Patents, TRIPS, Flexibilities & Access to Medicines –Legal Perspective

Lesotho Civil Society Consultation Meeting

12 August 2014

WTO – World Trade Organisation

• The WTO is the only multilateral international body that creates, regulates, and manages the rules of trade between nations.

• There are 160 Member states.

• A majority of the Member States are developing countries with 34 designated as Least Developed Countries, including Lesotho that joined the WTO when it came into force in 1995

• Central to the WTO are the various negotiated agreements including the TRIPS Agreement

TRIPS

• World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (1994 Uruguay Round) came in to force 1. Jan 1995

• Most comprehensive international agreement on intellectual property rights

• Sets forth minimum standards for Intellectual Property Rights protection(IPRs) that must be met by all WTO Members

• This includes copyright protection on music, books etc. as well as patents on medicines

The Situation Pre-TRIPS

• India Patents Act, 1970 (Based on German model) • Brazil, No Pharmaceutical Patents • Pharmaceutical products became patentable in

West Germany, 1967; France 1967; Italy 1979; Spain 1992

• Until early 1990s, approx. 50 developing countries either excluded medicines from patentability or provided shorter periods of protection or operated conditions which restricted patent holders’ rights

What is a Patent?

• A Patent is an exclusive right granted for the protection of an invention.

• Patents are monopoly rights granted by the Government to protect inventions.

• Patents are granted a 20 year term (Duration)• The justification for the 20 year term is said to be to

allow the patentee time to recoup their expenditure, for without a monopolistic patent they would not invest in the research needed to produce new inventions.

Patents

• Titles granted by the State as a reward to innovation

• Protects inventions (not product per se)ex: a molecule, a manufacturing process, a

therapeutic indication, a formulation, a combination, etc.

• that are new, inventive, and capable of industrial application on the date of the patent application

Many patents protect a single drug

Patents – What do they do?

• Give a temporary monopoly to their owner as long as annual fees paid

• Only a negative right: the exclusive right to prevent others from making, using, selling, importing the object of a patent

Up to patent owners to sue infringers (except when infringement is criminalized)

The Purpose of the Patent System

• Is to encourage technological innovation by rewarding intellectual creativity through providing patent protection on the invention – granting a patent

• It is argued that patents are given as a reward – a recognition of the inventor’s contribution and that society benefits as the information disclosed in patents is published

TRIPS – General Principles

• Art 7… objectives: The protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations

TRIPS - Patentability• Threshold Test: Art 27.1 patents are available in all fields of

technology provided that they are: new, involve inventive step and are capable of industrial application

• Exclusions: Art 27.2 - Members may exclude from patentability inventions, the prevention within their territory of the commercial exploitation of which is necessary to protect human, animal or plant life or health or to avoid serious prejudice to the environment,

• Art. 27.3 Members may also exclude from patentability:• (a) diagnostic, therapeutic and surgical methods for the

treatment of humans or animals; (b) plants and animals other than micro-organisms

TRIPS – Key Provisions

• Key provisions:– Art 28… exclusive patent rights– Art 33… minimum 20 year term– Art 31… other use (compulsory licensing)– Art 6… Principle of Exhaustion (parallel

importing permissible)

– Art 7… objectives– Art 8… principles

TRIPS

• Compulsory licenses can be issues at the discretion of individual governments, for public and private sector

• Leaves patent disputes to be resolved through the judicial system

• Requires a patent term of 20 years

• Allows for Parallel Importation of patented products

Compulsory Licence and Government Use

• An authorisation given by the national patent office, or a Court, to any interested person (or the Governement itself)

• to legally overide a patent, i.e. to manufacture, sell, import or export a patented product, or to use a patented process for these purposes

• without the authorization of the patent owner

Doha Declaration on TRIPS and Public Health

Health was given priority over commercial concerns: para 4.

“We agree that the TRIPS Agreement does not and should not prevent Members from taking measures to protect public

health. Accordingly, while reiterating our commitment to the TRIPS Agreement, we affirm that the Agreement can and should be interpreted and implemented in a manner

supportive of WTO Members' right to protect public health and, in particular, to promote access to medicines for all.

In this connection, we reaffirm the right of WTO Members to use, to the full, the provisions in the TRIPS Agreement,

which provide flexibility for this purpose.”

- WTO Ministerial Declaration on the TRIPS Agreement and Public HealthNovember 2001

Doha Declaration

• Recognize gravity of public health problems afflicting developing countries

• It was affirmed by all WTO Members that:• TRIPS “does not and should not prevent Members

from taking measures to protect public health”• TRIPS “can and should be interpreted and

implemented in a manner supportive of WTO Members’ right to protect public health and, in particular, to promote access to medicines for all”

The Doha Declaration – Reaffirmed the flexibilities in the TRIPS Agreement

The right of countries to issue a compulsory license at their discretion, not only in cases of emergency.

The right of countries to determine for themselves what constitutes a national emergency or extreme case of urgency, in which case the procedure for issuing a compulsory license becomes easier and faster.

Lesotho as an LDC

• recognising the importance of trade and development for all member states, a number of the WTO Agreements have specific provisions for taking into account the interests of LDCs.

• The special and differential treatment provisions (S&Ds) are set out in a number of the WTO Agreements provide LDCs flexibility in the implementation of certain rules and commitments including longer implementation periods

LDCs – Special and Differential Provision in TRIPS

• TRIPS Agreement contains two key special and differential provisions specifically for LDC member states.

• First, the Preamble notes that Members recognize the special needs of the least-developed country Members in respect of maximum flexibility in the domestic implementation of laws and regulations in order them to create a sound and viable technological base

LDCs – Special and Differential Provision in TRIPS

• TRIPS Article 66 recognizing the special needs and requirements of least developed countries affords a longer period for implementation of the agreement in order to develop a sound and viable technology base.

• Initially, least developed countries had until 2006, with the possibility of a longer transition period to implement the TRIPS Agreement.

TRIPS implementation and Pharmaceutical Products

• In 2002, the deadline for implementation under Article 66 for LDC’s TRIPS obligation for pharmaceutical products was extended until 2016.

• This extension period took into account the instructions of Paragraph 7 of the Doha Declaration on TRIPS and Public Health that held LDCs would not be obliged to implement or apply Sections 5 and 7 of Part II of the TRIPS Agreement with respect to pharmaceutical products

LDCs -Transition Period extended for pharmaceutical products

• In 2005 the transition period was extended to 2013 and

• on 11 June 2013, the TRIPS Council adopted a Decision (IP/C/64) that further extended the transition period until 1 July 2021

So finally - what does this mean for Lesotho?

• The extension period removes LDCs (Lesotho) obligations with regards to pharmaceutical patents until at least 1st July 2021

In other words:• Lesotho should not be granting patents on

medicines until at least 2021 and should use this period to develop a sound and viable technology base to be able to respond to the health needs of its people.

Thank you for your time and attention

Cailin Morrison