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Legal proceedings, including litigation, government investigations and enforcement actions could result in material costs, occupy significant management resources and entail civil and criminal penalties.
−Removed: In February 2021, the Company received notice and accepted service of a civil complaint that had been filed in the Western District of Texas and styled Carew ex rel.
−Removed: United States v.
−Removed: Senseonics, Inc., No.
−Removed: SA20CA0657DAE.
−Removed: The complaint was filed by a relator under seal in May 2020 pursuant to the qui tam provisions in the federal False Claims Act.
−Removed: Prior to the unsealing of the complaint, the government declined to intervene in the case.
−Removed: The case, therefore, is being pursued only by the relator and his counsel.
−Removed: The complaint alleges the Company’s marketing practices with physicians for its product, Eversense CGM system, violated the False Claims Act, 31 U.S.C.
−Removed: § 3729 and the Texas Medicaid Fraud Prevention Law, Tex.
−Removed: Code § 36.002.
−Removed: The court granted the Company’s motion to dismiss the complaint on March 31, 2022 but permitted the plaintiff to file an amended complaint.
−Removed: The court dismissed the amended complaint and entered judgment in favor of Senseonics Holdings, Inc.
−Removed: on March 30, 2023.
−Removed: The relator filed a notice of appeal to the United States Court of Appeals for the Fifth Circuit on April 28, 2023.
−Removed: The appeal was fully briefed and the case was argued before the Fifth Circuit on February 6, 2024.
−Removed: On February 28, 2024 the Fifth Circuit issued a Per Curiam order affirming the District Court’s decision that Carew failed to state a claim.
−Removed: This order affirms the District Court’s dismissal of plaintiff’s lawsuit.
In May 2024, the Company received notice and accepted service of a civil complaint that had been filed in the Eastern District of Texas and styled Cellspin Soft, Inc.
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The validity of all three of these patents currently is being challenged in Inter Partes Review proceedings at the U.S.
−Removed: Patent and Trademark Office by another party, and on September 30, 2024, the Patent Trial and Appeal Board instituted a review with respect to each of the asserted claims in these three patents.
−Removed: Together with LifeScan and Ascensia, on October 30, 2024, we filed a joint motion to join the Inter Partes Review as well as similar Inter Partes Review challenges to these patents.
−Removed: On February 5, 2025, the court issued an order staying the proceedings in the Eastern District of Texas pending resolution of the Inter Partes Review.
+Added: Patent and Trademark Office by another party, TikTok Inc., (the “TikTok IPR”) and on September 30, 2024, the Patent Trial and Appeal Board instituted a review with respect to each of the asserted claims in these three patents.
+Added: Together with LifeScan, Inc.
+Added: and Ascensia, on October 30, 2024, we filed a joint motion to join the TikTok IPR as well as our own independent, similar Inter Partes Review petitions challenging these patents.
+Added: On February 5, 2025, the court issued an order staying the proceedings in the Eastern District of Texas pending resolution of the Inter Partes Reviews.
+Added: On June 5, 2025, prior to the imminent TikTok IPR final hearings, the Acting Director of the U.S.
+Added: Patent and Trademark Office ordered a sua sponte review by the Acting Director of whether the TikTok IPR could proceed based on certain novel issues relating to TikTok’s Chinese ownership status.
+Added: On January 23, 2026, the Director of the U.S.
+Added: Patent and Trademark Office issued and order stating that, in view of a recent order by the Patent Trial and Appeal Board and TikTok Inc.’s announced joint venture (and the referenced ownership attributes thereof), the parties were authorized to file an additional brief addressing whether the evidence Cellspin Soft, Inc.
+Added: submitted is sufficient to put TikTok Inc.’s real party in interest identification into dispute, and what effect, if any, the announced joint venture has on the TikTok IPR proceedings.
+Added: and Cellspin Soft, Inc.
+Added: filed additional briefs on February 2, 2026.
+Added: To date, no decision has been rendered on by the Director whether the TikTok IPR can proceed.
+Added: The Inter Partes Review proceedings are all stayed pending the outcome of the sua sponte Director’s review.
+Added: The timing of this review remains uncertain.
+Added: TikTok IPR terminated, it is our belief that our independent Inter Partes Review should continue because the issues raised in the challenge to the TikTok IPR are not relevant to our filings.
Should any asserted claim in the three patents survive the invalidity challenge in the Inter Partes Review proceedings, the Company intends to vigorously defend the lawsuit.
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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.