Publications The Sound of Silence: Take Two

31 October, 2022

By: Allison W. Dobson, Ph.D. and Alexandra Farquhar, Ph.D.*

In claiming a negative limitation, where the specification is silent as to that limitation, the written description requirement for support is a showing of inherency.  So says a June 2022 split decision of the re-constituted panel of the Federal Circuit Court of Appeals on rehearing and reversal of Novartis Pharmaceuticals Corp. v. Accord Healthcare, Inc.  Judge O’Malley, who wrote the original Federal Circuit decision (also split) in January 2022, retired in March and was replaced with Judge Hughes for this appeal.  On rehearing, Chief Judge Moore wrote the majority opinion invalidating the patent, with Judge Hughes joining her and Judge Linn dissenting.

The Novartis patent claim includes a negative limitation: “absent an immediately preceding loading dose regimen.”  In the first decision in January, which we previously reviewed here, the Federal Circuit held that the negative limitation is supported by the as-filed specification, even though the specification does not mention a loading dose or the absence thereof.  The decision penned by O’Malley stated that implicit disclosure of the subject matter was sufficient for written description support and relied on a prophetic example to provide that support.

However, on rehearing the decision penned by Chief Judge Moore found that the loading dose limitation lacked written description support.  Implicit disclosure of a negative claim limitation is not sufficient and instead express or inherent disclosure is required.  In order to show sufficient support, the negative limitation must be “necessarily excluded” from the viewpoint of a skilled artisan reading the disclosure.

The reversal decision holds the Novartis patent invalid for lack of written description, and Novartis moved to stay the Federal Circuit mandate pending a filing and disposition of a petition a writ of certiorari, which was denied by the Federal Circuit on September 27.  Novartis then appealed to Chief Justice John Roberts with an emergency request to stay the Federal Circuit mandate, which he ordered in a rare Supreme Court action on September 29.  The Supreme Court vacated that order on October 13. Novartis has not yet filed a petition for writ of certiorari.

*Alexandra Farquhar, Ph.D. is a Law Clerk at Kilpatrick, Townsend & Stockton, LLP.