Negative and zero term SPCs OK says the ECJ
Merck & Co. Inc. v Deutsches Patent- und Markenamt (Case C-125/10)
ECJ decide on negative / zero term SPCs and the starting date of the six month extension under Regulation (EC) 1768/92 (SPC Regulation)
Background
The German Federal Patent Court (Bundespatentgericht) submitted the following question to the ECJ:
"May an SPC for pharmaceuticals be granted if the period between the filing of the application for the basic patent and the first market authorization in the Community, is less than five years?"
Decision by the ECJ
Although not bound to, the ECJ has followed the opinion of the Advocate General Yves Bot of 9 June 2011 and allowed negative / zero term SPCs.
The ECJ has found that the SPC Regulation does not require the prior grant of an SPC having a positive duration. According to the ECJ it follows from the purposes of the SPC Regulation, in particular its 26th recital, that it is intended to confer to laboratories that have carried out research recommended in the paediatric investigation plan which was developed for the product concerned a reward in the form of a six-month extension of the SPC. This purpose and the practical efficiency of the SPC Regulation would be undermined if negative / zero term SPCs were not possible.
On the issue of the starting point, the ECJ held that the six-month term starts from the date determined by subtracting from the date of expiry of the patent the difference between five years and the period which has elapsed between the filing of the patent application and the grant of the first authorization to place the product on the market.
Taylor Wessing says
This is an important decision. It helps to harmonize the law in the Member States as it gives clear answers to two intensely debated questions on negative/ zero term SPCs. The grant of the six-month paediatric extension is dependant on there being an SPC. Where, as in this case, the period between the patent application and the first market authorization is less than five years, no SPC with a positive term can be granted. Until this decision the EU Member States have given diverging decisions on the grant of an SPC without a positive term. The ECJ has, in this clear decision, left no doubt but that negative / zero term SPC should be granted and has given guidance on how the duration of the paediatric extension is be calculated.
Lawyers Christoph de Coster, Dr. Anja Lunze, Helen Cline
