Natco Pharma Files Application Seeking Compulsory License For COVID Drug Baricitinib

Indian generic drug manufacturer Natco Pharma Limited has filed an application before the Controller of Patents seeking compulsory license to produce the drug 'Baricitinib' which is used for treatment of COVID-19.

Natco filed application under Section 92(1) read with 92(3) of the Patents Act seeking compulsory license to produce 'Baricitinib' at an affordable rate amid the second wave of the COVID pandemic.

Section 92 is a special provision in the Patents Act empowering the Patent Controller to issue compulsory license to any interested person to manufacture a patented drug to meet a public health emergency.

In the application filed before the Mumbai branch of the Patents Controller, Natco says that patent of 'Baricitinib' was granted to a company named Incyte Holdings Corporation in 2018.

Natco says that the present production rate of 'Baricitinib' - which is approved for emergency use in India along with Remdesivir- is not adequate to meet the demands of surging COVID cases, and that vast majority of Indians cannot afford its expensive price.

It is pointed that the drug is being produced in India at a low quantity - 8870 tablets in 2019 and 8385 tablets in 2020- and that the average cost per tablet is Rupees 3230 per tablet. For a 14-day treatment, the price works out to INR 45,220.00 per patient. In contrast, Natco offers to sell the drug at Rs.15, Rs 20 and Rs 30 per tablet for its 1 mg, 2mg and 4g variants respectively.

It is also said that the present patent holder has a narrow distribution network in India which cannot address the demands surging from different parts of the country.

It is pertinent to recall that Natco is the first pharma company in India to be granted compulsory licensing for a drug in India. That was with respect to a life-saving drug for kidney cancer, which was held by a German company named Bayer.  Natco also won the litigiation instituted by Bayer to challenge the grant of compulsory license to it.

Last week, the Supreme Court had urged the Central Government to explore the option of compulsory licensing to make COVID-19 drugs more affordable and reachable. The Delhi High Court has also made similar observations.

With respect to 'Baricitinib', Natco offers to pay 7% royalty on net profits to the patent holder. It undertakes to give preference to patients in the economically weaker sections,government (both central and state government) welfare schemes and in remoter areas of the Country. In deserving cases, Natco said it will sell the drug free of cost.

On May 3, the Central Drugs Standard control Organization granted Natco Pharma received emergency use approval for Baricitinib tablets, 1 mg, 2 mg and 4 mg strengths.