Novartis Hepatitis C patent upheld by Delhi High Court
In a victory for Novartis, the Delhi High Court in India has issued a permanent injunction against two India-based companies which had allegedly sought to make a generic version of the Hepatitis C treatment, Revolade (eltrombopag).
Revolade is approved in more than 90 countries and Novartis’ patent is not due to expire until May 2023.
The eltrombopag ingredient raises the platelet count in patients with ITP aplastic anaemia and cirrhosis due to chronic Hepatitis C.
Novartis had filed complaints against Medipol Pharmaceuticals and Metrochem, after they allegedly submitted proposals for generic versions of the drug while participating in a tender process carried out by Odisha State Medical for various drugs in September 2021.
In the US, the drug is sold under the brand Promacta in the US, after it was approved in 2008 by the US Food and Drug Administration.
According to Novartis, the drug generated sales of $1.7 billion in 2020.
Medipol Pharmaceuticals had declared that it had manufacturing capacity to produce 225 million tablets of drug containing eltrombopag olamine monthly, according to Novartis.
But Medipol insisted that it had not received the tender by Odisha and that it had acknowledged Novartis’ patent.
Metrochem contended that it had a business relationship with Medipol, had never supplied quantities of the patented drug, and that it does not have a commercial manufacturing licence.
Metrochem also committed to refrain from making, using, selling, distributing or offering for sale the drug which infringes Novartis’ Indian patent.
Earlier this month, Justice Prathiba Singh sided with Novartis and ordered that a permanent injunction would be applicable until May 21, 2023.
However, she did rule that any use of the product, by the defendants, for the purposes of research or development strictly in terms of Section 107-A of the Patent Act, 1970 would be permissible.
The Delhi High Court recently granted an interlocutory injunction to Novartis against Natco’s use of eltrombopag olamine (EO).
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