In its application, 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, due to the Covid-19 second wave, as the main grounds for seeking the CL.
“The CL, if granted, will help in improving the accessibility and affordability of the drug, bringing its price down substantially”.
Under the World Trade Organisation TRIPS Agreement, compulsory licences are legally-recognised means to overcome barriers in accessing affordable medicines. Under the rules, governments allow a company to manufacture a patented drug without the consent of the innovator firm.
Analysts said Natco’s move puts pressure on the US drug maker. It has only two choices – either give a voluntary licence or sue Natco for the patent, which could result in a public backlash given the soaring Covid-19 case load and death toll in India.
Natco has applied for a CL at a time when India and South Africa have approached the WTO for a temporary suspension of intellectual property rights of pharma companies so that Covid-19 vaccines and other medicines can be accessible to poor countries.
Natco has urged the controller of patents to grant it a CL to manufacture and market Baricitinib, both as bulk API (active pharmaceutical ingredient) and finished dosage only for Covid-19 treatment in India till the pandemic prevails. It is also willing to pay a 7% royalty on net profits from Baricitinib sales to the patent-holder.
Making its case, Natco’s application said not only is Olumiant not manufactured in India, less than 9,000 tablets were imported in 2019 and 2020, at an average cost of Rs 3,230 per tablet.
Citing the pricing as a significant barrier, it said a 14-day regimen (one tablet a day) works out to approximately Rs 45,220 per patient, which most Indians can ill-afford.
Natco said it would structure its pricing 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.
It also pointed out 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-19 patients in India. “The tablets of Olumiant imported through 2020 by Lilly would serve at best to meet the needs of only approximately 600 patients,” Natco said in its application, a copy of which was reviewed by TOI.
“It’s time India set up an independent committee of experts to consider and advice on compulsory licensing and use of other safeguards for Covid-19 medical products including medicines and vaccines’’, lawyer and IP expert, Leena Menghaney told TOI.
This is not Natco’s first battle for CL with a global pharma biggie. In 2012-13 it took on Bayer for cancer drug Nexavar and won India’s first ever successful compulsory license.