We regularly hear about potential new medications, treatments and even possible cures for conditions across the medical spectrum, but only a small proportion of these ever actually make it to the market. Even where they do, this can take years from the first announcement. In order for a medical product to be brought to market, it of course must be subject to various rounds of clinical trials to confirm its efficacy, before being assessed for regulatory approval.
The IP lifecycle of a product can paint an interesting picture when viewed through the lens of advancing innovation. Patent protection in particular is likely to be sought long before a product is ready for launch, in order to protect that innovation, whilst trade marks will usually follow much closer to launch.
As a Type 1 Diabetic, diagnosed in the early 1990s, I have seen huge changes in Diabetes technology. I use medical devices to manage my condition, and new technology brings the possibility of easier management and, longer term, less risk of complications arising. As a result, I have been a keen follower of developments in the “Diabetes Tech” field for a number of years.
When I was diagnosed, my condition was managed using syringes, and blood glucose (BG) readings “guesstimated” based upon a colour scale on the side of the test strip pot. This quickly advanced to reusable injection pens, and BG meters, which read and displayed a specific number. Today, many patients rarely have to inject because they use an insulin pump, and finger pricks are hardly needed due to modern wearable sensor technology. My smartwatch also displays my BG level, and alerts me when action is needed. I thought it would be interesting to take a look at the IP lifecycle of these types of product, to illustrate how long it potentially takes for the new inventions we are hearing about now to become a reality.
One of the companies at the forefront of Diabetes Tech is Insulet, who are currently one of only a handful offering these reactive systems; their Omnipod tubeless insulin pumps were the first of their kind.
Insulet’s first patent appears to have dated from 1997, whilst they hold various later-filed patents dating right up to the present day. None of these patents cover their whole product as a single invention, however, with each one covering just a small element of the product, including the mechanism and insulin delivery of the “pod” which attaches to the user, and various individual aspects of the software and algorithms held on the “PDM” (being the handheld device used to control the pod). These reflect incremental improvements and additions to the original system, which can be seen in the different Omnipod products brought to the market over the years.
It’s also worth noting that for their more recent Omnipod models, the PDM itself is a repurposed third party mobile phone, loaded with Insulet’s Omnipod software. Insulet do not make the PDM themselves, and this will be why their patents cover elements of their software, rather than the device itself.
The first commercial version of the Omnipod system received FDA clearance in March 2005, and it was released in the United States later that year. I was not able to locate any information on when clinical trials began, but it is likely to be in the early 2000s. It appears the first patent relevant to this product was filed in 2000. The first US trade mark application for the OMNIPOD name was submitted in October 2004, which is after FDA clearance had been sought, and just a few months before the product was due to be launched.
The next Omnipod model was named “Dash”. This was the point where Insulet moved away from a custom-made PDM to a third party touchscreen mobile phone; this is reflected in the 2017 filing of a patent covering the user interface, and at the same time, Insulet also registered a number of US Design Patents covering the layout of specific screens within their software. No significant changes were made to the pod technology, and so largely the same patents apply to this product as the previous model. Omnipod Dash received FDA clearance in June 2018, and was released to market in early 2019. Interestingly, the first trade mark application for the OMNIPOD DASH name dates from 2015, so it seems Insulet settled on a name they liked before they had a fully developed product, which is unusual.
The most recent Omnipod system is “Omnipod 5”. This system featured a significant change over previous models, in that the system features an algorithm, which enables the system to react to BG data, and automatically adjust insulin doses without any user interference.
Several clinical trials were undertaken for this product, between around 2016 and 2020. Insulet’s website handily includes a list of each patent relied upon for each of their products, and the earliest claimed patent for this system dates from 2007, but ownership of this patent this resulted from an acquisition; the earliest patent on the list that was filed by Insulet themselves dates from 2017. It’s worth noting, however, that the now-expired year 2000 patent would probably also have applied to this product.
Insulet sought FDA clearance for the Omnipod 5 product in 2021, which was granted in January 2022. No new trade marks were filed for the OMNIPOD 5 name, however. This is presumably because OMNIPOD alone was already comprehensively protected worldwide, and the additional number 5 was considered to be of low distinctiveness, meaning fresh protection was not warranted.
Looking ahead, Insulet has sought patent protection for a dual-hormone delivery system, which would enable delivery of both insulin and glucagon. Glucagon is a hormone that raises BG levels, contrasted with insulin, which effectively lowers it, and so combining the two in one system is another innovative step to be expected in a future system. There is nothing to suggest any clinical trials have begun for this system, so it will likely be a few years before it comes to market. No new trade mark applications appear to have been filed, so we will have to wait to see what name is selected.
As you can see, from the above, patents are an early consideration in the product lifecycle, and this will at least in part be because protection must be sought before the product can be released for use by clinical trial participants outside of the company. Trade marks will generally be filed closer to launch, in an effort to keep the chosen name under wrap until closer to launch, but as a submission for FDA approval must name the product, this would need to be done before seeking approval. From the above, you can see that it has generally taken at least five years for each product to come to market, and in some cases, Insulet has clearly already begun developing their next product before release of a predecessor.
