A Supplementary Protection Certificate (SPC) extends the term of a patent for a medicinal or plant protection product by a period of not more than five years. The aim of SPCs is to compensate the patent owner for ‘lost’ patent protection which was caused by the time it took to obtain marketing authorisation for the product in question. An SPC is a national right, available in member states of the European Union (EU) by application to the national patent office of the state for which a certificate is desired. The SPC is based on a patent and is granted in respect of an active ingredient in a medicinal or plant protection product.
The grant of supplementary protection certificates (SPCs) has been the subject of numerous recent cases in Europe. In the UK, the latest development in Neurim Pharmaceuticals (1991) Limited v. Comptroller-General of Patents [2010] EWHC 976 (Pat) concerned the issue of whether a previously authorised product can be the subject of an SPC for a different…
In the beginning of 2010, Merck Sharp & Dohme (hereafter “Merck”) and E.I. Du Pont de Nemours (hereafter “Du Pont”) on the one hand and Mylan on the other hand entailed in a fight concerning the launch of a generic version of Cozaar Plus®. The Supplementary Protection Certificate (SPC) of Cozaar Plus®, a combination product consisting of losartan and HCTZ, would expire on 15 February 2010, but Merck and Du Pont tried to prevent the marketing of generic versions of Cozaar Plus® by invoking the SPC for Cozaar®, the monoproduct consisting of Losartan only. In Belgium and France, this case led to very diverging judgments on the interpretation of the SPC Regulation.
