4 unchanged sentences
The Company asserts infringement of the following eleven patents, which are listed in the FDA’s Orange Book for Arcutis’ ZORYVE ® 0.3% cream:
−Removed: 11,793,796;11,819,496;
and 12,016,848 (collectively, Asserted Patents).
−Removed: Arcutis seeks a judgment that Padagis has infringed or will infringe one or more claims of each of the Asserted Patents and based on that judgment, a permanent injunction prohibiting the commercial manufacture, use, offer to sell, or sale within the United States or importation into the United States of Padagis’s proposed generic product before expiration of each of the Asserted Patents found to infringe.
−Removed: On July 19, 2024, Arcutis filed its first amended complaint that added the last five of the above listed patents to its infringement allegations.
−Removed: These patents were issued by the U.S.
−Removed: Patent and Trademark Office and listed in FDA’s Orange Book for Arcutis’s ZORYVE® 0.3% cream after the filing of the original complaint.
−Removed: On August 2, 2024, Padagis responded to the first amended complaint, denying infringement and asserting counterclaims seeking a declaratory judgement that the asserted patents are not infringed, invalid, and/or unenforceable.
−Removed: The court issued a scheduling order on June 10, 2024, which sets trial at the court’s convenience, or around April 13-17, 2026.
−Removed: The automatic 30-month stay of FDA approval of Padagis’s ANDA seeking approval for Arcutis’s ZORYVE® 0.3% cream is set to expire on August 14, 2026.
+Added: Arcutis seeks a judgment that Padagis has infringed or will infringe one or more claims of each of the Asserted Patents and based on that judgment, a permanent injunction prohibiting the commercial manufacture, use, offer to sell, or sale within the United States or importation into the United States of Padagis’s proposed generic product before expiration of each of the Asserted Patents found to be infringed.
+Added: In March 2025, Arcutis agreed to file a joint stipulation to stay the ongoing patent litigation with Padagis at the request of Padagi s.
+Added: On April 3, 2025, the court stayed the case and cancelled all case deadlines, including the trial.
+Added: The automatic 30-month stay of FDA approval of Padagis’s ANDA seeking approval for Arcutis’s ZORYVE ® 0.3% cream was set to expire on August 14, 2026.
+Added: The 30-month stay will be extended for each day the stay is in place, starting March 24, 2025, until the stay is lifted.
Teva Pharmaceutical Industries Ltd.
−Removed: filed Oppositions with the European Patent Office against two of our European patents, European Patent Nos.
−Removed: EP 3634380 B1 and EP 3684334 B1, on September 20, 2024 and August 13, 2024, respectively.
−Removed: These patents relate to topical roflumilast compositions.
−Removed: Arcutis filed replies on January 23, 2025 and February 24, 2025, respectively.
−Removed: Hearings before the EPO’s Opposition Division are not yet scheduled and the proceedings are ongoing.
+Added: filed oppositions with the EPO against two of our European patents in the third quarter of 2024.
+Added: After oral proceedings for each of the respective patents, the EPO panel found in favor of Arcutis and maintained both patents .
We may from time to time be involved in various legal proceedings of a character normally incident to the ordinary course of our business.
−Removed: We are not currently a party to any material litigation or other material legal proceedings.
+Added: We are not currently a defendant in any material litigation or other material legal proceedings.
MINE SAFETY DISCLOSURES
−Removed: Index to Financial Statement s
+Added: Index to Financial Statements
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.