[Ip-health] Médecins Sans Frontières Statement on the EP Committee on Development's draft opinion on the proposal for a Council decision on the conclusion of the Anti-Counterfeiting Trade Agreement

Katy Athersuch katy.athersuch at googlemail.com
Mon May 7 05:08:34 PDT 2012

*Médecins Sans Frontières Statement on the EP Committee on Development's
draft opinion on the proposal for a Council decision on the conclusion of
the Anti-Counterfeiting Trade Agreement*

Médecins Sans Frontières believes that the EP Committee on Development's
draft opinion on the proposal for a Council decision on the conclusion of
the Anti-Counterfeiting Trade Agreement is flawed and should not be
accepted in its current form. This opinion which was prepared for the
Committee on International Trade has failed to address key concerns about
the adverse impact of ACTA on access to medicines. Specifically, it has not
addressed the following three concerns previously
highlighted by MSF:

1) ACTA is not restricted to trademark counterfeiting- All types of
trademark infringements (including civil trademark disputes) are included
in the purview of ACTA. The risks to access to medicines of such overbroad
trademark 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 (INN) ‘amoxicillin’
to describe the contents, infringed GSK’s trademark on the brand name
Amoxil (which besides is itself a use of the INN). See below for details.

2) Although ACTA excludes patents from border measures and criminal
enforcement sections, the risk that ACTA’s civil enforcement provisions
will extend to all IP rights, including patents, still exists. Civil
enforcement provisions are applicable on patents unless specifically
excluded by an ACTA member state.

3) Third Parties are still at risk: ACTA provisions clearly threaten access
to medicines as they include stricter and enhanced enforcement measures by
exposing third parties to the risk of enforcement in relation to
allegations of trademark infringement and potentially patents
infringements.Third parties such as API producers; distributors; retailers;
NGOs, such as MSF, who provide  treatment and funders who support health
programs are at risk of injunctions, provisional measures, and even
criminal penalties,  including imprisonment and severe economic losses.

For further details please see MSF's 'Blank Cheque for Abuse' briefing
document available at the following link and copied below:

A BLANK CHEQUE FOR ABUSE: The Anti-Counterfeiting Trade Agreement (ACTA)
and its Impact on Access to Medicines

*Eight countries -Australia, Canada, Japan, Morocco, New Zealand,
Singapore, South Korea and the United States – signed ACTA on 1st October
2011. The European Union and 22 of its Member States signed on 26th January
2012. Five EU Member States-Cyprus, Estonia, Germany, Netherlands and
Slovakia -have not yet signed the agreement. For the agreement to become
legally binding on a party it must first be signed and then ratified by
that party. Within the EU, the agreement must be separately ratified by the
European Parliament, individual Member States and the EU Council-this has
not yet happened.1 *

As a treatment provider, Médecins Sans Frontières (MSF) is deeply concerned
about the impact of the enforcement agenda on the production and supply of
affordable, legitimate medicines. *We urge contracting States not to sign
or ratify ACTA unless all concerns related to access to medicines are fully
addressed. *

*The context *

*MSF relies primarily on generic medicines procured internationally. *So
too do the major procurers of AIDS medicines worldwide -the Global Fund and
PEPFAR.2 Many developing countries have no domestic pharmaceutical
manufacturing capacity and governments and patients rely on imported
generic medicines. Generic competition is the main driver of pharmaceutical
price reductions.


*It is a public health necessity that the trade in affordable and
legitimate medicines functions smoothly and without undue burdens. *If a
patient misses a lifesaving drug, even due to temporary delays, there can
be potentially life-threatening health repercussions.


*MSF has been increasingly concerned by the proliferation of enforcement
measures that harm access to medicines *and which have been pushed in a
number of different forms– as a part of free trade agreements,
international treaties, domestic legislation and customs regulations.

ACTA is a part of this trend, and is the result of the intellectual
property enforcement agenda advanced by rich countries, outside of
multilateral norm-setting institutions.3 The enforcement agenda blurs
crucial distinctions between types of IP rights and provides excessive
punishment, increasing the likelihood that wrongful searches, seizures and
legal actions against legitimate suppliers of generic medicines will be
carried out. As well it widens the scope of actors that could have
penalties brought against them, so that the whole medicines supply chain
becomes affected.


*Overbroad enforcement measures can threaten access to medicines. *The
impact of this has already been documented, for example in relation to the
2008 Anti-Counterfeit Act in Kenya4 which is currently being by challenged
people living with HIV.


*International trade rules are clear on a countries’ right to protect
public health and in particular promote access to medicines for all. *The
TRIPS Agreement is the major international agreement governing trade and
intellectual property. The Doha Declaration, signed by all members of the
World Trade Organization, affirms that TRIPS can and should be interpreted
and implemented in a manner supportive of their right to promote public
health. This includes in relation to intellectual property enforcement
measures, such as the ones contained in ACTA.


*The TRIPS Agreement already requires countries to introduce enforcement
rules. *But crucially, the Agreement sets minimal rules. It does not
require countries to go beyond this and adopt more restrictive measures
that are known as ‘TRIPS-plus’. ACTA contains TRIPS-plus measures, and does
not contain sufficient safeguards to protect public health and access to

*The impact of ACTA on access to medicines *

Although a number of provisions that were harmful to access to medicines in
developing countries were removed during the negotiations, the final text
remains problematic.


*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 generic medicines. *

There are several issues here. First*, *not all trademark disputes amount
to a public health problem. Only ‘wilful trademark counterfeiting on a
commercial-scale’5 -a form of fraud with a deliberate intention to exactly
copy a product’s branding -presents a legitimate public health concern. The
World Trade Organization 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.6

But ACTA blurs this distinction. This means it would require countries to
impose stringent intellectual property (IP) enforcement measures for civil
trademark confusion disputes.7 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

ACTA even extends enforcement to patent challenges.8 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,9 a number of provisions apply to patents and data
protection as the default position, with the precision that signatories to
ACTA ‘may exclude’ them. As has been noted,10 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.

Lastly, ACTA’s civil enforcement section may also allow expanded
enforcement efforts based on fictional patent claims.11 These efforts
favour rights holders and contain few if any safeguards for defendants or
third parties.


*ACTA puts third parties that use medicines at the heart of an enforcement
dispute—like distributors and even non-governmental organisations like MSF,
or public health authorities—at risk of severe penalties. *

ACTA contains a number of provisions, which would expose third parties to
the risk of enforcement in relation to allegations of trademark
infringement and potentially patents infringements. Third parties are at
risk of injunctions,12 provisional measures,13 and even criminal penalties,
including imprisonment and severe economic losses.14 This could implicate,
for example, suppliers of active pharmaceutical ingredients (API) used for
producing generic medicines; distributors and retailers who stock generic
medicines; NGOs, such as MSF, who provide treatment; funders who support
health programs; and drug regulatory authorities who examine medicines.
These measures include powers for judicial authorities to issue orders
against third parties to prevent suspected but not yet proved infringement.

These provisional measures would take immediate effect, and even if a court
later found that there was in fact no infringement, the negative
consequences for access to medicines will not be reversible. For example,
an API manufacturer could be stopped from supplying a drug manufacturer;
and medicines purchasers, like MSF, could be prevented from continuing to
purchase or distribute the medicines.

All of these measures are TRIPS-plus and have potentially far-reaching
consequences. They could act as a significant deterrent to anyone involved
in the production, sale and distribution of affordable generic medicines.
>From the perspective of patients and access to medicines, this chilling
effect on the entire production and supply system of generic medicines is
of grave concern as it could limit the availability of affordable generic
medicines in pharmacies or through treatment programmes.


• *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. *

While the border measures section of ACTA no longer includes patents, it
still includes civil trademark infringement.15 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.16

The 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 (INN) ‘amoxicillin’ to describe the contents,
infringed GSK’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 rights17 that
led to many other detentions of medicines in transit between developing
countries which were not IP-protected in the source or destination

Under ACTA, too, even legitimate medicines just transiting through an ACTA
member country could be temporarily or permanently seized.19 *Ex
officio *mechanisms
without judicial review—and allowing the detention, seizure, and even
destruction of goods—are susceptible to over-enforcement.20 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.

Rights 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.

ACTA expands also the TRIPS requirement on border measures for import to
cover export as well.21 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 patients.


• *ACTA undermines the role of the judiciary in protecting the right to
health and balance private intellectual property rights with the larger
public interest*.

ACTA allows for extra-judicial processes and fundamentally changes how
courts and judges approach cases involving IP disputes. ACTA would limit
due process for IP challenges by permitting the seizure and destruction of
medicines without even advising the owner, or providing the owner the
opportunity to respond, or mandating judicial oversight.22 Such *ex
parte *measures
are manifestly susceptible to abuse.

Even where judicial process is outlined, the balance lies heavily in favour
of the rights holder alleging infringement.23 Under ACTA, judges have
limited power to balance health issues against the interests of private
companies. Yet, many countries place the right to health above private IP
rights.24 This is explicitly recognised in the TRIPS Agreement where the
judiciary is given the full scope to determine the appropriate remedy
particularly where public interest is involved.

A court may decide for example on public health grounds that a commercial
dispute should be resolved in the short term not by an injunction -which
would stop the rival medicines being produced and could deprive patients of
cheaper or adapted formulations -but by a requirement to monitor sales or
pay royalties, the amount of which would be finalised when the court
determines whether an infringement has in fact taken place. Or, as in the
US, that royalties should be given instead of a permanent injunction on the
basis of the public interest in having competition in medical devices.25

But ACTA requires injunctions to stop the distribution of goods even at the
early stage of an infringement allegation -except where a national law
prohibits it -and in some cases calls for the destruction of infringing
goods.26 In practical terms, this could mean effective and safe medicines
are stopped from being produced or destroyed to protect company profits.

Further, unlike TRIPS, ACTA does not require judicial authorities to
consider proportionality between the seriousness of the infringement and
the interests of third parties when deciding what remedies to grant.


*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. *

ACTA 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.27

The 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.

Further, 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.28


*ACTA is a cynical exploitation of concerns around unsafe medicines and is
not a legitimate response to the problem of falsified medicines. *

The spectre of harmful fake medicines is a concern that continues to be
used to justify ACTA. Yet ACTA is not designed to deal with fraudulent,
unsafe, and ineffective medicines; its purpose is to protect the commercial
interest of companies that hold IP rights. There is one small area of
overlap with fraudulent medicines, but even then the measures proposed
would pose greater harm to access to legitimate generic medicines than they
would act as a safeguard against fake medicines.

ACTA proponents consistently exploit public health concerns to advance
business interests, in part by conflating profit-maximizing IP issues with
true public health problems. The cynical use of public health concerns
undermines faith in the commitment of proponents to tackle public health
issues seriously. Further, because ACTA would inhibit generic competition,
raise medicine prices and decrease the availability of generic medicines,
it actually incentivizes the introduction of unsafe medicines to meet the
demand from patients who have been cut off from access to safe, effective
and affordable generic medicines due to over zealous IP enforcement
measures. The WHO has recognized that high drug prices are a cause of
counterfeit medicines: patients demand low-cost alternatives, and
counterfeiters respond.29


*ACTA will undermine the ability of developing country governments to apply
the Doha Declaration to protect public health. *

ACTA is intended and structured as a norm-setting tool. In addition to
being applicable to the negotiating parties, it is expected that other
countries, including developing countries, will be pressured to become
party to the agreement, mostly as a result of trade pressures.30

If enacted, it will minimize the flexibilities countries have under the
TRIPS Agreement and the Doha Declaration 2001 to incorporate appropriate
public health measures and balances in their laws.


*ACTA has been negotiated in secret with little room for public engagement.

Despite its anticipated far-reaching effects, over three years of secret
negotiations, an official version of the negotiation text was only released
once, in April 2010, after the text was leaked and the European Parliament
criticized the secret negotiations.31 Its application to countries with key
trading ports means its impact will be felt even by countries not party to
the treaty, if medicines are seized or detained in IP enforcement disputes.

It is also a blank cheque for the future. ACTA aims to institutionalize the
ambitious norm-setting and secrecy on which it was founded. In a move that
would circumvent open debate and due scrutiny: the agreement proposes an
annual meeting of signatories where amendments to the Treaty can be
negotiated.32 Even some of the most contentious issues that have been
removed during the negotiations could, within a year, be back in the text
once ACTA is out of the public spotlight. Any future changes to ACTA must
be subject to public scrutiny by all stakeholders and must receive
parliamentary approval.

*Conclusions and recommendations *

                        *ACTA is flawed, with fatal consequences on access
to medicines: *ACTA locks in the most controversial aspects of US and EU
intellectual property enforcement laws, and has insufficient safeguards to
prevent abuse and protect the public.

                        *ACTA does nothing to address the problem of poor
quality and unsafe medicines: *ACTA is an inappropriate and ineffective
response with counterproductive consequences for developing countries.

                        *ACTA undermines existing international
declarations to protect public health: *

ACTA circumvents the Doha Declaration by restricting the right of countries
to act in favour of access to medicines, imposes TRIPS-plus measures, and
is not an appropriate standard for developing countries.

*ACTA should: *

-Not be signed and ratified by contracting States unless all concerns
related to access to medicines are fully addressed.

-Only be applicable to wilful copyright and trademark counterfeiting on a
commercial scale. It should exclude both patents and civil trademark
infringement from the scope of the agreement.

-Not establish third party or aiding and abetting liability.
-Not include TRIPS-plus measures on civil and criminal enforcement
-Include protections against abuse, including judicial review, penalties
for abusive

 litigation and baseless allegations, access to information for the alleged
infringer, and the obligation to consider proportionality and the public
interests in setting the remedy.

-Ensure that any institutional structure established through ACTA be open
and transparent. It should not have the authority to amend ACTA without
public scrutiny and approval from elected democratic bodies.

PEPFAR has increasingly relied on generic medicines. In 2008 the proportion
of generic medicines procured through PEPFAR approached 90%. From
2005-2008, PEPFAR estimated savings of $325 million due to the purchase of
generic medicines. Charles Holmes, *et al.*, Use of Generic Antiretroviral
Agents and Cost Savings in PEPFAR Treatment Programs, *JAMA*.
2010;304(3):313-20. 3 US and Japan initiated ACTA in 2006. ACTA is being
negotiated by the US, EU and 27 member states, Japan, Canada, Australia,
Mexico, Morocco, New Zealand, South Korea, Singapore, and Switzerland. 4 ‘FATAL
FLAWS: How Kenya’s 2008 Anti-Counterfeit Act could endanger access to
medicines’ A Médecins Sans Frontières briefing document (March 2010)
10.pdf 5 TRIPS Ch. III, Sec. 5, Art. 61. 6 Originator pharmaceutical
companies are increasingly seeking protection on various non-functional
aspects of medicines, such as pill colour and shape, civil disputes over
such matters will continue to arise. Regardless of whether similarly-named,
coloured or shaped generic versions of medicines are ultimately found to
infringe a valid trademark in civil litigation proceedings (and companies
have the right to pursue these problems in the court), they need not, and
indeed should not, be confused with counterfeit medicines. Adopting an
overly-broad definition that would consider similarly named, coloured or
shaped medicines to be counterfeit would likely hinder access to
legitimate, safe, effective and affordable generic medicines 7 ACTA Ch. II,
Sec. 2, 3. Civil trademark disputes occur where one company accuses a
competitor of having a trademark or packaging too similar to its own
trademark. This has nothing to do with a deliberate intention to deceive
with a fake medicine, and must be distinguished from the fight against
counterfeit medicines. Civil trademark disputes will likely remain a common
occurrence in the pharmaceutical 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). 8 ACTA Ch. II,
Sec. 2. Footnote 2 provides that a Party *may *exclude patents and
protection of undisclosed information from the scope of section dealing
Civil Enforcement. This language is problematic as it only allows a Member
State to exclude patents if it wants to do so. Otherwise, patents are
included in the scope by default. 9 ACTA Ch. II, Sec. 3, Art. 13, fn. 6
(“The Parties agree that patents and protection of undisclosed information
do not fall within the scope of this Section.”); Ch. II, Sec. 4, Art. 23
(“Each Party shall provide for criminal procedures and penalties to be
applied at least in cases of willful trademark counterfeiting or copyright
or related rights piracy on a commercial scale.”). 10 Sean Flynn and Bijan
Madhani, *ACTA and Access to Medicines*, (10 June 2011) 13 at
http://goo.gl/Ge9Vl 11 ACTA Ch. II, Section 2, Art. 8.1 and 12.1 dealing
with injunctions and provisional measures. The risk that ACTA’s civil
enforcement provisions will extend to all IP rights, including patents,
still exists. If so, even though border agents will not be able to act
unilaterally or at the immediate behest of drug companies to seize
in-transit medicines, the patent holder will be able to go to court and
seek the seizure and destruction of generic medicines based on a so-called
manufacturing fiction. Under this fiction, even though the generic medicine
is not patent protected in the country of manufacture or in the country of
importation and use and even though the medicine is not commercialized in
the transit territory, the courts apply a fiction that the medicine should
be treated as if it had been manufactured in the transit country. This is
the fiction still allowed under EU law and applied in the Netherlands,
Germany, and France to intercept multiple shipments of Indian medicines
destined for Latin America and Africa. 12 ACTA Ch. II, Sec. 2, Art. 8.1:
Injunctions. 13 ACTA Ch. II, Sec. 2, Art. 12.1 (a). 14 ACTA creates a third
party aiding and abetting criminal liability: third parties can face
criminal measures including prison terms and high monetary fines; the
seizure, forfeiture, and/or destruction of goods and/or “any related
materials and implements used in the commission of the alleged offense”.
TRIPS includes no aiding and abetting liability in its criminal enforcement
provision. Compare TRIPS Ch. III, Sec. 5, Art. 61 with ACTA Ch. II, Sec. 4,
Arts. 23.4, Art.

25.1. 15 ACTA Ch. II, Sec. 3, Art. 13: Scope of the Border Measures. 16 ACTA
Ch. II, Sec. 3, Art. 20. Destruction is available as a remedy, and through
“competent authorities,” without specification of judicial oversight. This
is a significant expansion from TRIPS. Under TRIPS, *ex officio
*action is *permissible
*to seek information from the right holder, promptly notify both parties,
and order the destruction or disposal of infringing goods *with judicial
review*. TRIPS III, Sec. 4, Arts. 58-59. 17 EU Reg. 1383/2003 . This
Regulation is currently being amended and a proposed Regulation is released
to discussion and consultation. Though some safeguard provisions are added
in the proposed Regulation but it is still problematic and enables Custom
authorities to detain generic drugs in transit. 18 Among other seizures,
European customs authorities seized a blood pressure drug in transit to
Brazil; and AIDS drugs en route to Nigeria—and purchased by the Clinton
Initiative relying on funds from the international entity, UNITAID. 19 ACTA
Ch. II, Sec. 3, Art. 16 (Border Measures). Though the in transit seizures
provision is permissive and not mandatory (A Party may adopt or maintain
procedures with respect to suspect in-transit goods), but it would
effectively grant a right to exclude a developing country from receiving
medicines produced in another developing country—only because the medicines
must travel through one of the ACTA member countries. This provision also
further defines a norm that was explicitly left out of TRIPS.. Further, the
definition of counterfeit trademark goods in ACTA differs from TRIPS in one
essential respect: the infringement is asserted in the country where
invoked rather than the country of importation. This is a remarkable
expansion of TRIPS: goods never intended to enter into a country, and only
transiting through, could under ACTA be subject to infringement challenges
in the transit country. ACTA Sec. 2, Art. 5(d): Definitions (definition of
counterfeit trademark goods). 20 Increased power is handed to customs
officials based on information provided by a company, including a company
trying to deter its competitors. See ACTA Sec. 3, Art. 17. No notification
to the goods-holder is required (compare ACTA Sec. 3, Art. 17 with TRIPS
Ch. III, Sec. 4, Art. 54); eliminating judicial review (compare ACTA Sec.
3, Art. 17 with TRIPS Ch. III, Sec. 4, Art. 59); ACTA allows for a
detention of goods with no defined time limit (compare ACTA Ch. II, Sec. 3,
Art.19 with TRIPS CH III, Section 4, Art.55 ); and lacks any safeguards of
inspection, indemnification, or judicial review, even prior to the
destruction of goods. ACTA Ch. II, Sec. 3, Art. 17.. 21 ACTA Ch. II, Sec.
3, Art. 16 (Each Party shall adopt or maintain procedures with respect to
import and export Shipments) 22 ACTA Ch. II, Sec. 3, Art. 17.3. ACTA
requires that the competent authorities inform the applicant of the status
of the application, without giving consideration to the defendant whose
goods are seized. Compare this with Article 58 of the TRIPS Agreement which
provides that “the importer and the right holder shall be promptly notified
of the suspension.” 23 E.g., ACTA Ch. II, Sec. 2, Art. 10.2. Similar
provision is provided in Border Measures Section (ACTA Ch. II, Sec. 2, Art.
20) Under ACTA, judges have the authority to order the destruction of
infringing goods, and materials and implements predominantly used for the
manufacture of the infringing goods – but without the TRIPS limitation that
judges also consider the “proportionality” of the offense relative to the
remedy, and the “interests of third parties.” Compare ACTA Ch. II, Sec. 2,
Art. 10.2 with TRIPS Ch. III, Sec. 2, Art. 46. 24 For example Indian courts
distinguish drugs from other cases of IP infringement. Medicines are
different: courts have to tread with care and ensure there is no violation
of the Indian Constitution’s guarantee to the right to life when
considering remedies. F. Hoffmann-La Roche Ltd. & Anr. v. Cipla Limited,
I.A 642/2008 IN CS (OS) 89/2008, Delhi High Court, Order dated 19 March
2008 25 *eBay Inc v. MercExchange, L.L.C*., 547 U.S. 388 (2006)
((permitting the denial of a permanent injunction if the public interest
would be disserved). In a recent case, *Bard Peripheral Vascular, Inc. v.
W.L. Gore & Associates, Inc*., 2010-1510 (Fed. Cir. February 10), the
majority agreed with the district court that “it was in the public interest
to allow competition in the medical device arena.” 26 ACTA Ch. II, Sec. 2,
Art. 8. A limitation is also provided that: “where these remedies are
inconsistent with a Party’s law, declaratory judgments and adequate
compensation shall be available.” ACTA Ch. II, Sec. 2, Art. 8.2. 27 ACTA
requires high penalties for alleged infringers that are beyond those
required under TRIPS. These TRIPS-plus civil enforcement penalties include
injunctions, with limited exceptions, and even if the infringer had no


knowledge or the infringement was inadvertent, ACTA Ch. II, Sec. 2, Art. 8,
*compare with *TRIPS Ch. III, Sec. 2, Art. 44.1; excessive damages,
allowing the consideration of “any legitimate measure of value”, ACTA Ch.
II, Sec. 2, Art. 9.1and mandating judicial authority to order the payment
of “profits”, Ch. II, Sec. 2, Art. 9.1, and legal expenses, ACTA Ch. II,
Sec. 2, Art. 9.5; the removal and destruction of goods, and even of
manufacturing plants, at the infringer’s expense, ACTA Ch. II, Sec. 2, Art.
10.2 and 10.3, without the TRIPS limitation for consideration of
“proportionality” and the “interests of third parties”, TRIPS Ch. III, Sec.
2, Art. 46; the exposure of significant information, ACTA Ch. II, Sec. 2,
Art. 11, where TRIPS limited this to the identification of third parties
and further required that proportionality be considered, TRIPS Ch. III,
Sec. 2, Art. 47. ACTA would allow for the seizure of goods even before the
initiation of proceedings, and even without notification to the owner. See
ACTA provisions on Provisional Measures and Border Measures. This is also
TRIPS-plus. TRIPS-plus border measures likewise shift the balance. With
regard to border measures, TRIPS limits seizures of exports, TRIPS Ch. III,
Sec. 4, Art. 51, and goods in transit, TRIPS Ch. III, Sec. 4, Art. 51, note
13; sets a maximum term for the withholding of allegedly infringing goods
of 10-20 days, TRIPS Ch. III, Sec. 4, Art. 55; provides for an equivalent
opportunity for the *importer *to inspect, TRIPS Ch. III, Sec. 4, Art. 57;
provides for indemnification in the case of wrongful suspension, TRIPS Ch.
III, Sec. 4, Art. 56; and requires the right of judicial review prior to
the destruction of goods as a remedy, TRIPS Ch. III, Sec. 4, Art. 59. None
of these limitations exist within ACTA: ACTA requires border measures for
exports, ACTA Ch. II, Sec. 3, Art. 2.X.1, and allows them for goods in
transit, ACTA Ch. II, Sec. 3, Art. 2.X.2; sets no maximum term for
detention, requiring only that the detention is “reasonable”, ACTA Ch. II,
Sec. 3, Art. 2.10; and lacks any safeguards of inspection, indemnification,
and judicial review prior to destruction. ACTA Ch. II, Sec. 3. ACTA even
allows customs authorities to act at the behest of a right-holder to detain
allegedly infringing goods *with no obligation to even inform the alleged
infringer. *Compare ACTA Ch. II, Sec. 3 with TRIPS Ch. III, Sec. 4, Art.
54. With regard to criminal enforcement, TRIPS does not extend criminal
enforcement measures to those found to be aiding and abetting infringement.
ACTA does create this third party criminal liability with potentially
far-reaching consequences: third parties can face criminal measures
including prison terms and high monetary fines; the seizure, forfeiture,
and/or destruction of goods and/or “any related materials and implements
used in the commission of the alleged offense”. Compare TRIPS Ch. III, Sec.
5, Art. 61 with ACTA Ch. II, Sec. 4, Arts. 2. 14.4, 2.15, 2.16. 28 TRIPS
includes provisions to protect against abuse that are notably absent within
ACTA. These include provisions within TRIPS to indemnify the defendant for
civil enforcement or border measures taken. TRIPS Ch. III, Sec. 2, Art.

48.1 (the ability of judicial authorities to order “a party wrongfully
enjoined or restrained adequate compensation for the injury suffered” and
legal fees); TRIPS Ch. III, Sec. 4, Art. 56 (“appropriate compensation for
any injury caused to them through the wrongful detention of goods or
through the detention of goods released”). No comparable provisions exist
within ACTA. Strikingly, where TRIPS provides for indemnification of the
importer and owner in the case of wrongful detention, TRIPS Ch. III, Sec.
4, Art. 56, ACTA only requires that an application be denied, suspended, or
voided where a rights-holder has abused the process, ACTA Ch. I, Sec. 3,
17.4. This is essentially no punishment at all for an abuse of the system
despite harmful consequences. Further, TRIPS recognizes the right of all
parties to judicial review, TRIPS Ch. III, Sec. 1, Art. 41.4, and access to
information, TRIPS III, Sec. 2, Arts. 41.3, 42, 43. Under ACTA, customs
authorities can act at the behest of a rightholder to detain allegedly
infringing goods *with no obligation to inform the alleged infringer. *Compare
ACTA Ch. II, Sec. 3 with TRIPS Ch. III, Sec. 4, Art. 54. 29 World Health
Organization (WHO), Regional Office for South-East Asia (SEARO), Legal
Aspects of Defining “Counterfeit Medicines”: A Discussion Paper (2009), 2. 30
Susan K. Sell, ‘TRIPS was never enough: Vertical Forum Shifting, FTAs,
ACTA, and TPP’ at
European Parliament resolution of 10 March 2010 on the transparency and
state of play of the ACTA negotiations at

32 ACTA Ch. VI, Art. 42

Hafiz Aziz ur Rehman
Legal & Policy Advisor
Médecins Sans Frontières -Access Campaign
Rue de Lausanne 82
1211 Geneva, Switzerland
Tel: + 41(0) 22 849 87 54
Aziz.REHMAN at geneva.msf.org

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