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SPCs, Regulatory and Plant Variety Rights

J A Kemp is particularly renowned for expertise in the specialist fields of Supplementary Protection Certificates (SPCs) and Plant Variety Rights (PVRs).

SPCs and Regulatory

If you have a pharmaceutical or plant protection product you will understand the importance of building on the limited term of patent protection that may remain after the lengthy authorisation process.

Supplementary Protection Certificates (SPCs) are available in the UK, Switzerland, all EU/EEA member states and a few 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.

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 UKOrphan 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.

We can also help you with the corresponding term extensions for pharmaceutical patents available in other jurisdictions such as the USA and Japan.

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 and our full briefing on Supplementary Protection Certificates for Medicinal Products.

Plant Variety Rights

The availability, nature and extent of intellectual property protection for plants varies widely throughout the world. In the USA there are three relevant rights: regular utility patents, specialised plant patents and Plant Variety Protection. In Europe many plant-related innovations are patentable, but not a plant variety as such, an “essentially biological” process such as a plant breeding method, or a plant that is the product of such a method. Other countries adopt a range of positions, some much more favourable than others.

Plant Variety Rights, also known as Plant Breeders’ Rights in Europe and Plant Variety Protection in the USA, therefore have an important role alongside patents and trade marks in an integrated IP strategy for plant-related innovations. They can in particular be used to obtain IP protection in Europe and other markets where there are legal restrictions on what can be protected by patents.

In order to obtain a UK or EU Plant Variety Right, your variety must be distinct, stable and uniform. It must also be new, which means it must not have been commercialised within the UK/EU more than one year prior to filing your application, or outside the UK/EU more than four years prior to filing (six years for a tree or vine species).

We have specialist expertise in this area. We file applications for protection with the UK and Community (EU) Plant Variety Right Offices, and we advise on strategies to secure equivalent protection anywhere in the world. For more information on Plant Variety Rights, or on patents in the  Plant Science and Agriculture area.