The Specific Mechanism: when a patent could stop a parallel import from the newer member states

The rule it is an exception to

Once a patentee puts a medicine on the market anywhere in the European Economic Area, or allows someone else to, its patent rights in that pack are exhausted: it cannot use a patent in another member state to stop the pack being bought there cheaply and resold. That is the rule that parallel trade rests on, and the Court of Justice has applied it since the 1970s even where the exporting country gave the patentee no patent at all, on the footing that a patentee who chooses to sell in an unpatented market takes the consequences.

When ten states joined the EU on 1 May 2004, that rule would have opened the older markets to imports of medicines first sold in countries that, until the 1990s, had not allowed patents on pharmaceutical products at all. The originator had never had the chance to patent there. The 2003 Act of Accession therefore carved out an exception, repeated in the 2005 Act for Bulgaria and Romania and the 2012 Act for Croatia, and called in each the Specific Mechanism.

What it says

The 2003 text, as the Court of Justice quotes it:

With regard to the Czech Republic, Estonia, Latvia, Lithuania, Hungary, Poland, Slovenia or Slovakia, the holder, or his beneficiary, of a patent or supplementary protection certificate for a pharmaceutical product filed in a Member State at a time when such protection could not be obtained in one of the abovementioned new Member States for that product, 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, even if the product was put on the market in that new Member State for the first time by him or with his consent.

Any person intending to import or market a pharmaceutical product covered by the above paragraph in a Member State where the product enjoys patent or supplementary protection shall demonstrate to the competent authorities in the application regarding that import that one month’s prior notification has been given to the holder or beneficiary of such protection.

Cyprus and Malta, which had long allowed pharmaceutical patents, are left out. So three things have to be true for the Mechanism to apply to a product moving from, say, Poland to the UK or Germany:

1. The product is protected by a patent or SPC in the destination state.
2. That patent was filed at a time when equivalent protection could not be obtained in Poland for that product.
3. The importer has given the holder a month’s notice, and can show the licensing authority that it has.

The dates it turns on

The second condition is a comparison of two dates: when the patent was filed in the destination state, and when the exporting state began granting patents on pharmaceutical products. MPA compiled the second set in 2011; they are a guide, to be checked against the national office before anything turns on them.

Exporting state	Pharmaceutical product patents available from
Czech Republic	1 January 1991
Slovakia	1 January 1991
Romania	21 January 1992
Slovenia	4 April 1992
Latvia	31 March 1993
Poland	16 April 1993
Bulgaria	1 June 1993
Lithuania	1 February 1994
Estonia	23 May 1994
Hungary	1 July 1994

A worked example from MPA’s original note: a UK patent application filed in 1992, granted in 1998, first authorised in the EEA in 2000, patent expiring in 2012 and SPC in 2015. Estonia had no pharmaceutical product patents in 1992, so the Mechanism applied, and the product could not be brought from Estonia into the UK until the SPC ran out in 2015, eleven years after Estonia joined.

The two rulings that fixed how it works

The treaty text left most of the practical questions open, and for a decade there was almost no case law, because importers rarely had the resources to test it. Two references then settled the main points.

Singulair, 2015. Sigma imported Merck’s Singulair from Poland after writing to MSD’s UK marketing company and hearing nothing for eighteen months. The Court of Justice held that the patentee need not announce in advance that it will object; but a holder who lets the month pass in silence cannot claim for the imports made before it does object, though it can still stop future ones. The notice must go to the holder of the patent or SPC or to a person with rights under it, such as a licensee, not to a group company that merely holds the marketing authorisation; and it can be sent by someone other than the importer so long as it makes clear who will import. Sigma’s letter had gone to the wrong company. The case note.

Enbrel, 2018. An importer brought Enbrel into Germany from the accession states during the paediatric extension of Pfizer’s SPC, arguing that SPCs had been available in those states when Pfizer applied for its SPC in 2003, so the SPC was not a right “filed at a time when such protection could not be obtained”. The Court held that an SPC cannot be separated from its basic patent: the date that counts is the filing date of the basic patent, and if the patent could not be had in the exporting state then, the Mechanism covers the patent, the SPC and the six-month paediatric extension, even though protection became available there later. The case note.

Between them: the Mechanism’s reach is set by the oldest right, the basic patent, and lasts to the end of the youngest, the extension; and it is enforced by notice, with silence costing the holder its damages but not its injunction.

What to check

1. Whether the destination country’s patent or SPC is in force at all; if it is not, nothing else matters.
2. For an import from Croatia, the basic patent’s filing date against the date Croatia granted equivalent protection, and whether the destination SPC or extension is still running.
3. For any notice under the Mechanism, that it goes to the registered holder and any recorded licensee, names the importer, and is kept with proof of delivery; and that the month has run before the licence application.
4. For an old dispute or a historical price series, which of the dates above applied; the Mechanism explains why some products stayed out of the UK and Germany from the East for a decade after 2004.

MPA Search records the filing date of each patent and SPC by country, so the comparison the Mechanism calls for can be made from the record rather than reconstructed.