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June 27, 2023


The holding appears to be at odds with Millennium Pharm., Inc. v. Sandoz Inc., 862 F.3d 1356, 1367 (Fed. Cir. 2017) (finding that the district court clearly erred in holding “that the claims were obvious because they were the inherent result of an allegedly obvious process.")

MPEP guidance on this (§ 2112) is inadequate, and I've had to argue against "inherent to an obvious process" rejections several times, citing Honeywell and Millennium.

I think the appellant failed here because one needs an unexpected *effect*, not just an unexpected mechanism of action, arising from the combination.

I agree, Jim, that the issue here was there was no assertion that there was any surprising or unexpected result (one of the objective indicia) just a new recognition of an inherent consequence of drug administration.

I went back and looked at the Millennium case and the distinction I recognized when I posted on the case (July 18, 2017) was that the use of a routine process (lyophilization) produced a form of a known drug that was surprisingly stable enough to be used as a drug when D-mannitol was included as a bulking agent. What was surprising was that the process produced a new compound, an ester of the drug + mannitol. There was no teaching or suggestion in the art that this novel product would be made nor that the novel ester would have the observed beneficial properties (the lack of which prevented the compound itself from having therapeutic usefulness).

Here there was no change in what was administered, the consequences of administration, or the therapeutic effects; what was recited was the physiological consequence that administration of prior art drugs for prior art purposes to achieve a prior art effect that had a specific effect (increasing prostacyclin release in systemic blood vessels) unknown in the prior art that contributed to the prior art result.

Thanks for the comment and reminding me about the Millennium case.

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