On December 23rd, Abbott and Dexcom, the two leaders in the continuous glucose monitoring (CGM) market, reached a settlement agreement regarding their ongoing patent lawsuit.

A few weeks ago, the Paris Unified Patent Court made a ruling in favor of Abbott in the patent lawsuit against these two giants. DeKang has filed a lawsuit in court, accusing Abbott and its LibreLinkUp remote analyte monitoring system of infringing on its patents. DeKang Company holDaiichi Sankyo European patent 3 831 282 (EP282). According to the Unified Patent Court, this patent is the core of the ongoing global lawsuit between DeKang and Abbott. However, based on Abbott's request, the court completely revoked the EP282 patent in all contracting member states in Europe and dismissed all infringement claims made by DeKang based on the patent.

01. Abbott wins in CGM patent dispute
A few weeks ago, the Paris Unified Patent Court made a ruling in favor of Abbott, completely revoking the European patent 3 831 282 (EP282) held by DeKang and rejecting all claims of infringement based on the patent.

Abbott and Tecan, as the leaders in the global CGM market, have been providing advanced blood glucose monitoring solutions for diabetes patients worldwide for a long time. Abbott's FreeStyle Libre series and DeKang's G-series CGM products both enjoy high reputation and a wide user base in the market. However, with the increasingly fierce market competition, the patent dispute between the two companies has gradually escalated.

The core of this dispute lies in the EP282 patent held by DeKang Company. The patent relates to remote monitoring technology, especially blood glucose level monitoring of diabetes patients, and covers the function of sharing CGM blood glucose information with others. DeKang has filed a lawsuit in court, accusing Abbott and its LibreLinkUp remote analyte monitoring system of infringing on its patent rights. DeKang believes that Abbott's products have used its patented technology without authorization, infringing on its intellectual property rights.

In response to DeKang's accusations, Abbott has taken proactive legal measures. Abbott not only seeks to revoke the EP282 patent, but also counterclaims against DeKang for infringing on its patent rights. This patent dispute involves multiple countries, including the United Kingdom, Germany, Spain, and the United States, and has led to intense litigation battles in the European Patent Court (UPC), European Patent Office (EPO), and various national courts.
During the litigation process, the main focus of the dispute between the two parties was on the validity and infringement of the EP282 patent. DeKang insists that its patents are valid and points out that Abbott's products do indeed infringe on its patent rights. Abbott argues that the claims of EP282 patent are too broad and vague, lacking novelty and creativity, and therefore should be declared invalid.

After thorough examination, the court found that although DeKang received partial support for one of the claims in the patent, namely the patient's willingness to share blood glucose information and the ability to customize settings, DeKang's explanation regarding the notification of the system's "rules" was not reasonable. The court pointed out that patent claims cannot only serve as guidelines, and DeKang's interpretation goes beyond the scope of patent claims. Therefore, the court ultimately decided to revoke the EP282 patent.

This ruling has had a profound impact on the competitive lanDaiichi Sankyocape of the CGM market. Abbott's victory not only consolidates its leading position in the CGM market, but may also set an important precedent for other medical technology companies.

02. Two giants enter the over-the-counter CMG market
Although the patent dispute between Abbott and DeKang has come to an end, the competition in the trillion CGM market remains fierce. In 2024, Abbott and DeKang both entered the consumer CGM market. Abbott launches Lingo and DeKang launches Stelo, both products are sold in the over-the-counter (OTC) market. Non prescription CGM will become the next trillion dollar market, and Abbott and DeKang, two old rivals, will once again compete here.

This measure means that consumers can purchase and use these advanced blood glucose monitoring tools directly without a doctor's prescription. This is undoubtedly a new convenient way for consumers and patients to understand their own blood sugar levels.

Abbott Lingo
Lingo will be launched in the UK in January 2024, with a two-week Lingo package priced at 89 euros, including a sensor that can be used for 14 days and a bound app; The 8-week set is priced at 300 euros. Listed in the United States in June 2024.

Lingo measures physiological indicators by inserting a very small sensor (about the width of three hair stranDaiichi Sankyo) underneath the skin, which can track blood glucose levels, ketones, and lactate. The appearance and technology of Lingo sensors are similar to those of FreeStyle Libre, but the chemical composition detected by each Lingo will be different. This bio wearable device also comes with a "coaching" app designed to help users connect health data, highlight areas for improvement for patients or users, and provide recommendations and personalized action plans for their ongoing medical decisions. Without being used for diabetes management, Lingo's idea is to provide people with information about how diet affects blood sugar, and potential information about how blood sugar levels reflect daily trenDaiichi Sankyo (such as sleep quality).

Abbott CEO Robert Ford expressed optimism about the future of over-the-counter CGM, stating that it has "mass market potential". According to Ford, the global CGM market currently has about 10 million users, but there is still huge growth potential in this market. He pointed out that in developed countries, the number of diabetes patients is about 100 million, and globally, this number is as high as 500 million. This means that the CGM market has a huge potential user base and broad prospects for future development. Ford also mentioned that Abbott's target population in the CGM field is not limited to diabetes patients. He said: "It neeDaiichi Sankyo to be reminded that through this technology, we really focus on a very different group of people, that is, people without diabetes. Therefore, our business model and sales model will be different. But so far, we have seen a very, very good early interest."

DeKang launches Stelo
DeKang officially launched its Stelo over-the-counter CGM in August 2024, which received approval from the US Food and Drug Administration (FDA) in March, making DeKang the first OTC CGM company to receive FDA approval. Subsequently, Abbott Laboratories also obtained FDA approval in June.

As the first consumer grade CGM, Stelo is specially designed by Dekang for type 2 diabetes patients who do not use insulin. The sensor is worn on the back of the arm and can directly provide real-time blood glucose information to the user's smartphone. The Stelo system consists of wearable sensors and smartphone applications, which can automatically measure, record, analyze, and display blood glucose levels every 15 minutes. Each sensor can be worn for up to 15 days before replacement, providing users with a convenient and continuous blood glucose monitoring experience.

DeKang stated that the launch of Stelo makes it easier for the target audience to access CGM, especially providing a new option for those who do not have CGM insurance. The FDA also stated that the approval of this device is of great significance as it will enable more people to conveniently monitor blood sugar, improve healthcare accessibility, and bring health management into the home environment.

DeKang's Executive Vice President and Chief Operating Officer Jake Leach has also shown great enthusiasm for consumer grade CGM, stating, "DeKang has been at the forefront of glucose biosensing for 25 years. With the launch of Stelo, we have defined a new category and once again set the gold standard for people to easily control their health. Now, millions of people have access to 24/7, easy to understand glucose analysis, which can provide information for their daily lifestyle choices and support behavior correction.

With the continuous innovation of companies such as Abbott and DeKang in the field of continuous glucose monitoring (CGM), the launch of OTC CGM products is attracting widespread attention among non insulin dependent consumers. This trend indicates that blood glucose management is gradually evolving from a necessary means to treat diabetes to a new tool to pursue a healthy life. However, despite the broad market prospects, OTC CGM products still face multiple obstacles and challenges in expanding their target audience.

Firstly, as an invasive monitoring tool, the discomfort of wearing sensors in CGM products has always been a concern for users. Although new products such as DeKang's Stelo and Abbott's Lingo are developed based on their respective advanced CGM technology platforms, there seems to be no significant improvement in the discomfort of wearing sensors. For non diabetes patients, it may be more difficult for them to accept this inconvenience, which has become a major obstacle to OTC CGM product promotion.

Secondly, cost is also a key factor restricting the rapid popularization of OTC CGM products. If the new product still uses the original technology platform, there may not be much room for cost reduction. In order to achieve a downward trend in terminal selling prices, companies may need to rely more on simplifying their sales chain. However, consumer grade products often require more marketing expenses, which increases the risk of companies increasing revenue without increasing profits. How to effectively promote OTC CGM products while controlling costs has become a major challenge that enterprises need to solve.

In addition, for non insulin dependent patients or consumers, the degree of rigidity in their demand for real-time and accurate monitoring of blood glucose is still uncertain. The dependence of ordinary consumers on CGM is debatable.

Anyway, the launch of Abbott Lingo and DeKang Stelo has simplified the blood glucose monitoring process and improved the accuracy and timeliness of monitoring. Users only need to wear sensors to monitor their blood sugar levels in real-time and continuously, and view data at any time through devices such as mobile phones.

Source: http://qixieke.com/Font/index/detailPage.html?id=3310-19