Novartis vows to challenge heart drug patent loss
Decision affects a patent listed in the Orange Book | Generic drug makers have so far failed to secure approval for biosimilar versions of the blockbuster drug.
In a blow to Novartis, the US District Court for the District of Delaware has ruled that its combination patent covering the heart failure drug Entresto (sacubitril / valsartan) is invalid.
Following the decision on July 7, Novartis released a statement vowing to appeal to the US Court of Appeals for the Federal Circuit to reverse the lower court’s ruling.
Last week’s decision invalidated US patent number 8,101,659, one of the patents listed in the Orange Book for Entresto. This patent, with its associated paediatric exclusivity, expires on July 15, 2025.
Since October 2019, Novartis has been involved in patent infringement litigation with numerous Abbreviated New Drug Application (ANDA) filers, including Mylan, who are seeking approval to market generic versions of Entresto.
Currently, Entresto is protected by multiple Orange Book-listed patents which expire between 2023 and 2036 (including any paediatric exclusivity). As yet, no generic version of Entresto has received approval from the US Food and Drug Administration.
In its statement, Novartis insisted that it retains confidence in its growth forecasts, largely based on the future growth potential of other key brands including Kisqali, Pluvicto, Leqvio, Kesimpta, Scemblix and iptacopa.
The company has also maintained its mid-term outlook of +4% sales growth in the period spanning 2022 to 2027.
“The company will continue to vigorously defend its intellectual property rights relating to Entresto, including the combination patent as well as multiple patents covering additional innovations,” said Novartis.
“Currently no generic Entresto products have tentative or final FDA approval. If approved, any commercial launch of a generic Entresto product prior to the final outcome of Novartis appeal, or ongoing infringement litigations involving other patents, may be at risk of later litigation developments,” it added.
On July 6, the US District Court for the Northern District of West Virginia issued a decision holding that proposed generic products from Mylan will infringe US patent numbers 8,877,938 and 9,388,134, which also cover Entresto.
Novartis confirmed that it has previously entered into settlement agreements with several ANDA filers that will be able to launch a generic version of Entresto in the US on an agreed-upon date, or earlier in certain circumstances. Details of these settlements remain confidential.
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