Opinion of the Advocate General — ECLI:EU:C:1997:93
Date: 1997-02-27
Language of the case: Dutch
Based on: Treaty establishing the European Economic Community (1957)
Subject matter: Free movement of goods;Intellectual, industrial and commercial property;Approximation of laws;Patents
Procedure: Reference for a preliminary ruling
Origin: Netherlands

Summary of the Judgment
1. Free movement of goods — Quantitative restrictions — Measures having equivalent effect —
Use by a third party, with a view to obtaining a marketing authorization, of samples of a
medicinal product manufactured in accordance with a patented process — Opposition on the
part of the patentee — Circumstances amounting to a measure having equivalent effect —
Justification — Protection of industrial and commercial property
(EC Treaty, Arts 30 and 36)
I - 3929
SUMMARY — CASE C-316/95
2. Free movement of goods — Quantitative restrictions — Measures having equivalent effect —
Use by a third party, with a view to obtaining a marketing authorization, of samples of a
medicinal product manufactured in accordance with a patented process — Obtention of
authorization — Court order prohibiting marketing of the product for a specified period fol­
lowing expiry of the patent — Circumstances amounting to a measure having equivalent
effect —Justification — Protection of industrial and commercial property — Period of prohi­
bition exceeding that provided for in Directives 65/65 and 75/319 — Compatible with Com­
munity law
(EC Treaty, Arts 30 and 36; Council Directives 65/65, Art. 7, and 75/319, Art. 4(c))
1. Application of a rule of national law
which gives the proprietor of a patent in
respect of a manufacturing process for a
medicinal product the right to oppose the
submission by another person, before the
expiry of the patent in question, of
samples of medicinal products manufac­
tured in accordance with that process to
the authority competent for issuing mar­
keting authorizations constitutes a meas­
ure having equivalent effect to a quantita­
tive restriction within the meaning of
Article 30 of the Treaty. In the absence of
such a provision, it cannot be ruled out
that marketing authorization, the issuing
of which involves a certain delay, might
already be obtained while the patent was
still valid or that a medicinal product
manufactured in accordance with the
same procedure and legally in circulation
in another Member State could conse­
quently be imported immediately after
the expiry of the patent.
Application of such a rule is none the less
justified under Article 36 of the Treaty on
grounds relating to the protection of
industrial and commercial property. The
right which it confers on a patentee
relates to the specific subject-matter of
the patent — which includes, in particu­
lar, allowing the holder a monopoly of
first exploitation of his product — and to
preclude application of a national rule
providing for that right would in fact be
to allow an encroachment on that
monopoly.
2. When a person other than the patentee
has infringed the patent laws of a Mem­
ber State by submitting, before the expiry
of the patent in question, samples of a
medicinal product manufactured in
accordance with a patented process to the
authority competent for issuing market­
ing authorizations and has thus obtained
the authorization sought, an order of a
national court prohibiting the infringer
from marketing such a product for a
specified period following the expiry of
the patent in order to prevent him from
deriving any unfair profit from his
infringement constitutes, in so far as it
prohibits the marketing in one Member
State of a product lawfully sold in
another Member State, a measure having
equivalent effect within the meaning of
Article 30 of the Treaty.
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GENERICS v SMITH, KLINE & FRENCH
However, since the patentee, if the
infringer had respected his rights, could
have continued to market his product
without competition throughout the
period required to obtain the marketing
authorization, a temporary prohibition
placed by court order on the infringer, in
so far as it seeks to place the proprietor of
the patent in the position in which he
would, in principle, have been had his
rights been respected, cannot in itself be
held to be a disproportionate form of
reparation and is thus capable of being
justified under Article 36 of the Treaty on
grounds relating to the protection of
industrial and commercial property.
Community law, and in particular Article
36 of the Treaty, does not preclude such a
court order from being imposed for 14
months after the expiry of the patent,
when that period, although exceeding the
maximum period authorized by Article 7
of Directive 65/65 read in conjunction
with Article 4(c) of Directive 75/319,
both relating to proprietary medicinal
products, corresponds to the actual aver­
age duration of such a procedure in the
Member State concerned. The effect of
such a period of prohibition is to place
the proprietor of the patent in the posi­
tion in which he would in principle have
been if his rights had been respected. In
addition, the circumstance that the
14-month period exceeds the period pro­
vided for in the directives cannot be
relied on by an infringer as against the
proprietor of the patent without accept­
ing the risk of favouring the infringer
over the victim of the infringement.
I-3931