With so-called “preventative” cease and desist claims proprietors of industrial property rights can intervene against infringements that have not yet occurred, but are imminent. The legal condition of such “preventative” claims is a “risk of first infringement”, i. e. an existence of facts which justify the conclusion that an infringement will occur in the near future (cf. Court of Appeals of Düsseldorf, judgements of 29/5/2008 – 2 U 86/06 – Plasma-Erzeuger). For example, with respect to trademarks said condition of the risk of first infringement is met when a trademark registration is applied for (cf. Federal Court of Justice, judgment of 14/5/2009 – I ZR 231/06 – airdsl).
For pharmaceutical patents a question arises as to whether an initiation of the marketing authorisation procedure for a generic drug during the term of patent protection can give rise to a risk of first infringement. This question was negatively answered by the Court of Appeals of Düsseldorf (OLG Düsseldorf) a few years ago in a case in which an expiration of patent protection was impending since an initiation of the marketing authorisation procedure can be made with the purpose of making use of such authorization only after expiration of the patent protection (cf. order of 29/3/2006 – I-2 W 43/05).
The District Court of Düsseldorf (LG Düsseldorf) has now ruled in a similar case, in which the European marketing authorization for a generic drug had been applied for 22 months before the expiration of a respective patent (judgment of 12/4/2012 – 4a O 16/12). The Court has reasoned in particular with the so-called “sunset clause” of the European procedures for the authorization and supervision of medicinal products (Article 14(4) of Regulation (EC) No 726/2004), according to which “any authorisation which is not followed by the actual placing of the medicinal product for human use on the Community market within three years after authorisation shall cease to be valid”. Therefore, legal actions instigated by patent proprietors against generics manufacturers based on the initiation of the marketing authorisation procedures by the latter do not have any chances of success unless such procedures were inter alia initiated significantly earlier than three years before the expiration of the respective patent.
In the given dispute the patent proprietor has also supported his claim with the fact that the defendant initially ignored and then refused the proprietor’s request of a cease-and-desist declaration. In that connection the Court denied an obligation to respond if no risk of first infringement existed (see also Court of Appeals of Düsseldorf, order of 29/3/2006 – I-2 W 43/05).