Singulair (montelukast) from Poland: the Specific Mechanism's one-month notice, and what silence costs

What was decided

Merck Canada held the UK part of European Patent 0 480 717, claiming montelukast, the active ingredient of the asthma medicine Singulair, and the SPC on it. Montelukast was first authorised in the EU in Finland in August 1997, and in the UK in January 1998. Poland did not allow patents on pharmaceutical products when the Merck patent was filed, so the Specific Mechanism in the 2003 Act of Accession let Merck rely on its UK patent and SPC to stop Singulair bought in Poland being imported into the UK, provided the importer had given a month’s notice.

On 22 June 2009 Pharma XL, a company in the Sigma group, wrote to the Regulatory Affairs Manager of Merck Sharp & Dohme Ltd at Hoddesdon saying it intended to import Singulair 5 mg and 10 mg from Poland, referring to the Specific Mechanism and asking whether there was any objection. MSD held the UK marketing authorisation but, at that date, no rights in the patent or the SPC; the exclusive licensee was an Irish group company. No reply came. Pharma XL applied to the MHRA for parallel import licences in September 2009, obtained them in May and September 2010, sent three further trade-mark notification letters that also went unanswered, and Sigma began importing. On 14 December 2010 Merck’s solicitors objected. Sigma stopped at once, having sold more than £2 million of Singulair and holding more than £2 million of repackaged stock.

Merck sued in June 2011. The Patents County Court (Judge Birss QC) found for Merck in April 2012: the patentee did not have to show an intention to object before an import became an infringement, Merck was not estopped by its silence, and the court ordered an injunction, an inquiry as to damages and delivery up of the unsold stock. The Court of Appeal (Lord Justice Kitchin) dismissed the estoppel argument, since the letter imposed no duty on Merck to answer, but found the meaning of the Mechanism unclear enough to refer three groups of questions to the Court of Justice.

The Court of Justice’s three rulings. First, the Mechanism does not require the holder to notify its intention to object before invoking its rights. But the one-month period exists so that the holder can object promptly and the importer can know where it stands; if the holder lets the month pass in silence, the importer may lawfully apply for its licence and import, and the holder cannot rely on its rights against the importation and marketing carried out before it finally objected. It may still object to future imports; it has lost compensation for the past, not the right for the future. Second, the notice must be given to the holder of the patent or SPC, or to its “beneficiary”, meaning a person who enjoys rights under the patent or SPC by law, typically a licensee. A group company that merely holds the marketing authorisation, or that in practice receives such letters, is not enough: patents and SPCs are public documents and finding the holder is no great burden on the importer. Third, the notice need not be given by the importer personally; a licence-holding group company may give it, provided the person who will actually import can be clearly identified from it.

For Sigma the second ruling was the problem. Its letter had gone to the UK marketing company, which held no rights in the patent or SPC when the letter was sent, so Merck’s silence in response to it carried no consequence. No later reported judgment of the Court of Appeal was found; the dispute appears to have ended without one.

Timeline

Date	Event
25 August 1997	First EU marketing authorisation for Singulair (Finland); UK authorisation 15 January 1998
22 June 2009	Pharma XL writes to MSD’s UK Regulatory Affairs Manager giving notice of imports from Poland; no reply
14 September 2009	Parallel import licence applications filed with the MHRA
21 May and 10 September 2010	Parallel import licences granted for 5 mg and 10 mg; imports begin
14 December 2010	Merck objects; Sigma stops sales on receipt two days later
10 June 2011	Merck sues in the Patents County Court
27 April 2012	Judgment for Merck; injunction, inquiry as to damages, delivery up
18 April 2013	Court of Appeal refers the Mechanism questions to the Court of Justice
2013	The UK SPC, with its paediatric extension, reaches its end
23 October 2014	Advocate General Jääskinen’s opinion
12 February 2015	Court of Justice judgment (Third Chamber, Judge Fernlund as rapporteur)

What it means if you are…

A parallel trader. Three rules of conduct come out of this case, and they outlast the Mechanism itself. Address the notice to the registered holder of the patent or SPC, and to any recorded licensee, not to the local marketing company; the register tells you who that is. Say in the notice who will import, if the licence applicant is a different company. Then wait the month. Silence after a properly addressed notice protects you for the imports you make before an objection arrives, but it is not consent: the holder can still stop you from the day it objects, and stock on hand at that date is at risk.

A generics or launch planner. The case is about the originator’s own product moving between member states; it has nothing to say about generic entry. Its general lesson is the one the Court of Appeal stated: a patentee is under no duty to answer a letter, and a non-reply is not a licence.

A wholesaler or buyer. Stock bought from an importer who is later stopped can be the subject of a delivery-up order, as Sigma’s unsold £2 million was. Where supply depends on a parallel import licence from a state the Mechanism covered, ask the importer who it notified and when.

Status and what to watch

The Mechanism’s window for Poland and the other 2004 accession states has closed: the patents it could bite on, filed before those states allowed pharmaceutical product patents in the early 1990s, have reached the end of their SPCs and paediatric extensions. The rules on notice from this case remain the template for Croatia, where the Mechanism of the 2012 Act of Accession is still in force, and for any future accession. The Court of Justice’s 2018 ruling on Enbrel settled the other open question, which date and which rights the Mechanism covers; it is in the companion note. This note is a summary for commercial readers and is not legal advice.