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29 October 2019AmericasRory O'Neill

Novartis takes aim at Indian drug companies over Entresto generics

Swiss pharmaceutical company Novartis has filed a patent infringement lawsuit against three Indian rivals in a US federal court over proposed generics of its heart failure drug Entresto (sacubitril/valsartan).

The suit, filed at the US District Court for the District of Delaware last Thursday, October 24, claims that Indian drug companies Alembic, Natco, and Macleods had infringed Novartis’ patents for Entresto.

According to Novartis, the drug companies infringed the Entresto patents with abbreviated new drug applications (ANDA) filed with the US Food and Drug Administration (FDA).

The suit asserted a total of four patents for the heart failure drug (US numbers 8,101,659; 8,796,331; 8,877,938; and 9,388,134).

Novartis is suing for permanent injunctions against each of the defendants preventing them from producing Entresto generics until the patents expire.

The Swiss company is also seeking declaratory judgment that each of the defendants’ ANDAs infringe the Entresto patents, as well as an award of attorneys’ fees.

It is not the first time in recent months that Novartis has come into conflict with the Indian pharmaceutical industry over generic versions of its products.

In August, LSIPR reported that the Delhi High Court had suspended a separate Novartis patent infringement suit against Natco over the Indian company’s generic of Ceritinib, a small-cell lung cancer treatment.

The court’s decision to bring the Novartis suit to a halt followed a ruling of the country’s patents controller-general, who cancelled the Swiss company’s patent for the drug.

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29 August 2019   The Delhi High Court has cleared the way for a generic version of Novartis’ small-cell lung cancer drug Ceritinib, after the Swiss pharmaceutical company’s patent was revoked.

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29 August 2019   The Delhi High Court has cleared the way for a generic version of Novartis’ small-cell lung cancer drug Ceritinib, after the Swiss pharmaceutical company’s patent was revoked.

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29 August 2019   The Delhi High Court has cleared the way for a generic version of Novartis’ small-cell lung cancer drug Ceritinib, after the Swiss pharmaceutical company’s patent was revoked.