Patent Related Flexibilities in the
Pharmaceutical Field
Workshop for the GCC on the Protection of
Invention in the Pharmaceutical Sector, Patents,
Undisclosed Information and Health Policies
Riyadh, Saudi Arabia
15-16 October
2012
Marco Aleman
Deputy Director, Patent Law Division, and head, Legislative and
Policy Advice Section
Giulia Ragonesi
Consultant, WIPO
WTO/TRIPS
Trips Agreement provides minimum standards of
protection of IPRs
WTO members shall provide patents for any invention:
- Products (e.g. technical device)
- Processes (methods for producing the chemical
ingredients for a medicine)
Definition of Flexibility
“a range of rights, safeguards and options that WTO
Members can exploit in their implementation of the
TRIPs Agreement”
Vague international rules, that need to be circumscribed
in their content by the national legislation
Definition (2)
Idea of “alternative ways” for:
Legislative implementation
To accommodate national interests
It goes without saying that all these ways must be
compatible with the provisions and principles of the
Treaty
Patents and Public Health
How to strike a balance: using flexibilities
Stimulus of
Innovation/R&D
Patents
Early and
affordable access
to new medicines
Generic Drug
Public Health related flexibilities
Exhaustion
Transitional period
Research exception
Regulatory Review (Bolar)
exception
Compulsory licenses
Exhaustion (Art. 6 TRIPs)
Right of the patent holder « exhausted » once the product
incorporating the patented invention is put into the market
Exhaustion
National
Regional
International
Example of national exhaustion
country C
country B
Local price $ 1.50
Local price $
0.75
country A
Local price $
1.0
country D
country E
Local price
$ 2.00
Local price $
0,50
Example of international exhaustion
Exporting country C
Exporting
country B
Local price $ 1.50
Local price $
0.75
Importing
country A
Local price $
1.0
Exporting
country D
Exporting
country E
Local price
$ 2.00
Local price $
0,50
Example of regional exhaustion
country D
country E
local price $ 3.0
Local price
$ 0.50
country
A
Local
price $
1.75
country B
Local price $
0.75
country C
Local price
$ 2.05
National exhaustion
UNITED ARAB EMIRATES : Section 17 of the Patent Law No. 44 of
12/10/1992 – 1413
17. The rights conferred by a patent or utility certificate shall cover
only acts performed for industrial or commercial purposes. They
shall not extend to acts in relation to the protected product once it
has been sold in the United Arab Emirates. However, if the patent or
utility certificate relates also to a specific use of the product, the
owner shall have the right to reserve that use for himself.
OMAN: Article 11 C (4) of the Law on Industrial Property Rights of
2008
4 - The rights under the patent shall not extend:
A) to acts in respect of articles which have been put on the market in
Oman by the owner of the patent or with his consent, consequently
exhausting the patent owner's rights;
International exhaustion
JORDAN: Article 37 of the Law on Patents No. 32 of 1999, as last
amended by Law No. 71 of 2001
“The provisions of this law shall not prevent any person from
importing any materials or goods from a third party if that party
enjoys the legal protection of the same patent protected in the
Kingdom and if that importation is lawful, complies with the
principles of commercial competition and fairly takes into account
the economic value of the protected patent.”
EGYPT :Article 10 (1) of the Law on the Protection of Intellectual
Property Rights No. 82 of 2002
A patent shall confer on its owner the right to prevent a third party
from exploiting the invention by any means.
The right of a patent owner to prevent a third party from importing,
using, selling or distributing a product shall lapse when he
commercializes the product in any country or authorizes a third party
to do so.
Transitional Period for pharmaceuticals
Art. 66 (1) TRIPS
LDCs: time up to 2016 to provide protection for
pharmaceutical inventions (if not yet provided)
Art. 65 (4) TRIPS
Developing Countries. Time up to 2005 to provide
protection for patents in area of technology not so
protectable in the Member territory on the general date
of application of the TRIPS Agreement
Research and Regulatory Review (Bolar)
exception
Not explicitly provided in the TRIPs but possible to adopt them
according to the open clause contained in Art. 30 of the TRIPs
Agreement
Research exception: “the exception under which use of patented
product for scientific experimentation, during the term of the patent
and without consent, is not an infringement”*
Regulatory review (Bolar) exception: acts to carry out equivalency
tests for the regulatory approval of products such as generic
medicines before the expiration of the relevant patent
*Canada- Patent protection of Pharmaceutical Product
Examples
GCC : Section 14 (1) of the Patent Regulation of the
GCC of 1992 (as at 23/04/2002)
“The rights under the patent shall not extend to:
1) Acts done particularly for experimental purposes”
EGYPT : Article 10 no. 1 of the Intellectual Property Law 82
of 2002
“The following shall not be considered as infringements
of that right when carried out by third parties:
1) Activities carried out for scientific research purposes.
Examples Bolar
EGYPT : Article 10 (5) of the Intellectual Property Law 82
of 2002
“Where a third party proceeds, during the protection
period of a product, with its manufacturing, assembly,
use or sale, with a view to obtain a marketing license,
provided that the marketing starts after the expiry of such
a protection period.
JORDAN : Article 21 C of the Patent Act No. 32 of 1999,
as last amended by Act No. 71/2001
“Notwithstanding any conflicting provision in this law or
any other law, all types of scientific research and
development and filing applications for obtaining
marketing permits carried out before the elapse of the
patent protection period shall not be regarded as
infringement neither civil nor criminal
Compulsory license (CL) conditions in the
TRIPS
CL: Authorization granted by the government to a third
party to use the invention without the consent of the
patent holder. Conditions
Authorization on individual merits
Prior efforts for voluntary license (possibility to waive this
requirement in case of national emergency or other
circumstances of extreme urgency)
Limited scope and duration
CL conditions (2)
Non-exclusive and non-assignable
Used predominantly for the supply of domestic market of
the Member authorizing such use
Adequate remuneration to the patent holder
CL and local production
Problem in case of countries which insufficient or no
manufacturing capacities in the pharmaceutical sector:
how to use the system of CL?
Doha Declaration on TRIPS Agreement and
Public Health
WTO Members recognized:
the gravity of public health problems…, especially those resulting
from HIV/AIDS, tuberculosis, malaria and other epidemics
the importance of IP for the development of new medicines and the
concern about its effect on prices
WTO Members agreed:
TRIPS shall be interpreted and implemented in a way that supports
public-health by promoting ^both access to existing medicines and
the creation of new medicines
TRIPS doesn’t and shouldn't prevent members from taking
measures to protect public health
Doha Declaration on TRIPS and Public
Health (2)
Countries shall use flexibilities contained in the TRIPS
Each Member has the right to grant CL and the freedom
to determine the ground upon which such licenses are
granted
Each Member has the right to determine what
constitutes a national emergency or other circumstances
of extreme urgency
Each Member is free to establish its own exhaustion
regime without challenge
Exemption for LDCs on pharmaceutical patents until
2016
Paragraph 6 of Doha Declaration
Problem:
- Members lacking manufacturing capacities could issue
compulsory licenses for importation
- But: Art. 31 (f) requires production “predominantly for the
supply of the domestic market of the member”
Under Paragraph 6 of the Declaration, the General
Council mandated the TRIPS Council to find a solution to
the issue
The Decision of the General Council of WTO
of August 30,2003 (1)
3 distinct waivers granted:
- Exporting countries’ obligation under Art. 31 (f). Any
Member can export drugs made under CL to meet the
needs of importing countries
- Remuneration is only required on the export side
- Exporting constraints are waived
The Decision of the General Council of WTO
of August 30,2003 (2)
-
-
Paragraph 2 of the decision sets out conditions to
comply with:
Notification of the TRIPS Council
Confirmation of insufficient or no manufacturing
capacities in the pharmaceutical sector (except LDCs)
Determination of expected quantities
Products produced under license shall be clearly
identified
Adopting reasonable measures to prevent re-exportation
of these products
The Decision of the General Council of WTO
of August 30,2003 (3)
Eligible importing members:
- LDC members automatically eligible
- Any other Member eligible, subject to mandatory
notifications
- But: 44 Members have voluntarily opted out partially or
fully
Decision of 30 August 2003 is interim, terminates when
amendment replaces it for each member
Amendment of the TRIPS Agreement-new
Art. 31 bis (December 6,2005)
General Council adopted the Protocol amending the TRIPS
Agreement on December 6,2005
The protocol was opened for acceptance by Members until
December 1, 2007 and has been extended until 31 December 2009,
to 31 December 2011, and then to 31 December 2013*
The amendment will enter into force if 2/3 of eh WTO Members
notify their acceptance Currently 43 Countries + EU have
accepted
*General Council decisions respectively of 18 December 2007, 17 December
2009 and 30 November 2011
First notification
4 October 2007
Canada has authorized a company to make a generic
version of a patented medicine (AIDS therapy drug) for
export to Rwanda, which is unable to manufacture the
medicine itself
Are patents really a barrier to access to
medicines in developing countries?
95% of the products on the WHO Essential Drug List are
not patented
Antiretrovirals are not patented in half of the African
States
In the other half, only 3 out of 16 antiretrovirals are
patented total amount of patents 18%. There is no
patent on triple therapies
12 out of 13 malaria drugs are not patented in Africa
total amount of patents 5%
9 out of 11 tuberculosis drugs are not patented in
Africa total amount of patents 1%
Access to medicines in developing countries
TRIPS forms part of the solution next to the other
important factors: infrastructure, national health systems,
procurement regimes, reduction import tariffs, etc.
Extra effort needed to address the problem of neglected
diseases as patent as incentive does not work due to
lack of market
IP must be protected to trigger R&D and further
mechanisms must be developed to trigger R&D into
neglected diseases.
6. Statistics
Number of countries which used Transition Periods
7
6
5
Africa
4
Asia and Oceania
3
Latin America and
Caribbean
2
1
0
Africa
Asia and
Oceania
Latin America
and Caribbean
Transition Periods
%
100
80
60
40
20
0
Africa
Asia and Oceania
Latin America and
Caribbean
Express statement to use the general transition period
Transition Period related to Patent Product Protection
Countries analyzed: Exhaustion
35
30
Africa
25
Latin America
and Caribbean
Asia and
Oceania
Europe
20
15
10
OECD
5
0
National
Regional
International
Statistics: Exhaustion
%
90
80
Africa
70
Latin America
and Caribbean
Asia and
Oceania
Europe
60
50
40
30
20
OECD
10
0
National
Regional
International
Countries analyzed: Research and
Bolar exception
40
35
30
25
20
15
10
5
0
+
EU
Africa
Research exception
Bolar exception
Latin
Asia and
America Oceania
and
Caribbean
Europe
OECD
Statistics: Research and
Bolar exception
%
100
90
80
70
60
50
40
30
20
10
0
Research exception
Bolar exception
+
EU
Africa
Latin
Asia and
America Oceania
and
Caribbean
Europe
OECD
Countries analyzed: Compulsory Licenses
45
40
35
30
25
20
15
10
5
0
+
EU
Africa
Latin
America and
Caribbean
Asia and
Oceania
Europe
OECD
Countries
Statistics: Compulsory Licenses
(For non-working)
%
100
90
80
70
60
50
40
30
20
10
0
Africa
Latin America
and Caribbean
Asia and
Oceania
Europe
OECD
Countries
Statistics: Compulsory Licenses
(For dependent patent)
%
100
90
80
70
60
50
40
30
20
10
0
Africa
Latin
America and
Caribbean
Asia and
Oceania
Europe
OECD
Countries
Statistics: Compulsory Licenses
(To correct patent abuse)
%
100
90
80
70
60
50
40
30
20
10
0
Africa
Latin
America and
Caribbean
Asia and
Oceania
Europe
OECD
Countries
Statistics: Compulsory Licenses
(For public interest)
%
100
90
80
70
60
50
40
30
20
10
0
Africa
Latin
America and
Caribbean
Asia and
Oceania
Europe
OECD
Countries
Statistics: Compulsory Licenses
(Government use)
%
100
90
80
70
60
50
40
30
20
10
0
Africa
Latin
America and
Caribbean
Asia and
Oceania
Europe
OECD
Countries
Statistics: Compulsory Licenses
(Implementation of the Decision of the
General Council)
%
100
90
80
70
60
50
40
30
20
10
0
Africa
Latin
America and
Caribbean
Asia and
Oceania
Europe
OECD
Countries
Thank you!