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Evoke Pharma, Inc., a specialty pharmaceutical company, announced that a joint stipulation of dismissal has been filed in the Gimoti patent infringement case (Civil Action No. 1:22-cv-02019) in the United States District Court for the District of New Jersey.
The filing of the stipulation arises from Teva Pharmaceuticals, Inc. and Teva Pharmaceuticals USA, Inc.’s (Teva) conversion from a Paragraph IV certification to a Paragraph III certification. A paragraph III Abbreviated New Drug Application (ANDA) is not eligible for approval until the last expiration date of current and potential future orange book listed patents for the reference listed drug in conjunction with appropriate FDA review.
In addition, no future ANDA filer will be eligible to receive 180-day generic exclusivity for an ANDA that references Gimoti. This first-to-file regulatory pathway is typically highly sought after by generic firms.
“This case has now ended, and we believe the remarkably favourable outcome reflects the strength of the Gimoti intellectual property and acknowledges the validity of the Gimoti patents. It also adds to our resolve in defending our rights, even against larger, well-resourced companies," said Dave Gonyer, CEO, Evoke Pharma. "This dismissal will allow us to focus our efforts on continuing to uphold and enhance our company's intellectual property in this important category of healthcare innovation."
Evoke is a specialty pharmaceutical company focused primarily on the development of drugs to treat GI disorders and diseases.
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