Indian Pharma On A Profit Trip(s)

Whether WTO approves India-South Africa proposal for TRIPS waiver or not, Indian industry will remain pivotal to global plans to tackle pandemics

- Joe C. Mathew

In the first week of May, Hyderabad-based Natco Pharma approached the Supreme Court with an unusual request. It said it wanted to produce the low-cost generic version of Baricitinib, a patent protected medicine for Covid-19 treatment, and sought a directive to the Drug Controller General of India (DCGI) to quickly dispose of its applications for Emergency Use Authorisation (EUA) and clinical trial waiver. It sought similar directions for another experimental Covid-19 drug Molnupiravir. It also asked the court to ask the Indian Patent Office to expedite its request for Compulsory Licence to bypass market exclusivity of the patent holder, Eli Lilly. Natco said without the regulatory hurdles, it can bring down the per person cost (for a two-week regimen) of Baricitinib from ₹42,287 (innovator's price) to ₹420. But even before the court looked into the case, Natco received EUA. It launched the product at the pre-decided price without waiting for Compulsory Licence.

Natco’s action was fit case for a legal challenge from the patent owner over infringement of intellectual property rights (IPR). However, instead of a legal notice, on May 17, Lilly gave Natco a voluntary licence — a royalty-free, non-exclusive licence allowing it to continue selling the product. Lilly also granted similar licences for making and selling Baricitinib to over half-a-dozen local competitors of Natco. Luca Visini, Managing Director, Lilly India, considers this as proof of Lilly’s commitment to support India in its fight against Covid-19 by making available its breakthrough medicines. “We will continue to explore other initiatives to support patients and the healthcare system in India,” says Visini. Around the same time, US-based Merck (MSD) signed non-exclusive voluntary licensing agreements with five Indian generic companies for Molnupiravir.