What changed in this filing

/stocks — the workspaceLOADING

Item 3. Legal Proceedings

2025-02-27 compared with 2024-03-12 · 51 added, 19 removed, 13 unchanged (84% of the section changed)

7 unchanged sentences

The complaint seeks, among other relief, equitable relief enjoining Fresenius Kabi from infringing the CINVANTI Patents.

The parties are currently completing fact discovery and will be moving into expert discovery.

A five-day bench trial is scheduled for June 24, 2024.

On October 17, 2023, the Company received an updated Notice Letter from Fresenius Kabi advising that it had submitted an amendment to Fresenius’s ANDA to include a paragraph IV certification to Heron’s recently listed U.S.

11,744,800 (the “800 Patent”).

On May 15, 2024, the Court granted partial summary judgment of infringement for the Company and found no indefiniteness of U.S.

9,561,229 and 9,974,794.

On June 24, 2024, the parties commenced a four-day bench trial centered on Fresenius Kabi’s defense of obviousness of claims from U.S.

9,561,229 and 9,974,794 that cover CINVANTI.

Oral argument was held on August 29, 2024.

On December 3, 2024, the Court issued a ruling in the Company’s favor.

The Court found that the Company’s U.S.

9,561,229 and 9,974,794, which expire in 2035, are valid and would be infringed by Fresenius Kabi’s proposed generic product.

In view of the decision, the Court ordered that the effective date of any final approval by the FDA of Fresenius Kabi’s ANDA shall not be a date earlier than September 18, 2035, the expiration date of each of U.S.

9,561,229 and 9,974,794.

On January 8, 2025, Fresenius Kabi filed notice of appeal to the U.S.

Court of Appeals for the Federal Circuit.

The Company intends to vigorously enforce its intellectual property rights relating to CINVANTI.

As a result of filing our complaint for patent infringement, the FDA may not approve Fresenius’s ANDA until the earlier of December 14, 2024 or resolution of the litigation.

On August 14, 2023, the Company received a Notice Letter from Mylan Pharmaceuticals Inc.

(“Mylan”) advising that Mylan had submitted an ANDA (“Mylan's ANDA”) to the FDA seeking approval to manufacture, use or sell a generic version of CINVANTI in the U.S.

On August 4, 2023, the Company received a Notice Letter (the “Mylan August Notice”) from Mylan Pharmaceuticals Inc.

(“Mylan”) advising that Mylan had submitted an ANDA to the FDA seeking approval to manufacture, use or sell a generic version of CINVANTI (“Mylan’s CINVANTI ANDA”) in the U.S.

prior to the expiration of the CINVANTI Patents, which are listed in the Orange Book.

The Notice Letter alleges that the CINVANTI Patents are invalid, unenforceable and/or will not be infringed by the commercial manufacture, use or sale of the generic product described in Mylan’s ANDA.

On September 15, 2023, the Company filed a complaint for patent infringement of the CINVANTI Patents against Mylan in the Court in response to Mylan’s ANDA filing.

The Mylan August Notice alleges that the CINVANTI Patents are invalid, unenforceable and/or will not be infringed by the commercial manufacture, use or sale of the generic product described in Mylan’s CINVANTI ANDA.

On September 15, 2023, the Company filed a complaint for patent infringement of the CINVANTI Patents against Mylan in the U.S.

District Court for the District of Delaware in response to the filing of Mylan’s CINVANTI ANDA.

The complaint seeks, among other relief, equitable relief enjoining Mylan from infringing the CINVANTI Patents.

The Company intends to vigorously enforce its intellectual property rights relating to the CINVANTI Patents.

As a result of our complaint for patent infringement, the FDA may not approve Mylan’s ANDA until the earlier of February 4, 2026 or resolution of the litigation.

On December 18, 2023, the Company received a paragraph IV notice of certification (the “Mylan Notice”) from Mylan advising that Mylan had submitted an ANDA with the FDA, seeking approval to manufacture, use or sell a generic version of the Company’s product APONVIE in the U.S.

prior to the expiration of U.S.

11,173,118 and 11,744,800 (the “APONVIE Patents”), which are listed in the Orange Book and each of which expire September 18, 2035.

The Mylan Notice alleges that the APONVIE Patents are invalid, unenforceable, or will not be infringed by the commercial manufacture, use or sale of the generic product described in the ANDA.

As of the date of this filing, the Company is not aware of any other ANDA filers.

On January 11, 2024, the Company filed a complaint for patent infringement of the APONVIE Patents against Mylan.

The Company intends to vigorously defend and enforce its intellectual property rights protecting APONVIE.

In accordance with the Hatch-Waxman Act, because APONVIE is a new chemical entity the FDA cannot approve Mylan’s ANDA any earlier than 7.5 years from the approval of the APONVIE NDA unless a District Court finds that all of the asserted claims of the patents-in-suit are invalid, unenforceable and/or not infringed.

On November 9, 2023, the Company received an updated Notice Letter from Mylan advising that it had submitted an amendment to Mylan’s ANDA to include a Paragraph IV certification to Heron’s recently listed U.S.

The parties completed fact discovery and are in expert discovery.

A five-day bench trial is scheduled for May 19, 2025.

The Company intends to vigorously enforce its intellectual property rights relating to CINVANTI.

As a result of filing our complaint for patent infringement, the FDA may not approve Mylan’s CINVANTI ANDA until the earlier of February 4, 2026 or resolution of the litigation.

On December 16, 2023, the Company received a Notice Letter (the “Mylan December Notice”) from Mylan advising that Mylan had submitted an ANDA to the FDA seeking approval to manufacture, use or sell a generic version of APONVIE in the U.S.

(“Mylan’s APONVIE ANDA”) prior to the expiration of U.S.

and 11,744,800 (the “APONVIE Patents”), which are listed in the Orange Book.

The Mylan December Notice alleges that the APONVIE Patents are invalid, unenforceable and/or will not be infringed by the commercial manufacture, use or sale of the generic product described in Mylan’s APONVIE ANDA.

On January 11, 2024, the Company filed a complaint for patent infringement of the APONVIE Patents against Mylan in the U.S.

District Court for the District of Delaware in response to Mylan filing Mylan's APONVIE ANDA.

The complaint seeks, among other relief, equitable relief enjoining Mylan from infringing the APONVIE Patents.

On January 26, 2024, the Court consolidated this litigation concerning Mylan’s APONVIE ANDA with the previously-filed litigation concerning Mylan’s CINVANTI ANDA.

A five-day bench trial is scheduled for May 19, 2025.

The Company intends to vigorously enforce its intellectual property rights relating to APONVIE.

As a result of filing our complaint for patent

infringement, the FDA may not approve Mylan’s APONVIE ANDA until the earlier of June 16, 2026 or resolution of the litigation.

On December 11, 2023, the Company received a Paragraph IV notice of certification (the “Slayback Notice”) from Slayback Pharma LLC ("Slayback") (now owned by Azurity Pharmaceuticals, Inc.) advising that Slayback had submitted an NDA under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act to the FDA seeking approval to manufacture, use or sell a generic version of CINVANTI in the U.S.

(“Slayback’s NDA”) prior to the expiration of the patents listed in the Orange Book.

The Slayback Notice alleges that the CINVANTI Patents are invalid, unenforceable and/or will not be infringed by the commercial manufacture, use or sale of the generic product described in Slayback’s NDA.

On January 24, 2024, the Company filed a complaint for patent infringement of the CINVANTI Patents against Slayback and a related entity in the U.S.

District Court for the District of New Jersey in response to Slayback’s NDA filing.

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, to reflect Azurity Pharmaceuticals, Inc.’s (“Azurity”) acquisition of Slayback, the Court entered a stipulation adding Azurity and a related entity into the case.

On December 12, 2024, the Company filed a complaint against Slayback, Azurity, and related entities in the U.S.

District Court for District of Delaware for patent infringement of U.S.

12,115,254 and 12,115,255.

The parties are currently in fact discovery and preparing for claim construction.

A four-day bench trial is currently scheduled for November 17, 2025.

The Company intends to vigorously enforce its 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.

MINE SAF ETY DISCLOSURES.

1 unchanged sentence

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 3. Legal Proceedings