Merck KGaA v. Integra Lifesciences I, Ltd.
The Merck v. Integra case was decided by the Supreme Court in April 2005.
The Supreme Court held that 35 USC 271(e)(1) provides protection from patent infringment as long as the tested drug could reasonable become the subject of an FDA submission. This includes pre-clinical studies and pre-clinical research.
Listen to the Supreme Courts's published opinion. [MP3]
The Supreme Court held that 35 USC 271(e)(1) provides protection from patent infringment as long as the tested drug could reasonable become the subject of an FDA submission. This includes pre-clinical studies and pre-clinical research.
Listen to the Supreme Courts's published opinion. [MP3]
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