General disadvantages of fixed-dose combinations cannot reduce the reasonable expectation of success derivable from the prior art with respect to the formulation of a pharmaceutical composition containing two specific active pharmaceutical ingredients. A synergistic effect is not suitable to establish inventive step of a fixed-dose combination of two active pharmaceutical ingredients, where the synergistic effect was already observed for the simultaneous but separate administration of the same active ingredients.
1. Also in case a dependent claim is patentable on its own, fulfillment of all features of both the main claim and the dependent claim is required for infringement.
2. The scope of a patent is defined by its claims; the prosecution file may only be considered for interpretation if there are contradictions between the claims, the description and/or the drawings.
The Court of Appeal Düsseldorf held that the offering of certain products by the defendants was not covered by the scope of the patent due to the specific “Swiss type” wording, which does not grant an absolute product protection, and due to the fact that the advertising of the defendants did not address the patented use specifically enough.
The later finding of the biological relationships underlying the activity of a drug does not constitute a new teaching for technical action if the indication, the dosage and the way of using the drug coincide with an the prior disclosed use of a drug for the treatment of a disease (confirmed by FCJ 9 June 2011 – X ZR 68/08, GRUR 2011, 999 – “Memantine”). The selection of a value within a known range does not render an invention patentable, unless for special circumstances (e.g. the dosage instruction achieves a particular technical effect vis à vis the prior art).
The FCJ held that the right to claim priority, which is in fact the right to file a follow-up application, can be transferred to a third party who was not the applicant of the earlier application. This transfer is governed by the law of the earlier application, in this case German law. Neither German law nor the EPC requires a specific form for such a transfer. Therefore, a transfer is also possible implicitly.
In preliminary injunction proceedings: to fulfil the requirement of urgency a patentee must actively and with determination enforce the patent. A patentee does not have to wait for the outcome of nullity proceedings if a generic company has launched an infringing product on the market, thereby causing irreparable harm to patentee.