Novartis' patent on eltrombopag olamine upheld by Delhi High Court

The Delhi High Court has issued a permanent injunction against two Indian companies protesting Novartis (NOVN: VX) patent for eltrombopag olamine, an active pharmaceutical ingredient in its brand Revolade, till May 21, 2023.

Swiss pharma giant Novartis’ Revolade (eltrombopag) is approved in more than 90 countries for the treatment of chronic immune (idiopathic) thrombocytopenic purpura.

Medipol Pharmaceuticals India and Metrochem API had submitted a proposal for the supply of tablets containing eltrombopag olamine (EO) while participating in a tender floated by the Odisha State Medical Corporation in September 2021. Novartis approached the court against the two companies.

Medipol told the court it had a monthly manufacturing capacity to produce 225 million tablets containing EO.

Natco also restrained

Earlier, in a major relief to Novartis, the Delhi High Court had also restrained Natco Pharma (BSE: 524816) from using, manufacturing, importing or selling the formulation containing EO. The court opined that Natco had a heavy burden of proof to establish the EO patent’s invalidity.

At the end of 2021, the Delhi High Court granted an interlocutory injunction to Novartis against Natco’s use of EO. The debate at the crux of the dispute was the dichotomy between deference to the validity of a granted patent vis-a-vis the challenge to its validity and consequently disregarding the exclusivity granted to it, in litigation.

Revolade has sales of around $9.18 million annually in India and reportedly had $1.7 billion in global sales in 2020. The compound is also claimed to be the first orally available small molecular thrombopoietin receptor agonist.

The international filing date of the patent application for EO is May 21, 2003 and the proprietary right over EO was granted to GlaxoSmithKline in 2009.