In a move that could bring down the treatment cost for tuberculosis, the Controller of Patents office in Mumbai on Thursday rejected an application by United States pharmaceutical giant Johnson & Johnson for the patent of bedaquiline drug, used for treating the disease.
Bedaquiline is used in combination of other medicines to treat tuberculosis patients when the first line of treatment fails to kill the bacteria. The patent for the medicine will end in 2023.
The use of this oral drug has been crucial for tuberculosis treatment in the country. India has an incidence of 25.90 lakh tuberculosis cases, a report by the World Health Organization showed in 2021.
The Ministry of Health and Family Welfare figures show tuberculosis patients notified in 2021 stood at 19.33 lakhs, up from 16.2 lakh in 2020. Of the cases notified in 2021, the number of drug-resistant cases was 48,232. A large majority of these require bedaquiline in combination of other drugs for treatment.
The oral drug has lesser-known harmful effects than injectable drugs. Currently, the treatment cost for a six-month course is around Rs 65,000.
The cost of tuberculosis treatment by bedaquiline is expected to significantly drop due to the rejection of the patent as it would allow Indian manufacturers to manufacture generic medicines. The increase in competition in the market will also ensure a price drop.
“This decision will largely benefit TB patients and cost of treatment in India,” tuberculosis survivor Nandita Venkatesan told Scroll. “We expect generics will reduce cost of drug.
In 2009, Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson, had published the patent for its bedaquiline medicine. After the patent is published, the public can raise opposition under the Indian Patents Act, 1970.
In 2013, a group of people infected with both tuberculosis and HIV had challenged granting of the patent under Section 25(1)(h) of the Indian Patents Act, 1970. The provision deals with opposition to a patent and can be filed before the the drug is granted the patent and after the publication of the patent application.
In 2022, Venkatesan and another tuberculosis survivor, Phumeza Tisile, filed a second pre-grant opposition application against Janssen’s move to get the patent extended for the drug.
On Thursday, the Controller of Patent decided to allow the patent till July 2023 but rejected the pharmaceutical firm’s request for granting patent extension.
It observed that the company already has a patent for a similar compound and does not merit a new demand unless it can prove advanced therapeutic effect of the new compound.
In a statement, a Johnson & Johnson spokesperson its patent was filed over a decade ago as part of standard procedures when developing new medicines.
“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,” the spokesperson said.
Charity organisation Médecins Sans Frontières, also called Doctors Without Borders, said the decision was a significant step toward increasing access to the lifesaving drug.
“Moving forward, J&J must not block the supply of more affordable generic versions of bedaquiline to high TB burden countries and stand by its 2019 statement from the Managing Director in India of Janssen [J&J’s pharmaceutical division], that generic manufacturers will be able to make generic versions of bedaquiline starting in 2023,” it said in a statement.
It added that the firm should also urgently withdraw its patents in other countries, including those with high tuberculosis cases, where the equivalent of the Indian patent application still remains.
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