Drug manufacturer research and patent ruling [US SC] News
Drug manufacturer research and patent ruling [US SC]

Merck KGaA v. Integra Lifesciences I, Ltd, et al., Supreme Court of the United States, June 13, 2005 [ruling unanimously that drug companies can do "pre-clinical studies" under FDA rules on an existing patented drug in the process of developing a generic alternative to market in the future]. Excerpt from the Opinion by Justice Scalia:

[T]he evidence presented at trial has yet to be reviewed under the standards set forth in the jury instruction, which we believe to be consistent with, if less detailed than, the construction of §271(e)(1) that we adopt today. We decline to undertake a review of the sufficiency of the evidence under a proper construction of §271(e)(1) for the first time here. Accordingly, we vacate the judgment of the Court of Appeals and remand the case for proceedings consistent with this opinion.

Read the full text of the opinion here [PDF]. Reported in JURIST's Paper Chase here.