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

Key Takeaway: Heron Therapeutics, Inc. reported a positive ruling from the U.S. District Court for the District of Delaware regarding the validity of its CINVANTI patents. The court found that Fresenius Kabi USA, LLC infringed on Heron's patents, thereby allowing Heron to seek a prohibition against Fresenius launching a generic version of CINVANTI until the patents expire in 2035. While the decision is favorable for Heron, it is not final as it may be subject to appeal.
Price reaction · baseline $1.22 (2024-12-02 close) · hit after-hours · clean, no other HRTX news in the window
day 0 close · peak
-3.3%

Market Sentiment Analysis

POSITIVE FACTORS

  • Court ruled in favor of Heron, validating CINVANTI patents.
  • Decision prevents Fresenius from launching a generic version until 2035.
  • Heron's patents are expected to provide strong protection for their innovative drug.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Best trade, last catalyst
+23%
120-day peak, hindsight
Typical move
9.9%
average across 6 past catalysts
Cash runway
~58 mo
Minimal dilution risk
Lead asset
HTX-011A
Phase 2 · Postoperative Pain

Full Press Release Details

— 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:
Executive Vice President, Chief Financial Officer
Heron Therapeutics, Inc.

Frequently Asked Questions

What was the court's ruling in the Heron vs. Fresenius case?

The court ruled in favor of Heron, validating its patents and finding Fresenius would infringe.

When do Heron's patents for CINVANTI® expire?

Heron's patents for CINVANTI® expire in 2035.

What action will Heron take after the court's decision?

Heron will seek a court order to prevent Fresenius from launching its generic product.

What is CINVANTI® used for?

CINVANTI® is an injectable emulsion used for the treatment of CINV.

What is the focus of Heron Therapeutics, Inc.?

Heron focuses on developing therapeutic innovations for acute care and oncology patients.

Last updated: Dec 3, 2024