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22 June 2018Big Pharma

CJEU hands down Pfizer parallel imports ruling

The Court of Justice of the European Union (CJEU) today handed down its decision involving the parallel imports of medicines from new EU member states into existing ones.

In Pfizer v Orifarm, the CJEU held that a company which has a patent and supplementary protection certificate (SPC) in an existing EU member state can rely on the “Specific Mechanism” to object to parallel importation of a drug from an accession country in certain circumstances.

Under the mechanism, the owner of a patent/SPC which was filed in a member state at a time when it couldn’t be obtained in an accession member state can rely on the rights granted to prevent the import of the pharmaceutical into the existing member state where the product originally enjoys protection.

Pfizer had purchased pharmaceutical company Wyeth Pharma in October 2009 and, as part of the deal, Pfizer acquired an SPC on European patent number 0,939,121, which covered the protein etanercept.

Wyeth had received a marketing authorization (MA) for Enbrel in 2000 covering Switzerland and the MA had effect in the EU. In January 2006, the company was granted an SPC in Germany.

While new countries joined the EU in 2003, 2005 and 2012 (such as Latvia, Bulgaria and Poland), these countries didn’t provide patent protection for inventions including those disclosed in the Enbrel basic patent at the time it was filed (1990), explained Jason Rutt, patent attorney at Boult Wade Tennant.

In 2012, Danish group Orifarm, which operates as a parallel importer of medicinal products, sought to import Enbrel from certain new member states into the rest of the EU.

Pfizer objected, arguing that under the Acts of Accessions for joining the EU, the “Specific Mechanism” applies.

“This provides for the holder of a patent or SPC in an old EU member state to rely on its rights to prevent the importation of medicinal products from accession states if a patent or SPC was unavailable at that time,” said Rutt.

Pfizer claimed that if the new EU country didn’t provide for a basic patent at the time of filing, then the subsequent availability of SPC regulations was irrelevant.

Although patent protection wasn’t available in the accession states at the time of the patent filing, by the time the SPC was applied for in the existing EU member states, the accession countries also provided for SPCs.

“Consequently, although the legal systems of the exporting states already provided for the possibility of obtaining equivalent protection at the time when the SPC at issue was applied for, that possibility was in fact hypothetical, since a basic patent in each of those states is a necessary condition for effectively obtaining an SPC,” concluded the CJEU.

According to Rutt, if the decision had gone against Pfizer, it would have been “akin to making Pfizer play uphill in a game on Mount Everest”.

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