The UK
Government Response to the Report of the Commission on Intellectual Property
Rights “Integrating Intellectual Property Rights and Development
Policy”
1.
Last September, the UK Government welcomed the report of the Commission
on Intellectual Property Rights “Integrating Intellectual Property Rights and
Development Policy” which had been set up by the Government as a result of a
commitment in the Government's second
White Paper on International Development entitled: "Eliminating World
Poverty: Making Globalisation Work for the Poor." (December
2000). The report is a valuable contribution to
the debate on the complex issues surrounding the interaction of intellectual
property rights (IPRs) and development policy.
2.
The Government believes that IPRs can play a vital role in the course of
the development process for developing countries today, just as they did, and
continue to do, in the UK, other developed countries and the most successful
developing economies. The
Commission’s report emphasises that a prerequisite for sustainable development
in any country is the development of an indigenous scientific and technological
capacity. As the Commission
recognises, an IPR system is capable of being an important element in developing
that capacity, notably in those countries which have already developed a
scientific and technological infrastructure. But, as the Commission’s report makes
clear, an intellectual property system cannot of itself ensure a country attains
its developmental goals. The degree
to which this occurs depends on many different factors, particularly the
economic, social and environmental policies it chooses to pursue, for example,
openness to trade and effective governance.
3.
We agree with the Commission that IPR regimes can and should be tailored
to take into account individual country's circumstances within the framework of
international agreements such as the Agreement on Trade-Related aspects of
Intellectual Property Rights (TRIPS).
The Commission also raises the important issue of how technical
assistance from developed countries and international organisations such as the
World Intellectual Property Organisation (WIPO) can be provided so as to ensure
that developing countries fully understand how to create an effective
intellectual property system appropriate to their needs. The Government is committed to this
goal, both in its own technical assistance programmes and in influencing those
of international organisations
4.
In setting up the Commission, the Government’s intention was to explore
how IPRs could work better for developing countries within the overall framework
of development policy. The
Commission has found that intellectual property does indeed have a role to play
in promoting development but it has made a number of detailed recommendations
designed to improve the way these rules are developed and applied, both
nationally and internationally.
We are pleased to introduce the Government’s detailed response to these
recommendations, which will be used to inform the UK’s position in a range of
negotiations over the coming months and years.
5.
We should stress that the Government remains firmly committed to the
effective protection of IPRs in order to stimulate continued innovation and
creativity. But this is also
consistent with the use of various flexibilities in the TRIPS agreement by
developing countries as the Ministerial Agreement on the WTO Doha Declaration on
TRIPS and Public Health in November 2001 demonstrated in one important area for
developing countries.
6.
Finally, we would like to thank the Commissioners personally for a
comprehensive and well-written report.
While there are those who disagree strongly with aspects of the report,
just as others are in wholehearted agreement, nobody should ignore the
importance of the issues it raises and the quality of its analysis. We hope it will continue to serve as a
stimulus to ongoing debate on these important issues.
CLARE SHORT
PATRICIA HEWITT
Secretary of State for
Secretary of State for
International Development
Trade and Industry
The UK
Government Response to the Report of the Commission on Intellectual Property
Rights “Integrating Intellectual Property Rights and Development
Policy” [1]
The Government response consists of an introductory
general comment on each chapter, and a more detailed response to each of the
Commission’s recommendations (which are shown in bold).
1.
The Government welcomes the approach of the Commission in exploring the
rationale for IP protection, and the historical and contemporary evidence on the
impact of IP. In doing so, the
Commission notes that much of the evidence on the impact of IP is
inconclusive. The Government
believes that the Commission may have interpreted the available evidence in a
way that understates the impact of IP in developing countries. For example, too little emphasis seems
to be placed on the benefits that may accrue in countries such as India, China
and Brazil from implementing TRIPS-standard IP protection. Similarly, while the section on the
historical experience of developed countries with IP is of interest, it does not
logically follow that, because now-developed countries used IP selectively in
the past, this would be most appropriate for developing countries today. There remains room for differing
interpretations of the evidence marshalled by the Commission.
Appropriate
incentive policies in developed countries to promote technology transfer, for
instance tax breaks for companies that license technology to developing
countries.
2.
The Government agrees that developed countries should provide incentives
to promote technology transfer to developing countries. The provision of incentives for
technology transfer to Least Developed Countries is already mandatory under
Article 66.2 of the TRIPS Agreement.
The Government welcomes the fact that the TRIPS Council has just agreed
clearer procedures for reporting annually on these incentives. However, the Government agrees with the
Commission that the issue of technology transfer to least developed (and
developing) countries needs to be addressed in a much wider context than the
specific provisions of Article 66.2, and that context should include the issue
of how local capacity to absorb, use and adapt technologies from abroad can be
increased.
Establishment of effective competition policies in
developing countries.
3.
The Government believes that effective competition policies will help to
make developing countries' markets more efficient. For this reason, the Government has
strongly supported the inclusion in the Doha Development Agenda of negotiations
on trade and competition.
Making more public funds available to promote
indigenous scientific and technological capability in developing countries
through scientific and technological cooperation. For instance, supporting the proposed
Global Research Alliance between developing and developed country research
institutions.
4.
The Government agrees both that there is a need to build the capacity of
developing countries in science and technology and that international
cooperation between developed and developing countries is a means to this
end. The Department for
International Development (DFID) is amongst the largest spenders on research and
development of bilateral aid donors.
In addition it contributes its share to European Union programmes for
research cooperation with developing countries. Much of DFID's research expenditure involves
scientific and technological cooperation between developed and developing
country research institutions.
Following a review of its research policy, DFID plans to strengthen
the role it plays in building appropriate capacity in developing countries to
acquire, use and generate knowledge.
Commitments to ensure that the benefits of publicly
funded research are available to all.
Commitments to ensure open access to scientific
databases.
5.
The Government agrees that the results of publicly-funded research should
as a general rule be made publicly available, while recognising that there will
need to be exceptions, for example on grounds of national security.
6.
The Government agrees with the Commission that, without the incentives of
patents, it is unlikely that the private sector would have invested so much in
the discovery and development of medicines, many of which are currently in use
in both developed and developing countries. It is also clearly true that for
diseases that affect mainly developing countries, the incentives for research
and development provided by the market are inadequate in relation to the scale
of human suffering and the economic and social costs they cause in developing
countries. In those circumstances,
the IP system cannot overcome the insufficiency of market demand. The Government agrees that tackling
these diseases therefore requires public intervention either directly e.g.
through public funding or tax incentives to encourage private sector research,
or through stimulating private-public partnerships.
7.
The Government also agrees that much more needs to be done to increase
access to essential medicines. As
the Commission notes this is about much more than intellectual property
regimes. In addition to inadequate
research, weak health systems and infrastructure, a lack of funds and
limitations in existing national health and drug policies all play important
roles in impeding access to medicines by those who need them. The recent report from the UK Working
Group on Increasing Access To Essential Medicines in The Developing World[2]
(hereafter the Working Group) examined the range of policy approaches that can
help achieve more affordable prices and better access to essential medicines in
the developing world. In particular
it sets out the Government's support for a voluntary framework which would make
widespread, sustainable, and predictable differential pricing the operational
norm. The IP system also has a
contribution to make. That is why
the Government supports the Doha Declaration on TRIPS and Public Health
(henceforth the “Doha Declaration”) that requires WTO members to find a
long-term workable system that will permit compulsory licensing to be used by
those developing countries with inadequate manufacturing capacity of their
own.
Public funding for research on health problems in
developing countries should be increased.
This additional funding should seek to exploit and develop existing
capacities in developing countries for this kind of research, and promote new
capacity, both in the public and private sectors.
8.
The Government agrees.
Public funding for health problems in developing countries of relevance
to poor people needs to be increased at the global level. In addition, the Government
recognises that a range of public policies for research and development will be
required to stimulate an increase in research and development in the private
sector. Direct public investment
must be complemented by other approaches.
This is why the Government is increasingly providing public funding to
help create public-private partnerships (PPPs).
9.
The type of policy and investment will vary depending on the nature of
the disease condition as well the nature of the research problem. Last year DFID committed £16 million to
a consortium of public sector groups led by the UK Medical Research Council
(MRC) to develop and test microbiocides to prevent HIV infection in women. DFID commitments to PPPs include £14
million to the International AIDS Vaccine Initiative (IAVI), £5 million to the
Medicines for Malaria venture in 2001 as well as £2.5 million to the development
of the Malaria drug LAPDAP together with GlaxoSmithKline. It also supports work on lymphatic
filariasis and onchocerciasis.
Apart from annual investments by DFID of approximately £24 million per
annum in health research, the MRC spends about £23 million on research of
particular relevance to developing countries.
Countries need to adopt a range of policies to
improve access to medicines.
Additional resources to improve services, delivery mechanisms and
infrastructure are critical. Other
macroeconomic policies need to be in harmony with health policy objectives. But so also does the IP regime. Countries need to ensure that their IP
protection regimes do not run counter to their public health policies and that
they are consistent with and supportive of such
policies.
10. The
Government agrees. Access to
medicines is a complex issue which requires a multi-faceted response. The Government actively supports
developing countries efforts to improve healthcare and DFID has invested over
£1.5 billion since 1997 to support the development of health systems in poorer
countries and has worked closely with the World Health Organisation (WHO) on the
recent major revisions to the Essential Drugs List.
11. The UK is
represented on the boards of GAVI and the Global Fund for HIV/AIDS, TB and
Malaria (GFATM). DFID made a
five-year commitment of $200 million to the Global Fund in 2001 and provided £38
million to the Global Alliance for Vaccines and Immunisation (GAVI). DFID is also funding a new organisation
to promote access to health technologies for the poor through improved
management of intellectual property in research and development – the Centre for
the Management of Intellectual Property in Health R&D (MIHR).[3]
Developed
countries should maintain and strengthen their legislative regimes to prevent
imports of low priced pharmaceutical products originating from developing
countries.
12.
Existing EU rules mean that imports of cheaper patented drugs from
outside the EU (“parallel imports”) are prohibited. The Government, along with the European
Commission and other EU member states, is working to strengthen further border
measures to prevent differentially priced pharmaceuticals (i.e. parallel
imports of medicines specifically priced at a lower rate for developing
countries) from entering the EU.
This is important as it will help keep pharmaceutical products priced for
poor people in the developing world in the intended market and thus support the
wider differential pricing framework (see para 7 above).
Developing
countries should not eliminate potential sources of low cost imports, from other
developing or developed countries.
In order to be an effective pro-competitive measure in a scenario of full
compliance with TRIPS, parallel imports should be allowed whenever the
patentee's rights have been exhausted in the foreign country. Since TRIPS allows countries to design
their own exhaustion of rights regimes (a point restated at Doha), developing
countries should aim to facilitate parallel imports in their
legislation.
13. The
Government agrees in principle. The
Doha Declaration confirmed that each Member is free to establish its own regime
in this area. Parallel imports are
therefore entirely compatible with TRIPS.
14.
However, it is important that efforts to price drugs differentially for
poor people are not undermined.
This will require commitments from developing and developed countries
alike to prevent diversion of differentially priced drugs from their intended
users. This means that one potential source of low cost imports - the diversion
of differentially priced drugs to higher-priced markets - must be ruled
out.
Developing countries should establish workable laws
and procedures to give effect to compulsory licensing, and provide appropriate
provisions for Government use.
15. The
Government agrees that legislation and procedures should be established by
developing countries to allow the effective use of compulsory licensing and
government use, as provided for in TRIPS and in line with the Doha
Declaration. TRIPS also provides
for the adequate remuneration for the right holder, taking into account the
economic value of the authorisation of the compulsory licence. The Government considers that the
principal purpose of this recommendation is to bolster the ability of developing
countries to negotiate effectively with potential providers of patented
medicines. But the actual use of
compulsory licensing should be sparing and should follow the rules set out in
Article 31 of TRIPS (including any agreements or amendments which may be
endorsed by the WTO General Council pursuant to the Doha Declaration).
The choice between these options will be worked out
politically, but we strongly emphasise our concern that whatever legal solution
is adopted by the WTO is, it should proceed upon the following principles. First, it should be quickly and easily
implementable with a view to a long-term solution. Second, the solution should ensure that
the needs of poor people in developing countries without manufacturing capacity
are given priority. Third it should
seek to ensure that conditions are established to provide potential suppliers
the necessary incentive to export medicines that are needed.
16. The
Government agrees. The Government
is committed to finding a sustainable long-term solution for WTO members with
insufficient or no pharmaceutical manufacturing capacity so that they can make
effective use of compulsory licensing.
The Government is disappointed that no agreement was reached by the end
of December 2002 but remains committed to working with all WTO members to find a
long-term multilateral solution as quickly as possible.
17. The
Government believes that the solution should be easy to use by both exporting
and importing countries and that the process should be clear and
transparent. The Government also
believes that effective safeguards against abuse should be put in place. It recognises that creating a positive
incentive through the TRIPS Agreement alone may be very difficult.
A way needs to be found to reconcile the nature of
the solution adopted with the objective of providing medicines of the
appropriate quality at the lowest possible cost. If that cannot be achieved, the legal
solution will have little practical reality. Nor will the option of compulsory
licensing be effective as a negotiating tool.
18. The
Government agrees. For the solution to be effective it must provide developing
countries with a real negotiating tool.
The underlying principle should be to aim for strict
standards of patentability and narrow scope of allowed claims, with the
objective of:
19. The
Government believes that these are all aspects which developing countries should
take into account when designing an overall legislative framework to increase
competitiveness through innovation whilst safeguarding against abusive
behaviour. As noted in our response
to chapter 6 of the report, the Government is fully supportive of having fixed
and measurable quality standards for granting of patents.
20. As we also
note in our response to chapter 6, developing countries will have differing
requirements in respect of IPRs.
Thus while some countries may benefit from a more restrictive scope of
patentable subject matter in this area, others may benefit from a less
restrictive approach. As the
Commission notes, in particular industries, such as chemicals, and for
particular activities such as R&D, a strong IPR regime can be a significant
factor in the decision to invest.
For instance, one of the responses to the Commission report considers
that investment in pharmaceuticals in Brazil and Mexico increased significantly
when those countries strengthened their IPR regimes in the 1990s.
Most developing countries, particularly those without
research capabilities, should strictly exclude diagnostic, therapeutic and
surgical methods from patentability, including new uses of known
products.
21. The UK and
the EU have specific exceptions for diagnostic therapy and surgical
methods. Developing countries
should give consideration to a similar approach.
Developing countries should include an appropriate
exception for "early working" to patent rights in their legislation, which will
accelerate the introduction of generic substitutes on patent
expiry.
22. Use of
"early working" provisions (such as the Canadian version of a
"Bolar
exemption" which has been judged compatible with TRIPS) should be
considered
by developing countries. This is
particularly the case for those countries who have, or wish to encourage, a
generic medicines industry. Even in
countries with no manufacturing capacity, there may be circumstances where early
regulatory approval of generic substitutes will be facilitated by a “Bolar
exemption.”
Countries may allow health authorities to approve equivalent generic substitutes by "relying on" the original data. Developing countries should implement data protection legislation that facilitates the entry of generic competitors, whilst providing appropriate protection for confidential data, which may be done in a variety of TRIPS-compatible ways. Developing countries need not enact legislation the effect of which is to create exclusive rights where no patent protection exists or to extend the effective period of the patent monopoly beyond its proper term.
23. The
Government agrees that developing countries should consider all means compatible
with TRIPS and the protection of confidential data to ensure that the entry of
generic competitors is not hindered either when patent protection has expired or
when there is no patent protection.
Those LDCs which already provide pharmaceutical
protection should consider carefully how to amend their legislation to take
advantage of the Doha Declaration.
Consistent with our analysis elsewhere, the TRIPS Council should review
the transitional arrangements for LDCs, including those applying to join the
WTO, in all fields of technology.
24. The
Government agrees that LDCs should consider carefully whether and how to amend
their legislation, following the WTO General Council endorsement of the
extension of the transition period for pharmaceutical patents in line with the
Doha Declaration. Acceding LDCs
should be allowed to use all the flexibilities in the TRIPS agreement and there
should be no "TRIPS plus" for latecomers.
The issue of extending transition arrangements for LDCs in all other
fields of technology is addressed in the response to Chapter 8.
CHAPTER
3
AGRICULTURE
AND GENETIC RESOURCES
25.
Intellectual property rights play an important role in the area of
genetic resources and agriculture as a stimulus to research and innovation. However, the Government recognises that
countries have different needs. For
example, those developing countries which have, or which would like to develop,
a biotechnology industry have different needs to those without. There are also different traditional
systems for the exchange of seed between farmers which are important for
maintaining biodiversity and food security. For these reasons the Government
believes that developing countries should make full use, as appropriate, of the
flexibilities available under the TRIPS agreement to ensure that their
intellectual property systems are tailored to their individual
needs.
Developing countries should generally not provide patent protection for animals and plants, as is allowed under Article 27.3(b) of TRIPS, because of the restrictions patents may place on use of seed by farmers and researchers. Rather they should consider different forms of sui generis systems for plant varieties
26. We believe
that this approach to the patenting of plants and animals should be carefully
considered by developing countries.
Indeed, in the EU plant and animal varieties and essentially biological
processes for the production of plants or animals are excluded from
patentability under the Directive on the Legal Protection of Biotechnological
Inventions. Some developing
countries, as noted in the report, have gone further in defining the exclusion
of living matter from patentability.
Under TRIPS
WTO member countries are obliged to provide patents for inventions involving
microbiological and non-biological processes, which would include genetic
modification technology.
Essentially biological processes for the production of plants and
animals, such as plant breeding, may be excluded. In addition, countries may exclude
inventions from patentability on moral grounds, including to protect human,
animal or plant life or health or avoid serious prejudice to the
environment. In deciding where the balance of benefit lies for
them, developing countries will need to consider, amongst other things, the role
patent protection could have in stimulating investment in research. Exceptions can be made to patent rights,
which could address the restrictions patents may place on the use of seed by
farmers and researchers, but sui
generis systems for protecting plant varieties may well be a more suitable
option for many developing countries.
Those developing countries with limited technological capacity should restrict the application of patenting in agricultural biotechnology consistent with TRIPS, and they should adopt a restrictive definition of the term “microorganism”
27. We support
the conclusion that it may be in the interests of many developing countries to
restrict the application of patenting in biotechnology consistent with
TRIPS. The absence of a definition
of the term "microorganism" in TRIPS means that it is legitimate for WTO member
states to make a reasonable definition themselves. They should do so based on the potential
research benefits to the extent that they have, or wish to develop,
biotechnology research capacity.
Countries that have, or wish to develop, biotechnology-related industries may wish to provide certain types of patent protection in this area. If they do so, specific exceptions to the exclusive rights, for plant breeding and research, should be provided. The extent to which patent rights extend to the progeny or multiplied product of the patented invention should also be examined and a clear exception provided for farmers to reuse seeds
28. The
Government agrees that it may be in the interests of some developing countries
to provide additional patent protection for biotechnology even beyond what is
required under TRIPS, for the reasons given by the Commission. We agree that in these circumstances it
would be appropriate for developing countries to consider the use of exemptions
for research (and plant breeding) and to
enable farmers to reuse seed.
The
continuing review of Article 27.3(b) of TRIPS should also preserve the right of
countries not to grant patents for plants and animals, including genes and
genetically modified plants and animals, as well as to develop sui generis regimes for the protection
of plant varieties that suit their agricultural systems. Such regimes should permit access to the
protected varieties for further research and breeding, and provide at least for
the right of farmers to save and plant-back seeds including the possibility of
informal sale and exchange
29. The
Government strongly agrees that the flexibilities currently contained in Article
27.3(b) of the TRIPS Agreement, including the option of sui generis regimes for the protection
of plant varieties, are important for developing countries and should be
maintained. It would also be right
for developing countries to consider the inclusion of appropriate provisions in
sui generis regimes on the right of
farmers to save and plant back seed, including the possibility of informal sale
and exchange. TRIPS does not
explicitly address whether genes (in their natural state or modified) should be
patentable but we agree that genes in their natural environment should not be
patentable. Countries are also free
to define their own patentability criteria for gene-based inventions in line
with the provisions of TRIPS.
However, while TRIPS would allow the exclusion of genetically modified
plants and animals from patenting, as noted above, countries are obliged to
grant patents on technical processes involving genetic modifications, subject to
any exclusions they may wish to make consistent with Article 27(2) of
TRIPS.
Because of the growing concentration in the seed industry, public sector research on agriculture and its international component should be strengthened and better funded. The objective should be to ensure that research is oriented to the needs of poor farmers; that public sector varieties are available to provide competition for private sector varieties; and that the world’s plant genetic resource heritage is maintained. In addition, this is an area in which nations should consider the use of competition law to respond to the high level of concentration in the private sector
30. The
Government agrees that publicly funded research has an important role to play,
particularly in addressing the needs of poor farmers which may not be catered
for by private sector research.
The
Government is fully aware of the crucial role of the public sector generally,
and the international community in particular, in supporting research directed
at the problems of the poorest countries and the poorest people. DFID is
amongst the leading bilateral funders of agricultural research for the benefit
of developing countries but we recognise a continuing level of
under-investment at the global level. Details of our contribution to
agricultural research are in the DFID Annual Report.[4] The UK will continue to work for greater
focus and strengthened global research efforts on the needs of the poor along
the lines recommended by the Commission.
The Government also agrees that it
is important to maintain a competitive environment if the potential benefits of
new technology for poor farmers and consumers are to be maximised.
- Not granting IPR protection of any material transferred in the framework of the multilateral system, in the form received
-
Implementation
of Farmers’ Rights at the national level, including (a) protection of
traditional knowledge relevant to plant genetic resources for food and
agriculture; (b) the right to equitably participate in sharing benefits arising
from the utilisation of plant genetic resources for food and agriculture; (c)
the right to participate in making decisions, at the national level, on matters
related to the conservation and sustainable use of plant genetic resources for
food and agriculture
31. The
Government fully supports the rapid, effective and transparent implementation of
the International Treaty on Plant Genetic Resources for Food and
Agriculture. The UK signed the
Treaty on 6 June 2002 and hopes to ratify it soon. We would urge all other countries that
have not yet done so to sign and ratify the Treaty as soon as
possible.
32. The
Government broadly endorses the Commission’s analysis in this chapter. It
recognises that traditional knowledge plays an important part in the livelihoods
of many poor communities in developing countries. It agrees with the Commission that the
issue of “protecting” traditional knowledge goes well beyond the question of how
IP protection might be applied to it.
Nevertheless, it recognises the importance of obtaining an equitable and
fair solution in the interaction between traditional knowledge and IP
protection. As a signatory to the
Convention on Biological Diversity (CBD) the UK believes that there should be an
equitable sharing of benefits arising out of the utilisation of genetic
resources and that TRIPS and CBD need to be implemented in a mutually supportive
manner. The CBD adopted
Guidelines on Access and Benefit Sharing at the Conference of the Parties in The
Hague in April 2002. These will
provide a valuable reference point for Governments and stakeholders in their
implementation of the access and benefit sharing arrangements of the CBD.
There is much to gain by considering the issue in a number of fora, while ensuring coherent approaches are developed and that effort is not duplicated.
33. The
Government agrees. WIPO has an
important role to play, but the issues go well beyond intellectual property in
the conventional sense, and a multi-pronged effort is desirable, involving both
national and international processes.
The debate should continue internationally in official fora (such as WIPO
or the CBD) and also in unofficial dialogues between stakeholders. For instance, the World Business Council
for Sustainable Development has just published the results of a stakeholder
dialogue on this topic.[5] At national level, similar diverse
processes may be required.
With such a wide range of material to protect and
such diverse reasons for “protecting it”, it may be that a single
all-encompassing sui generis system of protection for traditional
knowledge may be too specific and not flexible enough to accommodate local
needs
34. The
Government agrees that an internationally agreed sui generis system is
not necessarily a desirable or realistic goal.
Digital libraries of traditional knowledge should, as soon as practical, be incorporated into the minimum search documentation lists of patent offices therefore ensuring that the data contained within them will be considered during the processing of patent applications. Holders of the traditional knowledge should play a crucial role in deciding whether such knowledge is included in any databases and should also benefit from any commercial exploitation of the information.
35. The
Government agrees that these libraries will play a valuable role in helping to
ensure that patents are granted on the basis of a full knowledge of extant
“prior art”. But the information in
such libraries should only be included with the consent of those who lay claim
to that knowledge. The UK is
working with other members of WIPO in the Intergovernmental Committee on Genetic
Resources, Traditional Knowledge, and Folklore on the setting up of appropriate
databases. Preliminary work has
been based on databases provided by India and China, amongst others, and the UK
Patent Office is reviewing these to identify those that provide useful search
tools.
Those countries that only include domestic use in
their definition of prior art, should give equal treatment to users of knowledge
in other countries. In addition, account should be taken of the unwritten nature
of much traditional knowledge in any attempts to develop further the patent
system internationally.
36. The UK
gives equal treatment to users of knowledge in other countries. The Government agrees that if the
same policy were adopted in all countries this would be an important safeguard
against the granting of patents on knowledge which is already in the public
domain. The Government will
therefore work with others to get this principle extended. The development of digital libraries
should aim to include traditional knowledge of an unwritten nature, but only
provided this is with the consent of the holders of that knowledge. We recognise the need to address the
legitimate concerns amongst traditional knowledge holders over the use of such
data banks, particularly where their knowledge is of important cultural or
religious significance, and where disclosure might be damaging to their
interests.
The principle of equity dictates that a person should
not be able to benefit from an IP right based on genetic resources or associated
knowledge acquired in contravention of any legislation governing access to that
material. In such cases the burden
should generally lie with the complainant to prove that the IP holder has acted
improperly. However, a precursor for any action is knowledge of the wrong. It is
to assist in this respect that we believe that a disclosure requirement of the
type discussed above is necessary.
37. The
Government agrees in principle that a disclosure requirement in patent
applications is desirable. The EU
is now actively supporting this in the TRIPS Council, on the basis that any
sanctions should not affect the validity of the patent.
All countries should provide in their legislation for the obligatory disclosure of information in the patent application of the geographical source of genetic resources from which the invention is derived. This requirement should be subject to reasonable exceptions as, for example, where it is genuinely impossible to identify the geographical source of material. Sanctions, possibly of the type discussed above, should be applied only where it can be shown that the patentee has failed to disclose the known source or where he has sought to deliberately mislead about the source. This issue should be considered by the Council for TRIPS, in the context of paragraph 19 of the Doha Ministerial Declaration.
38. The
Government agrees that it would be beneficial if all countries adopted a
disclosure requirement in their legislation. When the TRIPS Council decides on this
issue, we will consider with our European partners how best to implement this in
EU and UK legislation. This will
include definition of the kind of sanctions that would be appropriate where it
can be demonstrated that the applicant has deliberately failed to disclose or
has provided misleading information about the source.
Consideration should also be given to establishing a system whereby patent offices examining patent applications which identify the geographical source of genetic resources or traditional knowledge pass on that information, either to the country concerned, or to WIPO which may act as a depository for patent-related information on alleged “biopiracy”. Through these measures it will be possible to monitor more closely the use and misuse of genetic resources.
39. The
Government will pursue this recommendation with its EU partners and in
WIPO. There would be considerable
value in establishing such a depository.
Further research should be undertaken, as a matter of urgency, by a competent body possibly UNCTAD, to assess in respect of developing countries:
40. The
Government agrees with this recommendation. DFID intends to include this research
agenda in its follow-up activities in response to the report.
CHAPTER 5
COPYRIGHT, SOFTWARE AND THE INTERNET
41. The
Commission rightly notes that “stronger copyright protection may help to
stimulate local cultural industries in developing countries”, but that it may be
a necessary but not a sufficient condition for the development of such
industries. The Commission’s concern is whether copyright rules strike the right
balance for developing countries between providing incentives for creation and
ensuring adequate access to knowledge and knowledge-based products. This led the Commission to focus on the
cost of accessing such products and the adequacy of “fair use” or “fair dealing
exemptions” from the point of view of developing countries.
42. Most
developing countries are long standing members of the Berne Convention for the
Protection of Literary and Artistic Works (for example, Brazil since 1922) and
have already taken steps to bring their copyright laws and enforcement
procedures into compliance with TRIPS.
The Government welcomes this development and notes that their
representatives in the TRIPS Council have not expressed any concerns
regarding the international rules for the protection and enforcement of
copyright and related rights.
Moreover, as noted in the report, developing countries are seeking to
find ways in which, for instance, folklore can be better protected through
such rights.
43. The
Government believes that developing countries stand to benefit from the
encouragement and protection of creative endeavour, and that it is in the
interests of developing countries to continue to provide levels of copyright
protection and enforcement that do not fall below TRIPS standards. In the internet age it will become
increasingly important for developing countries to protect their creative
industries as they integrate more fully into the global economy; and it is
gratifying that 37 developing and transitional countries have so far ratified
the 1996 WIPO Copyright Treaty and the 1996 WIPO Performances and Phonograms
Treaty.
44. The
Government notes the Commission’s concerns about “fair use” provisions but
believes that existing provisions in TRIPS, and other international copyright
conventions are adequate for the needs of developing countries. However, the Government remains
concerned about poor enforcement and high levels of copyright infringement in
some countries and will continue to work for effective action against piracy,
wherever it occurs. It will
continue to contribute to the development of international systems for the
protection and enforcement of rights in this important field. Our commitment to capacity building and
to providing copyright training for peoples from developing countries will be
maintained and, wherever possible, strengthened.
Publishers, both of hard copy and on-line books and
journals, and software producers should review their pricing policies to help
reduce unauthorised copying and to facilitate access to their products in
developing countries. Initiatives
being undertaken by publishers to expand access to their products for developing
countries are valuable and we encourage an expansion of such schemes. The extension of free on-line access
initiatives for developing countries to cover all academic journals is a good
example of what could be done.
45. The
Government welcomes the existing initiatives by publishers and software
producers to facilitate access to their products, and will encourage them to
make access more widely available wherever appropriate. Copyright laws provide the foundation on
which access initiatives can be built.
In order to improve access to copyright works and
achieve their goals for education and knowledge transfer, developing countries
should adopt pro-competitive measures under copyright laws. Developing countries should be allowed
to maintain or adopt broad exemptions for educational, research and library uses
in their national copyright laws.
The implementation of international copyright standards in the developing
world must be undertaken with a proper appreciation of the continuing high level
of need for improving the availability of these products, and their crucial
importance for social and economic development.
46. The
Government agrees that competition and copyright laws and policies in developing
countries should act to deter and prevent anti-competitive practices, as they do
in the United Kingdom. However, we
recognise that comparable levels of supervision and regulation of market
behaviour frequently do not exist in developing countries. The Government accepts that, in some
defined circumstances, exceptions and limitations to copyright can be justified,
in particular, for educational, research and library purposes; and we
acknowledge that (subject to recognised safeguards) developing countries are
entitled to use Berne and TRIPS flexibilities to further public policy and
educational objectives.
Developing countries and their donor partners should
review policies for procurement of computer software, with a view to ensuring
that options for using low-cost and/or open-source software products are
properly considered and their costs and benefits carefully evaluated. Developing countries should ensure that
their national copyright laws permit the reverse engineering of computer
software programmes beyond the requirements for inter-operability, consistent
with the relevant IP treaties they have joined.
47. The
Government agrees that a review of procurement policies may be needed. We have already concluded that in
looking at cost-effective software for our own use we will consider open source
software solutions alongside proprietary ones in IT procurements. The Government will only use products
for interoperability that support open standards and specifications in all
future IT developments. We would
recommend developing countries similarly to consider the use of open source
software. DFID is reviewing on the
same lines its software procurement policies in developing countries.
48.
TRIPS
requires computer programmes to be protected as literary works under the Berne
Convention. Likewise, the WIPO Copyright Treaty states that computer
programmes are protected as literary works within the meaning of Berne.
The Government agrees with the Commission that developing countries' national
copyright laws should be consistent with the treaties they have joined. In the European Union computer
programmes are protected by copyright as literary works, though it is
permissible to make a back-up copy; decompile a programme to achieve
interoperability; and (subject to safeguards) study or test a
programme in order to determine the underlying ideas and principles.
Users of information available on the Internet in the
developing nations should be entitled to “fair use” rights such as making and
distributing printed copies from electronic sources in reasonable numbers for
educational and research purposes, and using reasonable excerpts in commentary
and criticism. Where suppliers of
digital information or software attempt to restrict “fair use” rights by
contract provisions associated with the distribution of digital material, the
relevant contract provision may be treated as void. Where the same restriction is attempted
through technological means, measures to defeat the technological means of
protection in such circumstances should not be regarded as illegal. Developing countries should think very
carefully before joining the WIPO Copyright Treaty and other countries should
not follow the lead of the US and the EU by implementing legislation on the
lines of the DMCA or the Database Directive.
49. The
Government supports “fair use” exceptions provided in international treaties and
other measures, including the WIPO Copyright Treaty. It agrees that exceptions may be
guaranteed under national law despite contractual terms to the contrary; and
recognises that developing countries are free to determine their own approach to
technological protection measures, consistent with any international obligations
they may have undertaken. For
example, the EC’s Information Society Directive (2001/29/EC) permits Member
States to ensure that users benefit from “fair use” exceptions even where
technological protection measures are applied.
CHAPTER
6
PATENT
REFORM
50. The
Government believes that IPRs, including patents, can play a vital role in the
course of the development process for developing countries today, just as they
did, and continue to do, in the UK, other developed countries and the most
successful developing economies.
The Government agrees with the Commission that, in order to achieve this,
patent regimes can and should be tailored to take into account individual
country's specific circumstances.
And that in order to be effective in promoting development, patent and
other intellectual property rights need to be effectively managed. The Government also welcomes the
Commission’s discussion of the issues raised by patenting in universities and
public sector research, and the need to strike the right balance between the
incentives offered by the patent system, and the possible disincentive to
further research drawing on protected technologies.
THE DESIGN
OF PATENT SYSTEMS IN DEVELOPING COUNTRIES
This should be achieved, within the constraints of international and bilateral obligations, by:
·
limiting the scope
of subject matter that can be patented
· applying standards such that only patents which meet strict requirements for patentability are granted and that the breadth of each patent is commensurate with the inventive contribution and the disclosure made
·
facilitating
competition by restricting the ability of the patentees to prohibit others from
building on or designing around patented inventions
· providing extensive safeguards to ensure that patent rights are not exploited inappropriately
·
considering the
suitability of other forms of protection to encourage local
innovation.
51. The
Government agrees with the Commission that different developing countries will
have different requirements in respect of IPR, and that a country’s IP system
should reflect these. Thus the
Government believes that these recommendations are all aspects which developing
countries should take into account when designing an overall legislative
framework to increase competitiveness through innovation whilst safeguarding
against abusive behaviour.
52. In
particular, while some countries may benefit from a more restrictive scope of
patentable subject matter, others may benefit from a less restrictive
approach. For example, in chapter 3
the Commission highlights that countries that have, or wish to develop,
biotechnology-related industries may wish to provide patent protection in that
area, beyond that required by TRIPS.
A stronger IPR regime is one factor that may be important in attracting
investment in particular sectors and activities, as noted in para
20.
53.
Therefore, as we indicate in our response to chapter 8, the Government
agrees with the Commission that developing countries should decide for
themselves if accelerated compliance with TRIPS, or adoption of stronger IP
rights than TRIPS requires, would be beneficial for their own
development.
54. In
addition, the Government is fully supportive of having fixed and measurable
quality standards for granting of patents.
For example, the UK has recently initiated the setting up of a common
quality framework in discussions at WIPO and has been actively involved in
discussions on protection of traditional knowledge, as noted in the response to
chapter 4 of the report.
Developing countries providing patent protection for
biotechnological inventions should assess whether they are effectively
susceptible to industrial application, taking account of the USPTO guidelines as
appropriate.
55. The
Government agrees. Developing
countries may well be able to learn from the experience of developed countries
in searching for appropriate criteria for patentability in this rapidly
developing area of technology.
Developing countries should adopt the best mode provision to ensure that the patent applicant does not withhold information that would be useful to third parties.
56. The
Government considers the full disclosure of information to be an important
benefit of the IP system, especially in the context of technology transfer, and
we agree that developing countries should consider adopting best mode
provisions. Developing
countries will need to consider both the potential benefits, and costs such as
increased legal uncertainty, of such an additional requirement.
If developing countries allow patents over genes as such, regulations or guidelines should provide that claims be limited to the uses effectively disclosed in the patent specification, so as to encourage further research and commercial application of any new uses of the gene.
57. The Government agrees that developing countries should consider carefully the case for limiting patent protection to the uses effectively disclosed in the application.
Rather than diluting the patentability standards to capture the incremental type of innovations that predominate in many developing countries, lawmakers and policy makers in these countries should consider the establishment of utility model protection for stimulating and rewarding such innovations. Further research would seem desirable to assess the precise role that utility model protection, or other systems with similar objectives, might play in developing countries.
58. The
Government agrees that other models of protection may be useful tools for
developing countries. We support
this recommendation as an option for developing countries to consider, but agree
that there needs to be more research as to the precise role of utility models,
or other supplements to patent protection, in developing countries.
THE USE OF
THE PATENT SYSTEM IN PUBLIC SECTOR RESEARCH
Based on the above, w