Sanofi has sought patent on a specific fixed dose combination of rifapentine and isoniazid for film coated tablet and dispersible formulations. (Reuters)
After French pharmaceutical giant Sanofi withdrew applications from European Patent Office (EPO) and Indonesia to get patent on a combination of isoniazid and rifapentine drugs, activists in India have demanded a similar withdrawal from the country claiming if granted a patent, the move will hamper tuberculosis (TB) prevention treatment for a large population.
Sanofi has sought patent on a specific fixed dose combination of rifapentine and isoniazid for film coated tablet and dispersible formulations. Isoniazid was approved and was available in market in 1952 while rifapentine in 1998. Activist and TB survivor Ganesh Acharya, who filed a pre-grant patent opposition with the Indian Patent Office in Kolkata in December last year, said the patent is not a new invention but “simply combination of two existing drugs”.
A standard TB prevention therapy involves a six-month regimen of isoniazid. It, however, has side effects like liver toxicity. A newer regimen, basically a combination of isoniazid with rifapentine, has showed less liver toxicity and is required to be taken for only three months. Sanofi filed a patent application for the combination in 2014 in India.
While China and USA granted the pharmaceutical company a patent for child formulation in 2019, Russia, Australia and South Africa granted patent for both, child formulations and film coated tablets. Sanofi withdrew its patent application from Indonesia and European Patent Office last December. Its patent application remains pending in India, Thailand, Nigeria, Brazil and few more countries.
“We are concerned India will not be able to procure generic combination if a patent is granted. Supply of these drugs will be hampered in high burden countries. Already in South Africa the patent grant would prevent local manufacturers from preparing cheaper dose combination. It is a cause of worry,” said Leena Menghaney, lawyer with Médecins Sans Frontières.
According to Treatment Action Group, a US-based organisation, isoniazid has never been patented, and the main patents on rifapentine expired long ago. “We now expect Sanofi to surrender its patents in other countries where they were granted and withdraw its applications everywhere else,” the organisation said in a statement.
A Sanofi spokesperson told The Indian Express that it plans to withdraw the patent from India. “Sanofi does not have the monopoly for the combination of rifapentine/isoniazide, and generic companies could and should enter the market if we - all stakeholders - want to reach the goals of the UN declaration, which is to provide treatment for latent TB infection to at least 30 million people until 2022,” the spokesperson said.
India has a TB incidence of 27 lakh. According to India TB Report 2019, 30-40 per cent population is infected with latent TB bacteria. In 2018, 21.5 lakh new cases were notified, of which only 19.1 lakh initiated treatment. India has an ambitious commitment to eliminate TB by 2025, five years ahead of global target.