Law \ Legal

Novartis: Inherency in Written Description

by Dennis Crouch

Novartis Pharms Corp. v. Accord Healthcare, Inc. (Fed. Cir. 2022)

Without any fanfare or dissent, the Federal Circuit has denied the Novartis en banc petition.  The court used a questionable procedure flip its own prior decision by replacing Judge O’Malley with a more defendant-friendly Judge Hughes for the rehearing.

The merits decision appears to further tighten-up on the written description requirement — especially with regard to ‘negative’ claim limitations.  The basic holding is that the written description must either expressly or inherently disclose the invention.  Novartis Pharm. Corp. v. Accord Healthcare, Inc., 38 F.4th 1013 (Fed. Cir. 2022) (rehearing majority decision).  Here, ‘inherently’ is a term of art in patent law and has much stricter definition than its cousin ‘impliedly.’  Inherency in patent law indicates unstated certainty.

The patent at issue in Novartis claims a drug treatment method.  Sometimes in drug treatment, you start a patient off with a high ‘loading dose’ to get the blood-levels up to an operational state.  The patent application does not discuss a loading dose one way or the other.  During prosecution, the patentee added a no-loading-dose negative limitation: “a daily dosage of 0.5 mg, absent an immediately preceding loading dose regimen.”

Someone skilled in the art might read the specification as implying that no loading dose was necessary. But, that same person would have to admit that the specification could be interpreted in alternative ways–and that the absence of a loading dose was not necessarily inherent in the disclosures.  Since the majority required inherency, the claim lacked written description support.


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