Brand's Off-Label Promotion: Valuable Tool For Generics

Law360, New York (December 8, 2011, 1:07 PM EST) -- On Nov. 3, GlaxoSmithKline PLC announced that it will pay $3 billion to settle civil and criminal allegations that it promoted the drug Avandia for off-label uses.[1] This is only the latest in a long list of such settlements. Since 2004, pharmaceutical companies have paid a combined $13 billion to settle charges of off-label promotion of numerous brand-name drugs.

A little-appreciated consequence of this promotional activity is its potential impact on patent infringement claims brought by brand companies against generics. Experience from the recently settled multibillion-dollar patent...
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