The European Court of Justice has found that drug companies with supplementary protection certificates in EU countries can oppose parallel imports from other member states even when they weren’t members of the bloc at the time the basic patent was filed.

The 21 June judgment said that “specific mechanisms” in the acts of accession of four countries that joined the EU since the turn of the century allowed US drugmaker Pfizer to seek to block imports of its arthritis drug Enbrel from the new member states into Germany.

Swiss pharma company Roche made the initial patent application for Enbrel in August 1990. Over the course of the following decade, the basic patent passed to a subsidiary, Wyeth, which was granted EU marketing authorisation for the drug in 2000, and a supplementary protection certificate by the German Patent and Trademark Office (DPMA) in 2006.

When the basic patent expired in August 2010 – a year after Pfizer acquired Wyeth for US$68 billion – the German SPC came into effect until February 2015. Following a decision by the DPMA in 2012, the SPC was extended until August 2015.   

In April 2015, Pfizer learned that packages of Enbrel that had been manufactured in Poland, Slovenia, Lithuania and Croatia were being sold in Germany. Citing the specific mechanisms in the exporting countries’ acts of accession from 2003, 2005 and 2012, Pfizer filed a lawsuit before the Dusseldorf Regional Court to require drug importer Orifarm to stop the imports of Enbrel, arguing they infringed the SPC.

Each of the acts of accession included a specific mechanism that the holder of a patent of SPC “filed in a Member State” at a time when such protection couldn’t be obtained in one of the countries to whom the Act applied, “may rely on the rights granted by that patent or supplementary protection certificate in order to prevent the import and marketing of that product in the Member State or States where the product in question enjoys patent protection or supplementary protection”.

After the SPC expired later that year, Pfizer amended its claim to ask the court for orders requiring the overseas manufacturers to disclose information about their activities over the course of the five years the SPC was in effect, including copies of their invoices, as well as the recall and destruction of all packages of Enbrel that were imported into Germany during that period. It also sought a declaration of a right to damages.

Pfizer and Orifarm agreed that when the basic patent was issued in 1990 it would have been impossible for the patent holder to gain equivalent protection in the exporting countries. Orifarm, however, argued that the patent and the SPC should be considered separately. The specific mechanisms were inapplicable, it argued, because Pfizer had the option to seek equivalent protections in the exporting countries at the time the SPC was in effect but didn’t act on it.

The Dusseldorf court was torn between the conclusion that the basic patent was an inseparable “necessary condition” of the SPC, meaning the specific mechanisms should apply in the case, and the risk that such a conclusion could be seen to flout EU rules on free movement of goods. It passed the case up to the ECJ in December 2016.

The court noted that it had “consistently held” that holders of IP rights under the national law of a member state couldn’t rely on that local legislation to prevent imports of a product “which has been lawfully marketed in another Member State by the holder himself or with his consent”.

However, the court said that the specific mechanisms in the acts of accession existed to prevent a situation whereby EU market principles would expose IP holders to parallel imports from new member states without having been able to protect their invention in those states or to receive adequate compensation. The specific mechanisms “thus derogate from the free movement of goods,” the court said, but noted that the provisions that allowed such derogation “must be interpreted strictly”.

Turning to the specific mechanisms themselves, the ECJ said it followed from the wording of the acts of accession that the ability of the patent or SPC holder to oppose parallel imports was based on there being no equivalent protection in the exporting states. Working out the application of the specific mechanisms was thus based on the date on which such protection was acquired, the court said, adding that it followed from the use of the word “filed” in the texts of the three acts that this date should be held to be the date when the application for protection was lodged.

This raised the question of whether the date to be taken into account was the date on which the application for the basic patent was filed, which would mean the special mechanisms applied, or the date that the application for the SPC was filed, meaning the special mechanisms were inapplicable.

The court said it had consistently held that SPCs were designed merely to re-establish the effective protections of basic patents so as to offset the years spent bringing drugs to market, and that SPCs could only be granted to medicinal products with valid marketing authorisations that were protected by a patent in force. As such, it added, “there is an unbreakable connection between the existence of an SPC and that of a basic patent, since, if there is no basic patent, a product cannot be protected by an SPC.”

With this in mind, the ECJ concluded that, in circumstances were the legal system in new member states didn’t provide for the possibility of equivalent protection at the time a basic patent for a medicinal product was filed in a different member state, the special mechanisms in the new states’ acts of accession allowed the holder of the patent or its SPC to oppose parallel imports of the drug.

The court added that the special mechanisms applied even in cases where the duration of an SPC had been extended by a decision similar to that of the DPMA in 2012.