Benzinga | Nov 9, 2021 11:08AM EST

Pacira Biosciences Reports Filed Suit Against eVenus For Patent Infringement

Pacira BioSciences, Inc. (NASDAQ:PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today announced that it has filed a lawsuit in the United States District Court for the District of New Jersey against eVenus Pharmaceutical Laboratories, Inc. for patent infringement of U.S. Patent Number 11,033,495. The '495 patent is related to EXPAREL(r) (bupivacaine liposome injectable suspension) and has an expiration date of January 22, 2041. The complaint is seeking an injunction to prevent the infringing manufacture, use, and sale of a potential generic product described in an Abbreviated New Drug Application (ANDA) that eVenus filed with the U.S. Food and Drug Administration in August 2021. The filing of the lawsuit triggered a 30-month stay of final approval of eVenus' ANDA under the Hatch Waxman Act.

The '495 patent was listed in the U.S. Food and Drug Administration (FDA) Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book) on July 30, 2021. This patent marks the first deliverable from the company's comprehensive patent strategy. eVenus's Paragraph IV challenge does not account for several additional Pacira patents that are forthcoming, including another application that recently received an Issue Notification from the U.S. Patent and Trademark Office (USPTO). After the USPTO issues this patent, Pacira will submit it for listing in the Orange Book. Once listed, FDA guidelines require the amendment of an existing ANDA application to provide an additional appropriate patent certification or statement to the newly listed patent.

EXPAREL utilizes the company's unique and proprietary multivesicular liposome delivery technology that encapsulates drugs without altering their molecular structure and releases them over a sustained period. In February 2018, the FDA published rigorous guidance for proving bioequivalence to multivesicular liposomal bupivacaine. Matching comparative characteristics must be conducted on at least three batches of an ANDA product with at least one batch manufactured at commercial scale and include liposome composition, internal aqueous environment of the liposome, and in vitro drug release rates. Unlike traditional liposomes, multivesicular liposomes consist of a non-lamellar honeycomb structure.

Pacira intends to vigorously defend its intellectual property rights relating to EXPAREL.