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Supplementary Protection Certificates

Supplementary Protection Certificates (SPCs), and the associated pediatric extensions, are key assets of the pharmaceutical industry for extending the duration of the protection of medicaments and maintaining the exclusivity and sales in the last years of the patent life cycle. They are economically very valuable.

We are the firm of reference in Spain for filing and prosecuting SPC applications. So far, we have directly handled the prosecution of more than 160 SPC applications at the Spanish Patent & Trademark Office, and coordinated the filing and prosecution of several SPC families in other European countries for important active ingredients.

Over the years we have acquired a lot of experience in the European Regulation 469/2009, dealing with all sort of objections arising from the SPC prosecution practice before the Spanish Patent and Trademark Office and the Spanish administrative courts. Also in infringement and nullity proceedings relating to SPCs.

The case law relating to SPCs is highly complex and rapidly evolving, but we are at the forefront of the law in this very specialized area. We have solved difficult situations and obtained effective protection for blockbuster drugs.

For example, we were coordinating SPC applications in several countries for the product Circadin (melatonin) for our client Neurim Pharmaceuticals. This resulted in a referral and decision of the Court of Justice of the EU that changed the game and opened the door to obtaining additional SPCs for second medical uses of medicaments.

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