A win for Pfizer over Enbrel parallel imports

The European court has ruled for Pfizer on stopping parallel imports of Enbrel into Germany. The dispute arose over packages sold in central and eastern European countries like Poland and Slovenia finding their way onto the German market while Pfizer's German supplementary protection certificate was in force.

Patent protection for Enbrel

Blockbuster biopharmaceutical Enbrel is marketed by Pfizer outside of the US, Canada and Japan, Pfizer having acquired them with the Wyeth takeover in 2009. The basic patent protecting active ingredient etanercept was filed by Hoffman La Roche in August 1990. A normal 20 year patent term would leave the product potentially exposed to biosimilar competition from 2010 onwards.

Then owner Wyeth filed for supplementary protection certificates (SPC) to extend protection around Europe. In Germany, the patent office granted an SPC lasting until 1 February 2015, and this period was subsequently extended for six months through a  paediatric extension.

New EU member states

When central and eastern European countries that were formerly part of the Soviet Union became part of the EU, patents and SPCs for pharmaceutical products received special treatment. A “Specific Mechanism” in the Acts of Accession of 2003, 2005 and 2012 included a derogation from the normal rules of free movement of goods around the EU. This allowed patent owners to stop parallel imports from the joining member states, relying on patents and SPCs filed at a time when equivalent protection in those new member states was not available.

Bad timing could lead to an unfair result

The question in this case was one of timing. When the basic patent was applied for, it was not possible to apply for equivalent protection in the central and eastern European countries. By the time the SPC was applied for, they had joined the EU and did offer SPCs. But Wyeth could not apply for SPCs in those countries because there was no patent on which to base the application.

Although the European court generally takes a restrictive approach to anything that waters down the fundamental principle of free movement of goods within the EU, it decided that Pfizer could take enforcement action over the parallel imports. Although SPCs were theoretically available when the Enbrel SPC applications were filed, they were effectively unavailable in the new EU member states because of the lack of a basic patent there.

It would not be fair to deprive Pfizer of the protection of the Specific Mechanism in these circumstances. Similar reasoning applied to the paediatric extension.

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