Final hearing in tuberculosis drug patent case ends, verdict likely in a month
New Delhi: The Indian Patent Office had held its final hearing on a challenge filed by two tuberculosis survivors to prevent the Indian arm of drugmaker Johnson & Johnson from extending its patent on bedaquiline, used against drug-resistant TB, beyond the primary patent’s expiry in July
New Delhi: The Indian Patent Office had held its final hearing on a challenge filed by two tuberculosis survivors to prevent the Indian arm of drugmaker Johnson & Johnson from extending its patent on bedaquiline, used against drug-resistant TB, beyond the primary patent’s expiry in July.
If the patents regulator decides in the favour of the challengers, it will pave the way for generic versions of the drug in the local market that will likely be 80% cheaper for a six-month course. The hearing took place on January 17.
“The arguments have been concluded, pronouncing objections against the patent. This was the 4th hearing in the matter and the verdict is expected in about four weeks,” a person familiar with the development said, seeking anonymity.
The TB survivors—Nandita Venkatesan from Mumbai and Phumeza Tisile from Khayelitsha in South Africa—who filed the challenge at the Mumbai Patent Office in 2019, along with Médecins Sans Frontières (Doctors Without Borders, or MSF), has been urging the rejection of the secondary patent application filed by Johnson.
In 2019, the managing director of Janssen in India, the local arm of Johnson, stated that in July 2023, generic manufacturers will be able to make their own versions of bedaquiline, and yet, the corporation reportedly began pushing for another patent for the drug in India that triggered the survivors challenging the development.
Both the challengers survived severe forms of TB, but lost their hearing because of the toxicity of older treatments before there was access to the improved and better-tolerated drugs like bedaquiline and delamanid. Johnson has primary patent on the bedaquiline compound that will expire in July.
As an evergreening strategy, a common practice used by pharma corporations to delay the entry of affordable generics, Johnson has filed for multiple secondary patents on bedaquiline in India and in many other countries for obvious and routine changes on the compound that is now already known, MSF said in a statement.
One of them is the secondary patent application on the fumarate salt of bedaquiline filed in India, which would potentially extend Johnson’s monopoly till December 2027, blocking domestic manufacturers from entering the supply chain with more affordable generic versions for four more years.
Since 2020, bedaquiline has become the backbone for all drug-resistant TB (DR-TB) regimens recommended by the World Health Organization. However, it currently accounts for 35-70% of the overall cost of most of the DR-TB treatment regimens. With treatment scaleup and competition among generic manufacturers to begin by July, the price of bedaquiline could come down by as much as 80%. It currently costs a minimum of $45 per person per month that could decline to as low as $8-17 per person per month, experts said.
In India, the drug is procured directly by the government and distributed under conditional access through state health programmes.
“I had to battle with this deadly disease for nearly eight years, enduring taking multiple medicines and painful injections with debilitating side effects,” said Venkatesan, two-time TB survivor. “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 the agony for people with DR-TB who have to continue taking less effective and painful DR-TB treatment.”
“By rejecting the patent, the Indian Patent Office will help save lives of people with DR-TB and enable India to continue to play a crucial role as the pharmacy of the developing world,” she added. “I am not gaining anything personally out of this as my treatment is over, but I don’t want others to go through this cycle of pain.”