Natco Pharma files waiver of patent rights to launch COVID-19 drug in India

Hyderabad-based Natco Pharma has taken the compulsory licensing (CL) route to launch a COVID-19 drug in India. As such, it has filed for a waiver of patent rights to manufacture rheumatoid arthritis drug Baricitinib.

If the CL is granted, it will help in the improving of accessibility and affordability of the drug. Baricitinib was discovered by Incyte and licenced to Eli Lilly and Company, and marketed under the brand name Olumiant. Baricitinib, an inflammatory drug, and remdesivir, according to New England Journal of Medicine, has reduced the time to recovery for people hospitalized with COVID-19. Researchers hypothesized that because many severe symptoms of COVID-19 are caused by a poorly regulated inflammatory response, a therapeutic designed to target inflammation could be helpful for the patients.

Natco Pharma’s application has been filed under Section 92 of the Patents Act, which can be invoked by the Centre due to a national emergency, circumstances of extreme urgency or in case of public non-commercial use. According to ToI, Natco has cited the unmet medical needs due to the lack of supply and affordability in light of the grave and life-threatening national public health emergency caused by the second COVID-19 wave as the main grounds for seeking the CL.

The World Trade Organization says compulsory licensing is when a government allows someone to produce the patented product or process without the consent of the patent owner. The agreement allows CL as part of the agreement’s overall attempt to strike a balance between promoting access to existing drugs and promoting research and development into new drugs. CL and government use of a patent without the authorization of its owner can only be done under a number of conditions aimed at protecting the legitimate interests of the patent holder.

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Natco’s move, as per the report, is expected to force the government to examine the application carefully given that former Prime Minister Manmohan Singh had pointed to the flexibility available under the law. Analysts say that the application puts pressure on the US drug maker. And as such, the patent owner has two options – to give a voluntary licence or sue Natco for the patent. If it goes with the latter, then it would definitely result in a public backlash amid the surging COVID-19 cases and deaths in India.

The Hyderabad-based pharma company said it would structure its pricing for the drug at Rs 30 each for a  4mg tablet, which translates to Rs 420 for a 14-day course; Rs 20 for a 2mg tablet (Rs 280 for the regimen) and Rs 15 for each 1mg tablet costing only Rs 210 for the entire 14-day therapy. Natco also highlighted that the drug’s limited imports, which dropped from 8,870 tablets in 2019 to 8,385 tablets in 2020, would not be enough to cater the nearly 34 lakh COVID patients in India.