The Swiss Federal Administrative Court recently decided on the appeal against a decision of the Swiss Patent Office to deny grant of a supplemental protection certificate (SPC) for a newly approved pharmaceutical product (Panitumumab). The Court held that an SPC cannot be granted on a basic patent for a combination of two different active ingredients, if the marketing authorisation is only for one active ingredient of this combination.
This decision complements the current practice which allows for the opposite situation, where an SPC can be granted on a basic patent for a single active ingredient while the marketing authorisation is for a combination product containing this single active ingredient. The reason behind the present decision and the mentioned practice is the Swiss concept that the approved pharmaceutical product has to be protected by a basic patent. Under this concept the Federal Administrative Court had to decide in this case whether the patent claim, directed to a combination of two elements, is not infringed by implementing one element only.
The court had to consider this question in the light of claim two of the patent, which claimed the separate administration of the two components of claim one. The scope of the claims was established by the court considering an expert opinion ordered by the court as the Administrative Court – contrary to the Swiss Federal Patent Court – does not have the technical experts on the bench. Based on the expertise the Administrative Court found that the single active ingredient of the market authorisation did not infringe the combination claim one – neither as literal infringement nor when considering the concept of equivalence.
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| Brendan B Bolli
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Rainer U Schalch
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E Blum & Co AG
Vorderberg 11
CH-8044 Zurich, Switzerland
Tel: +41 43 222 56 00
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