Monday, 12 May 2008

Court concern on baseless Para IV filings: Do your home work before challenging patent

The act of filing ANDA is not willfull infringement (Glaxo v/s Apotex, 2004: decision of court that act of filing ANDA on Cefuroxime Aexitil by Apotex is not a willfull infringement), but court in certain cases can grant attorney fees to winning party on baseless ANDA filing (21 U.S.C. 285) The US courts in the recent times have seen many ANDA filings with baseless para IV grounds, which are not strong cases to invalidate or design around the para IV certified patent. Now a generic company should be careful while filing Para IV, as a baseless ANDA filing can result in punishmnet from court. Orange book blog has concluded the above fact in a recent article : Link to orange book blog

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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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