US court rejects Jazz attempt to revive Xyrem patents

The US Court of Appeals for the Federal Circuit has rejected Jazz Pharmaceuticals’ attempt to revive patents covering its narcolepsy drug Xyrem (sodium oxybate).

On Friday, July 13, the Federal Circuit affirmed a series of inter partes reviews (IPRs) which had found seven of Jazz’s patents to be obvious.

The patents (US numbers 7,668,730; 7,765,106; 7,765,107; 7,895,059; 8,589,182; 8,457,988; and 8,731,963) are members of a family relating to a system for tracking prescriptions of a “sensitive drug” (a drug which can be abused or has addiction properties).

Xyrem is a sensitive drug—the active ingredient in Xyrem, gamma-hydroxybutyrate, may also be illicitly used as a ‘date-rape drug’.

Because of its potential for abuse, the Food and Drug Administration (FDA) approved Xyrem under “restricted distribution regulations” and scheduled an advisory committee meeting to deliberate on risk management issues.

The meeting was open to the public (a notice was placed on the Federal Register) and the FDA website hosted the meeting minutes, transcript, and slides. These materials are referred to as the advisory committee art (ACA) materials.

Amneal petitioned for IPRs of all seven patents in a bid to clear the way for its generic version, and the Patent Trial and Appeal Board (PTAB) instituted review.

In six final written decisions, the PTAB concluded that the ACA materials were public and that a person of ordinary skill had “sufficient motivation” to locate the notice and FDA website for Xyrem.

The board found that all instituted claims of the patents were obvious in light of the ACA materials or in combination with the book “Information Storage and Retrieval”, written by Robert Korfhage.

Jazz Pharma appealed against the decisions to the Federal Circuit.

Last Friday, the Federal Circuit found that the materials were publicly accessible and that a person of ordinary skill would have been “motivated to run the ACA materials’ distribution system over multiple computers, as taught in Korfhage”.

The Federal Circuit affirmed the PTAB’s decisions, paving the way for a generic version of Xyrem, a drug which generated revenues of more than $1.1 billion last year.

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