Company: HRTX
Filing Date: 2025-09-09
Form Type: S-3
Source: 0000950170-25-113834
Chunk: 24

Company: HERON THERAPEUTICS, INC. /DE/
Filing Date: 2025-09-09
Form: S-3
Chunk 24
---
. The complaint seeks, among other relief, equitable relief enjoining Slayback from infringing those patents. On July 2, 2024, the U.S. District Court for the District of New Jersey granted Slayback’s motion to transfer this matter to the U.S. District Court for the District of Delaware. On December 12, 2024, we filed a complaint against Slayback, Azurity, and related entities in the U.S. District Court for District of Delaware for patent infringement of the U.S. Patent Nos. 12,115,254 and 12,115,255. On May 23, 2025, we filed an amended complaint against Slayback, Azurity, and related entities adding an allegation of patent infringement of U.S. Patent No. 12,290,520. The parties are currently in expert discovery. A four-day bench trial is currently scheduled for November 17, 2025. we intend to vigorously enforce our intellectual property rights relating to CINVANTI. As a result of our initial complaint for patent infringement, the FDA may not approve Slayback’s NDA until the earlier of June 12, 2026 or resolution of the litigation.

On February 28, 2025, Azurity, Azurity Pharma India LLP, and Slayback requested Post-Grant Review (“PGR”) of U.S. Patent Nos. 12,115,254 and 12,115,255 in PGR2025-00035 and PGR2025-00036, respectively. On April 14, 2025, the Petitions were accorded a filing date. On June 16, 2025, we filed a brief requesting discretionary denial in the petitions in PGR2025-00035 and PGR2025-00036. The briefing was completed on July 16, 2025, and we are awaiting a decision. On July 14, 2025, we filed our Patent Owner Preliminary Response.

On February 7, 2025, we received a Notice Letter (the “Qilu Notice”) from Qilu Pharmaceutical (Hainan) Co., Ltd and Qilu Pharma, Inc. (“Qilu”) advising that Qilu had submitted an ANDA to the FDA seeking approval to manufacture, use or sell a generic version of APONVIE in the U.S. (“Qilu’s ANDA”) prior to the expiration of U.S. Patent