International IP Protection for Plants
Dr Humphrey Foote
humphrey.foote@ajpark.com
AJ Park
I.
Introduction
Protecting plant-based intellectual property internationally presents unique challenges. The law
around what and how plant subject matter can be protected in different countries varies
considerably, and in some countries options are quite limited. Creative approaches are therefore
beneficial to maximise protection in the jurisdictions in which protection is desired.
Described here are some of the available options for protecting both genetically modified (GM)
and non-GM plants in 16 of the most important markets for such plants.
The chosen
jurisdictions are Australia, Argentina, Brazil, Canada, Chile, China, Europe, India, Indonesia,
Japan, New Zealand, the Philippines, Thailand, United States, Vietnam and South Africa.
II.
Protecting genetically modified (GM) plants
A. Protecting GM plants with patents
Generally the broadest protection for GM plants and products is provided by patents. However
the extent of patent protection available varies significantly between countries. The author
believes it is important to be aware of the limitations and challenges, and to have a global focus
from the outset, when drafting patents which may ultimately be filed many different
jurisdictions.
1. Patent eligible subject matter
The issue of patent eligible subject matter has recently come to prominence with the decision, in
June this year, of the US Supreme Court in Association for Molecular Pathology v. Myriad
Genetics, Inc. (the "Myriad" case). As has been well publicised, the Court ruled that naturally
occurring DNA, even in its isolated form, is no longer patent eligible subject matter in the US,
but that cDNA with some exceptions is. The Myriad decision has prompted a great deal of
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discussion and blogging concerning how, and if, various gene-based technologies can be
protected in the United States now that naturally occurring DNA is no longer patentable.
It is interesting to note that the United States is not the first territory to take this position. Those
of us who have been protecting GM plant technology around the world have likely had to deal
with the exemption of isolated naturally occurring DNA from patent protection in some countries
for quite some time.
Table 1 below provides general guidelines to what is patent eligible subject GM plant subject
matter in the listed countries. There may be subtle exceptions, for example based around
whether or not the plant parts and seeds can be used to reproduce further plants. Furthermore,
patent offices and/or courts in some countries sometimes adopt unexpected interpretations of the
wording of the relevant statutes. Therefore this information should be considered as a guide
only.
Table 1 – Patent eligible subject matter for GM plants internationally
Country
Isolated
DNA
sequences
from plants
Modified
sequences /
expression
cassettes with
heterologous
sequence
elements
Transgenic
plant cells
Australia
yes
yes
Argentina
no
Brazil
Transgenic
plants
Transgenic
plant parts
(e.g. seeds)
Methods
for
producing
transgenic
plants
yes
yes
yes
yes
yes
no
no
no
yes
no
yes
no
no
no
yes
Canada
yes
yes
yes
no
no
yes
Chile
yes
yes
no
no
no
yes
China
yes
yes
yes
no
no
yes
Europe
yes
yes
yes
yes
yes
yes
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India
no
yes
no
no
no
no
Indonesia
yes
yes
yes
yes
yes
yes
Japan
yes
yes
yes
yes
yes
yes
New Zealand
yes
yes
yes
yes
yes
yes
Philippines
yes
yes
yes
no
no
yes
Thailand
no
yes
no
no
no
yes
United States
no
yes
yes
yes
yes
yes
Vietnam
yes
yes
yes
yes
yes
yes
South Africa
yes
yes
yes
yes
yes
yes
2. Some observations with reference to Table 1
Some observations based on the author's experiences and with reference to Table 1 are discussed
below.
a. Value in a claim to a construct including heterologous elements
A claim to the sequence that is used to transform the plant can be the most desirable claim to
have, especially in situations where transgenic plants are not patentable. In some cases a claim to
the sequence may also protect a plant or plant part transgenic for the sequence.
As mentioned above, and shown in Table 1, several countries do not allow protection of isolated
naturally occurring DNA. It is worth noting that in all countries listed above a claim to an
expression cassette including a heterologous element (e.g. a promoter or terminator heterologous
to the coding sequence) is eligible. Therefore such a claim is certainly worth including.
In theory use of the heterologous element such as a promoter could be avoided by transforming
the coding sequence alone into the genome of the plant where its expression could be controlled
by an endogenous promoter. However this would be relatively unusual and most expression
cassettes used to produce GM plants include a heterologous promoter anyway.
Claims to such constructs can also be useful for overcoming novelty objections in jurisdictions
such as Europe where examiners often object to claims generally directed to plants simply
"comprising" a specified plant polynucleotide on the basis that such plants are not distinguished
from wild-type plants.
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Similarly, post Myriad, the author has received s101 objections from examiners at the USPTO
arguing that plants simply defined as comprising a specified plant polynucleotide are not
distinguished from naturally occurring plants. Again having the option to amend to include a
heterologous element in the expression cassette can be useful to overcome such objections.
b. Good method claims are important
It is also worth noting that while in many countries at least some GM plant subject matter is
excluded from patentability, all countries in the table with the exception of India allow claims to
methods for producing transgenic plants. Therefore good method claims are important.
However in some countries examiners may still object if they consider such claims encompass
the transgenic plants themselves if these are not patent eligible. Therefore alternative method
claims for example directed to altering a phenotype in a plant, or growing/cropping plants under
certain conditions, are also be worth including.
c. Conclusion
Exclusions of certain GM plant materials as eligible subject matter, as illustrated in the Table 1,
highlights the need for multiple further claims formats (beyond the scope of this paper) when
filing patents for GM plants internationally. This is especially true when considering the
challenges to protecting subsequent generations of the primary transformed plants, and
protecting material harvested from the GM plants.
B. Protecting GM plants with "plant variety-type protection"
Individual varieties of GM plants can also be protected by "plant variety-type protection". The
term "plant variety-type protection" as used here, is intended to include plant variety protection
and plant patents in the United States, as well as the similar plant variety rights and plant
breeders' rights protection provided in other countries.
Plant variety-type protection is typically limited to a single variety, and so is generally much
narrower than the classical type gene-based patent protection for GM plants. In addition plant
variety-type protection in not available for every species in every country. However plant
variety-type protection does have the advantage that no inventive step is required among other
advantages.
In many countries a degree of regulatory approval for a GM plant variety is required before a
plant variety-type application can progress. It is therefore often important to monitor dates of
first sale of the variety to ensure that there is sufficient time to consider obtaining such regulatory
approval within filing time limits typically governed by the novelty requirements for the plant
variety-type protection in the chosen territories (see Table 3 below).
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C. Protecting GM plants with "event" patents
Another option for protecting GM plants in addition to the typical claims built around the
sequence transformed is to protect a particular transformation event. The event may be defined
in part by the sequences flanking the inserted DNA.
This type of protection is also narrower than the classical gene sequence-based patents for GM
plants, but can be broader than plant variety-type protection because such patents can encompass
plant produced through further crossing that also contain the same event. This type of protection
may therefore be particularly useful for species that are often used to produce hybrids.
D. Combining protection methods to extend protection for GM plants
The approaches described in sections A, B and C above can be used in combination to
effectively extend the term of patent protection for particularly preferred GM plants. For
example a particularly beneficial variety or transformation event could be protected by "plant
variety-type" protection or in an "event" patent respectively, beyond the term of an initial
broader gene-based patent. This approach however requires careful management/planning to
ensure that the novelty/inventive step requirements of the later plant variety-type protection or
event patent are met
III. Protecting non-GM plants
Protecting non-GM plants offers further challenges with some but not all of the approaches
discussed above being available for such traditionally bred plants.
A. Protecting non-GM plants with patents
Because patent protection is generally broader than plant variety-type protection, patent
protection for non-GM plants, or methods for producing them, is an attractive option. However
such protection is not available in all jurisdictions. In some countries plant varieties are excluded
from patent protection. In others countries plant varieties can be protected by either patent of
plant variety type protection. Table 2 below shows summarises this information for the same 16
jurisdictions in Table 1. Again this information should be treated as a guide only.
Table 2 – Availability of patent protection for non-GM plants and methods for their production,
and for plant varieties.
Country
Non-transgenic
plants
Refined methods* for
the breeding of nontransgenic plants
Plant varieties
Australia
Yes
Yes
No
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Argentina
No
Yes
No
Brazil
No
Yes
No
Canada
No**
Yes
No
Chile
No
Yes
No
China
No
Yes
No
Europe
Yes
No
No
India
No
No
No
Indonesia
No
No
No
Japan
Yes
Yes
Yes
New Zealand
Yes
Yes
Yes
Philippines
No
No
No
Thailand
No
Yes
No
United States
Yes
Yes
Yes
Vietnam
Yes
Yes
No
South Africa
No
No
No
*For methods for production of non-GM plants to be protectable by patents, additional technical steps beyond standard breeding
practices, such as steps that cannot occur in nature, may be required.
**In Canada, a claim to a non-transgenic cell is eligible, and should be enforceable against a plant comprising the cell
B. Protecting non-GM plants 'plant variety-type' protection
Varieties of non-GM plants, as well as GM-plants as discussed above, are of course protectable
by plant variety-type protection. As noted above however, plant variety-type protection in not
available for every species in every country. Table 3 below summarises some relevant
information for the same 16 jurisdictions discussed above. Again this information should be
treated as a guide only.
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Table 3 – Novelty provisions and term of protection for plant variety-type protection.
Country
Protection
Plant breeder's right
Novelty provisions
No sale in AU more than 1
year before filing
No sale abroad more than 6
years (trees/vines**) or 4
years (other plants) before
filing
Term
20 years from grant
25 years from grant (trees
and vines)
Plant variety protection
No sale in AR before filing.
No sale abroad more than 6
years (trees/vines) or 4
years (other plants) before
filing
Between ten and twenty
years, depending of the
species or group of species.
Plant variety protection
No sale in BR more than 1
year before filing
No sale abroad more than 6
years (trees/vines) or 4
years (other plants) before
filing
15 years from Provisional
Protection Certificate
18 years from Provisional
Protection Certificate(trees
and vines)
Plant breeder's right
No sale in CA prior to
effective date of application
No sale abroad more than 6
years (woody plants) or 4
years (other plants) before
filing.
18 years from grant
No sale in CL more than 1
year before filing
No sale abroad more than 6
years (trees/vines) or 4
years (other plants) before
filing
15 years from grant
20 years from grant (trees
and vines)
Plant variety protection
No sale in CN more than 1
year before filing
No sale abroad more than 6
years (trees/vines) or 4
years (other plants) before
filing
15 years from grant
20 years from grant (trees
and vines)
Community plant variety
right
No sale in EP more than 1
year before filing
No sale abroad more than 4
years or 6 years (trees and
vines) before filing
25 years from grant (other)
30 years from grant
(potatoes, trees and vines)
Plant variety protection
No sale in IN more than 1
year before filing
No sale abroad more than 4
years or 6 years (trees and
18 years from grant ( trees
and vines)
15 from the date of
notification of that variety
Australia
Argentina
Brazil
Canada
Chile
China
Europe
India
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vines) before filing
by the Central Government
under the Seeds Act, 1966
for extant varieties
15 years from grant (other)
Plant variety protection
No sale in ID more than 1
year before filing
No sale abroad more than 4
years (seasonal plants) or 6
years (annual plants) before
filing
20 years from grant
(seasonal plants)
25 years from grant (annual
plants)
Plant variety protection
No sale in JP more than 1
year before filing
No sale abroad more than 6
years (trees/vines) or 4
years (other plants) before
filing
25 years from grant
30 years from grant (trees
and vines)
Plant variety right
No sale in NZ more than 1
year before filing
No sale abroad more than 6
years (woody) or 4
years(non-woody) before
filing
20 years from grant (nonwoody)
23 years from grant (woody
plant)
Plant variety protection
No sale in PH more than 1
year before filing
No sale abroad more than 4
years or 6 years (trees and
vines) before filing
20 years from grant
25 years from grant (trees
and vines)
Plant variety protection
No sale in TH or abroad
more than 1 year before
filing
-12 years if yield
characteristics within 2
years
-17 years if yield
characteristics in more than
2 years
-27 years for woody plants
that yield characteristics in
more than 2 years
Plant patent - Asexually
reproduced (except tubers)
As for utility patents.
1 year grace period
20 years from filing
Plant variety protection –
Sexually reproduced
No sale in US more than 1
year before filing
20 years from grant
Indonesia
Japan
New
Zealand
Philippines
Thailand
United
States
No sale abroad more than 4
years or 6 years (trees and
vines) before filing
Plant variety protection
Vietnam
No sale in VN more than 1
year before filing
No sale abroad more than 4
years or 6 years (trees and
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25 years from grant (trees
and vines)
20 years from grant
25 years from grant (trees
and vines)
vines) before filing
Plant breeders' rights
South
Africa
No sale in ZA more than 1
year before filing
No sale abroad more than 4
years or 6 years (trees and
vines) before filing
20 years from grant
25 years from grant (trees
and vines)
* "Sale" in many countries includes an "offer for sale". "Sale" may also be limited to sale of reproductive material.
** "Vine" in many countries is interpreted as "grapevine"
IV. Conclusion
The information above provides an overview of options for protecting plant intellectual property
in 16 of the most important jurisdictions for such material. This information is by no means
comprehensive, but is intended to highlight some of the important differences between the
jurisdictions that plant biotechnology IP practitioners should be aware of or wary of when
considering IP protection strategies for their companies or clients.
V.
Acknowledgement
The author acknowledges the following for helping provide some of the information with respect
to the countries discussed above: Marval, O'Farrell & Mairal - Argentina, Dannemann Siemsen Brazil, Sim & McBurney, Smart and Biggar - Canada, Estudio Villaseca - Chile, Melvin Li China, Kan & Krishme - India, Lumenta, Sitorus & Partners - Indonesia, TMI Associates Japan, SyCipLaw - The Philippines, Domnern,Somgiat & Boonma - Thailand, Greenlee Sullivan
Winner - United States, VCCI-IP CO., LTD - Vietnam, Adams Adams - South Africa,
http://www.katzarov-manual.com, Karl Rogers and Marcia Rosenfeld.
VI. Disclaimer
While the author has tried to ensure that the information provided is accurate, the information
provided is not a substitute for legal advice. The author, the author's firm, and those
acknowledged above are not responsible for any errors or omissions.
Humphrey Foote (humphrey.foote@ajpark.com) – August 2013
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