A supplementary protection certificate (SPC) compensates the proprietor of a patented and approved drug for the time that it takes for a new drug to pass clinical trials and obtain a marketing authorisation. If granted, an SPC can extend patent protection for an approved drug for up to five years after expiry of the patent. The duration depends on the date of the first marketing authorisation of the drug in the EU and on the filing date of the patent, but the maximum monopoly for the drug is fifteen years from that date.
If the drug which is the subject of an SPC application has undergone specific paediatric clinical trials, then it is possible to extend the duration of the SPC for another 6 months (paediatric extension). Even if the drug is not eligible for a positive term SPC, i.e. if the period between the filing date of the patent and the first marketing authorisation is less than five years, it might still be worth applying for an SPC if a paediatric extension could also apply. This is because of recent case law allowing negative-duration SPCs.
Like patents, SPCs are jurisdictional. However, they are not available in every country where patent protection is available. The national filing provisions differ from country to country, but the deadline for filing an SPC application in European countries is six months from the date of the local marketing authorisation in that country. In the US, the deadline for applying for a patent term extension (PTE), which is similar to an SPC, is much shorter.
Until recently, it was thought that an SPC was only available if the drug that is the subject of an SPC application had not already been the subject of a marketing approval. However, a recent CJEU ruling (Neurim) suggests that an SPC may be granted if the drug has previously been approved for a different medical use.
Gill Jennings & Every’s Chemistry & Life Sciences teams have considerable experience obtaining SPCs, not only in the UK, but worldwide. The case law in the area is evolving rapidly, seeking to clarify the wording of the European regulation governing SPCs, and we draft applications in the pharmaceutical sector with this in mind.
We recently acted for Gilead Sciences in successfully arguing Gilead Sciences Inc.’s appeal against the UKIPO Comptroller’s decision refusing its application for an SPC application, SPC/GB05/041, for Truvada™, which accounted for $3.1 billion of Gilead’s sales in 2013.