case against ACTA
While it is claimed that ACTA will protect against falsified
medicines by allowing countries and companies to take strong measures
in trademark disputes, this may in fact impede access to genuine
are several issues here. First, not all trademark disputes amount
to a public health problem. Only 'wilful trademark counterfeiting
on a commercial scale' - a form of fraud with a deliberate intention
to exactly copy a product's branding - presents a legitimate public
health concern. The World Trade Organisation itself distinguishes
between 'trademark counterfeiting' and 'trademark infringement'.
This means that trademark infringement disputes that companies
may have over similar names or packaging by competitors cannot
be considered as trademark counterfeiting.
ACTA blurs this distinction. This means it would require countries
to impose stringent intellectual property enforcement measures
for civil trademark confusion disputes. Worryingly, disputes over
allegations of similar-sounding names or packaging are common
in the medicines field, as companies will often choose brand names
for medicines that sound inevitably similar, in that they are
derived from the drug's international non-proprietary name (INN).
Similar names and packaging are often even desirable to demonstrate
medical equivalency, but they do not mean that the medicines are
unsafe or indeed that there has been a trademark infringement.
even extends enforcement to patent challenges. These IP infringements
are generally commercial disputes where no inherent public health
concerns exist. While patents and protection of undisclosed information
are explicitly excluded from the border measures and criminal
enforcement sections of the agreement, significantly reducing
the negative effects on access to medicines, a number of provisions
apply to patents and data protection as the default position,
although signatories to ACTA 'may exclude' them. As has been noted,
this suggests that such exclusion should be the exception and
not the norm, and it is highly likely that such distinctions will
be blurred in the course of negotiations with developing countries.
ACTA's civil enforcement section may also allow expanded enforcement
efforts based on fictional patent claims. These efforts favour
rights holders and contain few if any safeguards for defendants
or third parties.
ACTA allows the border detention of in-transit medicines destined
for developing countries, which will interfere with the trade
in legitimate medicines, and leaves trade in generic medicines
open to disruption.
the border measures section of ACTA no longer includes patents,
it still includes civil trademark infringement. This means a customs
official could decide to detain and even destroy an allegedly
infringing good - without any court oversight or even notification
to the rights holder or the generic company alleged to have violated
the trademark - on the basis of the customs official's own view
on whether the goods in question infringe a commercial trademark.
risks to access to medicines of such overbroad provisions have
been recently highlighted when medicines were detained in Germany
based on the wrong assumption that a generic medicine, using the
required international non-proprietary name 'amoxicillin' to describe
the contents, infringed GlaxoSmithKline's trademark on the brand
name Amoxil (which besides is itself a use of the INN). At the
core of this detention was an expansive EU customs regulation
designed to expand the enforcement of IP rights that led to many
other detentions of medicines in transit between developing countries
which were not IP-protected in the source or destination countries.
ACTA, too, even legitimate medicines just transiting through an
ACTA member country could be temporarily or permanently seized.
Ex officio mechanisms without judicial review - and allowing the
detention, seizure, and even destruction of goods - are susceptible
to over-enforcement. Civil trademark infringement is a very grey
area of fact and degree that requires judicial oversight to resolve.
It is not appropriate for untrained border guards acting ex officio
to make determinations that courts are best suited to make - particularly
in cases where the result of these determinations would be the
denial of medicines to patients.
holders could also use border measures as a commercial tactic
to delay or destroy rivals' goods on a mere allegation of similar
names, without a health threat, before a court hearing to determine
whether their claim is in fact valid.
expands also the TRIPS requirement on border measures for import
to cover export as well. For countries which are exporters of
generic medicines for the developing world, the application of
border measures to exports threatens to disrupt the lifeline for
ACTA acts as a deterrent to the production and trade in generic
medicines, as it provides for excessive punishment, shifts the
risks entirely on to the generic manufacturer, and grants few
protections against abuse.
is imbalanced. On a mere allegation and not proof, including allegation
brought by a competitor, generic suppliers allegedly infringing
a trademark and potentially a patent may face the delay or destruction
of goods, disproportionate damages, potential bankruptcy, and
in some cases, even criminal proceedings.
severe punishment for infringement obstructs and deters legitimate
generic competition by dramatically altering the risks faced by
generic medicines manufacturers, intermediaries and third parties.
By generally focusing on harsh remedies before infringement has
been proven, ACTA seeks to shift the risk on to the generic manufacturers
rather than waiting until the IP holder has proved its case. The
possibility of issuing injunctions and seizing medicines on a
mere suspicion of infringement is extremely problematic and goes
beyond what is required under the TRIPS Agreement. This will have
a chilling effect on the manufacturers of generic medicines.
ACTA provides great incentives for abuse because of the greater
access to information and the potential for competitive advantage,
coupled with limited liability for abuse. There are few penalties
for false accusations, and few protections for the alleged infringer.
is extracted from 'A blank cheque for abuse: The Anti-Counterfeiting
Trade Agreement (ACTA) and its impact on access to medicines',
a briefing paper (updated February 2012) published by Medecins
Sans Frontieres' Access Campaign.