Patent office rejects J&J TB drug move
2 min read 23 Mar 2023, 11:41 PM ISTJ&J currently has a monopoly through its primary patent on the bedaquiline compound that will expire in July 2023.
PremiumNew Delhi: The Indian Patent Office on Thursday rejected US pharmaceutical firm Johnson & Johnson’s (J&J) attempt to extend its monopoly in India on the TB drug bedaquiline beyond the primary patent’s expiry this July, according to people familiar with the matter.
The ruling paved the way for the entry of generic versions of the tuberculosis (TB) drug that are likely to be 80% cheaper for a six-month course for patients suffering from drug-resistant TB.
J&J currently has a monopoly through its primary patent on the bedaquiline compound that will expire in July 2023.
The patent challenge was filed by two TB survivors, Nandita Venkatesan from Mumbai and Phumeza Tisile from Khayelitsha, South Africa. They together filed the patent challenge at the Mumbai Patent Office in 2019, along with Médecins Sans Frontières, or Doctors Without Borders (MSF).
The final hearing of the case was held in January this year.
In 2019, the managing director of Janssen in India, the local pharmaceutical division of J&J, publicly stated that in July 2023, generic manufacturers will be able to make their own versions of bedaquiline. However, the company allegedly began pushing for another patent for this drug in India that triggered the survivors challenging the patent.
“We wanted to ensure that the safer, oral and more efficacious drug bedaquiline was available to all people who need it and to make sure that no one ever has to endure side effects like we did, such as permanent hearing loss due to toxic injected drugs. We are thrilled to see that our attempt to break the monopoly of a pharmaceutical corporation over this lifesaving 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 really reduce unnecessary suffering caused by older toxic drugs and treatment regimens," said Venkatesan on the verdict.
Both the challengers survived severe forms of TB but lost their hearing because of the toxicity of the older treatments they had to take before there was access to the improved and better-tolerated drugs, like bedaquiline and delamanid.
Since 2020, bedaquiline has become the backbone for all drug-resistant TB (DR-TB) regimens.
While the company has the legal option of appealing against the verdict, generic drugmakers will technically be free to manufacture the medicine after the primary patent expires in July and the original verdict is not overturned later.
J&J said, “Whether this patent was granted or not, a formulation patent would not have prevented generic manufacturers from developing the active pharmaceutical ingredient in their own formulations after July 2023, when our API patent expires in India. We remain committed to supporting India’s efforts to end TB and look forward to participating in the TB high level summit hosted by Prime Minister Modi later this week."
