Enbrel (etanercept) from the accession states: the Specific Mechanism reaches SPCs and paediatric extensions too

What was decided

Etanercept, the active ingredient of Enbrel, was claimed in European Patent 0 939 121, applied for on 31 August 1990 and expired on 31 August 2010. Pfizer’s German SPC on it, applied for in June 2003 and granted in January 2006, ran from September 2010 to 1 February 2015, and in October 2012 the German office extended it by six months, to 1 August 2015, for paediatric studies.

In November 2012 a parallel importer notified Pfizer that it would import Enbrel into Germany from Estonia and Latvia, and from February 2015 from Bulgaria, the Czech Republic, Hungary, Poland, Romania, Slovakia and Slovenia. Packs made up for Poland, Slovenia, Lithuania and Croatia were found on the German market in April 2015. Pfizer sued in Düsseldorf in June 2015 for infringement of the SPC and of its extension.

Two things were common ground. On 31 August 1990, when the basic patent was filed, none of the exporting states allowed a patent on a pharmaceutical product. On 26 June 2003, when the German SPC was applied for, all of them except Croatia allowed SPCs. The importer’s argument was that the patent and the SPC must be looked at separately: the Specific Mechanism protects a patent or SPC “filed in a Member State at a time when such protection could not be obtained” in the new state, and when the SPC was filed, SPC protection could be obtained. The Düsseldorf court referred four questions.

The relevant date. The Court of Justice (Second Chamber, Judge Toader as rapporteur, following Advocate General Tanchev) held that the Mechanisms are a derogation from free movement and must be read strictly, but that an SPC cannot be separated from its basic patent: it exists only to extend the patent’s protection, and a holder who could not obtain the patent in the exporting state could never have obtained the SPC there either. The date that matters is therefore the filing date of the basic patent. An SPC holder in an older member state may oppose imports from a new member state where equivalent protection was unavailable when the basic patent was filed, even if it became available before the patent was published or before the SPC was applied for.

The paediatric extension. The Acts of Accession do not mention the six-month extension, and the Paediatric Regulation of 2006 did not exist when the 2003 and 2005 Acts were concluded. The Court held that this does not matter: the extension is ancillary to the SPC, is calculated as part of its duration under the SPC Regulation, and serves a comparable purpose; to leave it outside the Mechanism would open a six-month hole in the protection. The Mechanism applies to the extension. Arguments about the price effect of the ruling did not alter the analysis.

Timeline

Date	Event
31 August 1990	Basic patent EP 0 939 121 applied for; no pharmaceutical product patents available in the future accession states
2000	Enbrel first authorised
26 June 2003	German SPC applied for; SPCs by then available in every accession state except Croatia
11 January 2006	SPC granted
31 August 2010	Basic patent expires; SPC takes effect
October 2012	Paediatric extension granted, to 1 August 2015
November 2012	Importer notifies Pfizer of imports from Estonia and Latvia
1 February 2015	SPC’s ordinary term ends; the extension runs on; importer extends its notice to seven more states
April 2015	Packs for Poland, Slovenia, Lithuania and Croatia found on the German market
1 June 2015	Pfizer sues in Düsseldorf
15 December 2016	Düsseldorf refers four questions
7 February 2018	Advocate General Tanchev’s opinion
21 June 2018	Court of Justice judgment

What it means if you are…

A parallel trader. The Mechanism’s reach is set by the oldest right in the chain, the basic patent, and it runs to the end of the youngest, the paediatric extension. The comparison to make is the basic patent’s filing date against the date the exporting state began granting pharmaceutical product patents; whether SPCs were available when the SPC was filed is beside the point. By the time of this ruling that comparison bit only on the last SPCs of patents filed in the early 1990s, and those have since run out for the 2004 and 2007 states.

A generics or biosimilar planner. The case says nothing about biosimilar entry, which turned on the same SPC and extension dates in the ordinary way; etanercept biosimilars reached Europe once they had passed. Its value is as the clearest statement from the Court that an SPC and its extension are one continuous protection growing out of the basic patent, a reading that matters wherever an SPC’s scope is in issue.

A wholesaler or buyer. Imports from the newer member states during an SPC’s paediatric extension were not a safe harbour, and the German court could treat them as infringing for the six months in question. Where a product’s extension is in force in the destination country, the import position is the same as during the SPC proper.

Status and what to watch

The questions the Mechanism raised are now answered: this case fixed the date and the rights, and the Singulair case fixed the notice. For the states that joined in 2004 and 2007 the Mechanism has done its work, since every patent it could cover has reached the end of its SPC and extension. Croatia, where SPCs date only from accession in July 2013, is the one state where it can still arise, and its application there has not been tested beyond this reference. This note is a summary for commercial readers and is not legal advice.