On Wednesday, Heron Therapeutics, Inc. (NASDAQ:HRTX), a commercial-stage biotech firm, experienced a significant pre-market stock price increase of 66% following a favorable U.S. District Court ruling in Delaware. The court sided with Heron in its patent litigation against Fresenius Kabi USA, LLC, concerning the drug CINVANTI® (aprepitant) injectable emulsion.
The litigation, which began in July 2022, was initiated by Heron after Fresenius submitted an Abbreviated New Drug Application to the U.S. Food and Drug Administration. Fresenius was seeking approval for a generic version of CINVANTI®. The court's decision confirmed the validity of Heron's U.S. Patent Nos. 9,561,229 and 9,974,794, which are not set to expire until 2035, and found that Fresenius' proposed generic product would infringe upon these patents.
As a consequence of the court's decision, Heron intends to request an order to prevent Fresenius from launching its generic version of CINVANTI® until the patents expire. However, it is important to note that the court's decision can still be appealed.
Craig Collard, the Chief Executive Officer of Heron, expressed satisfaction with the court's ruling. "We are pleased with this anticipated result of the proceeding and will continue to vigorously defend the CINVANTI® patent estate in the future," Collard stated. He also highlighted the company's commitment to developing injectable products and the strength of their intellectual property.
The court's ruling is a significant development for Heron, as it protects the company's rights to exclusively market CINVANTI® until the expiration of the patents. This injectable emulsion is used in the medical field to address serious unmet needs in patient care.
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