SPC

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.

France, Injunction, SPC

(Véron & Associés)/

The holder of a SPC fearing that competitors submit before the expiry of its title a tender in response to invitations to tender, for a products’ supply after the expiry of the title, requested an interlocutory injunction to prevent an imminent infringement. Therefore, by three orders issued on 19 August 2010, the Judge in preliminary proceedings at the Tribunal de Grande Instance of Paris deals with two important questions, already known by other courts in Europe: which elements can characterise the imminence of the infringement? is an offer formulated during the validity of the title an infringement although the supply of the products at issue would take place after the expiry of the title?

Enforcement, Extent of Protection, Italy, Procedure, SPC

(Trevisan & Cuonzo)/ /1 Comment

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….

Antibodies, Biologics, Netherlands, Scope of protection, SPC

(Brinkhof)/

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…

(Indirect) infringement, Biologics, Extent of Protection, Italy, SPC

(Trevisan & Cuonzo)/

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,…

Belgium, France, SPC

(Crowell & Moring)/ /2 Comments
Landmark European Patent Cases

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.