SPC-holder authorised by Specific Mechanisms to oppose to parallel imports from new Member States where it was impossible to apply for an equivalent patent at the time of application
25-06-2018 Print this page
Holder of an SPC issued in another Member State than the new Member States is authorised by the Specific Mechanisms to oppose the parallel importation of a medicinal product where the legal systems of those States did not yet provide for such a possibility at the time when the application for a basic patent was filed, with the result that it was impossible for the holder to obtain an equivalent patent and SPC. Specific mechanisms apply to the extension provided for in Article 36(1) of the Regulation on medicinal products for paediatric use.
PATENT LAW - SPCs
Prejudicial question on the explanation of the Specific Mechanism. Pfizer is holder of an SPC on the basis of European patent No No 0 939 121 for Germany and the authorisation to place the medicinal product Enbrel on the market. Orifarm informed Pfizer in November 2012 of its intention to carry out parallel imports of this product from Estonia and Latvia – from February 2015 – and from Bulgaria, the Czech Republic, Hungary, Poland, Romania, Slovakia and Slovenia. Pfizer repeatedly opposed those imports. In April 2015, it came to the attention of Pfizer that packages of the medicinal product Enbrel, which had been manufactured for Poland, Slovenia, Lithuania and Croatia and all of which identified Orifarm as parallel important, were available on the German market. Given that the Specific Mechanisms prevent parallel import on the products concerned into Germany, Pfizer brought an action before the Landgericht Düsseldorf. On the date on which the application for the basic patent was filed, namely 31 Augustus 1990, there was no equivalent protection for the product at issue. The application for the SPC at issue was filed on 26 June 2003, when it was possible to obtain protection of that product by means of an SPC in all those states. In this case the question before the court is whether the levels of protection should be compared on the basis of the date of application of the SPC or the date of application of the patent. The CJEU decides that the date of application of the patent is determinative. Furthermore, it is decides that the Specific Mechanisms apply to the extension provided for in Article 36(1) of the Regulation on medicinal products for paediatric use.
“57 In the light of the foregoing considerations, the answer to the first and second questions is that the Specific Mechanisms must be interpreted as authorising the holder of an SPC issued in a Member State other than the new Member States to oppose the parallel importation of a medicinal product from the new Member States in a situation where the legal systems of those States provided for the possibility of obtaining equivalent protection at the time when the application for the basic patent was published and/or the application for an SPC in the importing Member State was filed, but did not yet provide for such a possibility at the time when the application for a basic patent was filed, with the result that it was impossible for the patent holder to obtain an equivalent patent and SPC in the exporting States.
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73 Having regard to the foregoing, the answer to the third and fourth questions is that the Specific Mechanisms must be interpreted as applying to the extension provided for in Article 36(1) of Regulation No 1901/2006.”
IPPT20180621, CJEU, Pfizer v Orifarm
