[Ip-health] Public Citizen comments on customs regulation 1383/2003
peter.maybarduk at essentialinformation.org
peter.maybarduk at essentialinformation.org
Mon Jun 7 08:01:49 PDT 2010
[Apologies for cross-posting.]
Public Citizen's comments to the European Commission on the DG TAXUD
consultation paper, Review of EU legislation on customs enforcement of
intellectual property rights, are available here:
Summary: Findings and recommendations
* The European Commission should propose revisions to Council Regulation
1383/2003 limiting ex officio intellectual property customs actions to
cases of willful commercial scale trademark counterfeiting and willful
commercial scale copyright piracy.
* Accordingly, patent infringement, similar marks and other civil
intellectual property infringements should be excluded from the
regulation, and excluded from customs actions absent a judicial order or
equivalent legal process. (Textual references in 1383/2003 to other
intellectual property rights should be deleted.)
* These limitations on the scope of the regulation should apply equally to
goods entering or exiting the European market and goods in transit. But
if the revised regulation continues to cover a broad range of intellectual
property categories for goods destined for the European market, then the
provisions applied to goods in transit nevertheless should be limited to
willful trademark counterfeiting and copyright piracy on a commercial
scale. Commercial rights held in EU member states should not impede the
free movement of legitimate goods that are not destined for the EU market.
Intellectual property rights are national (or, in some cases, European
Community) in scope. Stopping legitimate in transit goods may create a de
facto international intellectual property regime, beyond the appropriate
scope of EU authority, with global costs for competition.
* Among IP infringements, only willful commercial scale trademark
counterfeiting of certain potentially dangerous classes of products poses
a categorical public safety risk. Willful commercial scale counterfeiting
and willful commercial scale piracy are criminal offenses under
TRIPS, and appropriate targets for law enforcement actions at state
* By contrast, other categories of IP infringements - civil infringements,
including patent and similar, non-counterfeit trademark infringement -
do not pose an inherent safety risk. Civil infringements generally do
not represent a fraud on the public. Generally, alleged civil
infringements are fundamentally commercial disputes between legitimate
entities, for which traditional legal remedies are and should be
available. As civil infringements are not fakes, and the parties
generally do not operate in a cloak of secrecy in the manner of criminal
organizations, they do not require preemptive law enforcement interdiction
wherever they appear in the channels of commerce. Rather, assessing
infringement requires judicial process, and often, expert legal analysis,
that is beyond the competence of customs authorities.
* Council Regulation 1383/2003 does not adequately distinguish between
civil and criminal infringement (with the exception of a few provisions of
limited but important effect, such as Article 14). Treating civil and
criminal infringements equally imposes costs on competition, including but
not limited to restricting the free movement of generic medicines.
To support these recommendations, our subsequent comments (available at:
* Note the essential role of competition and the generics trade in
promoting global access to safe, effective and affordable medicines,
* Note the risks to access to medicines that overly broad intellectual
property enforcement measures can pose,
* Analyze the relationship between the major categories of intellectual
property infringement and the interests of health and safety,
distinguishing between civil, similar mark infringement and criminal
We draw on the above to answer consultation paper questions one and two in
further detail (situations in which customs authorities should be
competent to take action; range of intellectual property rights the
regulation should cover and possible derogations), and suggest some
specific revisions to the text of 1383. We conclude with a few further
recommendations to protect consumers from fraudulent, unsafe products.
 We note the importance of de minimis provisions to prevent costly and
draconian enforcement measures against the citizenry.
 Article 61.
 See discussion infra, Relationship of IP categories to health and safety.
 Article 14 provides for release of goods suspected of certain civil
infringements, with payment of a security, under certain conditions,
including initiation of a procedure to determine whether an intellectual
property right has been infringed.
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