The "Special Mechanism": some 'Merck-y' questions for the CJEU

In April The SPC Blog reported on Merck Canada Inc and another v Sigma Pharmaceuticals plc [2013] EWCA Civ 326, a Court of Appeal for England and Wales reference to the Court of Justice of the European Union (CJEU) for preliminary rulings on a number of questions -- not precisely articulated at that time -- on SPCs and the "special mechanism". Case C-539/13 Merck Canada and Merck Sharpe and Dohme.

The UK Intellectual Property Office (IPO) is now seeking your opinion as to how these questions should be answered. Writes the IPO:

"We have received notification of a new case referred to the Court of Justice: C-539/13. This is a request for a preliminary ruling in a case concerning the importation into the UK from Poland of a drug by the defendant. The claimant states that the importation of the drug in question was an infringement of the Claimant companies' rights covered by a Supplementary Protection Certificate.

The filing date of the application for the Patent was prior to the date when Poland introduced patent protection for pharmaceutical products under its laws, and the application date for the SPC was before the date when SPCs could be applied for under the laws of Poland.

The questions referred relate to the Specific Mechanism in Chapter 2 of Annex IV to the Act concerning the conditions of accession of (inter alia) the Republic of Poland".

The questions are somewhat cumbersome on account of their interrelationship:

Conditions for reliance upon the Specific Mechanism

1. May the holder, or his beneficiary, of a patent or supplementary protection certificate rely upon his rights under the first paragraph of the Specific Mechanism only if he has first demonstrated his intention to do so?

2. If the answer to Question 1 is yes:

(a) How must that intention be demonstrated?

(b) Is the holder, or his beneficiary, precluded from relying upon his rights with respect to any import or marketing of the pharmaceutical product in a Member State that occurred prior to the demonstration of his intention to rely upon those rights?

The notifier

3. Who must give the prior notification to the holder or beneficiary of a patent or supplementary protection certificate under the second paragraph of the Specific Mechanism? In particular:

(a) Must the prior notification be given by the person intending to import or market the pharmaceutical product?

or

(b) Where, as permitted by the national regulatory system, an application for regulatory approval is made by someone other than the intended importer, can prior notification given by the applicant for regulatory approval be effective if that person does not itself intend to import or market the pharmaceutical product but where the intended importation and marketing will be carried out under the applicant's regulatory approval?; and

(i) Does it make any difference if the prior notification identifies the person that will import or market the pharmaceutical product?

(ii) Does it make any difference if the prior notification is given and the application for regulatory approval is made by one legal person within a group of companies which form a single economic unit, and the acts of importation and marketing are to be carried out by another legal person within that group under licence from the first legal person, but where the prior notification does not identify the legal person that will import or market the pharmaceutical product?

Who should be notified? 

4. To whom must prior notification be given under the second paragraph of the Specific Mechanism? In particular:

(a) Is the beneficiary of a patent or supplementary protection certificate limited to persons who have a legal right under national law to bring proceedings to enforce that patent or supplementary protection certification?

or

(b) In a case where a group of companies forms a single economic unit comprising a number of legal entities, is it sufficient if the notification is addressed to a legal entity which is the operating subsidiary and marketing authorisation holder in the Member State of importation rather than the entity within the group that has a legal right under national law to bring proceedings to enforce that patent or supplementary protection certificate, on the basis either that such legal entity may be characterised as a beneficiary of the patent or SPC. or that it is to be expected that such notification in the ordinary course of events will to come to the attention of the persons who make decisions on behalf of the patent or SPC holder?

(c) If the answer to Question 4(b) is yes, is a notification which is otherwise compliant rendered non-compliant if it is addressed to the "the Manager, Regulatory Affairs" of a company when that company is not the entity within the group that has a legal right under national law to bring proceedings to enforce that patent or supplementary protection certificate but is the operating subsidiary or marketing authorisation holder in the Member State of importation and when that Regulatory Affairs department in practice regularly receives notifications from parallel importers regarding the Specific Mechanism and other matters?

Adds the IPO (if you're still reading after all this!):

"If you would like to comment on this case please email policy@ipo.gov.uk by 27 November 2013. 

We understand how difficult it is to provide detailed comments in the time available. The IPO has tight time limits in which to consider and provide advice to ministers on ECJ cases. In order to help us provide the right advice, we just need a short email by the deadline stating whether you think the UK should intervene and some general points about how you think we should answer the questions.  

You are welcome to follow this email up with more detailed comments after the deadline, which can be taken into consideration if we have chosen to submit observations or if we decide to attend a hearing".