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news.The Japanese patent office has said that a patent relating to the active ingredient of cholesterol lowering drug, pravastatin, made by Japanese company Sankyo is invalid. The ruling is a result of a challenge by Israeli generic drug manufacturer, Teva Pharmaceuticals.
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Pravastatin is marketed by Bristol-Myers Squibb in the US under the name Pravachol.
The ruling in Teva’s favour is the second decision regarding this product that has been granted to Teva this year. In April, the Japanese patent office invalidated Sankyo’s patent in Japan, which relates to a process for the extraction of pravastatin with iso-butyl acetate.
This request by Teva for invalidation of Sankyo’s patent represents the first time that a generic drug company has challenged the patents of a brand name company in Japan.
Teva currently manufactures and supplies the bulk active pharmaceutical ingredient for the finished dosage pravastatin in several countries including Japan.