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Can I have an SPC for my drug-device combination?

01/11/2018
Spoiler alert: No, you can’t, says the CJEU in its ruling on C-527/17 (Boston Scientific)

Spoiler alert: No, you can’t, says the CJEU in its ruling on C-527/17 (Boston Scientific) - available here.

When asking what type of products should receive extensions to their exclusivity under the SPC regime, many think the answer should include all patented products which benefit human health but are delayed to market due to the process of obtaining regulatory approval.  Whilst this is a tempting - and understandable - response, the CJEU has confirmed that it is not always as simple as that.

A key objective of the SPC Regulation(1)  for medicinal products is to compensate companies where the period of patent protection becomes insufficient to cover the investment put into research as a result of rigorous and time-consuming regulatory authorisation processes.  However, whilst the Explanatory Memorandum to the SPC Regulation  also stresses the objective of encouraging "research and development in the health field", Article 2 of the SPC Regulation specifically limits the products eligible for an SPC to those that are subject to the approval process under the Medicinal Products Directive(2).

What happens, then, when a medical device includes the use of a pharmaceutical?  These drug-device combinations are subject to two alternative regulatory regimes.  Which regime applies depends upon whether the "principal intended action" for the combination product is the action of the medicinal product or of the medical device.  If the action of the medicinal product is the principal intended action in the combination, the medicines legislation principally applies, but in addition certain essential elements of the device legislation will be applicable.  In this particular case, the action of the medicinal product was ancillary to that of the device and therefore the Medical Devices Directive(3) (MDD) regulated the product.  The Commission Guidance document MEDDEV 2.1(3)v3 provides that for such cases the notified body is required to seek a scientific opinion from a member state competent authority in accordance with the Medicinal Products Directive or from the EMA in accordance with Regulation 726/2004.  The question for the court was whether such products nevertheless benefit from an SPC.

A literal interpretation of the SPC Regulation leads to the simple conclusion that drug-device combinations regulated under the MDD are not eligible for SPCs.  However, in recent years, most notably in the Neurim decision, the CJEU has taken a purposive approach to the interpretation of the SPC Regulation.  Moreover, whilst the UK IPO has adopted a literal interpretation and refused SPCs for drug-device combinations , other EU Member States (e.g. Germany, the Netherlands, Italy and France) have granted SPCs on the basis of authorisations granted under the MDD.

The CJEU was asked to specifically consider this issue in July last year by the German Federal Patents Court, which sympathised with Boston Scientific’s request for a German SPC for a stent having Paclitaxel as an integral part of its product.  Given the inconsistent approach taken by different EU Member States, this CJEU decision has been eagerly awaited by many in the industry.

Fast-forward almost a year and the CJEU has dashed the hopes of many in the life sciences industry: even when an active ingredient is an integral part of a medical device – and has been subject to a regulatory assessment by member states or the EMA analogous to an assessment carried out under the Medicinal Products Directive - it cannot be equated to an approval prescribed under Article 2 of the SPC Regulation.

The CJEU's position is that such an interpretation of Article 2 "is borne out by both the context of that article and the objective pursued by that regulation".  However, from a policy perspective it seems counterintuitive and at odds with the objectives of the SPC Regulation that patentees are not entitled to compensation where the often long and complex authorisation procedures result in delay in getting patented drug-device combination products to market.  Indeed as far back as 1990, the Explanatory Memorandum to the SPC Regulation envisaged the expansion of the SPC regime to products beyond medicinal products in light of the experience gained in the pharma sector.  Perhaps this is one area where the UK might decide to be more generous towards patentees post-Brexit?

Interestingly, the Commission's recent study on legal aspects of SPCs recognises that the question of whether SPCs should be available for medical devices is an economic one.  In relation specifically to drug-device combinations, the report distinguishes between drug-device combinations(4) where the active ingredient has never been authorised before as a medicinal product – and could, in principle therefore, be eligible for SPC protection – and to drug-device combinations like this one, where an 'old active ingredient' is being used.  The report recognises that this latter category is complex and essentially requires the Commission to make a policy decision as to whether or not such products should be eligible for SPC protection (based on the earlier case of Neurim).  It seems, therefore, that Neurim is the key to opening the door to a more favourable policy decision by the Commission.  Nevertheless, unless and until the Commission takes that approach, the door has seemingly been closed by the CJEU to SPC protection for drug-device combinations.

Acknowledgements – many thanks to Alison Dennis, Nicole Jadeja and Beatriz San Martin for their useful guidance in writing this blog.

(1) Regulation (EC) No 469/2009

(2) Directive 2001/83/EC, as amended

(3) Directive 93/42/EEC, as amended

(4) BL O/141/14 and BL O/325/14

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