Transcript Legal Aspects of the Anti-Counterfeiting Legislation

Legal Aspects of the AntiCounterfeiting Legislation
MULUMBA MOSES
What are IPRs
 Refers to a bundle of rights awarded to individuals or organisations over
creative works: inventions, literary and artistic works and symbols, names,
images, designs as a bargain that the outcomes of the rights will benefit
society at large.
 gives the creator the right to prevent others from making unauthorised use
of their property for a limited period
 generally can be categorised as follows:
 Industrial Property (functional commercial innovations),
 Patents, Industrial designs, Trademarks, Geographical Indications, Trade
Secrets, Geographical Indications
 Artistic and Literary Property (cultural creations)
 Copyright
 Sui Generis Systems
 Integrated Computer Circuits
 Plant Breeders’ rights
Patents
• A patent is an exclusive right awarded to an inventor to
prevent others from making, selling, distributing, importing or
using their invention, without license or authorization from the
patent holder, for a fixed period of time (TRIPS stipulates at
least 20 years of protection).
• Is this an absolute right? Under what circumstances can this
right be taken away?
The TRIPS Agreement (Trade Related Aspects
of Intellectual Property Rights)
•
First multilateral agreement prescribing minimum standards….all countries
have to harmonise to these standards…except LDCs that have transitional
period until 1 July 2013 (which can be further extended)
•
The TRIPS Agreement prescribes minimum standards for patent, copyright
and related rights, trademarks, geographical indications, industrial designs,
layout-designs of integrated circuits, protection of undisclosed information,
enforcement of IPRs etc.
Article 1: “members may but shall not be obliged to implement in
their law more extensive protection than is required”. Further it
states “Members shall be free to determine the appropriate
method of implementing the provisions of this Agreement within
their own legal system and practice”. In short it is up to Member
states to decide how to implement the provisions of this Agreement.
Flexibilities in TRIPS
• TRIPS introduces very important flexibilities – Because
high standards of IPR protection and enforcement is
known to have a negative impact on development as
well as access to essential items such as medicines,
technology and other tools necessary for development
particularly in LDCs.
• Examples: Compulsory Licenses, Parallel importation
Doha Declaration on the TRIPS
Agreement and Public Health
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Adopted on 14 November 2001
TRIPS Agreement does not and should not prevent
Members from taking measures to protect public health
The right of WTO Members to use, to the full, the
provisions in the TRIPS Agreement, which provide
flexibility.
For example each Member has the right to grant
compulsory licences and the freedom to determine the
grounds upon which such licences are granted.
The LDCs are not be obliged, with respect to
pharmaceutical products, until 1 January 2016
TRIPS plus/Concern
No explicit recognition of safeguards/exceptions/limitations
that exist in National IP legislations….uncertainty as to
whether the safeguards apply.
Bill’s scope is broad and covers patents, trademarks,
copyright and related rights, undisclosed information, plant
variety protection.
Makes the Bill “TRIPS-plus” since WTO-TRIPS Agreement
limits “counterfeit” to trademark infringements.
Issues at Hand
•
As a LDCs….countries should stick to the minimum standards of IP
enforcement.
•
The laws contain many TRIPS plus provisions….which is going to be
problematic for a LDCs….as it is already problematic even for
developed countries as seen by the case of seizures.
•
There are existing IP laws that already deal with infringement
issues….thus conflict needs to be addressed
•
The Bills conflates different categories of IPRs into one “counterfeiting”
definition….will result in problems since each IP category works
differently.
•
Counterfeit has a specific meaning within the context of IP laws (i.e.
trademark infringement)….this meaning should be adhered to….to
avoid confusion as to what is intended by the term.
Extra-territorial application of IPR Laws
• IPR laws are territorial in nature…e.g a product may be patented in Brazil
but not in Uganda.
• The laws present a significant shift in the application of the territorial
principle.
•
“Counterfeiting means without the authority of the owner of any intellectual
property right subsisting in Uganda in respect of protected goods- (a) the
manufacturing, producing, packaging, re-packaging, labeling or making,
whether in Uganda or outside Uganda, of any goods by which those protected
goods are imitated in such manner and to such a degree that those other goods
are identical to or substantially similar to protected goods”.
• It suggests that if a product is patented in Uganda, but the act of manufacturing
the product took place in India (where the product is not patented), the Co.
would have committed an act of counterfeiting in Uganda.
• Would have significant impact on investment from developing countries!!
Wrongful Border Measures: Resulting in
Access Problems
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Recent situations: EU customs officials seized medical shipments in transit
although no evidence of IPR violation in the importing or the exporting
country….denying timely access to medical products to patients in the
importing developing countries
-- Oct. 2008, Dutch Customs at Amsterdam airport seized shipment of generic
blood-thinning drug, clopidrogel, en route to Colombia. Drug produced by
Indian firm Ind-Swift. Seizure made on behalf of Sanofi, which consented to
the release of the drugs only in May this year. Ind-Swift re-routed all its
shipments through Malaysia and Singapore at double the cost.
-- Nov. 2008, Dutch officials seized two shipments en route to Peru
(rivastigmine for treating Alzheimer’s disease and olanzapine an antipsychotic
medicine) from an Indian company Cipla. The rivastigmine medicine, seized
on behalf of Novartis company, was detained for 5 months before being
allowed to proceed to Peru. The olanzapine medicine, seized on behalf of
Lilly, is still held in the Netherlands.
-- Dec. 2008, Dutch Customs seized blood pressure drug Losartan which was en
route to Brazil, and held it for 36 days before returning it to India.
-- Feb. 2009, the AIDS medicine Abacavir bound for Nigeria was seized in
Amsterdam and was released after a complaint by the UN, which was the
recipient.
-- May 2009, the generic drug Amoxicillin (used in treating many bacterial
infections) was seized in Frankfurt airport en route from India to Vanuatu. It
was released after GSK, the company holding the patent, informed the
Customs that there was no trademark infringement.
•
Seizure of medical products by EU customs officials has become a global
controversy since it has delayed and in some case denied patients in
developing countries access to essential medicines.
•
It has an adverse systemic impact on legitimate trade of generic medicines,
South-South commerce, and universal access to medicine. Many developing
countries have raised concern about these seizures in the WTO.
Possible Violation of WTO Rules
• Article 41 of TRIPS: enforcement of IPRs “shall be applied in such a manner
as to avoid the creation of barriers to legitimate trade” and that procedures shall
be “fair and equitable”.
• Article V of WTO-GATT on “Freedom of Transit”: “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. No distinction shall be made which is based on the
flag of vessels, the place of origin, departure, entry, exit or destination, or on
any circumstances relating to the ownership of goods, of vessels or of other
means of transport”.
• Article V further requires that all charges and regulations imposed on traffic in
transit be “reasonable”. It also states that with respect to all charges,
regulations and formalities there should be equal treatment notwithstanding
where the traffic in transit comes from.
What do we see now?
• The global IPR agenda is based on the fact that multinationals have
enough protection in US, EU and Japan, and now they need in LDCs to
guarantee markets and maintain monopoly.
• They find it cheaper for LDC governments to enforce their IPRs on their
behalf and even define IPR infringement as a crime on the State.
• TRIPS also seeks to cut enforcement costs by increasing the role of
states in enforcement.
• The argument is that some products might contain harmful substances,
and must be banned, but the true motive is stifle competition.