years, endured taking multiple medicines and painful injections with debilitating side effects. We filed this patent challenge to ensure access to the safer, more effective oral drug Bedaquiline for all those who need it and to reduce agony for people with drug resistant-TB,” said petitioner Nandita Venkatesan, in a statement.
We did it! In a landmark verdict, the Indian Patent Office rejected Johnson and Johnson’s patent application that would have extended the monopoly on key anti-TB drug #Bedaquiline! @ptisile and I – both of us TB survivors — had filed pre-grant opposition against the application pic.twitter.com/gSUazHex5M
— Nandita V (@nandita_venky) March 23, 2023
“While DR-TB is on the rise for the first time in years due to the pandemic setback, the new WHO-recommended DR-TB treatment regimens released last year that contain Bedaquiline offer a ray of hope in reducing unnecessary suffering and death caused globally by this treatable disease.
The J&J monopoly on Bedaquiline could have blocked manufacturers from supplying generic versions and that would keep this life-saving drug from reaching all the people who need it,” MSF’s Access Campaign advisor Dr Ilaria Motta said, in a statement.
GOOD NEWS! ⚡
A patent challenge by two tuberculosis (TB) survivors was successful!
The Indian Patent Office rejected Johnson & Johnson’s (@JNJNews) attempt to extend its monopoly on the lifesaving TB drug bedaquiline. https://t.co/I92fEHNXqw
🧵👇🏽 pic.twitter.com/Dfq1WndLmK
— MSF Access Campaign (@MSF_access) March 23, 2023
On 17 March, the Indian Patent Office held the final hearing and on 23 March, it gave the final order. Assistant Controller of Patents and Designs Latika Dawara ruled against that application, saying that it did not meet the requirements of patent law.
“We are thrilled to see that our attempt to break the monopoly of a pharmaceutical corporation over this life-saving drug has been successful. Now, this win needs to be followed by the scale-up of shorter, oral TB treatment regimens by TB programmes globally to truly reduce unnecessary suffering caused by older toxic drugs and treatment regimens,” said Nandita after the final order.
MSF, in a statement, said that 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.
As #WorldTBDay approaches this Friday, MSF endorses @WHO’s call to action to roll out shorter, safer oral regimens for drug-resistant #tuberculosis (DR-TB) & increased access to diagnostic tests. https://t.co/6TWdykuV8c
— MSF Access Campaign (@MSF_access) March 22, 2023
“MSF calls on J&J to not enforce this secondary patent in other high TB burden countries and stand by its previous commitment to allow generic manufacturers to supply more affordable, quality-assured generic versions of this life-saving drug,” said MSF, in the statement.
India accounted for nearly 29 percent of 10.6 million tuberculosis cases worldwide, according to the World Health Organization’s (WHO) 2022 Global TB report.
In 2019, the Bedaquiline drug was launched and India procured over 20,000 doses. In July 2020, the pharma company slashed prices of the drug by 32 percent to $340 (₹27,200) for a six-month regimen.
In India, Bedaquiline is included in the Revised National TB Control Programme (RNTCP) guidelines, which provide recommendations for the diagnosis and treatment of tuberculosis in the country.
It is available only through the government route and not through retail pharmacies. Therefore, while it is free for the patient, it brings a lot of red-tapism with it.
In 2017, the Delhi High Court gave a judgement in a case where an 18-year-old girl, who was suffering from DR-TB, was refused Bedaquiline. After, the judgement, the government provided her the drug.
