Austrian SPC decision on an SPC application based on a variation type II of an existing MA

Bianca-Lucia Vos and Klemens Stratmann of Hoffmann-Eitle have generously provided a copy of a recent decision of the Higher Regional Court of Vienna (here) regarding an SPC application based on a variation type II of an existing marketing authorisation.  An English translation of the decision can be obtained here.  Bianca-Lucia and Klemens comment:

On January 21, 2016 the Higher Regional Court of Vienna, Austria, issued a decision (34 R 104/15) on the interpretation of Art. 3(b) of Regulation 469/2009 in the light of the Neurim judgment of the CJEU (case C-130/11). In the case underlying the appeal to the Higher Regional Court of Vienna, the Austrian Patent Office had rejected an SPC application that was based on a second medical use patent (EP 0 758 900) and a Type II variation of an existing (national) marketing authorization for Botox due to which the indication protected by the selected basic patent, i.e. treatment of chronic migraine, was added to the already approved indications of Botox. The Examiner had calculated the 6-month time limit for filing the SPC application according to Art. 7(1) of Regulation 469/2009 from the date of the very first marketing authorization for Botox in Austria. In his view, the amendment by a Type II variation of a marketing authorization does not newly trigger the 6-month time limit for applying for an SPC.

However, following the considerations of the European Court of Justice in the Neurim decision C-130/11, the Higher Regional Court of Vienna ruled that a marketing authorization as amended by a Type II variation can be considered as a valid marketing authorization in the sense of Art. 3(b) of Regulation 469/2009. The Court also emphasized that patent protection and marketing authorization must harmonize in terms of content, and that earlier authorizations do not deprive the more recent authorization of a patented use from being the “first authorization” pursuant to Art. 3(d) of Regulation 469/2009, if the earlier authorization refers to areas not protected by the basic patent.

Accordingly, the Court also held that an earlier authorization granted for a use outside the scope of protection of the patent has no negative effect in so far as it does not trigger the 6-month time limit pursuant to Art. 7(1) of Regulation 469/2009.  Therefore, the contested decision had to be reversed, and the Patent Office ordered to render a decision on the merits as to whether the application had been filed in due time.

Applying the principles set forth by the CJEU in Neurim, the Higher Regional Court Vienna hence confirmed that an SPC application may be filed on the basis of a Type II variation of an existing marketing authorization as “valid authorization to place the product on the market” according Art. 3(b) and “first authorization” in the sense of Art. 3(d) of Regulation 469/2009.

Many thanks to Bianca-Lucia and Klemens for sharing this decision!