Supplementary protection certificates on reformulations and new uses after Neurim: where do we go from here?

摘要

In 2012, the EU's Court of Justice (CJEU) gave a positive decision for the applicant in the Neurim Pharmaceuticals supplementary protection certificate (SPC) case [1], going against previous, less favorable decisions on SPCs for reformulations and new uses of known pharmaceuticals. As with many recent CJEU decisions on SPCs, however, the decision leaves as many questions open as it answers and could continue the legal uncertainty on eligibility for SPCs in this field.It is almost 20 years since SPCs were introduced across the EU, firstly for medicinal products, and later for plant protection products that require marketing authorization by a regulatory body. The aim of SPCs is to compensate the patent holder for the patent term lost due to the need to obtain marketing authorization. In the EU, SPCs can extend the term of protection for such a patented product by up to 5 years. As the term of the SPC is often the time when the product achieves its peak sales, obtaining SPCs is of critical importance to the pharmaceutical and agroscience industries.