Launching “At Risk” in the UK: Why Recent Patent Injunction Decisions Matter for MedTech and Digital Health Companies

Launching a product while a patent dispute remains unresolved has never been risk‑free, but many companies have taken the view that the commercial upside justified it. This is particularly true when there are credible doubts as to the validity of the patent in issue. Recent decisions from the UK Patents Court and the Court of Appeal suggest that calculation needs to be revisited.

While the headline cases have involved pharmaceuticals, the underlying reasoning has much wider relevance. For MedTech, digital health and AI‑enabled medical devices, the UK courts are willing to intervene early to preserve the status quo, even where the consequences for the would‑be entrant are commercially severe.

The legal test for interim injunctions has not changed; the courts continue to apply the familiar principles from American Cyanamid. Recent cases emphasise that market disruption following a competing launch is, subject to the evidence, treated by the Court as largely irreversible. This approach was reinforced by the Court of Appeal’s willingness in AstraZeneca v Glenmark to overturn first‑instance refusals of interim relief where the trial judge was considered to have underestimated that disruption, particularly in the context of healthcare markets. More recently, the High Court granted an interim injunction in Dr Reddy’s Laboratories v Boehringer, accepting that the market effects of price erosion are practically irreversible even where the patent may later be found to be invalid.  

Those operating in the MedTech and digital health sectors should be careful not to treat these decisions as confined to pharmaceutical patent disputes. Many of the factors that the courts have found persuasive arise with equal force in these markets. Devices are often embedded within broader hospital systems and subject to NHS budgets; clinicians may be trained around a particular interface or workflow; and AI tools may learn from deployment‑specific data. Once adoption occurs, switching is rarely straightforward. The UK courts are increasingly receptive to the argument that early market entry in such contexts confers advantages to the challenger that cannot readily be undone through damages, even if the product is later withdrawn. This significantly increases the litigation risk for MedTech and digital health companies at the interim stage, well before validity or infringement has been finally determined.

A common mindset, particularly among engineering‑led teams, is that patent risk can be managed once a product is live. It will be assumed that validity can be contested, that design arounds will be possible, or that damages will ultimately be an adequate remedy. However, the recent case law on preliminary injunctions undermines that way of thinking. A granted patent (even one whose validity is disputed) can operate as a powerful tool to restrain entry pending trial.

These developments have clear consequences for technology‑led MedTech businesses. More particularly:

1. Freedom‑to‑operate analysis should not be considered as optional. Where interim injunctive relief is a realistic possibility, a strategy of addressing patent risk only after product launch carries significantly greater exposure.
    
2. Decisions about when to obtain regulatory approval and when to enter the market should not be made in isolation. They directly affect exposure to patent enforcement, and poor timing can lead to the product being pulled or delayed product launch.
    
3. UK proceedings should not be underestimated. Given the speed and practical impact of the UK Patents Court, an interim decision in London can shape commercial strategy well beyond the UK and long before the merits are determined.

For MedTech and digital health companies, recent preliminary‑injunction decisions show that patents are not simply matters for trial. A credible patent, supported by the right evidence, can determine whether a product reaches the market at all.