aibioDelaware court holds Heron CINVANTI patent claims invalid; Heron plans appeal
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The court ruled June 1, 2026 in Heron's patent suit against Azurity Pharmaceuticals and Slayback Pharma entities. Heron says it will appeal to the Federal Circuit and that the ruling does not affect a prior settlement.
Key facts
- Company
- Heron Therapeutics, Inc. (NASDAQ: HRTX)
- News type
- Legal
- Primary source
- HERON THERAPEUTICS, INC. /DE/ Form 8-K filed June 2, 2026 (SEC EDGAR)
Heron Therapeutics, Inc. (Nasdaq: HRTX) said on June 2, 2026 that the U.S. District Court for the District of Delaware ruled on June 1, 2026 that the asserted claims of its U.S. Patent Nos. 12,115,255 and 12,290,520 are invalid. The patents cover CINVANTI (aprepitant) injectable emulsion. The company disclosed the ruling in a Form 8-K and a press release. Heron says it intends to appeal to the United States Court of Appeals for the Federal Circuit. No appeal date is given in the filing.
The defendants are Slayback Pharma LLC and Azurity Pharmaceuticals, Inc., which now owns Slayback Pharma LLC, along with Azurity Pharmaceuticals India LLP, formerly Slayback Pharma India LLP, and related entities. Heron is the plaintiff.
What the ruling removes
Two of the patents Heron asserted are now held invalid as claimed. The 8-K says the decision has no effect on any prior settlement agreement related to CINVANTI or APONVIE (aprepitant) injectable emulsion. The filing does not say what the invalidity finding means for generic entry. The company's chief executive, Craig Collard, said: "We are disappointed with this initial result of the litigation and will vigorously pursue our appeal and all available remedies, including equitable relief if necessary, as we continue to defend our intellectual property rights." That is the company's view, and the ruling is the court's.
How the case reached this point
On December 11, 2023, Heron received a Paragraph IV notice of certification from Slayback Pharma LLC. The notice said Slayback had filed a new drug application under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act seeking approval to make, use or sell a generic version of CINVANTI before the listed patents expire, and it alleged those patents are invalid, unenforceable or will not be infringed.
On December 12, 2024, Heron filed a complaint in Delaware against Slayback, Azurity and related entities over U.S. Patent Nos. 12,115,254 and 12,115,255. On May 23, 2025, it filed an amended complaint adding U.S. Patent No. 12,290,520. On September 16, 2025, the parties filed a stipulation (Case No. 24-1363, D.I. 119) limiting the issues for trial.
The trial was a two-day bench trial. It began on November 17, 2025 and focused on Azurity's defenses under Section 112 against claims of Patent Nos. 12,115,255 and 12,290,520, which cover CINVANTI. Post-trial briefing was completed on February 6, 2026, and the court held closing arguments on March 24, 2026. The decision followed on June 1, 2026.
Other litigation on the same product
The 10-K, filed February 26, 2026, describes a separate settlement reached on May 6, 2025 with Mylan to resolve patent litigation in Delaware over Mylan's abbreviated new drug application for a generic version of CINVANTI. Under that settlement, Heron granted Mylan a license under the Orange Book-listed patents for CINVANTI to market a generic version in the United States. The 10-K describes a similar settlement with Mylan on APONVIE. The 8-K says the June 1 ruling does not alter those settlements.
Money behind the product
The 10-K reports net product sales of $154,904 thousand for 2025, up from $144,285 thousand for 2024. Those sales cover ZYNRELEF, APONVIE, CINVANTI and SUSTOL. The company still lost money. Its net loss was $20,195 thousand for 2025, against $13,580 thousand for 2024. Net cash used in operating activities was $27.6 million in 2025 and $22.5 million in 2024, according to the 10-K's financial data.
At December 31, 2025, Heron had cash, cash equivalents and short-term investments of $46.6 million. The 10-K says its indebtedness under the Working Capital Facility Agreement with Hercules Capital, Inc., as administrative agent, collateral agent and lender, together with its senior unsecured convertible notes due 2031, totaled $147.1 million. The ruling on two patents therefore lands on a company whose debt of $147.1 million is large against $46.6 million of cash and short-term investments.
Signatory
Ira Duarte, Executive Vice President, Chief Financial Officer, signed the 8-K and is the investor relations and media contact in the release.