On 7 February 2018, Advocate General Tanchev delivered his opinion in case C 681/16 Pfizer Ireland Pharmaceuticals, Operations Support Group ("Pfizer") v Orifarm GmbH ("Orifarm"), which examined the use of the Specific Mechanism exception to parallel imports in relation to Supplementary Protection Certificates ("SPCs") and paediatric extensions.
The Specific Mechanism is set out in the Acts of Accession of 2003, 2005 and 2012 and provides an exception to the free movement of goods. It enables a holder of a patent or SPC to rely on its rights in order to prevent the import of its medicinal products from the new Member States set out in the Acts of Accession, provided that the right's holder was not able to obtain equivalent protection in those new Members States at the time of filing the patent or SPC application in the Member State of import.
The case concerned Orifarm's importation of Enbrel (an arthritis drug to which Pfizer holds the rights) into Germany from 11 countries which acceded to the European Union in 2004, 2007 and 2013 respectively (the "New Member States").
Pfizer's SPC was issued on the basis of a European patent that had effect in Germany. At the time that the patent was filed (31 August 1990), none of the New Member States provided equivalent protection for pharmaceutical products or specific therapeutic indications that the applicant could apply for. Upon expiry of the basic patent, Pfizer's SPC entered into force and was due to expire on 1 February 2015. However, Pfizer was granted a paediatric extension to the SPC, such that it expired on 1 August 2015.
On 1 June 2015, Pfizer filed proceedings against Orifarm in the Landgericht Düsseldorf for infringement of its SPC (taking account of the paediatric extension) and requested an injunction prohibiting Orifarm's importation of Enbrel into Germany. The Landgericht referred four questions to the Court of Justice of the European Union ("CJEU"), which we consider below.
Advocate General's Opinion
The Advocate General summarised the referring court's questions as follows:
1. To clarify the scope of the Specific Mechanism where an SPC was available in the New Member States but the requisite patent did not exist;
2. Whether the answer to question 1 differs if the basic patent could have been obtained in the New Member States by the time of publication of the German patent application; and
3. In relation to questions 3 and 4, whether and to what extent the Specific Mechanism applies to paediatric extensions.
The Advocate General considered that the Specific Mechanism applies where protection could not be obtained in the New Member States for the particular product in question. As the basic patent did not exist in those New Member States, although those states provided for SPC protection, Pfizer would not have been able to fulfil the requirements for SPC protection without an underlying basic patent. The Specific Mechanism therefore prima facie applies.
However, the Advocate General considered that something further is required, namely that the basic patent itself could not have been obtained in the relevant Member State. He relied on the following points to support this conclusion:
- As an exception to the free movement of goods and a derogation from the principle of exhaustion, the Specific Mechanism should be interpreted narrowly;
- The aim of the Specific Mechanism is to protect patent owners that were unable to protect their invention or receive adequate compensation due to the New Member States having lower levels of protection prior to accession;
- Allowing parallel imports in these cases would also increase the price level of the pharmaceutical products in the New Member States due to the additional demand created by parallel exports from the lower priced New Member State; and
- It could otherwise lead to situations where free trade is permitted during the lifetime of the patent, but then restricted during the lifetime of the SPC – this is against the interim nature of the Specific Mechanism.
The Advocate General opined that the relevant date for considering the availability of patent protection in the New Member States is the date of filing the patent application in the old Member State. Key to his conclusion was the necessity to avoid the burden that would be placed on the patent owner in having to monitor, until the moment of publication of his patent application, whether the New Member States introduce new laws.
Third and Fourth Questions
The Advocate General considered that the Specific Mechanism also applies to paediatric extensions, despite not being referred to in the Acts of Accession. This was due to the fact that paediatric extensions are merely extensions to the protection term of an SPC, rather than a separate protection right.
The Specific Mechanism is a useful tool for patent holders, affording protection when countries which have lower levels of patent protection accede to the European Union. However, the Advocate General clearly acknowledges in his opinion the far-reaching impact that the rule has on the free movement of goods. Whilst the CJEU is not obliged to follow the Advocate General's opinion, its judgment will bring helpful clarity to the scope of this important right.