The USFDA granted emergency authorization for baricitinib in combination with Remdesivir last November.
Currently, a limited amount of the patented drug is available in the country, and that too, at an exorbitant price (see graph). The patent is owned by Incyte Holdings, with a license to Eli Lilly, which markets the drug under the brand name Olumiant. The application was filed under Section 92 of the Patent Act, which can be invoked by the Center in a national emergency, circumstances of extreme urgency, or public use for non-purpose. commercial.
In its request, Natco cited unmet medical needs due to lack of supply and affordability in light of the serious and potentially fatal national public health emergency caused by the second wave of Covid as the main reasons for the request. by CL. Under the TRIPS Agreement of the World Trade Organization, LCs are legally recognized means to overcome barriers to access to affordable medicines. Under the rules, governments allow a company to manufacture a patented medicine without the consent of the innovator. In 2012, Natco became the first company to obtain a compulsory license in India, linked to an anti-cancer drug called Nexavar. Although there have been attempts to invoke the provisions again, the government has opposed the regular use of the clause.
Natco’s decision, however, is expected to force the government to carefully consider the request given that former Prime Minister Manmohan Singh pointed out the flexibility available under the law, although his reference was in context. increase in immunization. The app puts pressure on the US drugmaker, analysts said. He has only two choices – either grant a voluntary license or sue Natco for the patent, which could lead to a public reaction to the spike in the number of Covid cases and death toll in India.
Natco requested a CL at a time when India and South Africa approached the WTO for a temporary suspension of intellectual property rights for pharmaceutical companies so that Covid vaccines and other drugs can be made available to poor countries. “It is time for India to establish an independent expert committee to review and advise on compulsory licensing and the use of other safeguards for Covid medical products, including drugs and vaccines,” said to YOU ââlawyer and intellectual property expert Leena Menghaney. the Controller General of Patents to grant him a CL to manufacture and market Baricitinib, both as bulk API (active pharmaceutical ingredient) and finished dosage only for Covid treatment in India until pandemic prevails . He is also prepared to pay a royalty of 7% on the net profits from sales of baricitinib to the patentee.
In its dossier, Natco’s app said that Olumiant is not made in India – less than 9,000 tablets were imported in 2019 and 2020, at an average cost of Rs 3,230 per tablet. Citing price as a major hurdle, he said a 14-day regimen (one pill per day) works out to around Rs 45,220 per patient, which most Indians can hardly afford.
Natco said he will structure his prices at Rs 30 each for a 4 mg tablet, which translates to Rs 420 for a 14 day course, Rs 20 for a 2 mg tablet (Rs 280 for the diet) and Rs 15 for each 1 mg tablet, costing only Rs 210 for the entire 14-day course. He also pointed out that limited imports of the drug, which have increased from 8,870 tablets in 2019 to 8,385 tablets in 2020, do not would not be enough to cover the nearly 34 patients with Covid lakh in India. âOlumiant tablets imported through 2020 by Lilly would best serve the needs of only around 600 patients,â Natco said in its application, a copy of which has been reviewed by TOI.
Why the drug is important
Baricitinib is a rheumatoid arthritis medicine used in combination with Remdesivir for the treatment of Covid in some countries. The United States Food and Drug Authority granted emergency use authorization for baricitinib in November 2020. The drug prevents a cytokine storm and calms the immune system by inhibiting the Janus Kinases (enzymes) that send signals to cells to make more cytokines. Using Baricitinib with Remdesivir reduces hospital stay, increases the chance of survival, and also has minimal associated side effects.