New Delhi: The Indian Patent Office on March 23, Thursday, rejected pharma major Johnson and Johnson’s application to extend its patent on anti-Tuberculosis drug Bedaquiline that expires in July this year.
The patent would have extended J&J’s monopoly on the drug in India. But with this judgment, generic manufacturers can now make their own versions at an affordable price from this year.
The patents office delivered its judgment on a plea filed by two tuberculosis survivors – Nandita Venkatesan, a two-time TB survivor, and Phumeza Tisile, another TB survivor from South Africa.
The petitioners had said that J&J’s secondary patent application could block manufacturers from supplying generic versions of the drug, and therefore, limit people’s access to it.
Hindustan Times had reported that a decision against the pharma company 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.
In India, the drug is procured directly by the government. It is then distributed under conditional access through state health programmes, the daily said.
Also read: TB Patients on Bedaquiline Have Half the Mortality of Those Not on the Drug: WHO Chief
The Economic Times reported Latika Dawara, assistant controller of patents and designs patent office, as saying: “[The] instant application [of J&J] does not meet the requirements of section 2(1)(ja) and sections 3(d) & 3(e) of the Patents Act brd on the findings from the investigation as well as from the matter presented by the opponents in the pre-grant opposition proceedings as discussed above.”
“Therefore, it is hereby ordered that the invention disclosed and claimed in the instant application has been refused to proceed further under section 15 of the Act and simultaneously, I dispose both of the pre-grant oppositions as per the provision under Section 25(1) of the Act and corresponding Rules made there under.”
According to the newspaper, generic manufacturers have already applied to the WHO’s ‘pre-qualification’ programme to supply the drug to low- and middle-income countries.
J&J had filed a patent for Fumarate salt of Bedaquiline in 2008 to extend its patent till the end of 2027. It was under review by the patent office.
The strategy is called patent evergreening, which refers to the continuing extension of patent rights. It also refers to the process of obtaining many patents for the same medicine.
“My fellow TB survivor Phumeza Tisile from South Africa and I filed a patent challenge against J&J in 2019, because 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,” Venkatesan said in a press release by MSF.
“We are thrilled to see that our attempt to break the monopoly of a pharmaceutical corporation over this lifesaving drug has been successful. This win needs to be followed by the scale-up of shorter oral TB treatment regimens by TB programmes globally to reduce unnecessary suffering caused by older toxic drugs and treatment regimens,” she added.
