Transcript TRIPS-plus-plus Enforcement and Anti

TRIPS-plus-plus Enforcement and
Anti-Counterfeiting Agenda and
Seizures of Medicines-in-Transit
Prof. Brook K. Baker, Health GAP
Northeastern U. School of Law
Program on Human Rights and the Global Economy
UKZN July 2010
Outline
• What does TRIPS require?
• What is the TRIPS-plus-plus enforcement
agenda?
• How does the anti-counterfeiting agenda fit
in?
• Is it o.k. to seize generic medicines in transit?
• Should African countries join the anticounterfeiting bandwagon?
• What are the enforcement dangers in FTAs?
General Enforcement
Obligations
• Art. 41.1: Members shall ensure that enforcement
procedures … are available under their law so as to
permit effective action against any act of infringement
of intellectual property rights covered by this
Agreement, including expeditious remedies to prevent
infringements and remedies which constitute a
deterrent to further infringements. These procedures
shall be applied in such a manner as to avoid the
creation of barriers to legitimate trade and to provide
for safeguards against their abuse.
General Obligations cont’d
• Art. 41.2: “Procedures … shall be fair and equitable. They
shall not be unnecessarily complicated or costly, or entail
unreasonable time-limits or unwarranted delays.”
• Art. 41.3: Decisions … shall … be in writing and reasonable ….
• Art. 41.4: Parties … shall have an opportunity for review by a
judicial authority….
• Art. 41.5: “[No] obligation to put in place a [distinct] judicial
system for the enforcement of IPR rights …. Nothing in this
Part creates any obligation with respect to the distribution of
resources as between enforcement of IPRs and the enforcement
of law in general.”
Fair and Equitable
Enforcement Procedures
• Art. 42: “Members shall make
available to right holders civil judicial
procedures concerning the enforcement
of any intellectual property right
covered by this Agreement.”
Art. V of the GATT
• Defines goods in transit, and provides that “There
shall be freedom of transit through the territory of
each contracting party, via the routes most
convenient for international transit, for traffic in
transit to or from the territory of other contracting
parties.”
• “All charges and regulations imposed by the
contracting parties on traffic in transit to or from the
territories of other contracting parties shall be
reasonable.”
Injunctions
• Art. 44.1: “The judicial authorities shall have the authority to
order a party to desist from an infringement … .”
• Art. 44.2: “Notwithstanding the other provisions of this Part
and provided that the provisions of Part II specifically
addressing [compulsory licenses] are complied with, Members
may limit the remedies available against such use to the
payment of remuneration in accordance with [Art. 31(h)]. In
other cases, the remedies under this Part shall apply or, where
these remedies are inconsistent with a Member’s law,
declaratory judgment and adequate compensation shall be
available.”
Damages and other remedies
• Art. 45: “The judicial authorities shall have
the authority to order the infringer to pay the
right holder damages adequate to compensate
for the injury the right holder has suffered
because of an infringement … .”
• Art. 46: The judicial authorities shall have
the authority to order that infringing products
be disposed of or destroyed.
Border Measures
• Art. 51: “Members shall … adopt procedures[13] to enable a
right holder, who has valid ground for suspecting that the
importation of counterfeit trademark or pirated copyright may
take place, to lodge an application in writing with competent
authorities, administrative or judicial, for the suspension by the
customs authorities of the release into free circulation of such
goods. Members may enable such an application to be made in
respect of goods which involve other infringements of [IPRs]
provided that the requirements of this Section are met.”
• [13. It is understood that there shall be no obligation to apply
such procedures to imports of goods put on the market in
another country by or with the consent of the right holder, or to
goods in transit.]
Laws of the Country of Import
• Art. 52: “Any right holder initiating [border
measures] shall be required to provide
adequate evidence to satisfy the competent
authorities that, under the laws of the country
of importation, there is prima facie an
infringement of the right holder’s intellectual
property …”
• Is an in-transition country the “country of
importation?”
Criminal Procedures
• Art. 61: “Members shall provide for criminal
procedures and penalties to be applied at least
in cases of wilful trademark counterfeiting or
copyright piracy on a commercial scale.
Remedies available shall include
imprisonment and/or monetary fines
sufficient to provide a deterrent…. In
appropriate cases, remedies available shall
also include the seizure, forfeiture and
destruction of the infringing goods….”
Temporary suspension of nonviolation complaints
• Strangely, it is possible to bring a nonviolation complaint against a country that
does not directly violate TRIPS but that
nonetheless “nullifies” or “impairs” the
exercise of IPRs.
• However, this right is temporarily suspended.
Summary: TRIPS Enforcement
for Patent Violations
• Private enforcement and appeal.
• Injunctions not required in cases of lawful
government use and compulsory licenses.
• Injunctions not required in cases where injunctions
are contrary to national law, in which case adequate
compensation – a royalty – must be available.
• Criminal measures and border control seizures are
not require for alleged patent violations, including
specifically for goods in transit.
What is a “counterfeit” under
TRIPS
 Art. 51“Counterfeit trademark goods” shall mean any
goods, including packaging, bearing without
authorization a trademark which is identical to the
trademark validly registered in respect of such goods,
or which cannot be distinguished in its essential
aspects from such a trademark, and which thereby
infringes the rights of the owner of the trademark in
question under the law of the country of importation.”
 Thus the term counterfeit should be reserved for
goods that violate trademark laws, those that
misrepresent the branded source of the goods.
What is a Counterfeit?
Misusing Trademark or Appearance
• Real
• 211943 FAFXG 9769
$850
•
http://www.gucci.com/us/us-english/us/fallwinter-09/web-exclusives/?redirect=true#0969396-211943FAFXG9769
• Fake
• Gucci Chain G114900
Apricot Coffee Leather
$117.63
•
http://www.bagsmerchant.com/gucci-130738fapricot-fabric-coffee-leather-p-8396.html
What are generic medicines?
• Generic medicines are medicines that are
therapeutically equivalent to the original
medicine, regardless of patent status.
– Equivalence is proven through bioequivalence
tests or production via the Pharmacopoeia.
– Generics must also have built-in quality (Good
Manufacturing Practices)
• Generics are not counterfeits.
What is a Generic Medicine?
• A generic medicine
is an identical twin.
What are “substandard”
medicines?
• Substandard medicines are a health risk.
– They may be contaminated or adulterated.
– They may have the incorrect ingredients, incorrect
quantities, or even no therapeutic ingredients.
– Incorrect quantities – too much or too little – can
create health risks for patients – overdose or nontherapeutic amounts leading to drug resistance.
– Incorrect ingredients can actually kill patients.
What is a Sub-Standard Medicine?
The role of Drug Regulatory
Authorities
• It is the drug regulatory authority’s job
to guard against substandard medicines
throughout the supply chain.
• In contrast, customs agents have no
qualification to determine is medicines
are substandard or not.
Safety, Efficacy, Quality
Safety
Few adverse
side effects
Animal trials;
Purity/Uniformity,
Stability/shelf-life,
Plant cleanliness,
Record keeping
Quality
Good
Manufacturing
Practices
Clinical trials:
Registration
Phase I, II, & III
Marketing
Approval
Efficacy
Improves
health
TRIPS-plus-plus enforcement
measures
• What is TRIPS-plus-plus enforcement?
– It is the utilization of stronger enforcement
measures, e.g., criminal sanctions,
enhanced damages, mandatory injunctions,
and intermediary liability even where they
are not required by TRIPS
– It is the elimination of enforcement
flexibilities allowed by TRIPS.
Examples of TRIPS-plus-plus
enforcement efforts
• WHO IMPACT
• ACTA
• European seizures of medicines-intransit
• Kenya Anti-Counterfeiting Act
• Trade Agreements
WHO IMPACT
• International Medical Products AntiCounterfeiting Taskforce (IMPACT) (2006)
– Initiated by WHO, Italy, and the Int’l Federation
of Pharmaceutical Manufacturers Association
– Disregards the impact of high prices of patented
drugs as an incentive to counterfeiting
– Seeks IP enforcement to counteract not only
trademark infringing drugs, but also other
substandard drugs, which it includes under the
“counterfeit” umbrella.
IMPACT Definition
• “A medical product is counterfeit when there is a
false representation in relation to its identity and/or
source. This applies to the product, its container or
other packaging or labeling information.
Counterfeiting can apply to both branded and
generic products. Counterfeits may include
products with the correct ingredients/components ,
with the wrong ingredients/components, or without
active ingredient, with incorrect amounts of active
ingredients, or with fake packaging.”
IMPACT Enforcement
• Establish criminal, administrative, and civil
enforcement frameworks
• Apply to transit/trans-shipments, bonded warehouses,
free-zones – all situations of international trade.
• Regulate throughout the distribution chain including
sanction against API manufacturers.
• Information exchange and cooperation in global
enforcement.
• WHO is backing off from use of counterfeit language
and now focusing again on substandard medicines.
Anti-Counterfeiting Trade Agreement
ACTA (2008)
• Secret negotiation between a limited number of rich
countries trying to establish a new, global standard
for “counterfeit” enforcement.
• “Is intended to assist in the efforts of governments
around the world to more effectively combat the
proliferation of counterfeit and pirated goods, which
undermines legitimate trade and sustainable
development of the world economy, and in some
cases contributes to organized crime and exposes
American families to dangerous fake products.” US
2009.
ACTA May Apply to Patents
• The EU and Japan are still pushing for ACTA
to apply to patents according to the law of the
transit country, meaning that right holders will
be able to stop generic medicines in transition
that are alleged to violation the
“manufacturing fiction” in the transit country.
Intermediary Liability
• There are still proposals to allow “injunctions
against intermediaries whose services are used
by a third party to infringe an intellectual
property right.”
• Who are intermediaries? API suppliers? All
suppliers? All transporters? Funders (Global
Fund)? Intermediaries (MSF)? Drug
Regulatory Authorities?
Enhanced damages and
injunctions
• According to leaked text, ACTA requires that
damages cover lost profits, the value of the infringed
good or service, measured by the market price, the
suggested retail price or some other legitimate
measure of value submitted by the right holder.
• It also requires that injunctions be available for
infringement, reversing flexibilities that exist under
TRIPS not to require injunctions during challenges to
government use or when the law provides other
systems of adequate compensation.
Customs Seizures of Medicines
Manufacturing Fiction in the Netherlands
No Patent in Brazil
No Patent in India
No Patent in Nigeria
Dutch seizures of medicines
in-transit
• Almost twenty incidents where Dutch authorities have confiscated
generic medicines in transit through Dutch ports from India to
Latin America and Africa.
• One shipment included WHO prequalified ARVs purchased by
UNITAID and headed to Nigeria.
• Patent holders initiate the request for seizures which are thereafter
undertaken by untrained customs officials using the
“manufacturing fiction.”
• One seizures included a claim of a trademark infringement
because the drug used the name Amoxicillin which is the
International Nonproprietary Name, which was similar to GSK’s
brandname “Amoxil”.
• India and Brazil have brought a WTO complaint on these seizures.
EC Reg. No. 1883/2003
• The Dutch justified the seizures under a
regulation that allows IP right holders
to petition customs officials to act
“when goods are suspected of
infringing intellectual property rights.”
• It’s a widespread European problem,
not just a Dutch problem, because there
have been seizures in Germany as well.
Getting African countries to join the
anti-counterfeiting bandwagon
• Kenya passed anti-counterfeiting legislation with
provisions that confuses counterfeiting with
violations of non-trademark intellectual property
rights.
• Uganda is considering a similar bill that calls for the
death penalty for drug “counterfeiters,” which might
erroneously be interpreted to apply to generic
manufacturers who use an international nonproprietary name that looks similar to the brand name
or whose pills look similar to the branded pills.
• These bills were funded by the EU.
TRIPS-plus-plus enforcement
demands in trade agreements
• Finally, both the US and Europe are asking
for enhanced enforcement measures – higher
damages, mandatory injunctions, border
controls, intermediary liability, criminal
sanctions, etc. – that could threaten trade in
cheaper generic medicines.
– See, e.g., proposed EU/Andean EPA, proposed
US/Thailand FTA.
The Enforcement Agenda is
the New Wild West
• The misguided Big Pharma enforcement
agenda is a major emerging threat to access to
affordable generic medicines and generic
trade.
• Rhetoric about “counterfeit” medicines is
designed to confuse governments, doctors,
and consumers and to create suspicion about
the quality of generic medicines.