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What is a Supplementary Protection Certificate (SPC)?

日期: 23 January 2019

 

By Lucy Holt

 

A Supplementary Protection Certificate (SPC) effectively extends the patent term for active ingredients present in pharmaceutical or plant protection products. SPCs are a national right, available in the member states of the EU.

 

The aim of an SPC is to compensate the patentee for the delay in obtaining this necessary regulatory approval required to use and sell such products.

 

Upon expiry of the patent, the SPC enters into force and usually lasts for up to five years. An extension of six months may be available for a medicinal active ingredient, if it has undergone paediatric testing.

 

Legal basis for SPCs

 

SPCs are available in the UK under the following European legislation:

  • Regulation (EC) No 469/2009 of the European Parliament and of the Council for pharmaceutical products.
  • Regulation (EC) No 1610/96 of the European Parliament and of the Council for plant protection products.
  • Regulation (EC) No 1901/2006 of the European Parliament and of the Council on medicinal products for paediatric use.

The corresponding UK legislation is Section 128B and Schedule 4A of the UK Patents Act 1977.

 

Conditions for obtaining an SPC

 

There are four conditions set out in Article 3, Regulation (EC) No 469/2009 for obtaining an SPC:

  1. The product is protected by a basic patent in force in the particular EU member state.
  2. A valid marketing authorisation has been granted to market the product in the particular EU member state.
  3. The product has not already been the subject of an SPC (i.e. one SPC per patent per product per patentee).
  4. The valid marketing authorisation is the first marketing authorisation to place the product on the market in the particular EU member state.

A number of cases are proceeding through the courts of Europe challenging these criteria, and the European Commission has appointed the Max Planck Institute and Copenhagen Economics to conduct studies on the legal and economic effects of SPCs respectively, and also launched a public consultation between October 2017 and January 2018. 

 

Duration of an SPC

 

Upon expiry of the patent, the SPC enters into force and can last for up to five years. An extension of six months may be available for a medicinal active ingredient, if it has undergone paediatric testing.

 

The duration of an SPC is equal to the period which has elapsed between the filing date of the patent application and the date of grant of the first marketing authorisation to market the product, less five years (Article 13, Regulation (EC) No 469/2009).

 

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You can find this article and others in our Patent Issues Newsletter Spring 2019. 

 

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