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 Italian Antitrust Authority (Autorità Garante della concorrenza e del mercato) announced on 26 October that it commenced proceedings against Pfizer following a complaint filed by Ratiopharm alleging that Pfizer’s behaviour in the enforcement of its patent rights amounts to abuse of a dominant position. It is too soon to make comments on this case….
In a decision of 7 September 2010, the Dutch Patent Office (NL Octrooicentrum) on appeal confirmed its earlier decision to not grant a supplementary protection certificate (SPC) for the medicinal product tocilizumab, a humanized monoclonal antibody against the human interleukin-6 receptor, which is approved as a human rheumatoid arthritis drug. The applicant had requested an…
By Legislative Decree no. 131 of 13 August 2010, which became effective on 2 September 2010, the Italian legislator passed a number of amendments to the Italian IP Code. One of these is new Art. 68 (1bis) on the statutory limitations to patent rights (which in paragraph 1 already included, and still includes, personal use,…
The General Court upheld, for the most part, the decision of the European Commission in AstraZeneca. The Court held that AstraZeneca infringed Article 82 EC (prohibition of abuse of a dominant market position) in so far as AstraZeneca requested the registration of Losec capsules market authorisations in Norway and Denmark. The Court further held that…
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.
