The CJEU rules on imports of patented pharmaceutical products from new EU Member States

On February 12, 2015
the CJEU handed down a ruling (case C-539 / 13) on the interpretation of the specific mechanism provided for in chapter 2 of annex IV of the
Act relating to the conditions of accession of the Czech Republic, the Republic
of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of
Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of
Poland, the Republic of Slovenia and the Slovak Republic, and to
adaptations of the Treaties on which the Union is based (“2003 Act of Accession  

This standard provides for a mechanism that empowers holders of patents or complementary protection certificates (SPCs) on
pharmaceutical products to oppose the importation of such products from
the new member states in which, at the time of applying for the patent
or CCP, such protection could not be obtained. What this standard establishes is a
exception to the principle of patent exhaustion. This exception is specified in the requirement that those who are going to import or market products
pharmaceuticals from the new Member States in a Member State where such product
is protected by a patent or SPC, notify
one month in advance to the owner or beneficiary of said patent or CCP
his intention to do so.

The sentence is due to a
dispute regarding the parallel importation from Poland to the United Kingdom of
pharmaceutical product called Singulair. Merck Canada, Inc. (“Merck Canada”)
is the holder of a patent and SPC on an active ingredient that is incorporated
on Singulair. Merck Sharp and Dohme (“MSD”) is the exclusive licensee of
said patent and SPC. Pharma XL Ltd (a company linked to Sigma) notified MSD
its intention to import Singulair from Poland to the United Kingdom. After three
months since you first reported it, Sigma begins to import
Singulair from Poland. It was not until several months later that Merck
expresses its opposition to said import, at which time Sigma paralyzes
Singulair imports. Still, Merck Canada and MSD
initiate patent infringement proceedings against Sigma for the acts
of Singulair that Sigma had carried out until now. He
The matter reaches the Court of Appeal of England and Wales, which suspends the
procedure to ask the CJEU about the interpretation of the aforementioned
specific mechanism of Chapter 2 of Annex IV to the 2003 Act of Accession.
The main question that arises, among others, can be summarized as follows:
Following way: If the owner or beneficiary of the patent or SPC who wants
prevent the importation in question must express it in advance and, in such
case, how should said opposition be formulated.

Indeed, the ambiguity of
applicable normative statement lends itself to conflicting interpretations. So
occurs in the main proceedings, in which the positions held by each
one of the parts They can be summarized as follows:

– On the one hand, Sigma maintains that
the provision of the rule on the importer's obligation to notify the
patent holder or CCP one month in advance of his intention to import
the protected product, implies that, once the notification has been made and after the
period of one month without the owner or beneficiary of the protection invoking his
rights, the importer will have the right – once the authorization of the
competent authorities - to import and market said product in the State
member in question. It understands, consequently, that the term imposed by
The norm entails the implicit obligation of the owner or beneficiary of the
patent to exercise your rights fairly and notify your intention to
invoke them within the aforementioned period, since the opposite would mean for the
importer a situation of legal uncertainty detrimental to his interests and
legitimate expectations.

– For its part, Merck maintains
that the repeated specific mechanism does not impose no obligation to the owner or
beneficiary of the patent or SPC to previously notify his intention to
prohibit parallel import, an obligation that, to exist, should have
expressly provided for, both in its enforceability and in the modality or
modalities of its fulfillment.

The CJEU rules in accordance with
the following assessments: (i) the owner or beneficiary of a patent who,
pursuant to the aforementioned specific mechanism, wants to prohibit an import
parallel of a pharmaceutical product, is not obliged, in order to be able to invoke its
rights on that product, to express their opposition to the importation into the
period of one month. However, (ii) if within that period of one month, the owner or
beneficiary does not express his opposition to the import, the parallel importer
–once obtained the corresponding authorization from the authorities
competent authorities - may proceed to import and market it; therefore, in
consequence, (iii) the owner or
beneficiary of the patent or CCP will not be able to invoke its rights with respect to the
import and marketing of the pharmaceutical product in question
made before it has expressed its intention to prohibit it.

It can be concluded that the
ruling contributes to establishing the meaning and scope of the regulatory norm
of the specific mechanism provided for in the 2003 Act of Accession on the basis of
a balanced balance between the rights conferred by patents and SPCs and
the principle of free movement of goods in the EU.