Tuesday, 12 August 2008

Clopidogrel Bisulfate (Plavix): Former Bristol-Myers Squibb (BMS) Vice-President Charged With Lying About patent deal

A false information submitted to regulatory or federal agency to get approval or monetary benefit for the company can be detrimental for the employee who sign or submit the wrong information.
Andrew Bodnar, a former senior vice-president of BMS, was indicted for his role in lying to the federal government about a patent deal on Clopidogrel Bisulfate (Plavix). The said official provided false information to Federal Trade Commission (FTC) about BMS’s deal with Apotex to delay generic launch till 2011. On 8th August 2006, Clopidogrel was launched by Apotex at risk of infringement of Product patent and after preliminary injunction opinion in favor of innovator on 31st August 2006, Apotex stopped the sale. Later on, Apotex settled with the innovator and agreed to launch generic version in 2011, innovator in turn agreed to stop authorized generic launch of Clopidogrel. The details of settlement provided to FTC by Apotex and BMS were not same and from Apotex's documnets FTC concluded that BMS official submitted false statement. The details are Here
The latest FDLI REVIEW ARTICLE highlights the same issues.

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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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