Legal Proceedings
−Removed: As previously disclosed in the Quarterly Report on Form 10-Q filed by La Jolla on August 15, 2022, on February 15, 2022, La Jolla received a paragraph IV notice of certification (the “First Notice Letter”) from Gland Pharma Limited (“Gland”) advising that Gland had submitted an Abbreviated New Drug Application (“ANDA”) to the FDA seeking approval to manufacture, use or sell a generic version of GIAPREZA ® in the U.S.
+Added: From time to time, the Company is involved in legal proceedings in the ordinary course of its business.
+Added: We are not currently a party to any material legal proceedings except as discussed below.
+Added: On February 15, 2022, La Jolla received a paragraph IV notice of certification (the “First Notice Letter”) from Gland Pharma Limited (“Gland”) advising that Gland had submitted an Abbreviated New Drug Application (“ANDA”) to the FDA seeking approval to manufacture, use or sell a generic version of GIAPREZA ® in the U.S.
prior to the expiration of U.S.
9 unchanged sentences
We intend to vigorously enforce our intellectual property rights relating to GIAPREZA ® .
−Removed: Fact discovery closed on March 31, 2024 and expert discovery is expected to be complete by August 16, 2024.
+Added: Fact discovery closed on March 31, 2024 and expert discovery was completed on August 19, 2024.
+Added: On September 13, 2024, La Jolla filed a motion for partial summary judgment of infringement regarding three claims from U.S.
+Added: 10,548,943 and 10,335,451.
+Added: Briefing for this motion concluded on October 15, 2024.
+Added: The court has not yet rendered a decision on this motion.
A trial date has not yet been set in this matter.
−Removed: Given the early stage of this matter, we cannot reasonably estimate a potential future loss or a range of potential future losses, if any, and have not recorded a contingent liability accrual as of June 30, 2024.
+Added: Given the current status of this matter, we cannot reasonably estimate a potential future loss or a range of potential future losses, if any, and have not recorded a contingent liability accrual as of September 30, 2024.
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.