Monday, May 11, 2009

Wyeth-Lupin Settles Effexor ER Patent Dispute

Business Standard reports on patent infringement settlement between Wyeth and Lupin over USD 3 billion antidepressant drug Effexor ER, generically known as Venlafaxine extended release capsule. As per the term of settlement, Lupin will be licensed to launch a generic version of the drug in the US after June 01, 2011, or earlier under certain circumstances (not disclosed) but not before January 01, 2011. Lupin earlier filed a paragraph IV certification challenging the validity or non-infringement to to Orange Book listed US Patent Nos. 6,274,171, 6,403,120 and 6,419,958. This settlement will give Lupin a definite launch date as OB listed patents for Effexor ER will run expiration till late September 2017, however, what would be really interesting is the profit margin that Lupin will possibly be making from this settlement considering that Wyeth had already made multiple settlements for the same drug with other generic drug manufacturers. Lupin settlement agreement is quite similar to Wyeth’s earlier settlement agreements with Impax Labs and Anchen Pharmaceuticals for the same drug. In July 2008 and November 2008, Wyeth under the terms of settlement licensed Impax and Anchen to launch their generic versions of the drug on or after June 01, 2011, or earlier under certain circumstances, but not before January 01, 2011 in return of certain percentage of profits from the generic sale. In October 2005, Wyeth settled patent lawsuit for the same drug with Teva and as per agreement licensed Teva to launch a generic version in July 01, 2010 in return of certain percentage of profits from the generic sale. In October 2007, in a significant development Wyeth issued a “Covenant Not to Sue” Sun Pharmaceuticals for generic tablet formulation of Effexor ER. Sun too filed a paragraph IV certification for the same drug. Wyeth seems to be moving good business strategy by avoiding any further legal cost in patent disputes and at the same time receiving certain percentage of profits from the generic competition.

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