23 unchanged sentences
9,561,229 and 9,974,794 that cover CINVANTI.
−Removed: The parties are currently conducting post-trial briefing.
+Added: Oral argument was held on August 29, 2024.
+Added: The parties are currently awaiting the Court’s decision.
The Company intends to vigorously enforce its intellectual property rights relating to CINVANTI.
8 unchanged sentences
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.
−Removed: 11,744,800.The parties are currently conducting fact discovery.
+Added: The parties completed fact discovery and are progressing into expert discovery.
A five-day bench trial is scheduled for May 19, 2025.
13 unchanged sentences
On December 12, 2023, the Company received a Notice Letter (the “Slayback Notice”) from Slayback Pharma LLC (“Slayback”) 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.
−Removed: (“Slayback’s NDA”) prior to the expiration of the patents, listed in the Orange Book.
−Removed: The Slayback Notice alleges that the CINVANTI Patents are invalid,
−Removed: unenforceable and/or will not be infringed by the commercial manufacture, use or sale of the generic product described in Slayback’s NDA.
+Added: (“Slayback’s NDA”) prior to the
+Added: expiration of the patents, listed in the Orange Book.
+Added: 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.
4 unchanged sentences
District Court for the District of Delaware.
−Removed: The trial in the U.S.
−Removed: District Court for the District of Delaware is not yet scheduled.
+Added: A four-day bench trial is scheduled for January 20, 2026.
The Company intends to vigorously enforce its intellectual property rights relating to CINVANTI.
35 unchanged sentences
and generic products including ondansetron (formerly marketed by GlaxoSmithKline plc as ZOFRAN), granisetron (formerly marketed by Hoffman-La Roche, Inc.
−Removed: as KYTRIL) and palonosetron (formerly marketed by Eisai in conjunction with Helsinn Healthcare S.A.
+Added: as KYTRIL), palonosetron (formerly marketed by Eisai in conjunction with Helsinn Healthcare S.A.
+Added: as ALOXI) and Posfrea (Palonosetron Injection, marketed by AVYXA).
Currently, palonosetron is the only 5-HT3receptor antagonist other than SUSTOL that is approved for the prevention of delayed CINV associated with MEC regimens.
6 unchanged sentences
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.