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Supplementary Protection Certificates (SPCs)

What is a supplementary protection certificate and for what length of time does it apply?

Supplementary Protection Certificates (SPCs) extend the life of pharmaceutical patents. They compensate IP rights holders for the delay between a pharma patent being filed and a marketing authorisation being granted. SPCs come into force following the expiry of the patent to which they apply.

Subject to minor variations across EU member states:

1. The certificate takes effect at the end of the lawful term of the basic patent for a perid equal to the period which elapsed between the date on which the application for a basic patent was lodged and the date of the first authorization to place the product on the market in the Community reduced by a period of five years.

2. Notwithstanding paragraph 1, the duration of the certificate may not exceed five years from the date on which it takes effect. 

This formula provides for 15 years of marketing cover, not to exceed the patent expiration date plus five years.

MPA's European Patent Status Review database includes data on SPCs in all 27 EU member states plus Switzerland. While the EU 1st Marketing Authorisation database shows the date of first EU marketing authorisation, which is relevant to both the calculation of SPC duration, as well as an assessment of data and marketing exclusivity. Is your product's loss of exclusivity approaching?

Background

On 2 January 1993, the EC regulation came into effect, six months after it was published in the Official Journal of the European Communities, entitled, "..the creation of a supplementary certificate for medicinal products." (EC Council Regulation No. 1768/92)

The need was perceived to create ‘fair’ legislation to allow a ‘reasonable’ period of marketing exclusivity and this is the culmination of years of debate between the pharmaceutical industry and the governments of the EC member states.

So, the European Supplementary Protection Certificate (SPC) was created whose primary objective is to provide a guaranteed period of 15 years marketing exclusivity. From January 1993 all products authorised for use in the European Community, in most cases, would be guaranteed this period of marketing exclusivity by adding up to 5 years on to the life of the ‘basic’ patent extending it from the present length of 20 years to a maximum of 25 years by means of a supplementary certificate.

Its aim is to give companies more time, hence greater protection and greater opportunity, to market their products than they had previously. The complexities behind reaching this agreement were manifold and in the main part undisclosed. This is understandable in light of all the vying interests of politics vs costs vs profits that exist reflecting the different national attitudes towards protecting their own industries.

Despite all the problems accompanying this regulation's inception and those associated with its implementation, it is here. So let us review how it works and what effect it will have. The primary objective is to provide a guaranteed period of marketing exclusivity. All products authorised for use in the European Community, in most cases, are guaranteed no less than 15 years by providing a supplement of up to 5 years on their existing cover for the ‘basic’ patent protecting the active ingredient. If because lengthy development and registration leaves less than 15 years patent cover, the SPC will ensure the difference of up to a maximum extra 5 years. So, even if less than 10 years is left when the product reaches the market an SPC would not be allowed to exceed 5 years.

Applying for an SPC

The application for an SPC can be made within six months of its authorisation for use in a member state and each country will be responsible for initiating the procedures necessary for granting these certificates. The SPC, when issued, will take effect the day after the expiration of the ‘basic’ patent in the country of issue and will comply with national patents existing in that country for the duration of the certificate.

The length of the SPC will be dependent upon date of first authorisation in any EC member state and the expiry of the basic patent in the country in which the application is made. The EC first authorisation will be common to all EC member states whereas the ‘basic’ patent expiry could vary from country to country by up to 12 months.

Necessary requirements for filing

So what is necessary for filing an SPC for a product in any EC member state?

• It must be authorised for use in the country in which the application is being filed.

• It must have a valid ‘basic’ patent still in force as at the date of the application.

• The application must comply with the transitional requirements dictated by the member states.

Determining the transitional period

Determining the transitional period proved to be one of the major stumbling blocks in bringing negotiations to a speedy conclusion. Basically, what it means is how long must a product have been on the market before it qualifies for an SPC application; various countries had different ideas.

Generally, the product must have been authorised for use after 1 January 1985; however because of the differing member state requirements the following table indicates the dates applying to each country.

EC/EEA first authorisation

Date of EC/EEA first authorisation after which an SPC maybe granted

Italy 1 January 1982

Belgium 1 January 1982

UK 1 January 1985

France 1 January 1985

Netherlands 1 January 1985

Rep. of Ireland 1 January 1985

Luxembourg 1 January 1985

Germany 1 January 1988

Denmark 1 January 1988

Although Greece, Spain and Portugal could not file for an SPC until 1 January 1998, the transitional provisions did not apply to those countries.

From 1 July 1994 those EFTA States which are party to the European Economic Area Agreement (Austria, Finland, Iceland, Norway and Sweden) have adopted EC Council Regulation 1768/92 on Supplementary Protection Certificates for Medicinal Products.

The date of EC/EEA first authorisation after which an SPC maybe granted in these countries are quoted here:

Austria 1 January 1982

Sweden 1 January 1985

Finland 1 January 1988

Norway 1 January 1988

The SPC provision for Iceland was derogated to 1998 as for Greece, Spain and Portugal.

Although Switzerland adopted its own national SPC regulations and is not in the EU Community, as Liechtenstein uses Swiss licensing for its own purposes, Switzerland will be considered for first EU authorisation in the calculation of SPC duration. This, however, has only recently been confirmed by the European Courts and there have been some modifications. The most significant of these is that the Swiss authorisation will come into effect in Liechtenstein 12 months after the Swiss date.

The creation of the EU Regulation on SPC’s did not have a smooth inception, in France and Italy national rules were already in place. Many of the products covered by French and Italian SPC’s are still relevant.

Also the introduction of Central and Eastern European countries into the European Economic Community meant that they had to adopt EU SPC rules. Some of these countries already had their own national laws in place. But, by and large, all will eventually have to comply after agreed transitional provisions. These countries include:

Cyprus

Czech Republic

Estonia

Hungary

Latvia

Lithuania

Malta

Poland

Slovakia

Slovenia

There is no doubt that those needing to know patent expiry of leading pharmaceuticals will have to know SPC expiry before anything else. Without this information strategic planning will be virtually impossible.

Extensions to SPCs Arising From Paediatric Trials

On 26 January 2007, regulation (EC) No. 1901/2006 came into force. This Regulation sets out the new legislative framework to promote the development of medicinal products for use in the paediatric population. Amongst the incentives introduced by Regulation No. 1901/2006 is the possibility of an extension to the duration of a SPC covering a marketed medicinal product.

Supplementary Protection Certificates

SPCs provide additional protection, beyond patent expiry, for products (medicinal or plant protection) that require a marketing authorisation.

Extension of SPC Duration

Before Regulation (EC) No. 1901/2006 came into force, the maximum duration of an SPC was five years.

Now, under the provisions of the new Regulation, an SPC covering a product may be extended (beyond the term that it would otherwise be afforded) by a period of six months. This extension of term applies to all of the authorised indications for the product (including the non-paediatric indications).

The SPC duration extension may apply if the results of a Paediatric Investigation Plan (PIP) agreed with the European regulators (the EMEA) are included in an application for Marketing Authorisation for:

(a) a product not previously authorised (Articles 7 and 36(1); or

(b) a new indication (including paediatric indication), new pharmaceutical form of a new route of administration of a previously-authorised product (Article 8 and 36(1)).

The extension of duration may be available even if the data from the PIP fail to lead to the authorisation of a paediatric indication. However, in this situation, the results of the paediatric studies must at least be reflected in the Summary of Product Characteristics (SmPC) for the medicinal product concerned (Article 36(1)). There are also some particular circumstances in which the extension of duration is not available.

An application for extension of the duration of an SPC can be made:

(a) when applying for an SPC;

(b) when an SPC application is pending; or, at the latest

(c) two years prior to the expiry of an existing SPC.

However, prior to 26 January 2012, it will be possible to file such an application for extension up to six months before the expiry of an existing SPC.

An extension of SPC duration may be based upon paediatric studies on a marketed product that have been completed by 26 January 2007 (not in accordance with an agreed PIP). However, the extension may only be granted if those studies are submitted by 26 January 2008 and additional significant studies contained in an agreed PIP are completed after 26 January 2007.

 
   
 
 
 
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