Saturday, August 20, 2005

Questionable text in NLJ on Merck v. Integra

The August 3 issue of the National Law Journal contains text:

The Federal Circuit ruled last year that the FDA exemption did not
extend to exploratory research, only to generics.

First, the decision of the Federal Circuit, as amended, made clear that the exemption of 271(e)(1) applied to INDs, and thus was not limited to ANDAs (generics).

Second, the Supreme Court stated that it did not understand the decision of the Federal Circuit (the initial one, not the amended one) to limit the scope of 271(e)(1) to clinical studies (and thus exclude preclinical studies).

The NLJ article also has text:

In a unanimous decision, the justices ruled that drug companies have
freedom under Food and Drug Administration (FDA) rules to ignore their rivals'
patents when starting research on competing medications.

[from National Law Journal, Pg. P16 Vol. 27 No. 46 (August 3, 2005), referring to Merck v. Integra, 125 S. Ct. 2372 (2005)]


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