On 21 June 2018 the CJEU gave its judgment in a preliminary reference from the Düsseldorf Court seeking clarity on the scope of the EU Specific Mechanism. In a clear judgment from the Court (Case C-681/16, Pfizer v Orifarm), which followed the Opinion of the Advocate General, the Court confirmed that the Specific Mechanism must be interpreted as applying to paediatric extensions.
Under the Specific Mechanism the holder, or the beneficiary, of a patent or SPC for a pharmaceutical product filed in an “old” EU Member State at a time when such protection could not be obtained in a “new” or Accession EU 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 the new Member State for the first time by the patent holder or with their consent.
As readers will recall from the report on the Advocate General’s opinion (reported here), the Düsseldorf Court referred 4 questions to the CJEU, namely:
- Can the holder of [an SPC] that was issued to it for [Germany] rely on the Specific Mechanism to prevent the importation of products into [Germany] from the Accession States the Czech Republic, Estonia, Latvia, Lithuania, Hungary, Poland, Slovenia, Slovakia, Bulgaria, Romania and Croatia if the SPC was applied for in [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 [Germany] because the basic patent required for the issuing of the SPC did not exist in the Accession State?
- 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 [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 [Germany] was based, it could be so obtained?
- Can the holder of an SPC that was issued to it for [Germany] rely on the Specific Mechanism to prevent the importation of products into [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 [the Paediatric Regulation]?
- 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 its judgment the CJEU took the first and second questions together and the third and fourth questions together. In answering the first and second questions, the Court noted that the Specific Mechanism seeks to achieve a balance between free movement of goods and the effective protection of IP rights under a basic patent. While the Mechanism should be interpreted strictly, the Court held that if there was no equivalent patent protection available in the New Member State (i.e. one of the Accession States e.g. Bulgaria or Croatia) at the time when the patentee applied for that patent in the Old Member State (in this case, Germany), then the holder of an SPC based on that patent in the Old Member State can oppose parallel importation into that state on the basis of its SPC. The Court considered the purpose of the SPC when answering these questions and held there was an “unbreakable connection between the existence of the SPC and that of the basic patent, since, if there is no basic patent, a product cannot be protected by an SPC”.
The answer to the third and fourth questions, as set out in the introduction to this article, was that the Specific Mechanism must be interpreted as applying to paediatric extensions. The Court clearly stated that, just because the Specific Mechanism did not expressly mention SPC extensions, it could not be inferred that such SPC extensions fall outside the scope of the Mechanism. The Court looked to the fact that the Paediatric Regulation is referred to in the SPC Regulation, and that paediatric extensions to SPCs do not alter the substance of the SPCs, but merely provide for their extension. Finally the Court held that even if a New Member State had joined the Union after the Paediatric Regulation had come into force (in this case Croatia) it should not be treated any differently, and that the paediatric extension can be used to oppose parallel importation from all New Member States, no matter when they joined the Union.
This judgment brings clarity to the scope of the Specific Mechanism for all users. While the Mechanism may not often be raised or relied on it is an important aspect of protecting patent and SPC rights in certain parts of the EU.