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Background to and Purpose of EU Supplementary Protection Certificates
Background to Pharmaceutical SPCs
SPC or pharmaceutical term extension is applicable in all European countries. In the EU it is covered by two regulations, the first of which was enacted January 1993 (EC 1768/92) and has been subsequently updated since then to incorporate changes to EU membership and changes in market conditions. One of the major changes has been to add a further six months exclusivity in accordance with the paediatric investigation plan (PIP). This extension is only available mainly in the submission of a new marketing authorisation (MA) containing the data from trials conducted in accordance with the agreed PIP.
This will bring the maximum extension allowed to five and a half years and will apply to all forms of the item covered by the allied patent. This is a little different from the paediatric extension used in the USA where it only relates to paediatric applications.
Purpose of the Pharmaceutical SPC
The purpose of the SPC, and all other pharmaceutical term extension, is to compensate for the erosion of patent duration during the lengthy procedures getting the item to a position to take advantage of its exclusivity. It has been estimated that on average almost half of the patents allotted span (20 years) is taken up by testing, clinical trials, legislative procedures covering licencing. This was always deemed to be contrary to the spirit of patent law, which is there to give the inventor a guaranteed period of exclusivity by the state. If the ‘state’ prevents this duration being fully utilised, then it was considered unfair. So the EU conducted investigations into how to rectify this apparent anomaly (no that the industry appeared to be suffering unduly from this deficiency). Nevertheless, the EU were empowered to seek a means of forming a pharmaceutical patent term extension that could satisfy all member states. It would have been impossible to satisfy all member states and direct them to change their own national patent law. After all, it must be remember that patent law is still a national issue covered by statutes implemented at the national level.
So, it was decided to conduct such activity in the form of an EU regulation. The SPC would be covered by a separate legal entity timed to come into effect immediately on the expiry of the patent to which it applies.
MPA SPC Database
This whole activity of legal wrangling was probably stimulated by the implementation of the USA extension under Waxman Hatch. This was considered to give the USA undue advantage in the area of drug development that would be detrimental to the European pharmaceutical industry. Now most countries have a similar system in place, copying either the USA or the EU approach. It is constantly under review, keeping track of the ever changing market conditions, which MPA as specialist try to follow in order to advise our clients accordingly.
The MPA SPC database covers expiry of supplementary protection certificates on pharmaceutical products marketed in the EU. Basic patent information, EU first authorization dates and more are also covered...
