Supplementary Protection Certificates For Medicinal Products

What are SPCs?

A Supplementary Protection Certificate (SPC) is an intellectual property right available for active ingredients of human and veterinary medicinal products requiring marketing authorisation1.

The highest tribunal hearing disputes involving SPCs for EU member states is the Court of Justice of the European Union (CJEU). Historically there have been numerous referrals to the CJEU on points of law relating to SPCs and this is expected to continue. Some of the key decisions are discussed below.

The SPC regime was introduced as a mechanism to compensate patent holders for loss in effective patent term resulting from the time taken to receive marketing authorisation for such products2. However, regulatory delay is not of itself sufficient to justify the grant of SPCs.

In particular, the relevant regulation provides that an SPC can be granted only for an "active ingredient". This has been held to exclude substances that may enable or enhance the activity of a therapeutic ingredient, but which have no therapeutic effect of their own on the human or animal body. Despite the clinical testing (and consequent regulatory delay) involved in developing such auxiliary substances, the CJEU has on two occasions3 held that they do not qualify for an SPC. Similarly, it is not currently possible to obtain SPC protection for a medical device, irrespective of whether or not the marketing of such a device has been subject to regulatory delay.

Where are SPCs available?

SPCs are national rights: at present there is no such thing as a Europe-wide SPC. Accordingly, individual applications must be made to national patent offices in countries where SPC protection is desired.

SPC protection is available in all EU member states, namely:

Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovak Republic, Slovenia, Spain, Sweden and the United Kingdom4.

SPCs in these countries are governed by EC Regulation 469/2009 ("the SPC Regulation" - excerpts of which are included as Annex 1).

SPC protection is also available in the following non-EU States

Norway and Iceland: these States are members of the European Economic Area (EEA), but not of the EU, and the governing legislation is the EU SPC Regulation. Switzerland: Swiss SPCs are governed by legal provisions which are based on the EU SPC Regulation. An SPC issued in Switzerland will also automatically take effect in Liechtenstein5. Albania, Bosnia & Herzegovina, Macedonia, and Serbia: These are non-EU/EEA countries which may nonetheless be covered by a European patent application granted by the EPO. SPC protection is available in these countries under national legal provisions. Similar provisions also exist in neighbouring jurisdictions including Russia and the Ukraine, and in other countries worldwide. Please ask your J A Kemp contact separately regarding rights in these jurisdictions.

What scope of protection is provided by the SPC?

The scope of an SPC is limited to the product of the relevant marketing authorisation. It protects that product to the same extent as the patent on which the SPC is based ("the basic patent"). For example, if the basic patent covers the product per se, the SPC will also cover the product per se. If the basic patent only covers a method of manufacturing or using the product, then the SPC will be similarly restricted.

The product of the marketing authorisation has long been established to encompass therapeutically equivalent salts and esters of small molecule drugs6, provided of course that they are covered by the basic patent.

The situation is less clear for active ingredients which are biological molecules. A decision of the Norwegian Court of Appeal7 following an advisory opinion of the EFTA court8 recognised that it would be desirable for therapeutically equivalent variants of a biologic product to be covered by an SPC, but provided little guidance as to the extent of such coverage. It is to be expected that this question will be referred to the CJEU.

Subject to the scope of the basic patent, an SPC for a given active ingredient will cover any use of that active ingredient in a drug which is authorised before the SPC expires. Subsequent marketing authorisations made after grant of an SPC will therefore extend the scope of the SPC, even when the later marketing authorisation is obtained by an entity unconnected with the owner of the SPC.

Also, subject to the scope of the basic patent, an SPC will cover all subsequently authorised combinations of active ingredients containing the product at issue.9

What additional term is provided by the SPC?

An SPC takes effect at the end of the normal expiry term of the basic patent on which it is based, provided that the patent is maintained up to that point.

For EU/EEA member states, the SPC will expire at whichever is the earlier of:

15 years from the first Marketing Authorisation in the EU/EEA10 5 years from the expiry of the basic patent The effective maximum term is therefore 5 years in addition to the term of the basic patent.

For non-EU/EEA member states, the term is determined by reference to the local marketing...