Supplementary Protection Certificates For Medicinal Products

• Published date: 01 February 2022
• Subject Matter: Intellectual Property, Food, Drugs, Healthcare, Life Sciences, Patent, Food and Drugs Law
• Law Firm: J A Kemp LLP
• Author: Mr Graham Lewis, Chris Milton and Ravi Srinivasan

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, although a national SPC application may be based on a European Unitary Patent in those countries in which the Unitary Patent takes effect. Additional information on the Unitary Patent is available here, with a guide to participating member states here.

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, and Sweden.

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:

• United Kingdom: SPCs in the UK are available on effectively the same terms as the EU SPC Regulation, which was transposed into national law at the end of the Brexit implementation period (31 December 2020)⁴. The EU SPC Regulation continues to apply directly to SPCs which were pending or granted prior to this date. Similarly, CJEU case law prior to this date is applicable, but deviation has become possible. See separate section below.
• Norway and Iceland: these States are members of the European Economic Area (EEA), but not of the EU. However the governing legislation remains the EU SPC Regulation.
• Switzerland: Swiss SPCs are governed by national 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 only covers a method of manufacturing or using the product, then the SPC will be similarly restricted.

Conversely, if the basic patent covers the product per se, the SPC will cover any use of the product which is approved for therapeutic use 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 product⁶.

The product of the marketing authorisation has long been established to encompass therapeutically equivalent salts and esters of small molecule drugs⁷, 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 Appeal⁸ following an advisory opinion of the EFTA court⁹ 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.

Are there any exceptions from infringement?

The EU/EEA has introduced a so-called "SPC manufacturing waiver" which came into effect on 1 July 2019. It allows manufacture of medicines protected by SPCs for the exclusive purpose of export to markets outside the EEA. Stockpiling for post-expiry use in the EU/EEA is permitted within the final 6 months of the SPC term.

The waiver does not apply to SPCs which were already in force on 1 July 2019. For SPCs which were applied for before 1 July 2019 but which come into force only after that date, the waiver will be applicable but only from 2 July 2022. The waiver will automatically apply to all SPCs applied for after 1 July 2019. An equivalent waiver has been transposed in UK law (see separate section below) and applies to manufacture for export to markets outside the UK and the EEA. No waiver presently exists in Switzerland.

More information is provided in our separate briefing on the manufacturing waiver, available here.

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...