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August 09, 2012



Nice summary of Moore's majority and the problems in it. Let me just say now that Moore's opinion reads 35 U.S.C. § 271(e)(1) in a manner contrary to the statutory language (by reading "solely for uses" virtually out of the statute), and more importantly, completely inconsistent with the clear legislative intent for when this “safe harbor” provision was to apply. Even more troubling, Judge Moore’s majority opinion cannot be easily squared with the earlier Federal Circuit case of Classen which strongly suggests (if it does not specifically hold) that the “safe harbor” does not apply to post-FDA approval activity. It is also questionable whether Momenta’s patented analytical method even qualifies as a “patented invention” that is subject to this “safe harbor” provision in view of Proveris Scientific Corp. v. Innovasystems, Inc.

I'll save "the rest of my story" for when you post about Rader's (vociferous) dissent.

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