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July 27, 2023


This does not seem correct on its face (regardless of case history), especially when the claim itself contains a direct reference to its utility.

I understand your confusion, skeptical, because utility is implied and arguably is a requirement under the "make and use" language of Section 112(a). I think the answer is that the Federal Circuit believes that the criteria for clinical/therapeutic utility should be applied by FDA, to the extent that FDA could produce a label precluding administration to Group 2 PH patient for example, and that patent law and USPTO should not be deciding validity/infringement on that basis.

Thanks for the comment

My mention of "(regardless of case history)" has more to do with the fact that any patent utility must be possessed at time of filing.

Patent utility that merely happens to be dictated by another portion of the Federal government remains the standard to be possessed at time of filing.

The Federal Circuit seems to be acting in an ultra vires manner by negating that determination.

The key words for me are directly in the claim: "therapeutically effective."

Would be patentees are fully capable of choosing claim language that does not reflect the desired utility THAT IS SET by the FDA.

They have not done so here (and OFTEN do not do so) - this is not an accident.

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