Supplementary Protection Certificates

Supplementary Protection Certificates (SPCs) are a commercially valuable form of intellectual property that is available for certain active ingredients of medicinal and plant protection products.

The protection provided by an SPC extends beyond the term of the patent upon which it is based.  In this respect, SPCs serve a similar purpose to Patent Term Extensions (PTEs) in other countries, such as the US.  However, SPCs have a number of unique characteristics that distinguish them from PTEs.

Due to a patchwork of legislation across Europe, SPCs come in a number of different flavours.  For example, the criteria for the grant of SPC protection differ subtly across all of the different regions (the EU and the EEA) and countries (such as the UK, Switzerland and certain non-EU Balkan states) in which SPCs are available.

The legislation governing SPCs is deceptively concise.  However, the surprising and sometimes contradictory ways in which courts have interpreted that legislation poses challenges for obtaining SPC rights, for assessing the validity or duration of such rights, and for determining the acts that might infringe such rights.  It is therefore important for those seeking to undertake any of these activities to obtain advice from IP practitioners having expertise in SPC law and practice.

See the full briefing below. This paper was prepared by CIPA’s Life Sciences Committee and published on 11 October 2021. If you have any comments or need more information please contact CIPA.

Summary

Supplementary Protection Certificates (SPCs) are a commercially valuable form of intellectual property that is available for certain active ingredients of medicinal and plant protection products.[1] The protection provided by an SPC extends beyond the term of the patent upon which it is based. In this respect, SPCs serve a similar purpose to Patent Term Extensions (PTEs) in other countries, such as the US. However, SPCs have a number of unique characteristics that distinguish them from PTEs.

Due to a patchwork of legislation across Europe, SPCs come in a number of different flavours. For example, the criteria for the grant of SPC protection differ subtly across all of the different regions (the EU and the EEA) and countries (such as the UK, Switzerland and certain non-EU Balkan states) in which SPCs are available.

The legislation governing SPCs is deceptively concise. However, the surprising and sometimes contradictory ways in which courts have interpreted that legislation poses challenges for obtaining SPC rights, for assessing the validity or duration of such rights, and for determining the acts that might infringe such rights. It is therefore important for those seeking to undertake any of these activities to obtain advice from IP practitioners having expertise in SPC law and practice.

SPCs: a brief outline of what they do and how (and where) they operate

A supplementary protection certificate (SPC) is a unique form of intellectual property that is available in the UK (as well as in EU Member States and various other countries in Europe) for certain patent-protected[2] active substances (or compositions) that are components of medicinal or plant protection products[3] whose marketing is subject to the prior grant of an authorisation by a regulatory agency.

The time that it takes to obtain the data[4] to support a marketing authorisation application often consumes a significant portion of the 20-year term of a patent that protects one or more active substances of a novel medicinal or plant protection product. SPCs are therefore designed to compensate, at least in part, for the loss of effective patent term in such circumstances.

SPCs are national rights that must be applied for on a country-by-country basis. An application for an SPC can only be filed if, in the country of application, there is both a valid marketing authorisation for a medicinal or plant protection product and an in-force patent that protects an active substance, or a combination of active substances, of that product. Timing is crucial, as, in each country, there will only be a limited window during which an SPC application may be filed.

SPCs are only granted to the holder(s) of the patent that protects the active ingredient(s), or to their successor in title. The underlying marketing authorisation may be held either by the patentee or by a different party, such as a licensee. In the latter instance, the legislation does not explicitly require the marketing authorisation holder to provide their consent to the filing or grant of an SPC. However, there is an ongoing, and as yet unresolved, controversy over whether such a requirement can be implied from the legislation.

The protection provided by an SPC commences immediately upon expiry of the patent upon which it is based. It endures for a maximum of five years, though this maximum can be extended by 6 months in some circumstances. Whilst the protection is patent-like, it is also highly focussed. This is firstly because it only encompasses the active substance(s) specified in the SPC application. However, it is also because the protection is limited to the use(s) for which the specified active substance(s) are authorised. Finally, the protection is further limited by the boundaries of the claims of the patent upon which the SPC is based.

The “stand-alone” nature of SPCs, as well as the very narrow scope of protection that they provide, distinguish them from similar types of protection provided in countries outside of Europe (such as Patent Term Extensions in countries such as the US and Japan).

SPCs come in different flavours

In at least the UK, EU Member States and EEA Member States, current legislation provides for two types of SPCs that, whilst they have much in common, are not identical. The two types are:

• SPCs for active substances of human or veterinary medicinal products; and
• SPCs for active substances of plant protection

SPCs were originally created by way of legislation (Regulations 1768/92 and 1610/96) passed by the European Parliament and Commission. However, there are now a number of similar yet distinct forms of SPC legislation in different parts of Europe. For example, the legislation in EU Member States differs, to a greater or lesser extent, from the SPC legislation in each of:

• the UK;
• Member States of the European Economic Area (Norway, Iceland and Liechtenstein);
• Switzerland; and
• various non-EU Balkan states (Albania, Bosnia and Herzegovina, North Macedonia and the Republic of Serbia).

In addition to the above, there is a possibility (in the UK, Switzerland and EU and EEA Member States) for SPCs for active substances of human medicinal products to be extended by 6 months. Such SPC extensions are available as a reward for the completion of clinical trials in the paediatric population (in accordance with an investigation plan agreed in advance with the relevant medicines regulator).

Interpreting and applying SPC legislation

At first glance, the legislation relating to SPCs appears to be both simple and easy to apply. However, court rulings over the past three decades have demonstrated that this is far from the case. Indeed, the Court of Justice of the EU (CJEU) has reached numerous surprising (and controversial) conclusions when interpreting various provisions of the EU legislation[5] and has even, on occasion, overturned its prior rulings.[6]

The complex and sometimes contradictory case law relating to SPCs can pose challenges for those seeking to market products that are, or could be, subject to SPC protection. In particular, it can make it challenging to assess the validity of a (hypothetical) SPC application, or of a granted SPC. The fact that SPC laws differ between different countries in Europe adds another layer of complexity.

Enforcement and geographic scope of SPC protection

SPCs are granted on a country-by-country basis. Once granted, they are maintained by the timely payment of national renewal fees. Also, they can be enforced and/or revoked before national courts.

For SPCs granted by the UK Intellectual Property Office, the protection provided can, depending upon the circumstances, extend to Great Britain only, to Northern Ireland only, or to the whole of the UK. This is a recent adaptation to UK law that reflects the fact that, since the beginning of 2021, the laws governing marketing authorisations for medicinal and plant protection products[7] differ slightly between Northern Ireland and the rest of the UK.

As mentioned above, the protection provided by SPCs is very narrow. However, an SPC can be infringed, amongst other things, by the marketing of a generic “copy” of the product upon whose authorisation the SPC is based. Litigation involving SPCs is therefore relatively common, especially between SPC holders and companies seeking to market generic versions of authorised medicinal products.

A relatively recent change to SPC legislation in the UK (and in EU Member States) has been the introduction of two exclusions from the protection provided by SPCs for human or veterinary medicinal products. In outline, the new exclusions are intended to permit:

• during the period in which an SPC is in force (i.e. after patent expiry but before SPC expiry), manufacturing for the purpose of exporting to “third countries”; and/or
• during the last six months of SPC term, manufacturing for the purpose of stockpiling in advance of SPC expiry.

It is important to note that these exclusions do not apply to all existing SPCs. Also, the precise scope of these exclusions differs between the UK and EU Member States.

Notes and references

[1] Plant protection products are agrochemicals, such as insecticides or herbicides, that fall within the definition provided in Article 1(1) of Regulation (EC) No 1610/96.

[2] The protection provided by the patent can be for the active substance(s) or composition as such, for a process to obtain such substance(s) or composition, or for an “application” (e.g. a new medical use) of such substance(s) or composition (see Article 1(c) of Regulation (EC) No 469/2009 and Article 1(9) of Regulation (EC) No 1610/96).

[3] In Europe, the only substances that are currently eligible for SPC protection are active ingredients of human or veterinary medicinal products, or of plant protection products.

[4] For example, both the pre-clinical and clinical data required to support a MA application for a medicinal product.

[5] For example, the CJEU’s ruling in C-650/17 (Royalty Pharma Collection Trust) makes it clear that SPC law and patent law use very different criteria for assessing whether a patent “protects” an active substance.

[6] The CJEU’s ruling in C 673/18 (Santen) held that SPC protection cannot be granted upon the basis of an authorization for a “new therapeutic indication” of a previously authorised active ingredient, thereby overturning its prior ruling in Neurim (C-130/11).

[7] In contrast to the rest of the UK, such marketing authorisations in Northern Ireland must still be issued in accordance with EU law.