Pacira BioSciences Rebuts DOMA Perpetual’s Claims on Intellectual Property and Affirms Robust Patent Strategy

Pacira BioSciences, Inc. (Nasdaq: PCRX), a leader in non-opioid pain therapies, issued a detailed response on May 26, 2026, to counter what it describes as misleading statements by DOMA Perpetual Capital Management LLC concerning Pacira’s intellectual property (IP) strategy. The company urged its stockholders to support the election of its nominees on the BLUE proxy card, underscoring confidence in its business and IP position.

Pacira criticized DOMA’s claims as reflecting a fundamental misunderstanding of the company’s business model, patent strategy, Paragraph IV certifications, and the broader biopharmaceutical industry. The company reaffirmed its commitment to transparent communication with stockholders regarding patent awards and infringement litigation.

The company’s initial patent litigation began in 2021 and concluded in 2024, focusing solely on one EXPAREL patent, the ‘495 patent, litigated in the United States District Court for the District of New Jersey. Pacira notes that this case holds no precedential value. Following the court’s decision, Pacira successfully obtained a favorable reexamination of the ‘495 patent from the U.S. Patent and Trademark Office (USPTO). During reexamination, the patent’s claims were amended to add volume limitations and address issues identified by the court, resulting in a reissued patent that Pacira considers the strongest within its Erucic Acid Family of patents.

Pacira clarified that none of EXPAREL’s 21 patents listed in the FDA’s Orange Book are manufacturing patents, which are not eligible for listing by statute. Instead, these patents cover chemical composition, product-by-process aspects of the drug product, and method-of-use claims.

Significantly, Pacira developed an enhanced, larger-scale manufacturing process for EXPAREL in San Diego. This innovation produced a more consistent and stable multivesicular liposome with improved yield and particle-size distribution. The unexpected nature of these improvements led to a patentable invention, culminating in the ‘940 patent, which extends protection through July 2044.

The ‘940 patent inaugurates a new, second family of EXPAREL patents that has not been previously challenged or litigated. Pacira regards this second family as even stronger than the Erucic Acid Family. The novelty of the ‘940 patent and its related family stems from an extensive dataset of in vitro release assay (IVRA) batch data collected from every batch of EXPAREL. A different USPTO examiner granted this patent after considering the court’s opinion in the earlier ‘495 patent litigation.

Pacira also highlighted the Fresenius Kabi settlement as a strategic victory for stockholders. This agreement grants Pacira full exclusivity for EXPAREL through early 2030, followed by a gradual, capped market entry for generics until 2039. The settlement provides a clear runway for Pacira to execute its diversification strategy without the rapid market disruption typically caused by generic competition.

To further mitigate litigation risk, Pacira has expanded EXPAREL’s patent estate to 21 Orange Book listed patents across two families, collectively providing exclusivity into the mid-2040s. The company anticipates additional patents will be issued and incorporated into this robust portfolio.

Pacira acknowledged that the potential for generic competition is an inherent aspect of successful biopharmaceutical products like EXPAREL. The company continues to innovate with the expectation of securing further patent protections.

Regarding recent Paragraph IV generic challenges, Pacira explained that these filings represent Abbreviated New Drug Applications (ANDAs) submitted to the U.S. Food and Drug Administration (FDA). However, such filings do not indicate that generic challengers have FDA-approvable products with demonstrated bioequivalence to EXPAREL or that these products have been manufactured at commercial scale. Paragraph IV challenges serve as a gatekeeping mechanism for the FDA to accept an ANDA for filing and occur prior to substantive review.

Pacira is currently in the early stages of litigation concerning these challenges and has filed a patent infringement lawsuit in the United States District Court for the District of Delaware. This litigation involves the IVRA patent family, which has not been previously challenged or litigated and will be adjudicated in a separate court.

With the strength of its intellectual property, Pacira emphasized that generic ANDA filers face significant hurdles, including overcoming both patent families, manufacturing at commercial scale, establishing bioequivalence, and obtaining FDA approval.

Finally, Pacira stated that publicly disclosing detailed legal strategies, as requested by DOMA, is not in the best interest of stockholders. The company remains confident in its IP strength and its efforts to protect the interests of the business, patients, and shareholders.