New Delhi: Drugmaker Bajaj Healthcare Limited (BHL) has requested the Indian patent office to grant a compulsory licence to it for manufacturing and supply of Baricitinib — one of the potential treatment options against Covid-19.
The manufacturer of Covid drugs favipiravir and ivermectin, BHL has requested the patent office for the licence to manufacture both active pharmaceutical ingredients (raw materials) and formulation of Baricitinib.
The Mumbai-based drugmaker approached the Office of the Controller General of Patents, Mumbai after its request for the grant of voluntary licence was turned down by the patentee Incyte Corporation and its exclusive licence holder, the American pharma giant Eli Lilly.
The drug is licensed to Eli Lilly by its originator company Incyte, giving Lilly the rights for marketing it across the globe.
Voluntary licence involves the permission given by the patent holder to manufacture and sell the drug whereas compulsory licence does not require taking permission from the owner of the patented drug.
BHL, which filed the application with the patent office on 26 May, is awaiting a response.
“We have not received any response until now,” Anil Jain, managing director at BHL, told ThePrint.
The official at the patent controller office told ThePrint via phone that the matter is being discussed with the central government ministries but they are awaiting the final response.
BHL says it can manufacture drug for as cheap as Rs 14
In the application, BHL said the price of Baricitinib sold by Eli Lilly in India is not affordable “as it is not even a monthly family income of the majority of people in India”.
“It has affected the availability as well as the affordability of the drug to Indian patients. The calculations on the basis of disclosures for the years 2018 and 2019 show that the average cost of the Baricitinib tablet is Rs 3,230. The Baricitinib tablet course for COVID-19 treatment is prescribed for at least 14 days. The total course would cost Rs 45,220 per patient.”
In turn, BHL says it can manufacture the same drug at an estimated price of Rs 14 (for 1mg), Rs 18 (2 mg), and Rs 28 (4 mg) tablet.
Earlier, Indian drug major Natco planned to seek compulsory licence for the same drug.
In May, Natco had received emergency use authorisation from the apex drug regulator, Drug Controller General of India, to manufacture and market Baricitinib in India. While Natco announced that it will request a compulsory licence based on emergency use, it was granted voluntary licence by Eli Lilly along with six other Indian drugmakers, including Sun Pharma, Lupin, Cipla, and Torrent.
‘Challenging to sign voluntary licensing agreements with all firms’
Citing email conversations from 16 May with Eli Lilly, BHL said that while they are willing to pay a royalty of up to 7 per cent of the net profits, Lilly said it has decided to stop responding to additional voluntary licensing requests at this stage.
“As you may have heard, Lilly is offering continuous donations of Baricitinib to the Indian government in big quantities to treat the eligible Covid-19 patients. Moreover, we have already announced the signature of a royalty-free voluntary licensing agreement to ensure Baricitinib is available in the country for the Covid-19 patients in sufficient quantities and good quality,” the emailed response from Eli Lilly said, according to the annexure attached with the application filed.
Eli Lilly also said a “couple of additional agreements are in the final phase of negotiations and may be announced soon” and that the pharma company will prioritise negotiations with those companies who reached out to them first.
BHL approached Eli Lilly again on 19 May, according to the application, this time with assurance on making the high-quality product available to the Indian patient population at an affordable price, to which Lilly responded, “As indicated earlier, it is really challenging for Lilly to sign voluntary licensing agreements with all the Indian companies who have requested for the same.”
“If the situation changes in the near future and in case the events would justify the issuance of additional licenses, we will reach out to you appropriately,” the American pharma company said in its email.
Citing the email exchange, BHL, in its application, said, “Thus, the applicant finds no other option than to reach to the Office of the Controller General of Patents, Designs and TradeMarks (CGPDTM)…,” while adding that, “All the attempts of the applicant (BHL) to get the voluntary license were futile. The patentee is not willing to consider the licensing request at this time and this may result in unnecessary delay in supply of the essential medicine in this emergency situation in India.”
Studies on Barcitinib effectiveness
Highlighting the national emergency posed by the Covid outbreak, BHL said, “There is extreme urgency for scientifically competent individuals/companies to step in and support the government to save the precious lives of our countrymen on a priority basis.”
Attaching several studies that support the use of Barcitinib in the treatment of Covid, it said, “There was an extreme urgency in filing this present application owing to the fearful situation due to the COVID-19 deaths crossed lakhs in numbers, the shortage of medicines and therapies, and the public health emergency situation.”
For instance, the New England Journal of Medicine (NEJM) found that Baricitinib plus remdesivir was superior to remdesivir alone in reducing recovery time and accelerating improvement in clinical status among patients with Covid-19, notably among those receiving high-flow oxygen or noninvasive ventilation.
(Edited by Neha Mahajan)