Natco seeks patent waiver for arthritis drug to fight Covid-19 in Hyderabad | Hyderabad News

HYDERABAD: In the first instance of a pharmaceutical company taking the compulsory license (CL) route to launch a Covid-19 drug in India, Hyderabad-based Natco Pharma applied for a license to manufacture the drug against the Rheumatoid arthritis Baricitinib, under Section 92 Patents Act, 1970. The patent is owned by Incyte Holdings, with a license granted to Eli Lilly, which markets the drug under the brand name Olumiant.
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, due to the second wave of Covid-19, as the main search motives for CL.
“CL, if granted, will help improve accessibility and affordability of the drug, drastically lowering its price.”
Under the World Trade Organization’s TRIPS Agreement, compulsory licensing is a legally recognized means of overcoming barriers to access to affordable medicines. Under the rules, governments allow a company to manufacture a patented medicine without the consent of the innovator.
Natco’s move puts pressure on the US drug maker, analysts say. 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-19 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-19 vaccines and other drugs can be made available to countries poor.
Natco urged the patent supervisor to grant it a CL to manufacture and market baricitinib, both as a bulk API (active pharmaceutical ingredient) and a finished dosage only for Covid-19 treatment in India until then. let the pandemic prevail. He is also prepared to pay a royalty of 7% on the net profits from sales of baricitinib to the patentee.
In its claim, Natco’s claim stated that not only is Olumiant 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 therapy.
He also stressed that the limited imports of the drug, which increased from 8,870 tablets in 2019 to 8,385 tablets in 2020, would not be sufficient to cover the nearly 34 patients with Covid-19 lakh in India. “Olumiant tablets imported through 2020 by Lilly would best serve the needs of only around 600 patients,” Natco said in its application, a copy of which has been reviewed by TOI.
“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-19 medical products, including drugs and vaccines,” lawyer and intellectual property expert Leena Menghaney told TOI.
This is not Natco’s first battle for CL with a global pharmaceutical giant. In 2012-13, he took on Bayer for the cancer drug Nexavar and won the first ever successful compulsory license in India.

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