The first Over-the-Counter Continuous Glucose Monitor (CGM) ever cleared in the United Stated by the FDA was launched by Dexcom. The Stelo Glucose Biosensor System (commercial name) has been cleared for anyone 18 years or older who does not use insulin (such as individuals with diabetes treating their condition with oral medications, or those without diabetes who want to better understand how diet and exercise may impact blood sugar levels).
The clearance drew media attention, given that although CGMs are not a new technology to FDA, Stelo is the first one cleared for purchase without medical prescription. Following Stelo, FDA cleared another two Over-The-Counter (OTC) CGMs: Lingo and Libre Rio, both by Abbott. All three CGMs were cleared through the 510(k) premarket notification pathway, meaning that FDA analyzed the data provided to verify that the device submitted is substantially equivalent to a predicate device already approved by FDA (i.e, the devices show no differences in its technological characteristics that raise questions of safety and effectiveness). As a follow up, we should see regulatory authorities all over the world proceeding in a similar way.
Given that the devices are substantially equivalent, it is reasonable to inquire as to why, in contrast to the previous models (prescription use only) these are available OTC. The answer is while the previous models were designed for the management of diabetes, including children, and had real time alarms for low and/or high glucose, the OTC models are indicated for adults (18 years and older) who are not on insulin (even though they might be diabetics). The CGMs are also designed to provide a better understanding of the correlation between the user’s glucose values and their nutrition, exercise and daily activities.
The OTC devices also come with a warning that it should not be used for medical decisions without the accompaniment of a healthcare provider. The differences in the indications of use of the CGMs that are only available through prescription to those that are available OTC may be seen as reasonable, as it’s designed more for the well-being market. However, experts are still concerned that OTC access may increase the risk of misuse of the device and even harm[1]https://www.statnews.com/2024/08/26/continuous-glucose-monitoring-over-the-counter-cgm/.
The topic is not new to FDA. Even before OTC access, FDA has warned about the issues surrounding the misuse of medical devices for diabetes management, especially with regard to the risk in combining devices/components that are not intended for use with other devices and might even not be FDA-cleared². The nuance of the regulatory approach to these devices will likely increase the need to implement intellectual property strategies to avoid substandard products in the marketplace.
In Brazil CGMs are considered OTC even when the indication of uses is equivalent to those that FDA only allows under prescription. For instance, the most used CGM in Brazil, Freestyle Libre 2 is indicated for adults and children on insulin use. In the case of Brazil, intellectual property and patent enforcement are going to play a key role for innovators as a way to protect consumer market.
The availability of such devices to the consumer illustrates a huge concern: the development of a more simplified and less bureaucratic regulatory framework for approval of medical devices in Brazil in addition to the consumer’s easy access to the devices creates a very propitious environment for counterfeit devices to enter Brazilian market. Thus, enhancing the risk of misuse of medical device by the population. For instance, a faulty CGM interoperable with a insulin pump becomes a harmful device to the user, as it could result in insulin overdose.
It should be noted that the Brazilian medical device market is significant. On average, more than U$6.7 billion worth of products are imported annually, with around 14,000 new products being introduced every year. When it comes to diabetes, Brazil ranks 6th globally in its incidence (approx. 15.7 million adults) having had, only in 2021, a total diabetes-related health expenditure of $42.9 billions[2]https://www.fda.gov/news-events/press-announcements/fda-warns-against-use-unauthorized-devices-diabetes-management. And with the discovery of new technologies, the scenario is for the federal government itself to invest in patient well-being.
For example, the incorporation of CGMs into the Brazilian Unified Health System (SUS) for the treatment of type 1 and type 2 diabetes mellitus is currently under analysis by the National Commission for the Incorporation of Technologies into SUS (Conitec). The latest news is that in June 2024, the Ministry of Health (MoH) opened a public call for patient perspectives, receiving 12,968 contributions. If favorably recommended by Conitec and approved by the MoH, SUS will make the device available to patients.
In parallel, 10 bills were proposed just between 2023 and 2024 with the aim of ensuring the free distribution of CGMs for diabetics patients in various regions of the country (Bill #868 of 2023 in São Paulo, Bill #517 of 2023 in Manaus, Bill #226 of2024 in Alagoas, Bill #2322 of 2023 in Mato Grosso do Sul, Bill #1036 of 2023 in Paraná, Bill #463 of 2024 in Rondônia, Bill #463 of 2024 in Rio de Janeiro, Bill #1700 of 2023 in Minas Gerais, Bill #1598 of 2024 in Pernambuco and Bill #96 of 2024 in Pará).[3]IDF Diabetes Atlas 2021
For these reasons, efficient patent strategy will likely be required and the current enforcement scenario is trending in a positive way for patent owners. A notable example is the leading Johnson & Johnson v Scitech, in which the São Paulo State Court granted permanent injunction, material and moral damages for the infringement of surgical stapler IP rights.
The infringement lawsuit was filed by JNJ against Scitech Medical Products Ltd., on the grounds that Scitech has copied their surgical stapler’s design and patented technology.
On January 16, 2024, São Paulo courts entered a permanent injunction confirming the patent and industrial design infringement and ordering the recall of all infringement products currently in circulation on the market. The court also awarded material and moral damages. The awarding of moral damages is a relatively uncommon practice in Brazilian patent cases, not so often applied by trial-level judges, meaning that the patent holder can preserve its intellectual property rights while ensuring that the infringing act per se is punished, serving as a strong deterrent against future infringements.
On August 28, 2024, the São Paulo State Court of Appeals dismissed Scitech’s appeal and upheld the trial decision. The Reporting appellate judge found Scitech’s claims on invalidity of the J&J’s patent and protection of industrial design not relevant for the infringement case, as it should be evaluated by the Federal Courts.
These decisions are great news for the medical device industry and could guide other areas such as diabetes devices – where the size of the Brazilian market and the facilitated regulatory scenario might allow the entrance of counterfeit products.
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