The US drug major Eli Lilly is fighting a patent infringement litigation against several Indian companies for the intellectual property rights on its compound baricitinib, even though it has issued eight royalty-free voluntary licenses to Indian pharmaceutical companies to distribute the drug solely for treatment of Covid-19, a few months back. Eli Lilly sells the drug under the brand Olumiant.

The company has filed a complaint at the Delhi High Court against almost 20 entities or individuals for allegedly marketing and advertising sale of Barinat - the brand name under which Hyderabad-based Natco manufactures and markets baricitinib - as a treatment for rheumatoid arthritis. Eli Lilly announced in May this year that it has entered into a royalty-free voluntary license agreement with Natco, only for the treatment of Covid-19.

Eli Lilly argued that the alleged marketing and advertising of the product for another ailment is “a clear breach of the license granted by the company to Natco, which permitted marketing of baricitinib, by Natco, only for the treatment of Covid-19”. In May, the US drug major received Emergency Use Approval (EUA) for the use of the drug in combination of remdesivir, for treatment of Covid-19.

Following this, the company entered into a voluntary license agreement with Indian pharmaceutical companies including Natco to distribute the compound under their individual trademark/brand names, solely for the purpose of treatment of Covid-19. The license did not permit the export of the drug or marketing of the drug for treatment of any ailment other than Covid-19.

Natco, acknowledging that the license granted was only for marketing of the drug to treat Covid-19, submitted to the Court that it has no objection if the Court injunction marketing and sale of Barinat for any purpose other than the treatment of Covid-19, as well as for export.

The company said that it has not breached the agreement with Eli Lilly, which the latter also agreed. Eli Lilly said that the cause of action in the complaint is not directed against Natco, but against the entities which are marketing Natco’s product for treatment of rheumatoid arthritis. The Court, following this, in September, granted an interim injunction restraining 20 defendants from marketing or selling Barinat, in any form except for the treatment of Covid-19, on any virtual platform or physically across the counter, apart from export till next hearing.

In a hearing held on November 15, one of the defendants - Bull Pharmachem - has submitted that the marketing or display of Barinat as a treatment for rheumatoid arthritis was an inadvertent error of the marketing team and that it had no intention of selling the drug as a treatment for rheumatoid arthritis or for which it was not produced. It has not sold the drug as a treatment for rheumatoid arthritis, it added.

The company said that it would not market or sell the drug as treatment for any ailment other than Covid-19 and would not export the tablets. Justice C Hari Shankar, in his order, observed that no cause of action survives against Bull Pharma after the undertaking and ordered that it shall not continue to be treated as in the array of parties.

According to reports, Eli Lilly has issued royalty-free voluntary licenses to Indian players including Sun Pharma, Cipla, Lupin and Torrent. Bajaj Healthcare, another Indian player, approached the Indian Patent authority seeking compulsory licensing for the drug, after Eli Lilly denied voluntary licensing to the company, said reports.

Baricitinib is authorised for use under an Emergency Use Authorization (EUA) for treatment of Covid-19 in hospitalised adults and pediatric patients two years of age or older requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).