Extended protection for medical devices – a hot topic in the United Kingdom

Manufacturers of medical devices are requesting an increasing number of patent term extensions in a bid to recover the cost of getting regulatory approval. Recent decisions show that the UK Intellectual Property Office (UKIPO) is taking a strict approach when examining patent term extensions for medical devices, but there are still situations where extra protection might be available.

The Leibniz Institute for New Materials requested a UK patent term extension – known as a supplementary protection certificate (SPC) – for its NanoTherm product, which kills cancer cells by using hot iron nanoparticles, but the application was recently refused by the UKIPO.  

What is an SPC?
An SPC is a patent term extension for a patented medical product that has received marketing authorisation in Europe. An SPC can extend patent protection for the product by up to five and a half years. Readers may be familiar with European SPCs for pharmaceuticals, but SPC applications have also been filed for medical devices.

SPCs are based on a patent and a marketing authorisation. There are several routes for requesting marketing authorisation for a medical product in Europe, including the EU Medicinal Product Directive and a number of Medical Device Directives. Only the Medicinal Product Directive is mentioned in the SPC Regulation. Nonetheless, Leibniz argued that an SPC application could also be based on a Medical Device Directives authorisation. If allowed, this approach would substantially increase the number of SPCs available for medical devices.

Leibniz’s SPC application
Leibniz’s NanoTherm device is an iron oxide nanoparticle formulation. These nanoparticles are injected directly into a tumour and then subjected to an alternating magnetic field, causing the particles to heat up and destroy the tumour cells. The iron nanoparticles have a coating to make them stick to the cancer cells and so the damage is localised to the tumour.

Despite including an injectable solution, Leibniz’s NanoTherm product was authorised under a Medical Device Directive as its principal mode of action is via physical means. It was defined as a Class III medical device, meaning that it constituted a high risk, so authorisation was required before sale. Having gone through this process, Leibniz requested the SPC which would compensate for regulatory costs and the patent term lost while the regulatory process was completed.

The SPC Regulation requires that the patented medical product have received marketing authorisation “in accordance with” the Medicinal Product Directive. The Medical Device Directives are not mentioned in the SPC Regulation, so the UKIPO argued that Leibniz could not base its SPC application on a Medical Device Directive authorisation.

Leibniz argued that the SPC Regulation should not be read literally and instead "in accordance with" should mean any valid authorisation granted by analogy with the Medicinal Product Directive. Leibniz noted that the Medical Device Directives and Medicinal Product Directive cross-reference certain requirements for receiving a marketing authorisation, and suggested this meant that its authorisation granted under the Medical Device Directives was “in accordance with” the Medicinal Product Directive. Leibniz also argued that the requirements for obtaining authorisation for its NanoTherm product under the Medical Device Directives were “at least as onerous” as those for obtaining authorisation under the Medicinal Product Directive, so it should be granted an SPC to reward it for its hard work.

The UKIPO disagreed and held that the assessment criteria for a medical device and a medicinal product are not the same; therefore, authorisations under the Medical Device Directives are not “in accordance with” the Medicinal Product Directive, even for highly regulated Class III medical devices. The officer noted that the regulatory process distinguishes between Medical Device Directive devices, where the principal mode of action is physical, and Medicinal Product Directive medicinal products, which act by pharmacological, immunological or metabolic means. Therefore, he stated that even though it may be time consuming to obtain authorisation under either the Medical Device Directives or the Medicinal Product Directive, he saw a clear distinction between the different types of authorisation, so Liebinz did not get its SPC.

The finding in Leibinz followed the UKIPO’s approach to Cerus’s SPC application for its Intercept product, which decontaminates blood using light-activated compounds. Cerus relied on a Medical Device Directive authorisation and so the UKIPO refused its SPC application.

These decisions show that a Medicinal Product Directive authorisation is likely to be required to apply for an SPC in the United Kingdom. In contrast, other jurisdictions such as the Netherlands and Germany have been more generous and allowed SPCs based on medical device authorisations. The UK courts or the European Court of Justice (ECJ) could overturn the UKIPO’s approach, and the ECJ’s 'teleological' approach might give more weight to the large amount of investment involved in bringing some medical devices to market.

Which devices can get an SPC?
At least at the UKIPO, it is preferable to have an authorisation under the Medicinal Product Directive. A device can fall under the Medicinal Product Directive where it contains a drug that assists with the function of the device via pharmacological, immunological or metabolic means. These devices may include pre-filed syringes, nebulisers pre-charged with a medicinal product and patches for transdermal drug delivery, as well as devices with a coating of active ingredient, provided that the drug is not ancillary to the device’s function.

In order to obtain an SPC, the first authorisation in Europe must occur at least four and a half years after the patent’s filing date. This can cause problems where an earlier marketing authorisation existed for the active ingredient before a device also containing that ingredient was authorised. However, the definition of 'first marketing authorisation' was liberalised in the ECJ’s Neurim decision. Following Neurim, there may be further options for filing SPC applications for medical devices.

Comment
The UKIPO takes a strict approach to SPCs for devices and at present it seems that SPC protection may be obtained only with a Medicinal Product Directive authorisation. However, this may be challenged in the UK courts. For devices with a Medicinal Product Directive authorisation, recent changes in the law following the ECJ’s Neurim decision open up more possibilities for filing SPCs.