New Delhi: In a big victory for TB activism and children suffering from TB in India, the country’s patent office rejected Johnson & Johnson’s (J&J) patent application for the paediatric formulation of Bedaquiline on Friday, July 5.
Bedaquiline is used for the treatment of multi-drug resistant TB (MDR-TB). The MDR-TB patients are those in which the first line of TB drugs fail, and require treatment with higher-grade drugs.
In India, an estimated 3.33 lakh children in the 0–14 years age group become ill with TB each year (28% of global childhood TB burden), says a government report. The caveat here is this might be an underestimation because many TB cases remain undiagnosed.
“This is a significant victory for TB survivors, civil society organisations who have been opposing evergreening of patents,” said Leena Menghaney, an access to medicine activist.
Pharmaceutical companies make attempts to extend the patent life of their products on one or another basis, such as enhanced effect of the drug, or making minor changes in the already existing formulation of the drug etc. The evergreening of patents allows pharma companies of the innovator drug to prohibit others from making the same drug, and thus extend their monopoly, and maximise profits.
This decision from the Indian Patent Office comes on the heels of J&J’s decision last year to not press for a patent over Bedaquiline salt for adult patients. This decision was preceded by two major developments.
A pre-grant opposition had been filed by TB survivors, Nandita Venkatesan and Phumeza Tisile (a South African TB advocate), in the Indian Patent Office. The activists won the case. Simultaneously, the activists in South Africa had moved the competition commission of their country, which as a consequence, launched enquiry into the pricing of Bedaquiline.
Pediatric Bedaquiline case in India
J&J had filed a patent application in August 2017 for the paediatric formulation of Bedaquiline. The application had 18 claims arguing why it must be granted a patent.
A civil society group, The Delhi Network of Positive People, and a Mumbai-based TB survivor Ganesh Acharya filed what is known as ‘pre-grant opposition’ in December 2020. An opposition before the grant of the patent can be filed by an interested party. This is known as ‘pre-grant opposition’.
In the pediatric Bedaquline case, the pre-grant opposition was filed on five grounds, out of which the patent office found three to be true.
One of the three grounds was a “lack of inventive steps” in manufacturing the drug. The joint controller of patents and designs, B. Ahilan, wrote in his order that at least seven things about this pediatric formulation were known before the patent application was itself filed.
They include: the salt, ‘Bedaquiline fumarate’, Bedaquiline fumarate’s antibacterial use, inactive excipients (used to facilitate drug manufacturing), the tablet composition of Bedaquiline fumarate, range of the active ingredient, i.e. Bedaquiline fumarate, ranges of other inactive ingredients in the drug composition, and the method of preparation of the tablet.
“Therefore the present invention is obvious to the person skilled in the art,” the order reads. In other words, the steps to make this drug were “obvious” to anyone, who is “skilled in the art” of making such a formulation, before the application was filed. Hence the patent office opined there was a ‘lack of inventive steps’.
The second such ground was the lack of any synergistic effect in the drug for which the patent application had been filed. That is, the effect of the drug as a whole was no greater than the sum of its ingredients when put together.
J&J had not replied to any of the grounds of opposition and said, in future too, it had no such plans. This became the third ground for the rejection of the patent application. The applicant did not file a reply statement to the opposition and did not appear for hearing, the order states.
It’s important to contextualise here that the company had already lost the case of patent on the Bedaquline salt, used in preparation of adult formulation, in 2023
“In reply to the hearing notice the applicant filed a letter stating that ‘the applicant does not plan to attend the official hearing, given that no further resource will be spent on this case’,” the joint controller’s order noted.
Government follow-up
TB activists and survivors are now hoping that the government will up its game following this order. The first major challenge is the non-adoption of modern diagnostic tools for children suffering from TB. The avoidance in using of ‘gene-expert’ technology along with testing stool samples, especially for infants, is one such hurdle.
“Only if we are able to bring more cases of children suffering from Tb, who remain undiagnosed, under the net, they can be provided this drug,” Menghaney said.
The activist also pitched for pooled purchase of anti-TB drugs, including Bedaquiline, so as to meet the demand and eliminate stock-outs which are frequently reported.
Another drug, Delamanid dispersible 25 mg, is registered in India as of April 2023 but is not approved for children below 10 kgs, though recommended by WHO. “It’s like that a resource exists, proven in science, and yet we are denying it to children,” she added.
