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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 all EU (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 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.

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 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.

 

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