Pacira BioSciences Comments on Ruling on EXPAREL Patent Litigation from U.S. District Court for the District of New Jersey

Rhea-AI Summary

Pacira BioSciences (Nasdaq: PCRX) has announced that the U.S. District Court for the District of New Jersey has ruled its U.S. Patent No. 11,033,495 for EXPAREL invalid. Despite this setback, CEO Frank D. Lee expressed confidence in the company's intellectual property and believes eVenus is infringing on their patents. Pacira is considering legal options, including an appeal to the U.S. Court of Appeals for the Federal Court. The company maintains that the EXPAREL franchise is well-protected, citing three ongoing infringement suits and additional pending patents. Pacira BioSciences remains committed to its position as a leader in non-opioid pain management and regenerative health solutions.

Positive

• Three separate infringement suits are ongoing, potentially protecting EXPAREL
• Additional patents are forthcoming, which may strengthen intellectual property portfolio

Negative

• U.S. District Court ruled Pacira's U.S. Patent No. 11,033,495 for EXPAREL invalid
• Potential loss of patent protection may impact EXPAREL's market exclusivity

Insights

Legal Expert

The ruling by the U.S. District Court for the District of New Jersey invalidating Pacira BioSciences' '495 patent is a significant setback for the company's intellectual property strategy. This decision potentially weakens Pacira's market position for EXPAREL, their flagship non-opioid pain management product.

However, it's important to note that this is just one battle in a larger legal war. Pacira still has three separate infringement suits ongoing and claims to have additional patents forthcoming. The company's plan to pursue an appellate review at the U.S. Court of Appeals for the Federal Circuit is a standard next step in patent litigation.

The outcome of this appeal and the other pending lawsuits will be critical for Pacira's future. If they can't protect their IP, it could open the door for competitors like eVenus to enter the market, potentially impacting Pacira's revenue and market share.

Financial Analyst

This court ruling poses a potential threat to Pacira's market exclusivity for EXPAREL, which could negatively impact the company's financial outlook. EXPAREL is Pacira's primary revenue driver and any erosion of its patent protection could lead to increased competition and price pressure.

Investors should closely monitor the progress of Pacira's other patent infringement suits and any appeals. The outcome of these legal battles will be crucial for the company's long-term financial health. In the short term, this news may cause volatility in Pacira's stock price as the market reassesses the company's future earnings potential.

It's worth noting that Pacira claims to have a strong portfolio of intellectual property beyond this single patent. The company's ability to leverage its remaining patents and potentially secure new ones will be key to maintaining its competitive edge in the non-opioid pain management market.

TAMPA, Fla., Aug. 09, 2024 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (Nasdaq: PCRX), the industry leader in its commitment to non-opioid pain management and regenerative health solutions, today announced that the U.S. District Court for the District of New Jersey has found that the company’s U.S. Patent No. 11,033,495 (the ‘495 patent) is not valid.

“We remain steadfast in our belief in the strength and validity of our intellectual property and that eVenus is infringing upon our patents,” said Frank D. Lee, chief executive officer of Pacira BioSciences. “In light of the Court’s decision, we are considering our legal options, which include pursuing an appellate review at the U.S. Court of Appeals for the Federal Court as warranted.”

“We firmly believe we have built a strong portfolio of intellectual property and that the EXPAREL franchise is well protected on multiple levels. Three separate infringement suits are underway, and we have additional patents that are forthcoming,” added Mr. Lee.

About Pacira

Pacira BioSciences, Inc. (Nasdaq: PCRX) is committed to providing non-opioid pain management options to as many patients as possible to redefine the role of opioids as rescue therapy only. Pacira has three commercial-stage non-opioid treatments: EXPAREL^® (bupivacaine liposome injectable suspension), a long-acting local analgesic currently approved for infiltration, fascial plane block, and as an interscalene brachial plexus nerve block for postsurgical pain management; ZILRETTA^® (triamcinolone acetonide extended-release injectable suspension), an extended-release, intra-articular injection indicated for the management of osteoarthritis knee pain; and ioveraº^®, a novel, handheld device for delivering immediate, long-acting, drug-free pain control using precise, controlled doses of cold temperature to a targeted nerve. To learn more about Pacira, including the corporate mission to reduce overreliance on opioids, visit www.pacira.com.

Forward-Looking Statements

Any statements in this press release about Pacira’s future expectations, plans, trends, outlook, projections and prospects, and other statements containing the words “anticipate,” “believe,” “can,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “project,” “should,” “will,” “would,” and similar expressions, constitute forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and the Private Securities Litigation Reform Act of 1995, including, without limitation, statements related to our intellectual property, our growth and future operating results and trends, our strategy, plans, objectives, expectations (financial or otherwise) and intentions, future financial results and growth potential, including our plans with respect to the repayment of our indebtedness, anticipated product portfolio, development programs, patent terms, development of products, strategic alliances, plans with respect to the Non-Opioids Prevent Addiction in the Nation (“NOPAIN”) Act and other statements that are not historical facts. For this purpose, any statement that is not a statement of historical fact should be considered a forward-looking statement. We cannot assure you that our estimates, assumptions and expectations will prove to have been correct. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to, among others: the integration of our new chief executive officer; risks associated with acquisitions, such as the risk that the acquired businesses will not be integrated successfully, that such integration may be more difficult, time-consuming or costly than expected or that the expected benefits of the transaction will not occur; our manufacturing and supply chain, global and U.S. economic conditions (including inflation and rising interest rates), and our business, including our revenues, financial condition, cash flow and results of operations; the success of our sales and manufacturing efforts in support of the commercialization of EXPAREL, ZILRETTA and iovera°; the rate and degree of market acceptance of EXPAREL, ZILRETTA and iovera°; the size and growth of the potential markets for EXPAREL, ZILRETTA and iovera° and our ability to serve those markets; our plans to expand the use of EXPAREL, ZILRETTA and iovera° to additional indications and opportunities, and the timing and success of any related clinical trials for EXPAREL, ZILRETTA and iovera°; the commercial success of EXPAREL, ZILRETTA and iovera°; the related timing and success of U.S. Food and Drug Administration supplemental New Drug Applications and premarket notification 510(k)s; the related timing and success of European Medicines Agency Marketing Authorization Applications; our plans to evaluate, develop and pursue additional product candidates utilizing our proprietary multivesicular liposome (“pMVL”) drug delivery technology; the approval of the commercialization of our products in other jurisdictions; clinical trials in support of an existing or potential pMVL-based product; our commercialization and marketing capabilities; our ability to successfully complete capital projects; the outcome of any litigation; the ability to successfully integrate any future acquisitions into our existing business; the recoverability of our deferred tax assets; assumptions associated with contingent consideration payments; the anticipated funding or benefits of our share repurchase program; and factors discussed in the “Risk Factors” of our most recent Annual Report on Form 10-K and in other filings that we periodically make with the Securities and Exchange Commission (the “SEC”). In addition, the forward-looking statements included in this press release represent our views as of the date of this press release. Important factors could cause actual results to differ materially from those indicated or implied by forward-looking statements, and as such we anticipate that subsequent events and developments will cause our views to change. Except as required by applicable law, we undertake no intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, and readers should not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this press release.

FAQ

What was the ruling on Pacira BioSciences' EXPAREL patent litigation?

The U.S. District Court for the District of New Jersey ruled that Pacira BioSciences' U.S. Patent No. 11,033,495 for EXPAREL is not valid.

How is Pacira BioSciences (PCRX) responding to the court's decision on the EXPAREL patent?

Pacira BioSciences is considering legal options, including pursuing an appellate review at the U.S. Court of Appeals for the Federal Court.

Are there any other ongoing patent infringement cases related to EXPAREL for Pacira BioSciences (PCRX)?

Yes, Pacira BioSciences has three separate infringement suits currently underway and additional patents forthcoming to protect the EXPAREL franchise.

Who is Pacira BioSciences (PCRX) accusing of infringing on their EXPAREL patents?

Pacira BioSciences believes that eVenus is infringing upon their patents related to EXPAREL.