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 Federal Institute of Intellectual Property can also issue a supplementary protection certificate to an applicant if a certificate for the same active pharmaceutical ingredients (API) or combination thereof has already been granted to a third person. By interpreting the law in that way – only restricting the grant of a certificate for the same…
In October 2009, we reported the UK Court of Appeal’s referral to the European Court of Justice (as it was then known) regarding the meaning of the term ‘the first authorisation to place the product on the market’ referred to in Article 13(1) of Council Regulation (EEC) 1768/92 (the “Regulation”) concerning the creation of a…
In this blog, we reported earlier about a new nullity action initiated in 2010 against the German supplementary protection certificate (SPC) for enantiomeric escitalopram and the judgment of the German Federal Patent Court (Bundespatentgericht – BPatG) in favor of the validity of the SPC. Meanwhile, the BPatG issued the written grounds for its decision.
If a supplementary protection certificate (SPC) should have been denied (or granted with limited scope), because the six month application period following the date of first marketing approval has lapsed, it is entirely or partially void. There is a lack of legal interest for a negative declaratory action directed at declaring the non-existence of claims…
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…
