Last updated: February 18, 2026
Adamis Pharmaceuticals Corporation sued Belcher Pharmaceuticals, LLC, alleging infringement of U.S. Patent No. 9,675,504, covering a naloxone hydrochloride injection product. Adamis sought a preliminary injunction to prevent Belcher from marketing its generic version of Symjepi®. The court denied Adamis’s motion for a preliminary injunction, finding that Adamis did not demonstrate a substantial likelihood of success on the merits or irreparable harm.
What is the core patent at issue in Adamis Pharmaceuticals Corporation v. Belcher Pharmaceuticals, LLC?
The central patent in this litigation is U.S. Patent No. 9,675,504, titled "Naloxone hydrochloride solution and method of use." This patent claims a naloxone hydrochloride injection product. Adamis Pharmaceuticals Corporation is the assignee of this patent. The patent's expiration date is March 27, 2035.
What is the product at the center of the dispute?
The dispute centers on Adamis’s product Symjepi®, a pre-filled syringe containing naloxone hydrochloride. Belcher Pharmaceuticals, LLC developed a generic version of Symjepi®. Adamis alleges that Belcher’s generic product infringes U.S. Patent No. 9,675,504.
What were the key legal arguments made by Adamis Pharmaceuticals Corporation?
Adamis’s primary argument was that Belcher’s proposed generic naloxone hydrochloride injection product infringes U.S. Patent No. 9,675,504. Adamis asserted infringement based on the composition and method of use claims within the patent.
Adamis also argued for a preliminary injunction, contending that Belcher’s entry into the market would cause irreparable harm by eroding Adamis’s market share and potentially leading to price erosion. They claimed that such harm could not be adequately compensated by monetary damages.
What were the key legal arguments made by Belcher Pharmaceuticals, LLC?
Belcher Pharmaceuticals, LLC challenged the validity and enforceability of Adamis’s patent. Belcher argued that the asserted claims of U.S. Patent No. 9,675,504 were not infringed by its generic product.
Belcher also contested Adamis’s claim of irreparable harm. They argued that any potential market impact or price changes could be quantified and addressed through monetary damages, thereby negating the need for an injunction.
What was the court’s decision regarding Adamis’s motion for a preliminary injunction?
The U.S. District Court for the Middle District of Florida denied Adamis Pharmaceuticals Corporation’s motion for a preliminary injunction. Judge W. Scott Hardy issued the order on December 18, 2018.
What were the court’s primary reasons for denying the preliminary injunction?
The court denied the injunction primarily because Adamis failed to demonstrate a substantial likelihood of success on the merits of its patent infringement claim. The court also found that Adamis did not establish that it would suffer irreparable harm absent the injunction.
Did the court find a substantial likelihood of patent infringement?
No. The court found that Adamis did not demonstrate a substantial likelihood of success on the merits of its patent infringement claim. This determination was based on the court’s analysis of the asserted patent claims and Belcher’s proposed product. The court indicated that Adamis had not shown a clear case of infringement under the relevant legal standards.
Did the court find that Adamis would suffer irreparable harm?
No. The court found that Adamis did not establish irreparable harm. The court concluded that any economic losses Adamis might incur due to market competition could be adequately compensated by monetary damages after a full trial on the merits. The court did not find the unique circumstances required to justify injunctive relief in the absence of a proven substantial likelihood of infringement.
What is the current status of the litigation?
The litigation, case number 8:18-cv-02379-WFJ-AAS, is ongoing. The denial of the preliminary injunction does not resolve the underlying patent infringement claims. Both parties continue to litigate the merits of the infringement and validity issues.
What are the implications of this ruling for Adamis Pharmaceuticals Corporation?
The denial of the preliminary injunction is a setback for Adamis. It allows Belcher to proceed with its market entry plans for its generic naloxone hydrochloride product, at least until a final decision on patent infringement is reached. Adamis will likely continue to pursue its infringement claims, but the immediate threat of market disruption has been mitigated for Belcher.
What are the implications of this ruling for Belcher Pharmaceuticals, LLC?
This ruling is a significant win for Belcher. It removes an immediate legal barrier to their generic product’s launch. Belcher can now proceed with marketing its naloxone hydrochloride injection, pending the final resolution of the infringement and validity claims.
What are the potential future developments in this case?
Future developments may include further discovery, claim construction proceedings, potential summary judgment motions, and ultimately a trial on the merits of patent infringement and validity. The parties may also explore settlement discussions. The outcome of the ongoing litigation will determine the market exclusivity for Adamis’s Symjepi® and the viability of Belcher’s generic product.
Key Takeaways
- Adamis Pharmaceuticals Corporation's motion for a preliminary injunction against Belcher Pharmaceuticals, LLC was denied by the U.S. District Court for the Middle District of Florida.
- The court found that Adamis did not demonstrate a substantial likelihood of success on the merits of its patent infringement claim concerning U.S. Patent No. 9,675,504.
- Adamis also failed to establish that it would suffer irreparable harm absent the injunction.
- The denial allows Belcher to continue its market entry plans for its generic naloxone hydrochloride product pending the final resolution of the case.
- The litigation regarding patent infringement and validity remains ongoing.
Frequently Asked Questions
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What is the expiration date of U.S. Patent No. 9,675,504?
U.S. Patent No. 9,675,504 is scheduled to expire on March 27, 2035.
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Can Belcher Pharmaceuticals, LLC launch its generic product immediately following the court's decision?
The denial of the preliminary injunction permits Belcher to proceed with its commercialization efforts, but the ultimate right to market is subject to the final outcome of the patent litigation.
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What is the asserted basis for patent infringement in this case?
Adamis alleges that Belcher’s generic naloxone hydrochloride injection infringes the claims of U.S. Patent No. 9,675,504.
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What is naloxone hydrochloride used for?
Naloxone hydrochloride is an opioid antagonist used to reverse the effects of opioid overdose.
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What are the next steps in the litigation after the denial of a preliminary injunction?
The case will proceed through further discovery, potential claim construction, motions for summary judgment, and ultimately a trial on the merits of the patent infringement and validity claims.
Citations
[1] Adamis Pharmaceuticals Corp. v. Belcher Pharmaceuticals, LLC, No. 8:18-cv-02379-WFJ-AAS (M.D. Fla. Dec. 18, 2018).
