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IP Cases & Commentary – Details

16 November 2011

Supplementary Protection Certificates (SPCs) - The Basics

Kirk Gallagher and Garreth Duncan

What is a Supplementary Protection Certificate?

Supplementary Protection Certificates (SPCs) extend the term of patent protection for medicinal (human or veterinary) or plant protection products which have had to undergo a marketing authorisation (regulatory approval) process. The aim of SPCs is to compensate the patent holder for the time lost in exploiting the patent due to the requirement to first obtain regulatory approval.

What does an SPC cover?

An SPC only covers the active ingredient (or combination of active ingredients) which is the subject of the marketing authorisation: it is not an extension of the entire claim scope of the basic patent. However, derivatives of the active ingredient, such as salts and esters, may also be covered by the SPC provided they are also within the scope of the basic patent.

What are the requirements for obtaining an SPC?

Four criteria must be fulfilled in order for a pharmaceutical or plant protection product to be entitled to an SPC:

  1. The product must be the subject of a basic patent, as defined below. The basic patent must be in force in the country where the SPC is sought at the time the SPC application is filed, and may be a national or European patent.
  2. The product must be the subject of a valid marketing authorisation, either as a medicinal product or as a plant protection product. The authorisation may be granted either by a national regulatory authority or, for medicinal products, an EU-wide authorisation granted by the European Medicines Agency (EMA).
  3. The product must not already be the subject of an SPC. There are certain exceptions to this rule, which we can discuss with you.
  4. The marketing authorisation must be the first authorisation to place the product on the market in the European Union (EU) / European Economic Area (EEA).

How long does an SPC last?

The duration of an SPC in Europe is calculated as follows:

  • 15 years from the date of the first marketing authorization anywhere in the EU, EEA or Switzerland;
  • capped at 5 years from the normal expiry date of the basic patent.

In addition, EU legislation now requires pharmaceutical companies to agree with the regulatory authority and then carry out paediatric studies on most authorised medicinal products (this requirement is waived for medicines unlikely to benefit children or considered unsafe to children). If the agreed studies are carried out, whatever their outcome, the patent holder is entitled to a six month extension of the SPC period. It is therefore worth applying for an SPC even if the 15 year term from marketing authorisation expires before the normal 20 year patent term, as the six month paediatric extension may extend the patent term beyond 20 years.

The SPC takes effect on expiry of the basic patent. Renewal fees are payable in most countries to keep the SPC in force.

On what type of basic patent can an SPC be based?

The basic patent may cover:

  • the active ingredient (or combination of active ingredients) of the pharmaceutical or plant protection product;
  • a process for manufacturing the active ingredient (or combination of active ingredients);
  • a use of the active ingredient (or combination of active ingredients); or
  • at least for plant protection products, a preparation containing the active ingredient (or combination of active ingredients).

Where are SPCs available?

SPCs may be obtained in all member states of the EU*, as well as in Norway and Iceland by virtue of those countries' membership of the European Economic Area (EEA). In addition, Switzerland, which is not a member of the EU or the EEA, has its own national system for granting SPCs based on Swiss patents and authorisations.

Where must an SPC application be filed?

There is no centralised European institution for the granting of SPCs: applications for SPCs must be made at the national patent office of each country where protection is required.

When must an SPC application be filed?

An SPC application must be made within the later of the following periods:

  • six months of the grant of marketing authorisation in that country; or
  • six months of the date of grant of the basic patent.

Applications for paediatric extensions may be made when the SPC application is filed or while the SPC application is pending and the statement of compliance with the agreed studies is issued. If the SPC is already granted, a paediatric extension application must be filed no later than two years before the SPC expires.

How can we assist you?

D Young & Co patent attorneys are qualified to practice before the UK Intellectual Property Office (UK IPO), which is responsible for granting SPCs in the UK. Patent attorneys in our Biotechnology, Chemistry & Pharmaceuticals Group have particular experience in obtaining SPCs and other forms of patent term extension. We can also assist you in obtaining SPC protection in other countries through our close association with patent attorneys in other EU and EEA countries, as well as in the US, Japan and other countries which permit term extensions for pharmaceutical and plant protection patents. We may be able to act for you on SPC matters even if we were not responsible for prosecuting the basic patent(s).

We can provide a centralised hub for managing your SPC portfolio and can ensure that a consistent SPC strategy is followed in different countries. As an example, our SPC services include:

  • Formulating a global SPC strategy for pharmaceutical and plant protection products based on all possible basic patents and relevant marketing authorisations;
  • Preparing and filing any SPC applications you may wish to pursue;
  • Preparing and filing any requests for extension of SPCs based on agreed paediatric studies;
  • Managing your SPC portfolio; and
  • Advising on SPC enforcement issues.

For further information or to discuss your requirements please contact:

Garreth Duncan: gad@dyoung.co.uk
Kirk Gallagher: kjg@dyoung.co.uk

 

*Current member states of the EU: Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom.

 

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