The Court Of Appeal for federal circuit (CAFC) has upheld a district judge's decision to dismiss Apotex Inc.'s counterclaims of noninfringement in connection with a patent fight over Johnson & Johnson subsidiary Janssen's anti-psychotic drug Risperidone (Risperdal) Oral Solution 1 mg/ml.
US4804663 (Expiry: Jun 29, 2008): Product patent
US5453425 (Expiry: Jan 11, 2015): which covers an aqueous solution for oral administration comprising water, risperidone or a pharmaceutically acceptable acid addition salt thereof, a buffer to maintain the pH in the range of 2 to 6, and a preservative, characterized in that said solution is essentially free of sorbitol.
US5616587 (Expiry: Jan 11, 2015): An aqueous solution suitable for oral and parenteral administration comprising water, risperidone or a pharmaceutically acceptable acid addition salt thereof, characterized in that said solution comprises a buffer to maintain the pH in the range of 2 to 6 and is essentially free of sorbitol.
USRE39181 (Expiry: Jan 11, 2015): An aqueous solution suitable for oral and parenteral administration comprising water, risperidone or a pharmaceutically acceptable acid addition salt thereof, characterized in that said solution comprises a buffer to maintain the pH in the range of 2 to 6 and is essentially free of sorbitol.(Reissue of ‘587 patent)
Teva has got 180 days exclusivity on this product. Apotex wants to get declaratory judgment on US5453425 and US5616587 from court. Innovator issued 'covenant not to sue' to Apotex for ‘425 and ‘587 patents. However, Apotex was not satisfied with this convenent not to sue. Apotex filed its declaratory judgment request in court, which rejected this request based on no article III controversy. The CAFC upheld the district court’s decision and thwarted Apotex’s attempt to trigger 180 day exclusivity of Teva.
Eralier news of Ippharma doc here
CAFC’ s opinion Here
US4804663 (Expiry: Jun 29, 2008): Product patent
US5453425 (Expiry: Jan 11, 2015): which covers an aqueous solution for oral administration comprising water, risperidone or a pharmaceutically acceptable acid addition salt thereof, a buffer to maintain the pH in the range of 2 to 6, and a preservative, characterized in that said solution is essentially free of sorbitol.
US5616587 (Expiry: Jan 11, 2015): An aqueous solution suitable for oral and parenteral administration comprising water, risperidone or a pharmaceutically acceptable acid addition salt thereof, characterized in that said solution comprises a buffer to maintain the pH in the range of 2 to 6 and is essentially free of sorbitol.
USRE39181 (Expiry: Jan 11, 2015): An aqueous solution suitable for oral and parenteral administration comprising water, risperidone or a pharmaceutically acceptable acid addition salt thereof, characterized in that said solution comprises a buffer to maintain the pH in the range of 2 to 6 and is essentially free of sorbitol.(Reissue of ‘587 patent)
Teva has got 180 days exclusivity on this product. Apotex wants to get declaratory judgment on US5453425 and US5616587 from court. Innovator issued 'covenant not to sue' to Apotex for ‘425 and ‘587 patents. However, Apotex was not satisfied with this convenent not to sue. Apotex filed its declaratory judgment request in court, which rejected this request based on no article III controversy. The CAFC upheld the district court’s decision and thwarted Apotex’s attempt to trigger 180 day exclusivity of Teva.
Eralier news of Ippharma doc here
CAFC’ s opinion Here
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