In the Netherlands, the Anti-Piracy Regulation (APR) has also
been applied to in transito goods. This means that goods
merely transiting the Netherlands from one country outside the EU
to another country outside the EU may also be detained by customs
This has proved to be controversial. Seizures of generic
medicines in transito by Dutch customs set off a worldwide
debate. A UK court recently declined this broad view on the scope
of the APR, although it recognised that its conclusion was not
Following questions in November 2009 from the UK Court of Appeal
and the Antwerp Court of First Instance, the European Court of
Justice (ECJ) now will answer the question of whether or not
(Dutch) customs are rightfully detaining goods in transito
with the APR as legal basis. Prior to the ECJ's judgment,
Advocate General Cruz Villalón delivered his Opinion on 3
Regulation (EC) 1383/2003 is the fourth Anti-Piracy Regulation
(APR). Under the provisions of the regulation, national customs
authorities have the right to detain or suspend the release of
goods if the goods are suspected of infringing an IP right. Customs
can take action based on an application by the right holder or
Scope of the APR
The current APR covers almost all intellectual property (IP)
rights, including patent, trademark and design rights as well as
copyright. Furthermore, customs authorities can take action against
all movements of goods, including import, export and
trans-shipment. Two important exceptions however apply: goods
moving within the EU and legitimate parallel imports are not
covered by the APR.
APR: also for goods in transit?
In the Netherlands, the APR has also been applied to in
transito goods on the basis of the "manufacturing
fiction". This means that a court employs the fiction that
in transito goods are produced in the Netherlands for the
purpose of establishing IP infringement. In the current APR the
manufacturing fiction can be derived from Recital 8, which states
that national infringement proceedings "will be conducted with
reference to the criteria used to establish whether goods produced
in that Member State infringe intellectual property rights".
In the previous APR (Regulation (EC) 3295/94) a similar rule could
be found in Article 6(2)(b).
The opinion of AG Gruz Villalón
In the case from the UK Court of Appeal (Nokia/HMRC),
UK customs authorities took the position that it would be unlawful
to seize in transito goods in the absence of evidence that
the goods might be diverted onto the EU market.
In his Opinion, AG Cruz Villalón held that customs may
seize in transit goods in the EU if "there are sufficient
grounds for suspecting" the goods are counterfeit and are
to be put on the market in the EU, either in conformity with a
customs procedure or by means of illicit diversion.
In the Belgium case (Philips/Lucheng Meijing), the
Court of Antwerp asked whether Article 6(2)(b) of the previous APR
entails that a court cannot take account of the in
transito status and must apply the fiction that the goods were
manufactured in the same member state, and consequently determine
on the basis of that law whether the law of the same member state
if such goods infringe the IP right in question.
The AG Cruz Villalón held that courts in EU member states
should not ignore the in transito status of goods when
ruling whether the goods infringe IP rights, thereby rejecting the
manufacturing fiction. To this end, AG Cruz Villalón
considered inter alia that the object of the APR is to
prevent counterfeit and pirated goods from being placed on the EU
market, not to prohibit their transit even before their destination
Consequences for your company?
We are more than happy to discuss with you the possible impact
of this Opinion on your IP enforcement strategies.
This publication describes the legal situation as of 7 February
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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Intellectual Property in the Life Sciences, second edition, which is published by Globe Law and Business and edited by Taylor Wessing and contains chapters written by Taylor Wessing lawyers, has been reviewed...
Legislative developments are two-fold: those affecting medicinal products marketed in the Strict Regulation Countries, and those affecting all medicinal products.
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