25 September 2017Americas

Kowa wins ANDA case against Amneal and Apotex

Japanese drug maker Kowa has won a patent infringement case against Amneal and Apotex over their Abbreviated New Drug Applications (ANDAs).

The decision was announced by Judge Paul Crotty in the US District Court for the Southern District of New York on Wednesday, September 20. The court declared that a patent owned by Kowa was valid.

Livalo, manufactured by Kowa, is protected under US patent number 8,557,993, called “Crystalline forms of pitavastatin calcium”.

The treatment is used to lower cholesterol.

Amneal and Apotex, which had filed ANDAs, believed that Kowa’s patent was invalid, but after holding a ten-day bench trial in January, the court felt otherwise.

The court also stated that claims 1, 22, 23, 24, and 25 of the ‘993 patent would have been infringed by Apotex’s ANDA.

Amneal had conceded infringement, agreeing that the active pharmaceutical ingredient in its proposed product would infringe Kowa’s product.

Apotex believed otherwise due to its expert, Dr Sacchetti, who said: “To have infringement in this case, we have to have a match in relative intensity.”

He also stated that the structure of Apotex’s drug was different to Livalo and did not meet the limitations of the asserted claims put forward by Kowa.

Kowa can still seek attorneys’ fees, according to the court.

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