Specific Mechanism applies to extended SPC period opines AG Tanchev

09/02/2018

GO

Katie Cambrook

On 7 February 2018 Advocate General Tanchev delivered his opinion in Pfizer Ireland Pharmaceuticals v Orifarm (C-681/16) regarding the protection afforded by the Specific Mechanism to holders of Supplementary Protection Certificates (SPCs) and extension of those certificates pursuant to the Paediatric Regulation. The Opinion follows the request for a preliminary ruling from the Landgericht Düsseldorf. By way of background, Pfizer had sought to prevent parallel imports made by Orifarm into Germany from Bulgaria, Croatia, the Czech Republic, Estonia, Hungary, Latvia, Lithuania, Poland, Romania, Slovakia, and Slovenia relying on the Specific Mechanism. Although Pfizer’s patent had expired, it had an extended SPC in Germany on which it sought to rely as means to prevent the imports.

Under the Specific Mechanism the holder, or his beneficiary, of a patent or SPC for a pharmaceutical product filed in an “old” Member State at a time when such protection could not be obtained in a “new” Member State (those relevant new Member States being set out in the relevant Act of Accession for the Member State) for that product, may rely on the rights granted by that patent or SPC in order to prevent the import and marketing of that product in the old Member State where the product in question enjoys patent or SPC protection, even if the product was put on the market in that new Member State for the first time by him or with his consent.

The Düsseldorf Court referred 4 questions to the CJEU, namely:

  1. Can the holder of a supplementary protection certificate that was issued to it for the Federal Republic of Germany rely on the Specific Mechanism to prevent the importation of products into the Federal Republic of Germany from the Accession States the Czech Republic, Estonia, Latvia, Lithuania, Hungary, Poland, Slovenia, Slovakia, Bulgaria, Romania and Croatia (Annex IV to the Act of Accession 2003; Part I of Annex V to the Act of Accession 2005; Annex IV to the Act of Accession 2012) if the SPC was applied for in the Federal Republic of Germany at a time at which the laws for obtaining such an SPC already existed in the respective Accession States but could not be applied for by, or issued to, the holder of the SPC issued for the Federal Republic of Germany because the basic patent required for the issuing of the SPC did not exist in the Accession State?

  2. Does it make any difference to the answer to Question 1 if it was merely at the time of the filing of the application for the basic patent issued for the Federal Republic of Germany that such protection through a basic patent could not be obtained in the Accession State but, by the time of publication of the application on which the basic patent issued for the Federal Republic of Germany was based, it could be so obtained?

  3. Can the holder of an SPC that was issued to it for the Federal Republic of Germany rely on the Specific Mechanism to prevent the importation of products into the Federal Republic of Germany from the Accession States the Czech Republic, Estonia, Latvia, Lithuania, Hungary, Poland, Slovenia, Slovakia, Bulgaria, Romania and Croatia if those products are imported after the expiry of the term of the SPC stipulated in the original decision to grant the patent but before the expiry of the six-month extension of the term of the SPC that was granted to it on the basis of Regulation No 1901/2006?

  4. Does it make any difference to the answer to Question 3, in the case of Croatia, that, on account of the accession of Croatia in 2013, the Specific Mechanism did not come into force until after the entry into force of Regulation No 1901/2006 – unlike in the other Member States which acceded prior to 26 January 2007, namely the Czech Republic, Estonia, Latvia, Lithuania, Hungary, Poland, Slovenia, Slovakia, Bulgaria and Romania?’

In his opinion AG Tanchev noted that since the Specific Mechanism constituted an exception to the free movement of goods within the EU it must be interpreted narrowly and should only be applied in situations where the patentee could not obtain the requisite patent protection, not in situations where he could have done so but did not. In considering question (2) he opined that the relevant time at which to consider whether it was possible obtain the requisite patent protection in the new Member State was the time of filing the patent application.  The AG noted some discrepancies between the different language versions of the various Acts of Succession with some using the term “registered” rather than “filed” but concluded that the correct term was “registered” by reference to the purpose and general scheme of the Specific Mechanism.  The AG explained that if the relevant time was the time of publication of the patent application this would be too onerous for the patentee as it would have to monitor whether new laws had come into force right up to the time of publication. In relation to questions (3) and (4) the AG commented that it does not matter that an extension to an SPC pursuant to the Paediatric Regulation was not expressly mentioned in the text of the various Acts of Accession for the new Member States as it is not a separate protection right but merely an extension of the term of the SPC.

The AG’s opinion is therefore in favour of Pfizer (and in agreement with the European Commission’s submissions) and if followed by the Court will be a welcome clarification for those in the industry.  

On 7 February 2018 Advocate General Tanchev delivered his opinion in Pfizer Ireland Pharmaceuticals v Orifarm (C-681/16) regarding the protection afforded by the Specific Mechanism to holders of Supplementary Protection Certificates (SPCs) and extension of those certificates pursuant to the Paediatric Regulation. 
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