Website blocking order targets sale of counterfeit medicines

Intellectual property law experts Charlotte Weekes and Gill Dennis of Pinsent Masons said the ruling of the High Court of England and Wales is a win for brand owners since it should help them enforce their intellectual property rights – and highlighted how blocking orders can now be obtained to tackle other online wrongdoing too.

Last week, the High Court accepted an application by Novo Nordisk to vary a so-called ‘blocking injunction’ the court had granted it in May. That initial injunction required BT, EE, Plusnet, Sky, TalkTalk and Virgin Media to block users’ access to four websites it claims supply counterfeit and unlicensed versions of its diabetes and anti-obesity prescription-only medicines.

On 23 June, the High Court extended the scope of its initial injunction to cover a further seven problem websites the company had identified and to further empower Novo Nordisk to assess whether other websites are facilitating the criminal supply of counterfeit and unlicensed versions of its medicines in breach of the Human Medicines Regulations 2012. If it assesses that they are, the company will be able to notify the six ISPs with the effect of compelling the ISPs to act to prevent users accessing those sites. That process will operate without Novo Nordisk having to secure a fresh court order to give effect to such measures each and every time it identifies a new problem website.

The judge who granted this ‘dynamic injunction’ explained his justification for doing so in his ruling.

Mr Justice Adam Johnson said: “A central feature is the authority given to [Novo Nordisk] to self-certify whether the relevant blocking criteria are engaged. That will involve them certifying whether there are infringements of the 2012 Regulations. One might think that more properly the role of the [UK’s Medicines and Healthcare products Regulatory Agency (MHRA)]. Three factors are relevant however in justifying the intended approach.”

“First … the MHRA's own efforts at closing down infringing websites have met with limited success, despite the remedial armoury available to it as the UK medicines regulator. Second, I am satisfied on the evidence that [Novo Nordisk] have the resources and skills available to be able to carry out the relevant and ongoing monitoring with an impressive degree of rigour and diligence: indeed, they are effectively doing so already. Third, and most importantly, the structure has the support of the MHRA, who have confirmed that there is significant alignment between the structure and the criteria applied by their own Criminal Enforcement Unit, and moreover have said that they welcome and support initiatives aimed at safeguarding the online environment and preventing the illegal sale of medicines in the UK market,” he said.

Mr Justice Adam Johnson said the granting of blocking injunctions in this way “has the potential to plug a gap in control of the online environment which presently exists and which creates a public health risk”. He said a series of safeguards are in place to guard against the risk of “over blocking”, including a sunset clause and obligations to notify affected website operators – which will have the opportunity to “challenge their designation”.

The power of UK courts to issue blocking injunctions has been established in a series of rulings over the past 15 years. In a landmark test case, major film studios were successful in persuading the courts that powers to issue blocking injunctions to ISPs under section 97A of the Copyright Designs and Patents Act 1988 should be used to combat online copyright infringement. Other rightsholders such as music labels and football authorities have been granted similar orders since.

The UK Supreme Court subsequently confirmed that blocking injunctions are also available to support brand owners to enforce trade mark rights online under separate statutory powers

With its May judgment, the High Court said that blocking orders need not be confined to cases of IP infringement. It said they can be used to address any civil and/or criminal wrongdoing online – and applied the powers in respect of the online sale of counterfeit and unlicensed medicines for the first time.

Charlotte Weekes of Pinsent Masons said: “The court’s approach here recognises the need to be able to deploy injunctive relief against future counterfeit sales which are anticipated. It demonstrates pragmatism to provide a solution which avoids the need for the IP holder to keep returning to court and the associated court time and legal costs that will be involved. This, coupled with the injunction remedy initially granted, will be encouraging and reassuring to companies selling genuine medicinal products that websites offering counterfeits, particularly those products as highly sought after as GLP-1s, can be tackled effectively.”

Gill Dennis, also of Pinsent Masons, added: “In this case, the sale of the medicines infringed Novo Nordisk’s regulatory exclusivity for these commercially successful drugs. They were also being sold under signs identical to Novo Nordisk’s UK registered trade marks. The sale of the medicines also amounted to criminal offences under the Human Medicines Regulations 2012. The court confirmed that these criminal activities alone would have been enough to justify the grant of a blocking injunction, even if there had been no concurrent IP infringement.”

“The court also relied on other factors to support the grant of the injunction, including the high risk to public health of these counterfeit medicines and the likely 98% reduction in UK visitors to the target websites that would result once the injunction was made. Overblocking of legitimate content was deemed not to be a material risk as no lawful products had been identified on any of the target websites and the injunction included appropriate safeguards, including a two-year sunset clause meaning that the order would cease to have effect at the end of two years absent further agreement between the parties or order of the court,” she said.

“This is arguably the latest in a series of steps by English judges to position the UK as a pro-brand owner jurisdiction. Website blocking orders are of enormous practical value, particularly in addressing sources of unlawful and infringing material where other enforcement measures have proved ineffective,” Dennis added.