Supplementary Protection Certificates

In 1993 the EU introduced an additional right for patentees for medicinal, veterinary, and plant protection products (that had been approved to be placed on the European market), the Supplementary Protection Certificate (“SPC”). The European legislation associated with this right allowed the holders of patents[1] protecting these products to obtain an extension to the protection under that patent for the product of up to five years.

The additional protection offered to patentees under an SPC is a vital tool for the pharmaceutical industry to help recover the costs of finding and developing a new drug and encouraging further research and development. This right therefore provides significant advantages for the pharmaceutical industry.

The legal basis for SPCs derives from two European Regulations, although they are applied for and granted individually at national patent offices in each EU country. Following the UK leaving the EU, European law will no longer apply to the UK. To enable current UK SPCs to continue, a post-Brexit UK parliament would need to enact legislation to provide legal basis for existing rights. We expect such transitional provisions to be put into place, given the economic importance of SPCs[2]. It is less certain whether a new government would wish to offer ‘new’ SPC protection in a post-Brexit UK, and, if so, whether the terms would be similar to the current EU system, or modified in some manner. New legislation would be required to implement an ongoing UK system for SPCs, and this simply offers an opportunity to debate the need for this protection at all. There is no guarantee that the rights would continue to be offered or, if they were offered, that they would be of the same form of SPCs as currently found in the EU.

In this regard, even if a post-Brexit UK government automatically applies the European SPC right to the UK, we find it hard to conceive of a situation where it in parallel allows the law associated with that ‘UK’ SPC to be interpreted in line with the CJEU’s rulings on the SPC Regulations. The validity and scope of protection of SPCs have been debated at length before the CJEU in recent years. Hence, the UK courts may take any UK legislation in a very different direction leading to greater uncertainty for the rights holder. More+