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PHD Proposal






Feng
(Jerry) Xia


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A (Draft) Proposal for PHD Research in Law



INTELLECTUAL PROPERTY RIGHTS AND
BIODIVERSITY
-
RELATED ISSUES IN DEVELOPING
COUNTRIES: A CASE STUDY ON CHINA

-

FROM A EUROPEAN AND INTERNATIONAL PERSPECTIVE



by
Feng (Jerry) XIA
, LL.M.*


(Proposed) Promotor:
Prof. Mr. Charles Gielen





* LL.M., Erasmus University Rotterdam, the Netherlands

Postgraduate Certificate of Copyright Law, Utrecht University, the Netherlands

LL.B., Peking University, China

B.E., Beijing University of Chemical Technology, China







Revised on October 28, 2002


Gelkingestraat 20, 9711 NC, Groningen, the Netherlands

Tel: +31(0) 6 1548 7509 Fax: +31(0) 50 311 7087

Email:
jerry_summer@justice.com


Website:
http://www.angelfire.com/folk/jerry


PHD Proposal






Feng
(Jerry) Xia


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INTRODUCTION TO THE FIELD OF STUDY


The relationship between
intellectual property rights (IPR) and
biodiversity
-
related issues
,
including biotechnology that is developed on the basis of
genetic res
ources
has been widely
touched upon in the European Union (EU) and international legal community during recent years.
1

For instance, there have been a number of concerns raised as to how the

EU
-
Directive 98/44/EC

on biotechnology patenting
may affect acces
s to the human genome data and possible restrictions
on the research and applications for which this data could be used.
2

The discussion is, however,
not only on the situation inside the EU or the rest of the Western world such as the U
nited
S
tates
,
but mu
ch more frequently, is directed towards the cases of major developing countries in Asia,
Africa and South America
such as China, Brazil, Mexico, etc.
because more than 80% of genetic
resources worldwide are located in these developing countries.
Although b
iodiversity is our most
valuable resource, it is often least appreciated and its

existence, along with other types of
traditional knowledge and expressions of folklore, is increasingly endangered
, for a variety of
reasons
.

Besides,
the present innovation r
egulations also seem to lag far behind the fast
advancement of biotechnology, especially in agricultural and
pharmaceutical

industries.
International community has therefore realized the keen need to
confer an effective and
internationally
recognized

vehic
le of legal protection on genetic resources and biotechnology

and
there is a consensus that the assignment of property rights,
inter alia
, intellectual property rights
may do the job well. Some most important endeavors that have been done by international
IP
community include
the
Agreement on Trade
-
Related Aspects of Intellectual Property Rights
(
TRIPS
)

(e.g., Art. 27.3(b))
and the 1992 Convention on Biological Diversity (CBD)

(e.g., Art.
8(j))
.

Nonetheless,
this job can never be easily done in reality as c
an be articulated in lines.
T
he
capability of
self
-
reproduction of plants, animals, insects, micro
-
organisms

and other biological
material

as carrier of genetic information

clearly reveals the limits of claiming the ownership;
once acquired, either

legally

or not, it is impossible for the original owner to prove that the genetic

information used was exclusively his or hers, e.g., seeds recovered for

use for further propagation,
genes isolated for producing transgenic animals

or plants, or for producing valu
able proteins
through cell culture, or for the

synthetic production of valuable, active biochemical substances,
and the

like. Furthermore,
not only whether or not and to what extent we should appropriate the
current IP regimes in developing countries in or
der to accommodate biological resources and
inventions have received numerous divergent voices but often beyond that,
when
reviewing

a

fact
that most developing
countries
that host rich

genetic resources have

not been able to gain from
their exploitation

w
hile the industrialized
Western
world

has apparently been successful,

the issue



1

See, e.g.,
“EU Study on
the Relationship
b
etween the Agreement on TRIPS and Biodiversity Related Issues”
,

Final Report,
c
ommissioned by
DG T
rade

European Commission, September 2000, available at:
http://europa.e
u.int/comm/trade/miti/intell/ceas.htm


2

See e.g., EU Internal Market website at:
http://europa.eu.int/comm/internal_market/en/indprop/invent/index.htm


PHD Proposal






Feng
(Jerry) Xia


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is sometimes

further complicated to be
a long
-
lasting controversy between

the North and the
South
,
and also entangled

with other N
-
S issues such as technology transfer,
environ
ment,
international trade, foreign direct investment (FDI), human rights, poverty, etc
.


The EU, as one most important component of the North, has been extensively involved in such
issues since it plays a key role in world’s research and development (R& D
) of biotechnology for
agriculture, food and pharmaceuticals and accounts for a considerable portion of international
trade in such industries, especially with developing countries. Once upon a time, for example,
some bio
-
industries within the EU were alle
ged by a few bio
-
diverse developing countries on

prospecting” for their species in order to patent or sell them without offering concessions or
benefits for local people, which we sometimes refer to as
“bio
-
piracy”
. Thus, the EU has on many
occasions expr
essed its
sensitivity to the concerns raised by developing countries with respect to
genetic resources, traditional knowledge and expressions of folklore, particularly in the context of
intellectual property protection.
3


H
owever
, t
he collective term “deve
loping countries” is
sometimes in
itself already too sweeping:
it takes in countries so different in economic and social terms and neglects such important specific
political and cultural circumstances as to preclude generalizations. Hence, focusing becomes

an
absolute necessity for a fruitful study in this field. Based on such an understanding this research
will look into the topic by conducting a specific case study on China, the world’s largest
developing country with a tremendous amount of biodiversity.
Even more specifically, discussions
will be made primarily from a European and international perspective,
i.e.
, the paper will seek to
examine the state of biodiversity and biotechnology in China against the existing Chinese IP
regime and study how the eme
rging international instruments in this regard may compare with and
fit into the present situation in China, particularly in contrast to the current practice and opinions
of the EU and, last and also most importantly, analyze how some possible approaches t
o the issues,
mostly in the context of IP protection, may affect technology development, agriculture, relevant
industry, environment, international trade, legal reform as well as international relations and other
relevant mutual policies between the South
and the North.


RESEARCH BACKGROUND AND SIGNIFICANCE


China has been selected as a case study country for a number of reasons. First,
China is the largest
developing country and also one of the countries with richest biodiversity in the world. There are



3

See, e.g., Do
cuments Submitted

by the European Commission to the First
S
ession of the World Intellectual
Property Organization
(WIPO)
Intergovernmental Committee on Intellectual Property and Genetic Resources,
Traditional Knowledge and Folklore, April 26, 2001.
WIPO/GR
TKF/IC/1/8, at
http://www.wipo.int


PHD Proposal






Feng
(Jerry) Xia


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m
ore than 30,000 species of higher plants and 6,347 species of vertebrate, accounting for 10% and
14% respectively of the world total.
4

In particular, such abundant biological resources have
contributed significantly to the development of Traditional Chines
e Medicine (TCM), which
serves a natural remedy for a variety of illnesses for individuals in both rural and urban
communities locally and worldwide. Therefore, China is a most representative country for the
study of biodiversity conservation. Second, biod
iversity in China is now under serious threat due
to its large population, economic underdevelopment, contradictions between conservation and
exploitation, excessive utilization of biological resources and fragmentation of the natural habitats.
Therefore,
it is very timely and important for lawmakers and scholars, within and outside China,
to think about new and appropriate regulatory measures to ready the crisis, for example, under the
IP regime. As an evidence of China’s endeavors in this respect, on Febr
uary 19, 2002, China,
together with Brazil, India, and nine other of the world's most bio
-
diverse countries, signed an
alliance for fighting bio
-
piracy and pressing for rules protecting their people's rights to genetic
resources found on their lands.
5

Thir
d, China
is a developing country with a large agricultural
sector and also one of the biggest providers of agricultural products and food in international
markets. China plays an important role in the R&D and commercialization of agricultural
biotechnology
. For example, China is one of the first countries that commercialized the
Genetically Modified (GM) crops and now ranges as the fourth largest country in term of sown
area of GM crops, just after USA, Argentina, and Canada. Therefore, to study how to shap
e an
appropriate vehicle of legal protection such as IP law in order to offer necessary incentives for
further biotechnology development in China has proven to be a very meaningful initiative. Fourth,
with China’s accession to the World Trade Organization
(WTO) in 2001, tailoring Chinese IP
regime into conformity with the requirements of the WTO TRIPS Agreement has been a widely
concerned topic by global legal scholars and international investors while so far little has been
written on how this should respo
nd to and affect the protection of biodiversity and biotechnology
and as a result, how it may in turn influence the further economic and legal reforms, international
trade, foreign investment, human rights situation, etc., in China. So from a scholarly poi
nt of view
such a case study may generate added values and have implications for other developing countries
and relevant international institutions.


From the EU side, as envisaged, a case study on China with regard to the relationship between
biodiversit
y, biotechnology and IP protection will be able to serve a valuable reference in many



4

See, “China's National Report on Implementation of the Convention on Biological Diversity”, organized by the
State Environmental Protection Administration of China, May 1994; an Eng
lish translation is available at:
http://bpsp
-
neca.brim.ac.cn/books/ntlrpt/content.html


5

See
Mark Stevenson
, “China, Brazil, India, 9 other nations form alliance against bio
-
piracy”,
Associated Press,

February 19, 2002, at
http://www.blackherbals.com/Alliance_against_biopiracy.htm



PHD Proposal






Feng
(Jerry) Xia


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aspects. As to trading relations,
China is the EU’s third trading partner after the US and Japan, and
the EU is China's second largest export market. Mutual agricultural
and food trade is even the
largest sector. Over the last three years the EU restrictions on imports of some Chinese biological
products, for example, animal products and GM crops, including the health and environment
concerns involved therewith, have raise
d extensive trade disputes between the two sides; EU
companies have also invested considerably in China during recent years (new annual flows of
utilized FDI of around USD 4.5 on average in the last 5 years), bringing up stocks of EU FDI to
over USD 25 bil
lion.
6

Understandably, China’s biotechnology policies will accordingly affect
EU’s FDI flows to biotechnology
-
related industries in China; In the field of R&D, cooperation
between the EU and China in biotechnology has already been among the most fruitful a
reas during
the past few years. Important initiatives and projects include, for example, EBNIC (European
Biotechnology Node for Interaction with China) and EFBIC (European Focus on Biotechnology in
China)
7
. Moreover, the legal reform in China, especially t
he shaping of Chinese IP regime
according to the international standards, has draw tremendous attention from the EU at various
levels with reference made to the EU external policy to China. For example, the European
Chamber of Commerce in China (EUCCC), in

association with the EU
-
China IPR Cooperation
Programme, issues annual working paper on IPR situation in China.
8

At another point, looking
into the patenting possibilities for biological inventions in China may also bring meaningful
implications for furth
er modification and implementation of the EU Bio
-
patenting Directive
(98/44/EC). Taking all this collectively and in order to
allow the Commission and member states to
balance their IPR and biodiversity objectives within the broad range of national and EU
interests,
the EU has been recommended by many relevant advisory bodies to study such a relationship in
non
-
EU jurisdictions with different socio
-
economic conditions, particularly in bio
-
diverse
developing countries and if necessary, also provide these cou
ntries with assistance to develop
appropriate regulatory measures, for example,
sui generis

systems for plant variety protection.
9

Against this background, such a research shall be deemed quite timely and of significance.


RESEARCH FOCUS AND AIMS


This res
earch will focus on the discussion on tailoring IP protection in China in the context of
biodiversity and biotechnology. In addition to looking into the legal nature of biological things
under Chinese regulatory system, particular but not exclusive focus w
ill be on the ethical and
ecological aspects as well as the likely legal, cultural, social and economic effects of applying
relevant international IP rules to biodiversity and biotechnology in China. Major references will be



6

See further e.g.,
http://europa.eu.int/comm/external_relations/china/intro


7

See further e.g.,
http://www.efbweb.org/activities/efbicintro.htm


8

See further the official website of the EUCCC a
t:
http://www.euccc.com.cn


9

See
supra

note 1, at p.124.

PHD Proposal






Feng
(Jerry) Xia


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made to environmental, health,
agricultural, industrial considerations that this topic may raise.
With much comparison made with the current EU practice and opinions, both at the Union level
and the national level, for example, the Netherlands
10
, Belgium
11
, etc. the paper will also
in
-
dep
thly analyze how this issue may relate to China’s external policy and international trade
with the Western world.


The proposed study aims, based on a comprehensive examination of the biodiversity status, legal
background and present regulatory systems in
China, to study the need, feasibility and
appropriation of incorporating international IP standards regarding biological resources protection
in major bio
-
diverse developing countries and to come up with recommended approaches to the
key issues for relevan
t authorities from legislative and practical points of views. Since such a case
study will be conducted on a specific country, China and primarily from an EU perspective, it has
been hoped that the study will in the first place be able to provide a referen
ce for China and the
EU in formulating their biotechnology regulations and policies; secondly, offer implications for
other developing and industrialized countries and international organizations concerned about the
issue and also enrich the global scholar
ship in this area; last but not least, contribute to some
degree to the developing bilateral relations and understanding between the EU and China.


RESEARCH QUESTIONS


Within the general framework specified above, the main but non
-
exhaustive research quest
ions
include:


1)

What are the general linkages between IPR and biodiversity
-
related issues? What
international and regional endeavors have been taken in this respect? For example, TRIPS,
CBD, UPOV (The International Union of New Varieties of Plants), IU (Th
e International
Undertaking on Plant Genetic Resources), etc.

2)

What is the present state of biodiversity and biotechnology in China? What roles do they
play in China’s society and economy?




10

The Netherlands is a representative case because, for instance, it is the EU member state who first officially
voiced against the implementation of the con
troversial EU Biotechnology Directive (98/44/EC), and has been
taking a strong resistant stand towards the Directive. Notwithstanding that in October 2001, the Netherlands,
supported by Italy and Norway, failed to persuade the ECJ that the Directive was co
ntrary to human rights
(C
-
377/98), the Dutch Parliament continued to request its government to reopen discussion on the Directive in
May 2002. See further e.g.
http://www.tjg
.co.uk/topical/life_sciences/ls_biotech_update.html


11

For instance, Belgium is the only EU member state that has made serious attempt to enforce recital 27 of the

EU
Bio
-
patenting Directive (98/44/EC) regarding the origin requirement in a bio
-
patenting a
pplication. A proposed
paragraph 3 of article 4 of the Belgian Patent Act (BPA) stipulated that exploitation of an invention is contrary to
ordre public

and morality, especially when, for example, an invention is developed on the basis of plant or animal
m
aterial which was imported in violation of the law of the country of origin of these materials.
See further Geertrui
van Overwalle, “Traditional Medicinal Knowledge, Patents and the Convention on Biological Diversity”,
ING.
-
CONS.


Nos 5
-
6
-
7, 2001, at p.17
6.

PHD Proposal






Feng
(Jerry) Xia


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3)

How do the existing Chinese national rules and policies regulate th
e use and access to
TCM and its genetic resources? What attempts and measures has China taken in order to
implement the CBD in terms of its equitable sharing objective?

4)

What is the legal nature of biological resources and indigenous knowledge under the
cur
rent Chinese IP system? Do they have property rights? If yes, who can claim for
ownership and who shall benefit from their exploitation? etc. In China a traditional point
of view is that genetic resources are a common heritage available for free use by all

interested parties. How does this tradition contrast to the international trend of assigning
property rights to traditional knowledge? What kind of political concerns shall be taken
into account?

5)

What are the difficulties and benefits of patenting biologi
cal materials in China? Can a
biological invention such as a product or process of genetic engineering be patented under
the current Chinese patent law? What about human genetic materials? What moral and
social concerns may be raised here? What environment
al effects of patenting genetically
engineered agricultural products shall be weighed? How does it compare with the EU
bio
-
patenting directive?

6)

How does Article 27.3(b) of the TRIPS Agreement apply to China? Has China developed
a
sui generis

system, for e
xample, Plant Breeders’ Rights (PBR), for plant variety
protection based on its current plant variety regulations? What are the social effects of
applying plant variety protection (PVP) regimes on farming systems in China?

7)

Did restrictions in access to cer
tain plants, animals, designs, or processes arise from a
concern to protect intellectual property or did they come from a need to conserve scarce
resources or to allocate social responsibilities within communities? What is the point of
view of China?

8)

Shou
ld China’s IP regime develop its own norms governing biodiversity and
biotechnology under the framework of TRIPS, or completely follow a developed
country’s approach, for example, the EU approach considering their similar civil law
jurisdiction?

9)

How would

IP protection affect the R&D and investment in biodiversity
-
related industries
in China, such as agriculture,
pharmaceuticals, etc.? For example, some have argued that
China has been absorbing the greater part of the FDI boom of recent years without
devel
oped IPR systems but
extending strong IP protection to
cover
biological product and
process

ma
y
nevertheless
play some adverse effects on
the

economic development
:

for
example,
p
rices in certain sectors such as seeds and medicines
may

rise; monopoly
condit
ions
may

constrain national firms;
and the costs for
R&D will rise; in the long
-
term,
the socio
-
economic fabric that supports innovation in
these developing countries

is likely
PHD Proposal






Feng
(Jerry) Xia


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to
erode.
Then what risks and benefits of biotechnology in such industries and
the role of
IPR in China shall be weighed?

10)

What policies does China take in the imports of foreign biological products or transfer of
foreign biological technologies that in nature do not qualify for IP protection under
Chinese IP law but do under foreign

or international law?

11)

How should we consider biodiversity and IPR issues in China from the perspective of
competition law?

12)

How should “compulsory licensing” play effects on biological technologies and industry
in China?
For instance, there is much intere
st in the use of compulsory licensing to obtain
lower prices pharmaceuticals for AIDS, various vaccines and other essential medicines.

13)

What is the connection between economic development, biodiversity conservation as well
as sustainable development in Chin
a? Some have already argued that the rapid pace of
economic development in China could lead to the tragic deterioration of its own cultural
and environmental heritage.
12

It has been worried, for example, that the recent China
state policy to “open the west”

and some imminent attempts to incorporate developed
countries’ standards after its accession to the WTO will bring pressure to bear on its
already fragile ecosystem. Then how would the assignment of property rights,
inter alia
,
IPR, under the existing reg
ulatory measures in China and according to modern
international environmental law, play a role in relation to this connection and impact upon
biodiversity policy in China?

14)

What is the connection between biodiversity and public health in China? How does Chi
na
address the issues of food security and bio
-
safety in the context of IPR?

15)

How do CBD and TRIPS interact with each other in the legal context of trade and
environment? Also how do they compare with other international instruments such as
UPOV Act and IU
? How should such interactions and comparisons relate to China?

16)

What efforts at national and international level has China taken or planned to take to fight
bio
-
piracy, particularly the so
-
called reverse piracy? How would policies on this issue
affect Chi
na’s international trade and foreign relations with the North, for example, with
the EU?

17)

Should China along with other countries in the South ask compensation from the North
for the use of its biological resources? Then who should pay? On what grounds? Ho
w
much? etc. What international contractual agreements, for instance, has China concluded
with technology rich countries on the payment for the right to analyze indigenous material
from plant and animal origin? How should disputes on these issues be settle
d under some



12

See e.g., Vaclav Smil, “China’s Environmental Crisis: An Inquiry into the Limits of National Development
(1993) & Marian Sullivan, “The Three Gorges Project: The Need for a Comprehensive Assessment” 8,
Georgetown Int’l Environmental Law Rev. 109 (199
5).

PHD Proposal






Feng
(Jerry) Xia


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international instruments after China joined the WTO in 2001?

18)

What technical and financial assistance can China and other developing countries expect
from the industrialized world such as from the EU with regard to initiatives on IPR and
biodi
versity?

19)

What implications can be drawn for the EU as well as other developed and developing
countries from a case study on biodiversity and IPR in China? etc.


ENVISAGED STRUCTURE OF DISSERTATION


An envisaged structure of dissertation will consist of fi
ve parts, each of which contains several
topics (the order of chapters and sub
-
chapters not duly organized yet):


Part I

Introduction to the subject, research background, focuses, goals, etc.; basic theories of
the interrelationship between IPR and biodiv
ersity
-
related issues; summary of major international
endeavors and instruments governing the subject; introduction to current Western practice; etc.


Part II

Examination of the state of biodiversity and biotechnology in China; general evaluation
of the e
xisting Chinese national strategies, measures and rules concerning biodiversity and
biotechnology; general evaluation of Chinese current IP regime; introductory remarks on China’s
emerging concerns over the relationship between IPR and biodiversity
-
related

issues; etc.


Part III

Discussions on Biodiversity / biotechnology and IPR in China:

1.

Protection of genetic resources vs. requirements of Chinese IP laws;

2.

Biodiversity piracy, protection of traditional knowledge (TK) and IPR;

3.

Case study: Traditional Chine
se Medicine (TCM);

4.

Bio
-
patenting: feasibility and consequences;

5.

Plant variety protection (PVP);

6.

Industry reports on biotechnology: agriculture, food, medical treatment, etc;

7.

Moral and ethical concerns;

8.

Social effects (e.g., on Chinese farming system, etc.)

9.

Case study: compulsory licensing of medicinal biotechnology in China;

10.

Economic issues: R&D, FDI, technology transfer:
risks and benefits
;

11.

Discussion: biodiversity, IPR and competition policy in China;

12.

Ecological, public health and environmental effects; e
tc.


Part IV

International Aspects:

PHD Proposal






Feng
(Jerry) Xia


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1.

Harmonization? TRIPS, CBD, UPOV, etc. and China: a feasibility study;

2.

Summaries and comparisons of some regional and national policies;

3.

Biodiversity/biotechnology, IPR and international trade;

4.

North
-
South: compensation f
or bio
-
use?
-

Equitable sharing objective;

5.

International contractual agreements on biodiversity analysis;

6.

Official Development Assistance (ODA);

7.

Cast study: EU
-
China: Biodiversity/biotechnology and IPR;

8.

International anti
-
bio
-
piracy alliance;

9.

Implications
for other countries; etc.


Part V

Conclusions


RESEARCH
METHODOLOGY


The methodology to be used will be a comparative study on the
basis

of original empirical
research. More specifically, the parts of examination of facts and regulations will be written by

means of conducting empirical research on current international and national resources concerning
the subject.
Literature
s

of fundamental theories, international instruments, reports and working
papers, EU, Dutch
, Belgian

and
other European
national legis
lation and case law are mainly
available from libraries and the Internet. Chinese laws,
policie
s, cases, articles, legal opinions and
industry reports are mostly within
good
reach
in terms of

the researcher

s C
h
inese background,
although sometimes necessar
y translation work needs to be done.
U
nder circumstances interviews
and investigations will
also
be taken for collection of first
-
hand information and data.
Based on

such an empirical study
many

comprehensive or executive evaluations

and discussions as reg
ards
certain selected topics will then be made
by a comparative method, for example,
often under the
framework of

some unified

international
instruments
.



T
he researcher will commit
himself

four years to
accomplish
ing the goals of this study and writing
a

dissertation
.


TENTATIVE BIBLIOGRAPHY (NOT REPRODUCED)


A number of literatures and references have been collected and partly studied. The full list is,
however, always non
-
exhaustive and therefore has not been reproduced here.