In a September 26 FDAnews article FLH Partner Brian J. Malkin was quoted regarding the latest decision. The article, “Jazz Appears to Win on Patent Claim Terms in Xyrem Fight.” The article concerned a recent development in Jazz Pharmaceuticals’ (“Jazz’s”) suit against generic competitor Roxane Laboratories (“Roxane”), where in an unpublished opinion, the District Court of New Jersey Judge Esther Salas Jazz appeared to side with virtually all of Jazz’s claim constructions for the disputed terms in the patents-at-issue for Xyrem® (sodium oxybate), indicated for excessive daytime sleepiness and cataplexy in patients with narcolepsy.
Malkin was quoted in the article as reproduced in the following passage:
One major upside for Jazz is that it could make it harder for Roxane to negotiate more favorable terms if it chooses to settle, Brian Malkin, a partner at Frommer Lawrence & Haug, noted.
Meanwhile, Jazz was also issued another Xyrem patent Sept. 11, which the company is submitting for listing in the FDA’s Orange Book. This move could prolong the case, Malkin said, as Roxane would have to amend its ANDA, likely by filing a Paragraph IV certification.
Finally, Jazz has outstanding citizen petitions related to Xyrem generics, including a July petition that demands the FDA rescind its acceptance of the Roxane ANDA because Roxane did not submit material related to a proposed risk management strategy for Xyrem when it originally filed the application (Generic Line, Aug. 1). FDA rulings on the citizen petitions are due on Nov. 18 for the earlier bioequivalence standards petition and on Dec. 10 for the July petition, Faerm said.
Malkin believes the FDA will deny Jazz’s citizen petition, given that it already accepted Roxane’s ANDA. However, the courts may be more apt to side with Jazz, given this latest opinion