Transcript Intellectual property protection of genetically modified plants

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REGIONAL PLANT BIOTECHNOLOGY
FORUM
INTELLECTUAL PROPERTY PROTECTION OF
GENETICALLY MODIFIED PLANTS
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DEFINITION OF GENETICALLY MODIFIED PLANT (GMP)
IN TERMS OF THE
GENETICALLY MODIFIED ORGANISMS ACT NO. 15 OF 1997
“genetically modified organism”
means an organism the genes or genetic material of which
has been modified in a way that does not occur naturally
through mating or natural recombination or both, and
“genetic modification” shall have a corresponding
meaning;
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WHAT IS INTELLECTUAL PROPERTY?
(ACCORDING TO WIPO)
Intellectual property (IP) refers to creations of the mind:
inventions, literary and artistic works, symbols, names, images,
and designs used in commerce.
IP is divided into two categories:
Industrial property, which includes inventions (patents),
trademarks, industrial designs, and geographic indications of
source; and
Copyright.
I wish to add animal and plant varieties under the category
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“inventions”.
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INTELLECTUAL PROPERTY RIGHTS:
Are the statutory and common law rights available for the protection
of IP and specifically for GMP.
These include:
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Patents
Trade marks
Registered designs
Copyright
Plant breeders’ rights
Other exclusive rights
Other statutory rights
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PATENT PROTECTION FOR GMP:
Territorially and time limited negative right granted for an
invention that is:
 New
 Inventive
 Industrially applicable
 Not excluded
•
as a reward to the inventor or successor in title in return for
a full disclosure of the invention in a patent specification.
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FOLLOWING ARE EXCLUDED
(AMONGST OTHERS):

Discoveries (non-isolated gene or microorganism in its natural
environment without asserted utility?);

An invention the publication or exploitation of which would be
generally expected to encourage offensive or immoral
behaviour (biopharmacy?):
“Researchers from the John Innes Centre in Norwich, Great Britain have
obtained genetically modified tomatoes rich in anthocyanins, a category of
antioxidants belonging to the class of flavonoids. These tomatoes, added to the
diet of cancer-prone mice, showed a significant protective effect by extending
the mice lifespan.”
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FOLLOWING ARE EXCLUDED
(AMONGST OTHERS):

Any variety of animal or plant or any essentially biological
process for the production of animals or plants, not being a
micro-biological process or the product of such a process
(plant variety produced by cross pollination?).
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PATENTING LIFE
THE EUROPEAN DIRECTIVE FOR
THE LEGAL PROTECTION OF BIOTECHNOLOGICAL INVENTIONS
(DIRECTIVE 98/44/EC):
Entered into force on 30 July 1998.
The EU member states implemented the Directive into their national
law by 30 July 2000.
Application by Kingdom of the Netherlands and others v European
Parliament, and others for the annulment of Directive 98/44/EC was
rejected on 9 October 2001 (1)
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PATENTING LIFE
DEFINITIONS IN DIRECTIVE:
“Biotechnological inventions”
are inventions which concern a product consisting of, or
containing, biological material or a process by means of which
biological matter is produced, processed or used.
“Biological Material”
means any material containing genetic information and capable
of reproducing itself or being reproduced in a biological system.
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PATENTING LIFE
DEFINITIONS IN DIRECTIVE:
A process for the production of plants or animals is essentially
biological if it consists entirely of natural phenomena such as
crossing or selection.
“Microbiological process”
means any process involving or performed upon or resulting in
microbiological material.
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PATENTING LIFE
DEFINITIONS IN DIRECTIVE:
“Plant variety”
means any plant grouping within a single botanical taxon of the lowest
known rank, which grouping, irrespective of whether the conditions for
the grant of a plant variety right are fully met, can be:
•Defined by the expression of the characteristics that results from a
given genotype or combination of genotypes;
•Distinguished from any other plant grouping by the expression of at
least one of the said characteristics; and
•Considered as a unit with regard to its suitability for being propagated
unchanged.
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PATENTING LIFE
PATENTABLE BIOTECHNOLOGICAL INVENTIONS
IN TERMS OF DIRECTIVE:
Biotechnological inventions shall also be p a t e n t a b l e if they
concern:
Biological material which is isolated from its natural environment or produced by
means of a technical process even if it previously occurred in nature;
Plants or animals if the technical feasibility of the invention is not confined to a
particular plant or animal variety; and
A microbiological or other technical process, or a product obtained by means of
such a process other than a plant or animal variety.
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PATENTING LIFE
CRITICISM OF DNA PATENTS:
a DNA sequence essentially constitutes a discovery or information and
are therefore not patentable.
RESPONSE TO CRITICISM:
distinguish between:
information discovered i.r.o. natural phenomenon (scientific information)
= mere discovery – not patentable; and
a natural or artificial phenomenon that constitutes information (genetic
information) - could be patentable.
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PATENTING LIFE
The Trilateral Project B3b sets the following guidelines
for the USPTO, EPO, JPO
in considering patentability of DNA fragments:
A mere DNA fragment without indication of a function or specific
asserted utility is not a patentable invention.
A DNA fragment, of which specific utility, e.g. use as a probe to
diagnose a specific disease, is disclosed, is a patentable invention as
long as there is no other reasons for rejection.
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PATENTING LIFE
The Trilateral Project B3b sets the following guidelines
for the USPTO, EPO, JPO
in considering patentability of DNA fragments:
A DNA fragment showing no unexpected effect, obtained by conventional
method, which is assumed to be part of a certain structural gene based on its
high homology with known DNA encoding protein with a known function, is not
a patentable invention. (EPO, JPO)
The above-mentioned DNA fragment is unpatentable if the specification fails
to indicate an asserted utility. (USPTO)
The mere fact that DNA fragments are derived from the same source is not
sufficient to meet the requirement for unity of invention.
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CASE STUDY
GM SOY BEAN
Monsanto Technology LLC v Cefetra
Article 9 of the Biotech Directive states that
“the protection conferred by a patent on a product containing or
consisting of genetic information shall extend to all material, save as
provided in Article 5(1), in which the product is incorporated and in
which the genetic information is contained and performs its function”.
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CASE STUDY
GM SOY BEAN
European patent No. EP 0546090 of Monsanto Technology
LLC’s, related to a gene in the soya plant which conferred herbicide
resistance. The claim did not extend to soya meal containing this
gene where the gene is no longer performing its herbicide resistance
function.
Article 9 of the EU Biotech Directive 98/44/EC therefore does not
confer protection on a patented DNA sequence when it is contained
in soya meal, where it does not perform the function for which it was
patented.
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CASE STUDY
TOMATO CASE
EP 1 211 926 was filed in 2000 by the Israeli Ministry of Agriculture
for a:
“method for breeding tomatoes having reduced water content and
product of the method”
Reduced water content in tomatoes would be more suitable for
producing ketchup and other foodstuffs.
This patent was granted in 2003 and was opposed on the basis that
it involved a biological process.
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CASE STUDY
TOMATO CASE
Article 53(b) of the European Patent Convention (the “EPC”) states that:
“European patents shall not be granted in respect of plant or animal varieties or
essentially biological processes for the production of plants or animals; this provision
does not apply to microbiological processes or the products thereof.”
The South African Patents Act Section 25(4)(b) states that:
“A patent shall not be granted for any variety of animal or plant or any essentially
biological process for the production of animals or plants, not being a microbiological
process or the products of such a process.”
The EPC Rule 26(5) defines an essentially biological process as a process which
consists entirely of natural phenomenon such as crossing and selection.
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CASE STUDY
TOMATO CASE
CLAIM 1 OF EP 1211926
“A method for breeding tomato plants that produce tomatoes with reduced fruit water
content comprising the steps of:
• crossing at least one Lycopersicon esculentum plant with a Lycopersicon spp. to
produce hybrid seed;
• collecting the first generation of hybrid seeds;
• rowing plants from the first generation of hybrid seeds;
• pollinating the plants of the most recent hybrid generation;
• collecting the seeds produced by the most recent hybrid generation;
• growing plants from the seeds of the most recent hybrid generation;
• allowing fruit to remain on the vine past the point of normal ripening; and
• screening for reduced fruit water content as indicated by extended preservation of
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the ripe fruit and wrinkling of the fruit skin.”
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CASE STUDY
BROCCOLI CASE
In 1999, Plant Bioscience Ltd, filed a patent for a method of
selectively increasing the anti-carcinogenic glucosinolates of
Brassica (broccoli) with the European Patent Office
The patent was granted in 2002 (EP 1 069 819) but was opposed,
on the basis that the patent was for a biological process (finding and
marking a particular gene and breeding plants showing the marked
gene) which is excluded from patentability.
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CASE STUDY
BROCCOLI CASE
CLAIM 1 OF EP 1069819
“1. A method for the production of Brassica oleracea with elevated levels of 4-methylsulfinylbutyl
glucosinolates, or 3-methylsulfinylpropyl glucosinolates, or both, which comprises:
a) crossing wild Brassica oleracea species selected from the group consisting of Brassica villosa and
Brassica drepanensis with broccoli double haploid breeding lines;
b) selecting hybrids with levels of 4-methylsulfinylbutyl glucosinolates, or 3-methylsulfinylpropyl
glucosinolates, or both, elevated above that initially found in broccoli double haploid breeding lines;
c) backcrossing and selecting plants with the genetic combination encoding the expression of elevated
levels of 4-methylsulfinylbutyl glucosinolates, or 3-methylsulfinylpropyl glucosinolates, or both; and
d) selecting a broccoli line with elevated levels of 4-methylsulfinylbutyl glucosinolates, or 3methylsulfinylpropyl glucosinlates [sic], or both, capable of causing a strong induction of phase II
enzymes,
wherein molecular markers are used in steps (b) and (c) to select hybrids with genetic combination encoding
expression of elevated levels of 4-methylsulfinylbutyl glucosinolates, or 3-methylsulfinylpropyl
glucosinolates, or both, capable of causing a strong induction of phase II enzymes.”
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CASE STUDY
TOMATO & BROCCOLI CASE
DECISION OF ENLARGED BOARD OF APPEAL OF THE EPO
After thorough consideration of the context, objective, purpose and
legislative history of the exclusion in Article 53(b) EPC, the Enlarged
Board of Appeal of the EPO decided that:
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A process for the production of plants involving sexually crossing
whole plant genomes, and the subsequent selection of plants,
is not patentable.
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While technical devices or means, such as genetic markers, may
themselves be patentable inventions, their use does not make an
essentially biological process patentable.
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CASE STUDY
TOMATO & BROCCOLI CASE
DECISION OF ENLARGED BOARD OF APPEAL OF THE EPO

Merely including a technical step to enable or assist the performance of
sexually crossing genomes of plants or of subsequently selecting plants
does not override this exclusion from patentability.
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Processes for producing plants by inserting or modifying a trait in the
genome by using genetic engineering do not rely on sexual crossing of
whole genomes and may therefore be patentable. However, in such a
case sexual crossing and selection steps should not be in the claims,
since adding further technical processing steps before or after the steps
of sexual crossing and selection does not render such processes
patentable either.
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PLANT BREEDERS’ RIGHTS
WHAT ARE PLANT BREEDERS’ RIGHTS (PBR)?
Statutory right to exclude others from dealing (as defined in
section 23) with plant material (propagating and harvested
material) of a particular variety of plant without prior authorisation.
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PLANT BREEDERS’ RIGHTS
WHEN DOES A VARIETY QUALIFY FOR PBR PROTECTION?
(GENERAL PROVISIONS OF THE ACT)
IF IT IS:
NEW
DISTINCT
UNIFORM
STABLE
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PLANT BREEDERS’ RIGHTS
WHEN DOES A VARIETY QUALIFY FOR PBR PROTECTION?
(a)
NEW if propagating material or harvested material thereof has not been sold
(or otherwise disposed of) by (or with consent of) the breeder:
(i)
in the Republic, not more than one year; and
(ii)
in a convention country, in the case of(aa) vines and trees, not more than six years;
or
(bb) other varieties, not more than four years,
prior to the date of the PBR application;
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PLANT BREEDERS’ RIGHTS
WHEN DOES A VARIETY QUALIFY FOR PBR PROTECTION?
(b)
DISTINCT –
clearly distinguishable from common varieties;
(c)
UNIFORM –
if, subject to expected variation, it is sufficiently uniform with
regard to the characteristics of the variety in question;
(d)
STABLE –
if the characteristics thereof remain unchanged after repeated
propagation.
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PLANT BREEDERS’ RIGHTS
WHAT IS THE TERM OF A PBR REGISTRATION?
•
25 years
– in the case of vines and trees
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20 years
– in all other cases
•
Calculated from date registration certificate is issued
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PLANT BREEDERS’ RIGHTS
WHAT ARE THE RIGHTS OF THE PBR HOLDER?
The exclusive right to undertake
– the production or reproduction
– conditioning for the purpose of propagation
– sale or any other form of marketing
– exporting
– importing
– stocking for any of these purposes,
of propagating material or harvested material
Legitimate procurement of material not infringement
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PLANT BREEDERS’ RIGHTS
WHEN DOES ONE INFRINGE A PBR?
•
Undertaking any of the actions reserved exclusively for the
breeder
•
Failing to comply with any term or condition of a licence
•
Using an approved denomination of a protected variety in relation
to plants or propagating material of another variety
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TRADE MARKS
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NO DESIGN PROTECTION
NO COPYRIGHT PROTECTION
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STATUTORY EXCLUSIVITY:
CONDITIONAL GMO PERMITS
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CASE STUDY
MON810
The patent containing the MON810 trait (ZA90/1417) lapsed in 2010.
Technology fee charge for the use of the patented technology in seed.
Should the technology fee still be charged in respect of the “post-patent” or
“off-patent” use of the technology?
Permit no 17/3(5/01/177) grants the exclusive rights to Monsanto to allow
planting of seed containing the MON810 trait.
Any seed company is free to apply for a permit now that the patent has
expired.
Technology and stewardship agreement purchaser undertakes to pay a technology fee to Monsanto. www.dmkisch.com
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CASE STUDY
MON810
Over and above the charging of a technology fee, Monsanto should be
justified in charging a fee for the administration involved in complying with
the permit conditions.
Heavy burden to ensure compliance with the permit conditions, including
inspections of farms and monitoring of refuge areas and spraying
practises.
To the benefit of the agricultural sector to have access to the technology
and to ensure that the technology remains effective and is used properly in
accordance with the permit conditions to prevent insect and weed
resistance from developing.
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CONCLUSION & QUESTIONS
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At van Rooy
Contact Details
Patent Director
Tel: 012 460 3203
Cell: 082 772 0952
Fax: 012 460 3270
[email protected]
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PO Box 3668
Pretoria
0001
Suite 3, Parkland Building
223 Bronkhorst Street
Nieuw Muckleneuk
Pretoria
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