Pacira BioSciences Sets the Record Straight Regarding DOMA's Misleading Statements About Pacira's Intellectual Property Strategy
Urges Stockholders to Vote " FOR " the Election of Pacira's Highly Qualified Nominees on the BLUE Proxy Card Today BRISBANE, Calif., May 26, 2026 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (NASDAQ: PCRX ) (the "Company" or "Pacira"), the industry leader in its commitment to deliver innovative, non-opioid pain therapies to transform the lives of patients, today issued the following statement with important facts stockholders should know regarding Pacira's intellectual property (IP) strategy, and DOMA Perpetual Capital Management LLC's ("DOMA Perpetual" or "DOMA") 1 recent inaccurate statements: DOMA's claims demonstrate a fundamental lack of understanding of Pacira's business, intellectual property (IP) strategy, Paragraph IV certifications and the biopharmaceutical industry at large. Pacira has clearly and frequently communicated information regarding patent awards or infringement litigation to its stockholders and remains committed to doing so. Pacira strongly believes in the strength of the EXPAREL franchise, and its patent estate protects the Company from multiple directions. Here are the facts: Pacira's initial patent litigation commenced in 2021 and continued through 2024. There is no precedential value to this case , which only involved one EXPAREL patent (the ‘495 patent). The ‘495 patent was litigated in the United States District Court for the District of New Jersey. Following the Court's decision, Pacira secured a favorable reexamination of its ‘495 patent from the U.S. Patent and Trademark Office (USPTO). Importantly, during this process, any weakness in this patent, which is from the Erucic Acid Family, was addressed through amended claims that added volume limitations and resolved other issues noted in the New Jersey Court's opinion. The ‘495 patent has been reissued, and the Company believes it is now the strongest in the Erucic Acid Family of patents. None of EXPAREL's "Orange Book" listed patents are manufacturing patents. The 21 patents currently listed in the Orange Book comprise chemical composition and product-by-process patents covering the drug product, as well as method-of-use patents. Manufacturing patents are not Orange Book listable by statute. Pacira engineered a new enhanced, larger-scale EXPAREL manufacturing process in San Diego that produced a more consistent and stable multivesicular liposome with improved yield and particle-size distribution. Because these results were unexpected, this was a patentable invention and became the ‘940 patent, which provides protection into July 2044. The ‘940 patent is the first of a new , second family of EXPAREL patents that has never been previously challenged or litigated. While the Company believes the Erucic Acid Family is strong, Pacira believes this second patent family is even stronger. The novelty of the ‘940 patent and its family derives from the large dataset of in vitro release assay (IVRA) batch data measured from every batch of EXPAREL . A separate USPTO examiner from the first family allowed the patent after considering the Court's opinion in the ‘495 patent litigation. The Fresenius Kabi Settlement was a strategic win for stockholders , giving Pacira full exclusivity for EXPAREL through early 2030 and a gradual, capped market entry until 2039. This presents a clear runway to execute Pacira's diversification strategy without the rapid decline and disruption normally seen with generic entry. Pacira has taken critical steps to strengthen its IP and mitigate litigation risk, including expanding EXPAREL's patent estate to 21 Orange Book listed patents across two families , which provide exclusivity through the mid-2040s. The Company expects additional patents to be issued, which will be added to this robust patent estate. The potential for additional generic competition is a common dynamic with successful products like EXPAREL and is inherent to the biopharmaceutical industry. Pacira continues to innovate with the expectation that additional patents will be issued. Importantly, the two most recent Paragraph IV generic challenges only mean that Abbreviated New Drug Applications (ANDAs) have been filed with the U.S. Food and Drug Administration (FDA) . It does not mean these generic challengers have FDA approvable products with demonstrated bioequivalence to EXPAREL that have been manufactured at commercial scale . A Paragraph IV challenge is a gatekeeping standard for the FDA to accept an ANDA for filing and occurs before a substantive review takes place. The Company is in the early stages of this litigation, and as an active legal matter Pacira is limited in what it can say. Pacira has filed a patent infringement lawsuit in the United States District Court for the District of Delaware. The IVRA family has never ... Full story available on Benzinga.com
