In brief
- The High Court has granted a website blocking injunction requiring major UK internet service providers (ISPs), such as BT, Virgin and Sky, to block websites selling counterfeit and unlicensed versions of Novo Nordisk's semaglutide and other prescription-only medicines.
- This is the first website blocking application concerned with the supply of counterfeit and unlicensed prescription-only medicinal products.
- The wrongdoing included advertising and offering for sale of unlicensed prescription-only medicines, which is a criminal offence under the Human Medicines Regulations 2012, as well as IP infringements.
- The court confirmed that the blocking injunction jurisdiction is not confined to intellectual property rights and extends to both civil and criminal wrongdoing, including regulatory offences.
What is a blocking injunction?
A website blocking injunction is an order requiring ISPs to prevent their subscribers from accessing specified websites. Rather than targeting the operators of infringing or unlawful websites directly - who are often anonymous, located overseas and beyond practical reach - a blocking injunction is directed at the ISPs through whose networks UK consumers access those sites and who are unwittingly mixed up in the wrongdoing. Blocking injunctions can have immense practical utility, particularly given their ability to tackle sources of unlawful material where other enforcement methods have failed and where mirror websites may be expected to arise.
Blocking injunctions were initially developed in the copyright context under section 97A of the Copyright, Designs and Patents Act 1988 in relation to pirated music. The Supreme Court in Cartier International AG v British Sky Broadcasting Ltd & Others then extended the principle to trade mark infringement under the court's inherent jurisdiction. In Nintendo v BT & Others, the court extended the jurisdiction further to include the blocking of websites offering for sale and distributing circumvention devices designed to circumvent the technological protection measures within the Nintendo Switch console, whose purpose is to prevent piracy and the playing of unauthorised and infringing games (Mishcon acted for Nintendo - we reported on this here: Nintendo obtains novel blocking injunction). The recent Novo Nordisk case takes that extension further still.
The legal test for a blocking injunction
The threshold requirements for an order are that: (i) the ISPs are intermediaries; (ii) either the users or the operators of the website are infringing the claimant's rights or committing a legal wrong; (iii) the users or operators are using the services of the ISPs; and (iv) the ISPs have actual knowledge of this.
Once jurisdiction is established, the court must be satisfied that the order is proportionate. The injunction must be necessary, effective, dissuasive, not unduly costly or complicated, must avoid barriers to legitimate trade, strike a fair balance between the fundamental rights engaged, be proportionate and be safeguarded against abuse. Proportionality is the key consideration. To ensure proportionality, it is appropriate to include safeguards in the order, such as a sunset clause (bringing the block to an end or requiring further review) and obligations to notify affected website operators.
The Novo Nordisk case: a novel application
Semaglutide is the active ingredient in Novo Nordisk's diabetes and anti-obesity medications, marketed under registered trade marks including OZEMPIC, RYBELSUS and WEGOVY. These products have been enormously successful; global sales of GLP-1 products in 2024 exceeded £17 billion. That commercial success has attracted a proliferation of potentially dangerous fakes.
Although semaglutide is not a generic medicine, and Novo Nordisk holds regulatory exclusivity until 2031, the popularity of these products has led to: outright counterfeits labelled as OZEMPIC or other Novo Nordisk brands; third-party manufactured unlicensed versions marketed under their international non-proprietary names; and products substituting a different substance or dosage altogether, such as insulin.
Routine applications for blocking injunctions are often decided on the papers, but this application was listed for a hearing owing to two unusual but related features. First, it was the first blocking injunction application concerned with counterfeit and unlicensed prescription-only medicinal products. Second, one of the legal wrongs relied upon - the advertising and offering for sale of unlicensed prescription-only medicines, a criminal offence under the Human Medicines Regulations 2012 - had not previously been considered in relation to such injunctions. This was in addition to the trade mark infringement and passing off claims.
Criminal wrongdoing as the foundation
The court accepted that each of the target websites was committing a number of criminal offences under the 2012 Regulations, wherever they advertised, offered to sell and sold unauthorised medicinal products. These included selling unauthorised medicinal products (contrary to regulation 46), supplying prescription-only medicines without a valid prescription (contrary to regulations 214 and 220), and publishing unlawful advertisements (contrary to regulations 279 and 284).
Critically, the court held that any form of civil or criminal wrongdoing will suffice to ground the court's jurisdiction, because that jurisdiction derives from ordinary principles of equity under which there is no relevant distinction between being mixed up in a civil or a criminal wrong. The Novo Nordisk decision is the first to apply this principle to pharmaceutical regulatory offences in a blocking injunction application.
The MHRA's involvement
The UK Medicines and Healthcare products Regulatory Agency (MHRA) had itself attempted, without success, to bring the websites down and had accordingly sought Novo Nordisk's assistance - a request which ultimately prompted the application. The court drew on this regulatory support in concluding that Novo Nordisk had the necessary standing to seek the injunction.
Public health and proportionality
The court placed significant weight on the public health dimension. Falsified products may not have been manufactured to the same quality-control standards, potentially containing impurities and allergens. For example, Novo Nordisk's evidence to a US Senate Committee identified over 300 serious health issues, 100 hospitalisations and 10 deaths linked to falsified semaglutide products. Meanwhile, the World Health Organisation has warned that substandard or fake products sold online could cause as many as one million deaths annually, with and that 50% of medicines sold online may not be genuine.
The court also noted that blocking was likely to be highly effective, with previous cases indicating average reductions in UK visitors of 98%, notwithstanding attempts to circumvent orders. It also accepted that, without a blocking order, the situation would likely devolve into a game of "whack-a-mole" as sites moved to mirror or replacement locations and resumed operations.
Comment
Novo Nordisk is significant for several reasons:
- The court accepted that blocking can protect the public from dangerous medicinal products and assists in protecting the value of rights and investment in developing and promoting useful medicines.
- It confirms that the blocking injunction jurisdiction is broad enough to encompass criminal regulatory wrongdoing under the Human Medicines Regulations 2012, not merely IP infringement.
- It establishes a precedent for pharmaceutical and life sciences companies to deploy this remedy against illicit online sellers of counterfeit (and other unlicensed prescription-only) medicines.
- It demonstrates that regulatory support and involvement - in this case from the MHRA - can assist in establishing standing and persuading the court of the merits of an application; companies seeking to pursue enforcement in this area should engage the regulator early.
- While the application addressed a new form of online wrongdoing, the court was satisfied that the order was proportionate for essentially similar reasons to those accepted in Cartier, Nintendo, and other website blocking cases, underscoring the flexibility of the framework.
- Brand owners facing online counterfeiting at scale should consider blocking injunctions as a primary enforcement tool alongside traditional IP remedies, particularly where the counterfeit products carry a public health risk.
How Mishcon de Reya can help
For more information on blocking injunctions, please get in touch with our IP Enforcement team, who advise on the protection and enforcement of IP and related rights, across a range of sectors and technologies.