English High Court grants dynamic website blocking order to tackle counterfeit medicines

In Novo Nordisk v British Telecommunications & Ors, the English High Court initially granted a website blocking order requiring various internet service providers (ISPs) to block certain websites selling counterfeit and unlicensed prescription medicines to UK consumers. The order was extended to make it a dynamic website blocking order, which will allow Novo Nordisk to self-certify against a confidential set of criteria that further websites should be blocked by the ISPs, subject to certain safeguards, without the need to return to court.

This is a positive decision for life sciences companies seeking to tackle the problem of counterfeit medicines. For the first time, the court has allowed applicants seeking website blocking orders to identify target websites selling counterfeit medicines through a self-certification process rather than requiring a fresh court application.

Not limited to IP rights

Although website blocking injunctions were developed in the intellectual property (IP) context, they are not limited to IP rights. In this case, the court acknowledged that there is also a wider public health issue at play because of the commission of criminal regulatory offences under the Human Medicines Regulations 2012. Novo will be able to self-certify and notify ISPs to block websites in circumstances where there are only criminal regulatory breaches and no IP infringement.

Novo is the sole marketing authorisation holder in the UK for Ozempic and Wegovy products and the owner of various registered trade marks and goodwill in the UK and EU. The court acknowledged the Medicines and Healthcare products Regulatory Agency's (MHRA) observation that counterfeit and unlicensed semaglutide products are "flooding the online market", and this decision empowers Novo both to protect public health interests and to defend its IP rights. If this "creative form of intervention" (per Mr Justice Adam Johnson) proves to be successful, it is likely there will be other life sciences companies seeking similar orders.

Static to dynamic

Mr Justice Mellor initially granted an order for various ISPs to block four target websites and any mirror or successor websites, which were all offering, selling and supplying counterfeit and unlicensed versions of Novo's semaglutide and other prescription-only medicines to UK consumers.

Attempts to circumvent the static blocking order with mirror domains and the proliferation of further websites promoting counterfeit and unlicensed medicinal products to UK consumers prompted Mr Justice Adam Johnson to extend the order to a dynamic website blocking order.

The court was keenly aware that creativity was needed to target the wrongdoing in this case effectively. While dynamic blocking mechanisms are not new, it is the first time one has been granted in England and Wales to address the issue of counterfeit and unlicensed medicines sales. 

The dynamic website blocking order will allow Novo Nordisk to self-certify that certain websites are also proscribed as target websites, which will require the ISPs to take steps to block them. The self-certification criteria have been kept confidential so that website operators cannot easily circumvent them.

Private rights and public wrongs

In these cases, the wrongdoing at issue involved both the infringement of private IP rights and raised a wider public health concern through the commission of criminal regulatory offences. The court acknowledged that there are very serious risks to patients from falsified products and noted that the  MHRA has, in practice, found it very difficult to police regulatory offences under the Human Medicines Regulations.

The court has therefore allowed Novo to notify the ISPs to block websites where there are only criminal regulatory breaches and no IP infringement. This is an important step that will allow Novo to tackle counterfeit medicines even where the wrongdoers have avoided IP infringement. The court justified this move on the basis that it is in the public interest. It also had the support of the MHRA, which welcomed initiatives aimed at safeguarding the online environment and at preventing illegal sales of medicines in the UK.

Overall, both Mr Justice Mellor and Mr Justice Adam Johnson were satisfied that the interests of the public, the MHRA and Novo in enforcing its IP rights "clearly outweighed" any possible interests of target website operators.

Safeguards

Nonetheless, while Novo is able to self-certify against the agreed confidential criteria, the court also put in place safeguards to allow target websites to challenge their blocking. The order is subject to a sunset clause and a requirement that target websites are notified (where practicable) and provided with a copy of the non-confidential version of the court order.

The order gives any affected party the ability to apply to vary or revoke the order insofar as it affects them. Any party looking to challenge their designation will be able to apply to see the confidential version of the order, if they can show a legitimate interest, and subject to appropriate confidentiality terms.

Osborne Clarke comment

These decisions mark a significant broadening of website blocking orders as tools for life sciences businesses facing increasing online sales of counterfeit and unlicensed medicinal products. 

The deployment of a dynamic website blocking order in this context shows that the courts are willing to be creative and act decisively where wrongdoers are moving quickly and also acting creatively. As Mr Justice Adam Johnson noted, "[t]he law is not afraid of adapting to new challenges…".

Allowing Novo to self-certify whether a particular website meets the confidential criteria agreed by the court (subject to safeguards) will enable it to act more quickly and will save court time. The extension of the dynamic order to circumstances where there is only criminal regulatory breach means that life sciences businesses will be able to tackle counterfeit medicines even where wrongdoers have taken care to avoid IP infringement.

This new solution, which was supported by the MHRA and was not contested by the ISPs, is likely to be sought more regularly in the life sciences sector in a bid to tackle the increasing proliferation of websites selling counterfeit and unlicensed medicines. Beyond the life sciences sector, these decisions may also have broader implications for tackling website operators carrying out other categories of criminal wrongdoing.