Supplementary Protection Certificates
Supplementary Protection Certificates (SPCs) exist to compensate patentees in Europe for the long time it can take to get pharmaceutical products to market. SPCs are available for medicinal products and can be extended when the product has been tested for paediatric use.
This system allows a patentee for a pharmaceutical product to obtain an extension of protection, beyond the patent term, for up to 5 years, plus a potential additional 6 month paediatric extension. There is no SPC covering the whole of Europe. It is necessary to apply for an SPC in each country of interest.
To obtain an SPC the patentee must have obtained a marketing authorisation (MA) for a product covered by their patent in the relevant country. The patent must also be in force in that country.
There are three ways to obtain a marketing authorisation (MA) in the EC:
1. the Mutual Recognition Procedure (MRP);
2. the centralised procedure; or
3. the decentralised
The MRP is used where, at the start of the procedure, the product is authorised in one or several member states. A MA granted in one Member State, can be recognised by one or more other member states. Once the original MA has been granted, MRP applications can be made in other states. The result is a bundle of national MAs covering the same product.
The centralised and decentralised procedures are used for applying for a market authorisation in cases where the product is not authorised in any EU member state at the start of the procedure.
In the centralised procedure, a single, central application is filed and, when granted, results in an MA valid throughout the EC. The application is submitted to the European Agency for the Evaluation of Medicinal Products (EMEA), and the authorisation is granted by the European Commission.
In the decentralised procedure, the applicant asks one member state to act as a Reference Member State (RMS). The RMS prepares a preliminary SPC, package insert, labelling and an assessment report for the product. The RMS subsequently requests the concerned member states (CMS) to accept these documents within 90 days. The marketing authorisation is therefore simultaneously applied for in the RMS and the CMSs.
Obtaining an SPC
Each country has its own law for obtaining an SPC. Generally speaking, the practice in most countries is the same as for the UK, although in some countries certain documents need to be translated.
The practice in the UK is:
- An SPC will only be granted to the holder of the basic patent;
- An SPC is limited to the particular “product” for which the MA was obtained;
- The patent must be in force in the UK and must “protect the product” to which the MA applies. To meet this requirement the patent can protect the product, a process of making the product or a use of the product;
- The “product” to which the MA applies and which is covered by the patent must be the active ingredient or combination of active ingredients of a medicinal product. For a combination of active ingredients, A + B, the basic patent must protect A + B and the MA must be for at least A + B;
- You can only have one SPC per product, but others may also have an SPC for the same product if they have a patent that protects the
- Where a patent protects the new application of a product protected by an SPC, a further SPC may be available for that product (see the discussion on the Neurim case below).
- The MA must be the first authorisation to place the “product” on the market in the UK;
- The SPC application must be filed:
- Within 6 months of the grant of the first MA to place the product on the market in the UK; or
- If the first MA is granted before the grant of the basic patent, within 6 months of the grant of the basic patent.
Term of an SPC
The SPC will take effect at the end of the 20-year term of a pharmaceutical patent, provided it has not first lapsed or been revoked. The SPC extends the patent protection only in respect of the product covered by the MA. It does not extend the patent itself.
An SPC term is calculated by subtracting 5 years from the period between the filing date of the patent and the date of first valid authorisation in the EC, but is a maximum of 5 years.
An additional 6 month paediatric extension may also be available (see below under “Extension certificate”).
Grant of an SPC
The patentee files an application for an SPC at the UK Intellectual Property Office (UK IPO). The UK IPO examines the application to ensure that it is in order. If there are any deficiencies in the application, the UK IPO give the patentee an opportunity to remedy them.
Once the UKIPO is satisfied that the requirements are met, they issue the SPC.
Renewal fees for an SPC
Each country has different requirements for the payment of renewal fees for SPCs – some require annual payment like for the basic patent, others require a single cumulative amount due before the SPC takes effect.
In the UK, the annual fees must be paid as a single cumulative amount before the SPC can take effect. This is important to remember because, while there is a grace period, re-establishment is not possible if you fail to pay the accumulated renewal fees. If you also only pay for one year and there is additional protection available, you may not be able to remedy this later, and you will be barred from obtaining a 6 month paediatric extension (see below under “Extension certificate”).
It is possible to obtain an SPC term that is less than the maximum term granted by paying a reduced annual fee amount, if you wish. However, taking a reduced term will mean you cannot obtain a 6 month paediatric extension (see below under “Extension certificate”).
It is possible to extend the SPC term by 6 months, if the marketing authorisation for the medicinal product extends to paediatric use by complying with a paediatric investigation plan (PIP). The medicinal product must also be authorised in all EC member states.
An extension certificate will only be granted where an SPC already exists. It is possible to obtain a negative term SPC (up to 6 months negative term), in order to then obtain a 6 month extension certificate, which would make the term of protection positive.
In most instances, the extension application must be filed in the UK:
- When the application for the SPC is filed, while the SPC is pending or after the SPC is granted;
- When the SPC is already granted, the extension application must be filed no later than 2 years before the SPC
A recent decision issued by the UK Patents Court found that it is only possible to obtain a paediatric extension if annual fees have been paid that allow the SPC to be in force for the full term granted by the UKIPO. Therefore, only paying annual fees that amount to an SPC term that is less than the maximum granted precludes the SPC holder from applying for a paediatric extension.
Lapse and Invalidity
The SPC will lapse:
- At the end of its effective period;
- If the patentee surrenders it; or
- If the product is no longer on the UK market, following withdrawal of the MA,
The SPC can also be declared invalid. Anyone can apply for a declaration of invalidity. The grounds are:
- The basic patent lapsed before its full term;
- The basic patent has been revoked, or limited so that it no longer covers the product; or
- The formal requirements have not been met.
If you have any questions concerning SPCs, please contact your usual Forresters attorney who will put you in touch with our SPC experts.