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.
Daiichi Sankyo (hereinafter referred to as “Daiichi”) was the holder, for a drug whose active principle was pravastatine, of a supplementary protection certificate (SPC) granted on 26 August 1992 which expired on 10 August 2006. This company claimed that Sandoz had, since July 2006, manufactured and put on the French market a generic drug of pravastatine, thereby infringing the exclusive…
The company governed by the laws of Switzerland, Novartis AG, is the holder of patent EP 0 443 983 entitled “Acyl compounds”, whose subject-matter is a group of antihypertensive compounds, including valsartan, pharmaceutical preparations containing them and processes for the preparation of these compounds. , This patent, filed on 12 February 1991, was to have expired on 12 February 2011. However, Novartis…
The Danish patentee H. Lundbeck A/S has during the past few years enforced its patent rights to the active pharmaceutical ingredient Escitalopram in several jurisdictions as also reported in several cases on the Kluwer patent blog. As previously reported (blog entry 3 May 2010), Lundbeck A/S has also succesfully enforced its patent rights in relation…
H. Lundbeck A/S (hereinafter referred to as Lundbeck) is the holder of European patent EP 0 347 066 entitled “new enantiomers and their isolation”, which designates France and was filed on 1 June 1989; it claims priority of a British patent dated 14 June 1988. The invention relates to the two new enantiomers of the antidepressant drug Citalopram and the use of…
The District Court of The Hague passed judgment today in a case between Sandoz and Glaxo regarding a combination patent held by Glaxo. The judgment comprises an extensive “lecture” on the assessment of inventive step and may become a benchmark for future cases.
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?
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…
