The EU Advocate General says that supplementary protection certificates can be issued with a negative term. This will benefit pharmaceutical companies in some cases.
In the EU, there are rules to ensure that the patent term of a pharmaceutical product can be extended if it takes more than 5 years to issue a marketing authorisation. Then the patent holder can obtain a supplementary protection certificate. But is an SPC available if less than 5 years have passed? That is the question on which the Advocate General has issued his opinion.
A global pharmaceutical company held the patent on a substance for the treatment of diabetes. It took 4 years, 8 months and 16 days to issue the authorisation to market the substance as a pharmaceutical product. The processing time was therefore not long enough to allow an extension of the patent term for that reason.
The company was interested in obtaining an SPC with a negative term of 3 months and 2 weeks anyway. This was because the company had conducted additional clinical trials to show that the product could also be used by children and young people. In such cases, the patent term can be extended by 6 months – what is known as a "paediatric extension". But a paediatric extension requires that an SPC has been issued for the pharmaceutical product.
Germans said no – Advocate General said yes
The German patent authorities would not issue an SPC with a negative term. They did not believe that was possible under the EU rules. The pharmaceutical company then turned to the German courts. But they were not sure how to interpret the EU rules and referred the matter to the EU Court.
The EU Court’s Advocate General has now issued his opinion. According to the Advocate General, the case can be decided neither on the wording of the EU rules nor in the interface between the EU rules about SPCs and the rules about paediatric extension.
That being said, the Advocate General felt that it would be best aligned with the purpose of the rules about SPCs if SPCs with a negative term were available in cases like this. It should therefore be legal.
Norrbom Vinding notes:
- that the Advocate General also concluded that the ‘minus period’ should be deducted from the 6 months' paediatric extension so that the patent holder in the case at hand would only have an extra patent term of 2 months and 2 weeks; and
- that a 6 months’ paediatric extension of the patent term is a very important incentive for pharmaceutical companies and their willingness to conduct the relatively expensive additional clinical trials on children and young people