Tuesday 24 March, 2009

Risperidone (Risperdal) Oral Solution: US highest court refused to hear Apotex's writ of certiorari

The US highest court has refused to hear Apotex Inc.'s “writ of certiorari” regarding 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. Following patents are listed for this product in Orange Book:
US4804663 (Expiry: Jun 29, 2008): Product
US5453425 (Expiry: Jan 11, 2015): Formulation
US5616587 (Expiry: Jan 11, 2015): Formulation
USRE39181 (Expiry: Jan 11, 2015): Formulation (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’, as it would have not triggered the Teva’s 180 days exclusivity. Apotex filed its declaratory judgment request in court, which rejected this request based on no article III controversy. In September, 2008, the CAFC upheld the district court’s decision (as reported earlier by IP pharm doc Here)and thwarted Apotex’s attempt to trigger 180 days exclusivity of Teva.

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Disclaimer: "IP Pharma Doc" blog is published for information purpose only. "IP Pharma Doc" blog contains no legal advice. I assume no legal responsibility for the views/information expressed here. “IP Pharma Doc” blog is my personal website and not edited by my employer, accordingly, no part of my blog should be attributed to my employer. All information on the present blog should be double checked for its accuracy and applicability. © Dr. Sarwal (2007)
 
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