# C_2014009EN.01001901.xml

| 11.1.2014 | EN | Official Journal of the European Union | C 9/19 |
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Reference for a preliminary ruling from Court of Appeal (United Kingdom) made on 14 October 2013 — Merck Canada Inc., Merck Sharp & Dohme Ltd v Sigma Pharmaceuticals PLC

(Case C-539/13)

2014/C 9/29

Language of the case: English

Referring court

Court of Appeal

Parties to the main proceedings

Applicants: Merck Canada Inc., Merck Sharp & Dohme Ltd

Defendant: Sigma Pharmaceuticals PLC

Questions referred

| 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? |
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| 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? | (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? |
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| (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? | | | | |

| 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? | (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? | (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? |
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| (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? | (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? | | | | |
| (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? | | | | | | | | |

| 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? | (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? |
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| (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? | | | | | | |

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