Supplementary protection certificates may have a negative term

The Court of Justice of the European Union (ECJ) has provided clarification
regarding supplementary protection certificates (SPCs) and whether it is possible for these to grant with a negative term.

SPCs allow a proprietor of a patent covering a medicinal or veterinarian product to extend the term of protection for the specific product, to take into account delays involved in obtaining marketing authorisation. The SPC term is calculated by deducting five years from the length of time between the application date for the patent and the date of grant of the marketing authorisation of the product. For Merck Sharp & Dohme’s diabetes drug Januvia, the calculated period was negative because the difference between the two dates was less than five years. However, Merck was still interested in obtaining an SPC because paediatric use of Januvia had been investigated and so Merck was entitled to a six month extension to the SPC period under the paediatric extension laws. With this extension, the SPC had a positive term and so was of commercial value to Merck.

Merck had applied for SPCs at patent offices across Europe and had been granted a zero term SPC in Greece and negative term SPCs in the Netherlands, Bulgaria and the UK but had been refused SPCs in some other countries including Germany. The refusal in Germany was considered by the German Federal Court, which referred the matter to the ECJ. The ECJ found that if zero or negative term SPCs were not allowed then patent holders would delay obtaining market authorization until at least five years had passed from the date of the patent application, which was contrary to the interest in protecting public health. On that basis, it was decided that SPCs may be granted with a negative term.