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Médecins Sans Frontières/Doctors Without Borders (MSF) along with the petitioners who challenged a patent application by Johnson and Johnson for its TB drug bedaquiline, urged the Indian Patent Office to reject the secondary patent application filed by the company.
The organisation said that the Indian Patent Office, on January 17, is set to hold the final hearing on a patent challenge filed by two tuberculosis (TB) survivors, against a patent which could extend the company’s patent rights on the drug beyond the primary patent’s expiry this July.
MSF also called on the pharmaceutical corporation to withdraw the patent application in India and other countries where equivalent patents remain, and stand by its statement that generic versions should be made available in 2023.
“In 2019, the Managing Director of Janssen in India, the local pharmaceutical division of J&J, publicly stated that come July 2023, generic manufacturers will be able to make their own versions of bedaquiline and yet, the corporation is now aggressively pushing for another patent for this drug in India,” alleged MSF in a press statement.
Nandita Venkatesan from Mumbai, India, and Phumeza Tisile from Khayelitsha, South Africa, who together filed the patent challenge at the Mumbai Patent Office in 2019, both 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.
“The pharmaceutical corporation J&J currently has a monopoly through its primary patent on the bedaquiline compound that will expire in July 2023. As an evergreening strategy, a common practice used by pharmaceutical corporations to delay the entry of affordable generics, J&J has also filed for multiple secondary patents on bedaquiline in India and in many other countries for obvious and routine changes on the bedaquiline compound that is now already known. One of them is the secondary patent application on the fumarate salt of bedaquiline filed in India, which if granted, would potentially extend J&J’s monopoly until December 2027, thereby blocking Indian generic manufacturers from entering the supply chain with more affordable generic versions for four more years,” alleged MSF.
Since 2020, bedaquiline has become the backbone for all DR-TB regimens recommended by the World Health Organization (WHO). However, it currently accounts for 35-70% of the overall cost of most of the drug-resistant TB (DR-TB) treatment regimens. With treatment scale-up and competition among generic manufacturers to begin by July 2023, the price of bedaquiline could soon come down by as much as 80%, i.e., from the current lowest price of US$45 per person per month to as low as $8-17 per person per month, it added.
Several Indian manufacturers are ready to supply the generic version of this life saving drug upon the expiry of the basic patent in July 2023. Generic manufacturers have already applied to the WHO’s ‘Pre-Qualification’ programme, which assures quality of products for low- and middle-income countries and treatment providers, averred the organisation.
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