SPCs & Regulatory

If you have a pharmaceutical or plant protection product (link to Plant Variety Rights) you will understand the importance of building on the limited term of patent protection that may remain after the lengthy authorisation process. The additional term provided by Supplementary Protection Certificates (SPCs) is particularly important, alongside other factors such as pharmaceutical trade marks and regulatory protections.

SPCs are available in all EU/EEA member states, the UK, Switzerland, and several other countries. They provide a separate, national IP right that extends the protection afforded by your patent for the active ingredient(s) of a medicinal or plant protection product.  J A Kemp has been at the forefront of this specialised area since SPCs first became available in 1993. We have experience at all levels including patent offices and national courts in the UK and across Europe, up to the Court of Justice of the EU.

J A Kemp has been at the forefront of this specialised area since SPCs first became available in 1993. We have experience at all levels including patent offices and national courts in the UK and across Europe, up to the Court of Justice of the EU.

The protection provided by SPCs is closely-linked to marketing authorisation of a product. Marketing authorisation may give rise to other forms of protection such as regulatory data and marketing exclusivity, and orphan drug status. The term of an SPC may also be extended in return for completion of an approved paediatric investigation plan. Our team has extensive experience in advising on the interplay between these complicated issues. For more information, see our separate briefings on Data Exclusivity and Market Protection in the EU / EEA and UK, Orphan Drugs in the EU/EEA and UK, and Paediatric Extensions in the EU / EEA and UK.

Additional complexity arises because there is no centralised European filing procedure for SPCs. As such J A Kemp routinely helps our clients to devise comprehensive SPC filing strategies. We then co-ordinate these strategies across the UK and Europe, using our in-depth knowledge and network of trusted associates across the continent.

Our specialist trade mark attorneys can also assist you with the particular complexities that apply to securing protection for brand names for pharmaceuticals.

For more information please see our introductory briefing on Supplementary Protection Certificates for Medicinal Products, our introductory briefing on Supplementary Protection Certificates for Plant Protection Products, our full briefing on Supplementary Protection Certificates for Medicinal Products and our introductory briefing on Pharmaceutical Trade Marks (this is the new briefing).