| 2006 |
|
YEAR BOOK |
Patents Office
|
What is a Supplementary Protection Certificate ?
|
Under Irish and European legislation, medicinal and plant protection products must undergo extensive testing to ensure their safety and efficacy before being authorised for placement on the market. This process may take years. In Ireland, authorisations for medicinal products are issued by the Irish Medicines Board or through a centralised European Commission procedure. The Department of Agriculture and Food issues marketing authorisations for plant protection products.
Before SPCs were introduced, it was agreed that the period that elapses between filing an application for a patent for a new medicinal/plant protection product and obtaining an authorisation to place that product on the market makes the period of effective protection under the patent insufficient to cover the investment put into the research.
As a result of the SPC regulations, holders of both a patent and a certificate may be granted a maximum of 15 years protection from the time the medicinal/plant protection product in question first receives a marketing authorisation. However, a certificate may not be granted for a period of more than five years.
The following conditions must be met when applying for an SPC:
1. (a) The product must be protected by a basic patent in force;
(b) A valid authorisation to place the product on the market as a medicinal/plant protection product has been granted;
(c) The product has not already been the subject of a certificate;
(d) The authorisation referred to in (b) is the first authorisation to place the product on the market as a medicinal/plant protection product.
2. The holder of more than one patent for the same product shall not be granted more than one certificate for that product. However, where two or more applications concerning the same product and emanating from two or more holders of different patents are pending, one certificate for this product may be issued to each of these holders.
Recently, the European Commission adopted a proposal for a regulation on medicinal products for paediatric use, the objective being to improve the health of children. It has been shown that more than 50% of medicines currently used to treat children have not been tested on and are not authorised for use in children. A key measure included in the draft regulation is a reward for compliance with an agreed paediatric investigation plan in the form of a six-month extension to the term of the SPC. This proposed regulation is expected to become law in 2007.
For more information on this or any other IP matter visit our website at
www.patentsoffice.ie ,
or contact us either at Kilkenny (lo-call) 1890-220223,
or Dublin (lo-call) 1890-220222.