U.S. District Court Upholds Validity of CINVANTI® Patents

Rhea-AI Summary

Heron Therapeutics (HRTX) announced a favorable ruling from the U.S. District Court for the District of Delaware in its patent litigation against Fresenius Kabi USA. The court upheld the validity of Heron's patents (U.S. Patent Nos. 9,561,229 and 9,974,794) for CINVANTI® injectable emulsion, which expire in 2035, and found they would be infringed by Fresenius' proposed generic product.

The litigation began in July 2022 after Fresenius submitted an Abbreviated New Drug Application seeking approval for a generic version of CINVANTI®. Heron will now seek a court order to prevent Fresenius from launching its generic version until the patents expire in 2035.

Positive

• Court ruling protects CINVANTI® patent exclusivity until 2035
• Prevention of generic competition for CINVANTI® for next 11 years
• Strengthens company's intellectual property position

Negative

• Decision is subject to appeal, creating potential future legal uncertainty

— Court Rules in Favor of Heron in Patent Lawsuit Against Fresenius Kabi USA, LLC —

SAN DIEGO, Dec. 3, 2024 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX) ("Heron" or the "Company"), a commercial-stage biotechnology company, today announced that the U.S. District Court for the District of Delaware ruled in Heron's favor in the Company's patent litigation against Fresenius Kabi USA, LLC with respect to CINVANTI® (aprepitant) injectable emulsion. The district court found that Heron's U.S. Patent Nos. 9,561,229 and 9,974,794, which expire in 2035, are valid and would be infringed by Fresenius' proposed generic product.

The district court decision concludes the litigation initiated in July 2022 in response to Fresenius' submission of an Abbreviated New Drug Application with the U.S. Food and Drug Administration seeking approval of a generic version of CINVANTI®. As a result of the decision, Heron will seek an order from the Court prohibiting Fresenius from launching its generic CINVANTI® until after the expiration of the patents in 2035. This decision is subject to appeal.

"We are pleased with this anticipated result of the proceeding and will continue to vigorously defend the CINVANTI® patent estate in the future," said Craig Collard, Chief Executive Officer of Heron. "The team at Heron takes great pride in the result of our successful history of developing injectable products, which is demonstrated by the strength of our intellectual property and the performance of our innovative drugs like CINVANTI® in serving patients with serious unmet needs."

About Heron Therapeutics, Inc.

Heron Therapeutics, Inc. is a commercial-stage biotechnology company focused on improving the lives of patients by developing and commercializing therapeutic innovations that improve medical care. Our advanced science, patented technologies, and innovative approach to drug discovery and development have allowed us to create and commercialize a portfolio of products that aim to advance the standard-of-care for acute care and oncology patients. For more information, visit www.herontx.com.

Forward-looking Statements

This news release contains "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995. Heron cautions readers that forward-looking statements are based on management's expectations and assumptions as of the date of this news release and are subject to certain risks and uncertainties that could cause actual results to differ materially. Therefore, you should not place undue reliance on forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements are set forth in our most recent Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q, and in our other reports filed with the Securities and Exchange Commission, including under the caption "Risk Factors." Forward-looking statements reflect our analysis only on their stated date, and Heron takes no obligation to update or revise these statements except as may be required by law.

Investor Relations and Media Contact:

Ira Duarte
Executive Vice President, Chief Financial Officer
Heron Therapeutics, Inc.
iduarte@herontx.com
858-251-4400

 

View original content to download multimedia:https://www.prnewswire.com/news-releases/us-district-court-upholds-validity-of-cinvanti-patents-302321651.html

SOURCE Heron Therapeutics, Inc.

FAQ

When will Heron Therapeutics' (HRTX) CINVANTI patents expire?

Heron Therapeutics' CINVANTI patents (U.S. Patent Nos. 9,561,229 and 9,974,794) will expire in 2035.

What was the outcome of Heron Therapeutics' (HRTX) patent lawsuit against Fresenius Kabi?

The U.S. District Court ruled in favor of Heron Therapeutics, finding that their CINVANTI patents are valid and would be infringed by Fresenius' proposed generic product.

When did the patent litigation between Heron Therapeutics (HRTX) and Fresenius Kabi begin?

The patent litigation was initiated in July 2022 following Fresenius' submission of an Abbreviated New Drug Application for a generic version of CINVANTI.