Needless to say, patients and doctors expect a particular medicine to be an effective way of dealing with an illness. At the same time the medicine has to be sufficiently safe. The European Medicines Agency will only issue a marketing authorisation for the active ingredient if extensive research shows that a medicinal product is safe and effective.
The patent will already be in force while this lengthy and valuable research is being conducted, but the product will not be on the market yet. By the time the medicine is put on the market, much of the 20 year term that protects the product will have expired. This means that the effective protection on the basis of the patent is often not enough to cover the investments in research and development.
This is why the Supplementary Protection Certificate (SPC)) was introduced at the end of the last century (codified in the SPC regulation).
SPCs provide an extra period of protection - up to a maximum of 5 years - for a product
- I) subject to a valid marketing authorisation,
- II) and protection by an active patent (basic patent).
At first glance the SPC regulation appears to be quite straightforward with the aim being to ensure that applying for an SPC is largely a formality. National courts nevertheless find it hard to interpret and apply the SPC regulation.
That is partly due to the fascinating and rapid developments taking place in the field of medicine, including the arrival of biological medicines such as antibodies and T-cells, combined therapies, 'personalised medicine', and the use of existing medicines for the treatment of new conditions.
These developments are constantly raising new questions about what can and cannot be protected under the SPC regulation. These questions, which are also important from an economic point of view, have to be answered by the European Court of Justice.
The European Court of Justice is soon going to provide an answer to various important questions raised by Mr Justice Arnold, a leading UK judge.
The first question relates to the criteria that determine whether a product is 'protected' by a basic patent. It is clear that these criteria are different to those relating to whether or not a product infringes a patent. Although a product may infringe a patent, it may not be protected as such for the application of the SPC regulation. This question is relevant for combinations of medicines.
If the patent were to claim 'A combination of active ingredient A and any other active ingredient', would it then be possible to obtain an SPC for A and active ingredient B, even if no mention is made of B in the patent and even if the combination does or does not contribute to the invention? If a patent were to claim 'An antibody against disease X', without stating a specific amino acids sequence, would it then be possible to obtain an SPC for an antibody against that disease with a specific amino acids sequence?
The second important question is whether it is possible to obtain an SPC for a product that is a new formulation for an old medicine. Although the European Court of Justice previously gave the impression that SPCs for a new application of an existing active ingredient are possible, it is unclear what the situation is in the case of a new formulation. Is it then important that the new formulation makes the medicine more effective?
It is expected that the answers to these questions will provide clarity with regard to the (im)possibilities of the SPC system. One thing that is certain is that, when it comes to SPCs, a shift is taking place from a purely formal procedure to a more and more substantive procedure and that the quality of the underlying patent is becoming increasingly important. Not everyone is aware of this and that can have some serious repercussions.