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.
Hungarian Supreme Court’s decision on conditions for granting supplementary protection certificates (SPC) under the transitional provisions of the Accession Treaty. The Supreme Court held that the first marketing authorization for the pharmaceutical product granted in any EU Member State (including the entire territory of the EU as enlarged due to the 2004 accessions, not restricted…
The Swiss Federal Supreme Court held in a recent decision that the Swiss company Teva Pharma AG had to bear the court costs and reimburse Novartis’s attorneys’ fees in preliminary injunction proceedings because of Teva’s contradictory conduct in this case. The decision was based on the following facts: On March 16, 2010, Teva was granted…
Combination products (containing two or more active ingredients) raise difficult questions with respect to supplementary protection certificates (SPCs). Can a SPC be based on the market authorisation (MA) of a combination product, if the patent only covers one active ingredient? On 13 July 2011, the Advocate General at the CJEU delivered her Opinion on the…
The Court, in infringement proceedings brought by Novartis against Actavis for marketing generic Valsartan, held that the assessment of infringement had to be made as of the time of infringement, not as of the priority date. This is the first decision in years in Norway taking a position on this issue. The judgement also deals…
A movement is emerging now among the French courts to stay the proceedings in litigations relating to supplementary protection certificates (SPCs) and more precisely relating to the interpretation of Article 3(a) of Regulation (EC) No. 469/2009 (former Regulation No. 1768/92): “the product is protected by a basic patent in force”. These proceedings are stayed waiting for future decisions…
Co-author Christiaen Dekoninck The Antwerp Court applied the infringement test to assess the validity of a supplementary protection certificate (SPC) covering a combination product. As a result, the Court decided that Novartis is entitled to invoke its SPC covering the “valsartan/HCTZ” combination product against Teva’s generic version of Co-Diovan. By its decision of 13 May…
The Court, in infringement proceedings brought by Novartis against Actavis for marketing generic Valsartan, held that the assessment of infringement had to be made as of the time of infringement, not as of the priority date. This is the first decision in years in Norway taking a position on this issue. The judgement also deals…
After the Federal Court of Justice (Bundesgerichtshof, BGH) had confirmed the validity of the German SPC for the enantiomeric escitalopram (and its underlying patent) in 2009, the Federal Patent Court (Bundespatentgericht) now confirmed in further nullity proceedings the validity of the SPC.
In this case the claimant filed an application for a supplementary protection certificate (SPC), however the application was refused by the Lithuanian patent office. Appeals before national courts were unsuccessful. The Supreme Court referred the question whether the six-month period for application for an SPC begins on the date of granting Community marketing authorization, or…
On 15 March 2011, in a dispute opposing the companies E.I Du Pont de Nemours and Merck and companies Mylan and Qualimed, the Cour d’Appel of Paris confirmed the order handed down on 12 February 2010 by the President of the Tribunal de Grande Instance of Paris, subject-matter of a previous post. The American company E.I. Du Pont de…
