Friday 10 July, 2009

Amlodipine besylate (Norvsac) 2.5 mg, 5 mg and 10 mg tablet: Ratiopharm Canada wins important patent legal battle with Pfizer

Generic player Ratiopharm Canada has won a five-year long legal battle against innovator Pfizer’s key patent covering Amlodipine besylate (Norvsac). The said decision will allow the marketing of Amlodipine Besylate (Norvasc) 2.5 mg, 5 mg and 10 mg tablets by generic manufacturers.

Generic player Ratiopharm challenged the following patent in 2004 :

CA1321393 (Expiry: August, 2010): which covers A process for preparing the besylate salt ofamlodipine characterised by the steps of reactingamlodipine base with a solution of benzenesulphonic acid or its ammonium salt in an inert solvent and recoveringthe besylate salt of amlodipine.

As per the Federal Court's decision announced on July 8, 2009 by Honorable Judge Roger Hughes, the disputed patent was declared invalid.

Ratiopharm was the first company to challenge the Amlodipine Besylate patent in 2004 and got favorable decision from Federal Court in February, 2006. Later on, Pfizer appealed the decision in the ratiopharm case and won the appeal.

Pfizer will appeal against said decision as reported by fiercebiotech Here

Link to Bloomberg news Here

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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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