Impax Announces Favorable Ruling Regarding Patent Validity for Zomig® (zolmitriptan) Nasal Spray

Impax Laboratories announced that Judge Richard G. Andrews of the U.S. District Court, District of Delaware, has found that the U.S. patents 6,750,237 and 7,220,767 protecting Zomig® (zolmitriptan) Nasal Spray are not invalid and are infringed by the Lannett Holdings, Inc. and Lannett Company, Inc. (the "Defendants") ANDA .  

As previously announced, Impax Laboratories, AstraZeneca UK, and AstraZeneca AB (the "Plaintiffs"), brought suit against Defendants for alleged patent infringement based on the filing of the Defendants Abbreviated New Drug Application relating to Zolmitriptan Nasal Spray, 5mg, generic to Zomig® Nasal Spray. At the trial, the Defendants had made certain arguments related to AstraZeneca standing and the Court provisionally ruled in the Plaintiffs favor on that point. The Court order allows Defendants one week to request an opportunity to cross-examine an AstraZeneca witness on the standing issue, in which case the Court will schedule a hearing. Otherwise, the parties are to submit an agreed form of final judgment within two weeks. This ruling is also subject to a potential appeal by the Defendants.

"We are pleased with the court's decision upholding the validity of the patents for Zomig Nasal Spray," said Paul Bisaro, President and CEO of Impax. "We look forward to continuing to supply this product to patients and will continue to actively protect our intellectual property."