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An at-risk launch, in the context of pharmaceuticals, is when a generic manufacturer challenges the validity of an existing patent.
If the company were to launch the drug before this first round of litigation and lose (ie. the patent is upheld), they would owe the patent-holder treble damages. This would be roughly three times the sales loss incurred to the patent-holder, and no small change to even a large company.
If, however, the court rules that the patent is invalid then the newcomer might choose to launch the product "at risk": while the erstwhile patent-holder appeals the initial court decision not to uphold the patent.
Ultimately the court will stand by its decision and the newcomer will have successfully launched at-risk, or it will revert back and support the appeal. In this situation, the newcomer only owes 1x damages. This is a considerably less prohibitive sum, one that theoretically begot the original risk-reward question of launching the product despite the appeal.
For examples, see Sanofi's Plavix, Eisai's Aricept, AstraZeneca's Nexium, and Wyeth's Protonix.
Mel
www.mpglobal.com
Wiki User
∙ 15y ago
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