Abbott Diabetes Care Inc v Sinocare Inc & Ors

The commercial setting was important. CGM systems are used by diabetes patients, but the judgment also recognised a growing wellness and fitness market. In the UK, products can be supplied through NHS reimbursement routes or sold directly to customers online in the cash-pay market.

Sinocare began UK website sales in January 2024. At an earlier stage of the case, it gave undertakings not to allow its CGM systems to be obtained through the NHS pending trial and to keep records of cash-pay sales. That meant the court was looking at a market entry dispute at a relatively early stage.

The judgment also gives useful background on the products themselves. A CGM system is not just one item. It includes an on-body unit, sensor components, an applicator and a reader or compatible smartphone. Abbott’s registered mark covered the shape of the on-body unit only, but Abbott argued that this unit had become the visual face of its wider CGM range.

Abbott said that mattered because users wear the on-body unit on the body, often visibly, and may be seen using it by others. Sinocare said that did not turn the shape into a badge of origin. The court had to decide which view was supported by the evidence.

If the mark was valid, the court then had to decide whether Sinocare’s product shape infringed it. Abbott relied on likelihood of confusion and on reputation-based infringement under section 10(3). Abbott also argued that Sinocare should not be able to rely on the defence for use of non-distinctive signs in accordance with honest practices.

The court also had to deal with passing off. That required more than showing that people recognised Abbott’s product. Abbott needed to show that the relevant public treated the shape as indicating trade origin, and that Sinocare’s conduct amounted to a misrepresentation causing damage.

The structure of the case is useful for business owners. Courts do not simply compare two products side by side and ask whether they look alike. They ask what right the claimant actually has, whether that right is valid, how the market works, what customers rely on, and whether the alleged similarity causes the kind of legal harm the law requires.

That is especially important in disputes about non-traditional marks such as shapes. A shape can be commercially recognisable without functioning as a trade mark. The court kept that distinction in view throughout the judgment.

On section 10(3), the court was not persuaded by Abbott’s evidence of changed economic behaviour or a serious likelihood of it. The judge said Abbott’s evidence did not properly explain how and why Sinocare’s use of a similar white circular on-body unit would produce the required legal harm. Instead, the evidence was treated as showing a general concern about Sinocare’s market entry.

The court also said Abbott had not shown unfair advantage on the evidence. Again, the judge saw assertion rather than meaningful analysis of how Sinocare’s use of its similar on-body unit would change consumer behaviour in the relevant way.

The judge also said that, if it had been necessary, Sinocare could rely on the defence for use of non-distinctive signs in accordance with honest practices. The court accepted evidence that Sinocare did not know of Abbott’s mark when it designed its on-body unit in 2019, had undertaken freedom-to-operate work with lawyers, used its own branding prominently and had legitimate reasons for choosing a circular shape.

On passing off, the court found that consumers did not identify trade origin from the shape of the on-body unit. Instead, they looked to traditional indicators such as word marks and logos. Without that origin-identifying function, there was no relevant misrepresentation.

That matters because many businesses overestimate how much customers rely on product form. A product may be recognisable without functioning as a badge of origin. The court drew that distinction clearly in the passing off analysis as well as in the trade mark analysis.

If your business wants to build legal protection around appearance, you need evidence that customers really use that appearance to identify your business. Recognition by itself may not be enough.

The second lesson is about evidence of harm. Abbott’s section 10(3) case failed because the court was not persuaded by evidence of changed economic behaviour or a serious likelihood of it. Concern about a competitor entering the market is not the same as proving the specific legal harm required.

For business owners, that means enforcement planning should start with evidence. Ask what customers actually do, what they rely on, and what commercial behaviour you say has changed or is likely to change.

The third lesson is about honest commercial conduct. Sinocare’s evidence about its design process mattered. The court accepted that the circular shape had practical advantages, including reducing snagging and making application easier. The judge also accepted that Sinocare had undertaken freedom-to-operate work and used its own branding prominently.

That did not mean similarity is always safe. It did mean that documented design reasons and responsible launch conduct can be highly important when a court assesses whether a business is competing fairly.

Several factual points helped Sinocare on the honest practices issue. The court accepted that Sinocare designed its on-body unit in 2019, before Abbott’s mark was filed. It also accepted evidence that Sinocare had carried out freedom-to-operate work with lawyers and that it did not know of the mark when the design was created.

The court further accepted that Sinocare had legitimate reasons for choosing a circular shape. According to the evidence the judge accepted, a circular form helped reduce snagging, catching and detachment, and avoided orientation issues that could arise with an oval design.

The timing of events also mattered. Sinocare first introduced its product to the Chinese market in April 2023. Abbott knew by October 2023 that the iCan i3 CGM would be launched on the UK market, but proceedings were not started until late February 2024. The court also noted that no evidence of actual confusion had emerged by the time of trial.

None of those points automatically decides a future case. But they show the kinds of documents, timelines and commercial explanations that can become central in a dispute about product appearance.

If you are the established brand owner, think about what you would need to prove if a rival launched something similar tomorrow. Could you show that buyers, clinicians or distributors treat the shape itself as indicating your business? Could you show actual confusion, or at least a clear route from similarity to changed economic behaviour?

If the answer is no, your enforcement strategy may need to rely more heavily on word marks, logos, packaging, design rights, regulatory positioning or other evidence-backed claims.

For practical purposes, this is a useful first instance decision on shape marks and related claims, but it should be read as a fact-specific judgment rather than a universal rule for all product-shape disputes. The court’s reasoning turned heavily on the evidence about this mark, this market and this launch.

That makes the case particularly useful for businesses planning evidence, branding strategy and launch conduct, even though the result should not be over-generalised beyond its facts.