Jazz Pharma (JAZZ) Unit Gets 'Markman Ruling' from U.S. Over Roxane Labs Patent Litigation
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On September 17, 2012, Jazz Pharmaceuticals, Inc., a wholly owned subsidiary of Jazz Pharmaceuticals plc (Nasdaq: JAZZ), received a claim construction order and opinion, also known as a “Markman ruling,” from the United States District Court for the District of New Jersey in connection with the ongoing patent litigation with Roxane Laboratories, Inc. (“Roxane”), Civil Action No. 10-6108. The litigation relates to Roxane’s abbreviated new drug application filed with the United States Food and Drug Administration requesting approval to market a generic version of Xyrem® (sodium oxybate) oral solution. The Company believes that the Markman ruling is generally favorable to the Company’s positions in the litigation going forward.
A Markman ruling is an interim order by a court that determines the meaning of certain patent claim terms as requested by one or more of the parties to a lawsuit, including the court’s determination that certain terms do not require construction. The ruling in this case follows a Markman hearing held on April 26, 2012. Neither the Markman hearing nor the ruling address the new patent related to Xyrem that was issued to Jazz Pharmaceuticals, Inc. on September 11, 2012, titled “Microbiologically Sound and Stable Solutions of Gamma-Hydroxybutyrate Salt for the Treatment of Narcolepsy” (Patent No. 8,263,650).
The Company expects that the next phase of the ongoing litigation will be expert discovery. No trial date has been scheduled. The Company cannot predict the outcome of this matter.
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A Markman ruling is an interim order by a court that determines the meaning of certain patent claim terms as requested by one or more of the parties to a lawsuit, including the court’s determination that certain terms do not require construction. The ruling in this case follows a Markman hearing held on April 26, 2012. Neither the Markman hearing nor the ruling address the new patent related to Xyrem that was issued to Jazz Pharmaceuticals, Inc. on September 11, 2012, titled “Microbiologically Sound and Stable Solutions of Gamma-Hydroxybutyrate Salt for the Treatment of Narcolepsy” (Patent No. 8,263,650).
The Company expects that the next phase of the ongoing litigation will be expert discovery. No trial date has been scheduled. The Company cannot predict the outcome of this matter.
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