AG backs Pfizer in parallel import dispute
An advocate general (AG) at the Court of Justice of the European Union (CJEU) yesterday backed Pfizer in a dispute over the parallel importation of an arthritis drug into Germany.
The Regional Court of Düsseldorf (Landgericht Düsseldorf) had requested a preliminary ruling from the CJEU after Pfizer sought an injunction prohibiting the parallel imports.
Pfizer was the holder of a supplementary protection certificate (SPC) in Germany for the protein Etanercept—the active substance of the drug Enbrel, which Pfizer markets for the treatment of arthritis. The SPC expired in August 2015.
The patent covered by the SPC had been filed in August 1990, but none of the 11 new member states concerned in the case (the countries where the parallel imports had come from) provided for comparable rules for the protection of pharmaceutical products or specific therapeutic indications.
The new member states became members of the EU in 2004, 2007 and 2013.
In 2012, a subsidiary of the Danish parallel importer Orifarm Group informed Pfizer that it would carry out parallel imports from Estonia and Latvia into Germany and, from February 2015, also from Bulgaria, the Czech Republic, Hungary, Poland, Romania, Slovakia and Slovenia into Germany.
Fast-forward three years, and Pfizer discovered that packages of Enbrel which had been produced for Poland, Slovenia, Lithuania, and Croatia were available on the German market.
Pfizer sued Orifarm for infringement of its SPC, requesting an injunction.
In response, Orifarm claimed that it had lawfully acquired Enbrel in the new member states, and referred to the defence of exhaustion.
AG Evgeni Tanchev explained that according to the principle of Community exhaustion, the exclusive rights granted by an SPC can’t be invoked for products protected by the patent that are legally marketed in another member state, even if the product is imported from a member state where it is not patentable.
Pfizer hit back against Orifarm’s contention, claiming that the Acts of Accession of 2003, 2005 and 2012, under the term of ‘Specific Mechanism’, have codified a rule which states that the holder of a patent/SPC may, under certain circumstances, rely on its rights to prevent imports from the new member states.
For the ‘Specific Mechanism’ to apply, the equivalent protection must have been obtainable in the new member states at the time when the patent/SPC was filed in the country of import.
The Landgericht Düsseldorf asked the CJEU to clarify the scope of the mechanism, because it constitutes an exception to the free movement of goods so must be interpreted narrowly.
The CJEU has been asked to clarify the scope where an SPC was available in the new member states at the relevant time, but the requisite basic patent didn’t exist, and whether it makes a difference if the basic patent could have been obtained in the Accession State by the time he German patent application was published.
Tanchev concluded that Pfizer has the right, for the entire term of its protection, to prevent the imports and that it doesn’t make a difference whether a patent could have been obtained at the time of publication, if it was not obtainable at the date of the patent application’s filing.
A spokesperson for Pfizer said: "We are pleased with the opinion of the AG, and we await the decision of the CJEU."
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