A recent decision of the European Court of Justice provides welcome news for the manufacturers of paediatric medicines. The decision was delivered in a case concerning the duration of supplementary protection certificates (SPCs), which can extend patent protection for medicinal products by up to five years. Once a patent is applied for, it begins to expire. However, medicinal products cannot be commercialised until the patent holder receives marketing authorisation, a process that can take up to 15 years. Where certain conditions are met, an SPC extension is granted in order to compensate pharmaceutical companies for the loss of patent protection pending marketing authorisation. The term of an SPC is the period of time from patent application to the grant of marketing authorisation less five years, and subject to a maximum term of five years. A 2006 EU Regulation introduced a six month extension to the SPC period in order to encourage patent holders to conduct research into medicinal products for paediatric use. The “paediatric extension”, as it is known, may only be granted to the holder of an SPC.
Merck Sharp & Dohme challenged the German Patent Office’s refusal to grant an SPC for the drug Januvia, which is used in the treatment or prevention of diabetes. The period between the date of grant of the patent for Januvia and the date of the grant of marketing authorisation was less than five years, which meant that the term of any potential SPC would be a negative term. However, Merck sought the SPC to allow it to apply for the paediatric extension.
The German Federal Patent Court referred the matter to the European Court of Justice for clarification. The Court noted that the pre-conditions to the grant of an SPC do not require that the SPC be of a positive duration. It also noted that while an SPC of a negative duration serves no purpose of itself, it may be of use to the holder of a basic patent who wishes to apply for the paediatric extension. The refusal of an SPC can thus jeopardise the objectives of the paediatric extension, namely to compensate the effort made to evaluate the paediatric effects of the medicinal product at issue. As the paediatric extension may be of benefit where the negative duration of the SPC is not more than six months, it follows that the grant of an SPC cannot be refused by reason only of the fact that its duration is not positive.
The Court also held that where the duration of an SPC is negative, it cannot be rounded to zero. It is only in the case where the period between lodging the basic patent application and the date of the first marketing authorisation is exactly five years that an SPC can have a duration equal to zero. Where the SPC is negative, the date the paediatric extension starts to run is determined by deducting from the patent expiry date the difference between five years and the duration of the period which elapsed between the lodging of the patent application and the grant of the first marketing authorisation.
The decision is a positive development for both patent holders and paediatric medicine in general as it rewards the efforts of those involved in evaluating the paediatric effects of medicinal products. It also provides welcome clarification as regards the duration of SPCs and the paediatric extension.
To view an article on two further decisions of the European Court on the scope of SPCs, please click here.
Contributed by Mary Drennan and Carol Plunkett.
