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Item 3. Legal Proceedings

2025-02-18 compared with 2024-02-08 · 43 added, 18 removed, 31 unchanged (66% of the section changed)

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In addition, from time to time we may bring claims or initiate lawsuits against various third parties with respect to matters arising out of the ordinary course of our business, including commercial and employment related matters.

Since June 2021, we and certain Abbott Diabetes Care, Inc.

(“Abbott”) entities have served patent infringement complaints against each other in multiple jurisdictions against certain continuous glucose monitoring products of each company.

Litigation and Settlement with Abbott

From June 2021 through December 2024, we and certain Abbott Diabetes Care, Inc.

(“Abbott”) entities served patent infringement complaints against each other in multiple jurisdictions against certain continuous glucose monitoring products of each company.

In June 2021, we initiated patent infringement litigation against Abbott in the United States (U.S.D.C., Western District of Texas) and Germany (National Court (“N.C.”) in Mannheim).

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In response to the lawsuits initiated by Abbott in the United Kingdom, Dexcom also filed patent infringement counterclaims in the Business and Property Courts of England and Wales.

Three trials on liability have already been conducted in the United Kingdom.

On October 18, 2023, judgment was handed down in favor of Dexcom in one of these trials.

On January 15, 2024, judgment was handed down invalidating both Abbott and Dexcom’s patents in another one of these trials.

The parties are awaiting rulings on the remaining trial.

Dexcom and Abbott sought injunctive relief and monetary damages as a result of their respective claims.

Three trials on liability were conducted in the United Kingdom.

On October 18, 2023 and June 28, 2024, judgment was handed down in favor of Dexcom, finding the Abbott patents to be invalid and not infringed.

On January 15, 2024, judgment was handed down invalidating both Abbott and Dexcom’s patents.

In December 2021, Abbott filed a breach of contract lawsuit against Dexcom in the United States (U.S.D.C., District of Delaware) alleging that Dexcom breached the parties’ Settlement and License Agreement dated July 2, 2014 (“SLA”).

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Ultimately, in November 2023, the PTO issued its Final Written Decision, upholding claims of two Dexcom patents to be patentable, which cover factory calibration and certain alarms and alerts, and two to be unpatentable, which cover certain sensor code and sensor configurations.

We will continue to enforce the remaining claims of the patents asserted in Delaware with trial set for February 2025.

In February 2023, Abbott filed patent infringement litigation against us in Germany (N.C.

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In response to the lawsuits initiated by Abbott in the United Kingdom, Dexcom also filed patent infringement counterclaims in that jurisdiction.

Abbott’s patent infringement action, “D1", against Dexcom is currently scheduled for trial in the U.S.D.C., District of Delaware on March 11, 2024.

Abbott’s patent infringement trial, “D1”, against Dexcom commenced in the U.S.D.C., District of Delaware in March 2024.

In the lead up to trial, the U.S.D.C., District of Delaware invalidated one of Abbott’s patents on factory calibration and Abbott dropped four other patents from the litigation.

The claims currently being litigated are isolated to the inserter mechanism and the wearable seal and mount of Dexcom’s G6.

Commencing in January 2024, Abbott has several patent infringement hearings against Dexcom in Germany (N.C.

in Hamburg and Munich) wherein Abbott is seeking damages and injunctive relief.

On January 31, 2024, the Court in Munich in two such hearings provided Dexcom additional time to brief certain issues Abbott raised late in the proceedings, thus postponing a decision in both proceedings until May 2024.

In March and April of 2024, Dexcom has several patent infringement hearings in the N.C.

in Mannheim and Munich against Abbott, wherein Dexcom is seeking damages and injunctive relief.

Dexcom has hearings in May and June 2024 in its first two proceedings in the UPC and in July 2024 in the N.C.

Due to uncertainty surrounding patent litigation procedures initiated by Dexcom and Abbott throughout multiple jurisdictions, we are unable to reasonably estimate the ultimate outcome of any of the litigation matters at this time.

We intend to protect our intellectual property and defend against Abbott’s claims vigorously in all of these actions.

The claims litigated were isolated to the inserter mechanism and the wearable seal and mount of Dexcom’s G6.

On March 22, 2024, a jury returned a mixed verdict.

The jury found that Dexcom infringes one patent, that Dexcom did not infringe a second patent, and that Dexcom also did not infringe a third patent, which the jury also found invalid.

The jury found that any infringement was not willful.

It could not reach unanimity as to a fourth patent.

No determination of damages was made or awarded.

Commencing in January 2024, patent infringement hearings between Abbott and Dexcom were scheduled to take place in Germany wherein each sought damages and injunctive relief against the other.

All but one of Abbott’s offensive hearings were either stayed or cancelled entirely due to parallel invalidity proceedings and nullity decisions.

After a February 28, 2024 hearing in Munich wherein Abbott asserted patent infringement claims against Dexcom, Dexcom received a favorable non-infringement decision.

On July 24, 2024, Dexcom received a decision from the Munich court related to the July 3, 2024 hearing, staying our offensive infringement proceedings pending the outcome of an opposition proceeding.

On July 31, 2024, Dexcom received a decision from the Munich courts related to hearings in April 2024, dismissing our claims for infringement.

On November 6, 2024, Dexcom received a favorable decision from the Munich District Court, finding Abbott infringes Dexcom’s patent and granting an injunction regarding Abbott’s LibrLinkUp application in Germany.

Under the Settlement Agreement described below, Abbott obtained a license to such patent and the injunction no longer applies.

In July 2024, after hearings in May and June in the Paris and Munich divisions of the UPC, each division issued a decision revoking our patents asserted against Abbott.

On December 20, 2024, Dexcom and Abbott entered into a settlement and patent cross license agreement (the “Settlement Agreement”) to resolve all outstanding patent litigation between the parties (the “Litigation”).

Under the terms of the Settlement Agreement, Dexcom granted Abbott and its affiliates, and Abbott and its affiliates granted Dexcom and its affiliates, a worldwide, royalty-free, non-exclusive, fully paid-up license to certain patents and patent applications relating to analyte sensing, including to all the patents asserted in the Litigation.

The Settlement Agreement does not obligate Dexcom or Abbott to pay any royalties or any other form of financial compensation.

As part of the Settlement Agreement, each party, on behalf of itself and its affiliates, has also (i) entered into a covenant not to sue until December 20, 2034;

and (ii) agreed on behalf of themselves and their affiliates to refrain from challenging the patents and patent applications licensed under the Settlement Agreement for periods of time which vary depending on the relevant patents or patent applications.

The description of the Settlement Agreement contained herein is qualified in its entirety by reference to the Settlement Agreement, a copy of which is filed as Exhibit 10.16 to this Annual Report on Form 10-K.

Securities Class Action Litigation

Between August 21 and October 9, 2024, three substantially similar putative class action complaints were filed against us and certain of our executive officers in the United States District Court for the Southern District of California.

On December 13, 2024, the court appointed lead plaintiff court and consolidated the three actions (now captioned In Re:

Class Action Securities Litigation, Lead Case No.:

24-cv-1485-RSH-VET).

On January 27, 2025, lead plaintiff filed a consolidated complaint.

The consolidated complaint alleges violations of the Securities Exchange Act against us and certain of our current and former executive officers for allegedly making false and misleading statements between April 28, 2023 and July 25, 2024, with respect to our expected revenue for fiscal 2024 and ability to capitalize on our growth potential.

Our deadline to respond to the consolidated complaint is March 13, 2025.

Derivative Actions

Between September 13 and October 16, 2024, two putative stockholders filed derivative lawsuits against us and certain of our current and former executive officers and directors in the United States District Court for the Southern District of California.

The derivative complaints allege factual allegations largely tracking allegations made in the Securities Class Action Litigation and seek, among other things, damages and restitution to be paid to the Company by the individual defendants, punitive damages, and attorney’s fees and costs.

On December 16, 2024, the court issued an order (i) consolidating the derivative actions, (ii) appointing lead counsel in the consolidated action (captioned In Re:

Stockholder Derivative Litigation, Lead Case No.:

24-cv-1645-RSH-VET), and (iii) staying the consolidated action until the court’s resolution of any motions to dismiss in the Securities Class Action Litigation.

We intend to vigorously defend against such claims;

however, we cannot be certain of the outcome of our ongoing proceedings and, if determined adversely to us, our business and financial condition may be adversely affected.

We do not believe we are party to any other currently pending legal proceedings, the outcome of which could have a material adverse effect on our business, financial condition, or results of operations.

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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.

What changed 10-K

Item 3. Legal Proceedings