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May 26, 2008



It would seem that any applicant could simply do a section viii "carve-out."

The drug was approved in 1991 and the patent has priority only to 1999, so either the patent is claiming a method that can (in theory) be carved out, or it is invalid (e.g, on an inherency argument). Giving the benefit of the doubt to King on validity, a carve-out would seem appropriate.

According to the OB, there are multiple exclusivities for different uses, so it would seem that a section viii carve-out would be the simple solution to the problem for a generic applicant.

However, that might lead to a delay in approval, for labeling review, so King (& Cobalt) might benefit from this maneuver anyway.

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