Regulation

UK court grants Novo Nordisk dynamic order to block counterfeit semaglutide sites

A UK court gave Novo Nordisk a faster way to block websites selling fake semaglutide, a tool that applies to UK internet providers and could spread to other drugmakers.

By the Semaglutides news desk··OzempicWegovy
UK court grants Novo Nordisk dynamic order to block counterfeit semaglutide sites
Image: osborneclarke.com

The English High Court has granted Novo Nordisk a dynamic website-blocking order that requires internet service providers to block sites selling counterfeit and unlicensed prescription medicines, including fake semaglutide products. The order lets Novo Nordisk flag additional sites for blocking without returning to court each time [1].

The case, Novo Nordisk v British Telecommunications & Ors, began with a standard blocking order. Mr Justice Mellor ordered various ISPs to block four target websites, plus any mirror or successor sites, all of which were offering, selling or supplying counterfeit and unlicensed versions of Novo's semaglutide and other prescription-only medicines to UK consumers [1].

When mirror domains appeared and more sites promoting counterfeit medicines spread, Mr Justice Adam Johnson extended the order into a dynamic one. Novo can now self-certify, against a confidential set of criteria, that further websites meet the threshold, and the ISPs must take steps to block them [1]. The criteria are kept confidential so site operators cannot easily build around them [1]. The court described this as a "creative form of intervention" [1]. Dynamic blocking is not new, but this is the first time one has been granted in England and Wales to address counterfeit and unlicensed medicine sales [1].

The order also reaches beyond intellectual property. Novo may notify ISPs to block sites where the only wrongdoing is a criminal regulatory breach under the Human Medicines Regulations 2012, with no trademark or copyright infringement [1]. The court noted the Medicines and Healthcare products Regulatory Agency has found it very difficult in practice to police those offences, and cited the agency's view that counterfeit and unlicensed semaglutide products are "flooding the online market" [1]. Novo is the sole marketing authorisation holder in the UK for Ozempic and Wegovy and owns related trademarks and goodwill there [1].

The court found the interests of the public, the MHRA and Novo in enforcing its rights "clearly outweighed" any possible interests of the target website operators [1]. The MHRA welcomed the approach, and the ISPs did not contest the order [1]. Safeguards include a sunset clause, a requirement to notify target sites where practicable along with a copy of the non-confidential order, and a right for any affected party to apply to vary or revoke it [1].

Why it matters for patients

The websites in question sold counterfeit and unlicensed medicines, and the court acknowledged "very serious risks to patients from falsified products" [1]. Falsified injectable medicines can look like the real thing, and the enforcement here targets sellers rather than buyers. The order applies only to UK internet service providers and does not change how US patients fill prescriptions. Whether any of the blocked sites shipped to the United States has not been reported. Lawyers at the firm Osborne Clarke wrote that orders like this are likely to be sought more often in the life sciences sector [1], so similar cases could follow in other markets.

What happens next

The order includes a sunset clause, but the article does not say when it expires [1]. Novo can self-certify new sites for blocking as they appear, subject to the safeguards [1]. Website operators that can show a legitimate interest may ask to see the confidential version of the order under confidentiality terms, and any affected party may apply to vary or revoke the order as it applies to them [1]. No further hearing dates have been reported [1]. The lawyers noted the ruling may also have implications outside life sciences, for other categories of criminal online wrongdoing [1].

Sources

  1. https://www.osborneclarke.com/insights/english-high-court-grants-dynamic-website-blocking-order-tackle-counterfeit-medicines

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