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EU SUPPLEMENTARY PROTECTION CERTIFICATES (SPCs) - The most important of pharmaceutical patent expiry

Over 13 years ago, on 2nd 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 before. The complexities behind reaching agreement were manyfold and in the mainpart undisclosed, but 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. Well, 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 make up the difference up to a maximum of an extra 5 years. So, even if less than 10 years is left when the product hits the market an SPC would not be allowed to exceed 5 years.

The application for an SPC can be made within 6 months of being authorised 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.

So what will be necessary to file an SPC for a product in any EC member state?

  1. It must be authorised for use in the country in which the application is being filed.
  2. It must have a valid "basic" patent still in force as at the date of the application.
  3. The application must comply with the transitional requirements dictated by the
    member states.

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; different countries had different ideas.

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

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

  Italy 1st January 1982
  Belgium 1st January 1982
  UK 1st January 1985
  France 1st January 1985
  Netherlands 1st January 1985
  Rep. of Ireland 1st January 1985
  Luxembourg 1st January 1985
  Germany 1st January 1988
  Denmark 1st January 1988

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

From 1st 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:

  Austria 1st January 1982
  Sweden 1st January 1985
  Finland 1st January 1988
  Norway 1st January 1988

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

Although Switzerland adopted their own national SPC regulations and is not in the EU Community, as Liechtenstein use Swiss licensing for their own purposes, Switzerland will be considered for first EU authorisation in the calculation of SPC duration. This, however, was only recently confirmed by the European Courts and there have been some modifications. The most significant of these has been 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 there were already in place national rules. 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:

Czech Republic

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

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.

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