Genetic Resources Policy and Intellectual

sidewalkhallBiotechnology

Oct 23, 2013 (3 years and 9 months ago)

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Genetic Resources Policy and Intellectual
Property

I.
Ownership and control of genetic resources

II.
Movement of genetic resources

III.
Intellectual Property Rights

IV.
African Union


Robert J. Lewis
-
Lettington

Legal consultant

rjl34@alumni.st
-
andrews.ac.uk


Regional workshop on Learning agrobiodiversity: options
for universities in Sub
-
Saharan Africa


ICRAF, Nairobi, Kenya. January 2009.

Ownership and control of genetic resources:
what is the relevant law?



A.
Convention on Biological Diversity (
www.cbd.int
)


-

applies to most genetic resources and is
default
framework


-

Country of origin is a key concept in access


-

not directly applicable in national law
but still
seen as framework for good conduct


-

usually reflected in national law through access
to genetic resources regulations in developing
countries




Ownership and control of genetic resources:
what is the relevant law?


B.
International Treaty on plant genetic resources
for food and agriculture (
www.planttreaty.org
)


-

as far as access and benefit sharing is concerned
this only applies to material of species listed
in
Annex I

and
under the management and control
of the state

and
in the public domain
; as well as


-

also applies to material in international and
other collections placed in Treaty framework


-

to date, mostly reflected in national law through
administrative practice (rules, contracts etc) but
this may change

Ownership and control of genetic resources:
what is the relevant law?


C.
Other initiatives


-

A
more detailed, binding, framework for access
and benefit sharing
is being developed under the
CBD


-

With the adoption of the Global Plan of Action
for the Conservation and Sustainable Use of
Animal Genetic Resources
, discussions on access
and benefit sharing are developing (probably
only domestic livestock but maybe also wild
relatives?)


-

The role of
microbial genetic resources
in
agriculture is beginning to be discussed in terms
of access

Ownership and control of genetic resources:
what is your source of material?



A.
Wild material


-

what is the
location

of the collection?


-

do you have
national access to genetic
resources regulations
?


-

is the sample
native or an alien species
?

B.
Ex situ collection


-

was it collected
pre or post
-
1992
?


-

who holds
the collection and
what species
are
you accessing?

C.
What country
are you accessing material from?




II. Movement of genetic resources: Sanitary
and phytosanitary standards A


‘SPS’ Agreement


Primarily umbrella agreement lending force to
technical agreements


More info:
http://www.wto.org/english/tratop_e/sps_e/
sps_e.htm


The ‘three sisters’


Codex Alimentarius Commission (CAC)


Food stuffs


Includes means of production, preparation,
storage etc




II. Movement of genetic resources: Sanitary
and phytosanitary standards B


The ‘three sisters’ cont.


International Plant Protection Convention
(IPPC)


Regulates plant pests,

Secures action to prevent
the spread and

introduction of pests of plants
and plant products; and promote

appropriate
measures for their control


More info:
https://www.ippc.int/IPP/En/default.jsp



Organisation Internationale des Epizooties


Technical mandate similar to that of IPPC but
animals rather than plants


M
ore info: http://www.oie.int/


Cartagena Protocol




II. Movement of genetic resources: Sanitary
and phytosanitary standards C


Cartagena Protocol


Biosafety
: The need to protect human health and
environment from the possible adverse effects of the
products of modern biotechnology.


Protocol Objective
: Adequate protection in the safe
transfer, handling and use of living modified organisms
(LMOs) resulting from modern biotechnology that may
have adverse effects on the environment & human
health


Scope
: Transboundary movement, transit, handling and
use of LMOs (Article 4) that can affect sustainable use of
biological diversity. Pharmaceuticals are excluded.


Adopts a Precautionary approach.





III. Intellectual Property Rights

WTO Trade Related Aspects of
Intellectual Property Rights
-

27.3(b)


Members may exclude plants and animals
from patentability


Members must protect microorganisms


Members shall provide for the protection of
plant varieties either by patents or by an
effective
sui generis
system or by any
combination thereof




III. TRIPs: other rights


Protection of undisclosed
information (e.g., hybrids)


Trademarks (associated with
seeds’ generic denomination)


Geographical indications



III. UPOV


The Union for the Protection of New Plant
Varieties (UPOV)


A ‘sui generis’ form of intellectual property right
for any kind of plant variety


Basic principles include:


commercial novelty


distinctness


uniformity


stability


Broad exceptions for research and breeding


Limited, optional, exceptions for small holder
use


This refers to the 1991 text but, in developing a
national law, a country could use earlier texts

III. Patents vs. PVP




PATENTS




PVPs

Genes, cells, plants,
varieties

Plant varieties

Novelty, inventive step,
industrial applicability

Novelty, distinctness,
uniformity, stability

Exclusive rights over use,
research and breeding

Farmers’ privilege

Breeders’ rights


III. Some IPR concerns


How do private intellectual property rights link with
sovereign rights over genetic resources?


Third parties can be prevented from producing or selling
goods or services using protected information without
the title
-
holder's authorisation, e.g. a common issue in
cut flower exports to Europe


Another issue that has generated concern is the impact
that the appropriation of genetic materials under IPRs
may have on the access to such materials for further
research and development


The granting of plant breeders’ rights (PBRs) does not
limit the use of the protected material as a source for
further research and breeding, because of the generally
accepted ‘breeders’ exemption’


The treatment of traditional knowledge in IPR regimes
has been seen as allowing for the appropriation of
developments based on such knowledge without
recognising rights to the knowledge itself

IV. African Union


There are two models:


The African Model Law for the Protection of the
Rights of Local Communities, Farmers and
Breeders, and for the Regulation of Access to
Biological Resources



Draft Model National Legislation on Safety in
Biotechnology


Not binding


advisory documents adopted
by OAU/AU ministerial conferences


Very useful for identifying principles and
key concerns


Do not replace the need for work at the
national level


difficult to implement in a
’cut and paste’ approach

IV. African Union


The African Model Law for the Protection of
the Rights of Local Communities, Farmers and
Breeders, and for the Regulation of Access to
Biological Resources


Where UPOV focuses on rights of downstream
users of biological materials, i.e. researchers
and breeders, Model focuses more on rights of
material providers


Seeks to establish/maintain rights to farmers’
varieties and other informally developed or
used material


Balance between role and rights of
individuals, communities, government and the
private sector can be difficult to achieve and
probably needs further analysis at the
national level

Concluding comments: what should a
university teach its students?


How to responsibly and fairly collect and
use material


How to protect their rights and those of
their institutions, as well as those of
others


Focus on promoting research and pre
-
empting problems


Universities will need to engage their
respective national authorities in policy
development