Miljø- og Fødevareudvalget 2016-17
MOF Alm.del Bilag 348
Offentligt
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Technical briefing: How should the exclusions in Article 53(b) be
interpreted to make them effective?
Discussion paper - February 2017
Christoph Then for
“No Patents on Seeds!”
1. Introduction
In November 2016, the EU Commission published an explanatory notice on some specific articles
in EU Directive 98/44. Significantly, the EU Commission takes the view that plants and animals
obtained by means of “essentially biological processes” for the breeding of plants and animals are
non-patentable.
This latest statement echoes demands made by the EU Parliament and reflects the position of
several European governments, such as Austria, Germany, the Netherlands and France. In these
countries national patent laws have already been changed to prohibit patents covering plants and
animals derived from “essentially biological” breeding.
The EU Patent Directive as well as the European Patent Convention (EPC) prohibit patents on
“plant and animal varieties” and on “essentially biological processes” for the breeding of plants and
animals. However, these prohibitions have been extensively eroded by the current practice of the
European Patent Office (EPO). The EPO continues to grant patents on plants derived from
conventional breeding e.g. on tomatoes and broccoli. This has led the organisations in the
international coalition of
No Patents on Seeds!
to be seriously concerned about the policy of the
EPO and its impact, namely the increasing monopolisation of seed and food production.
Political decision-makers must now ensure that the EPO adopts the EU notice, and that this new
interpretation of patent law becomes legally binding. Most importantly, the Administrative Council
of the European Patent Office should include relevant provisions into the Implementing Regulations
to the EPC.
There are three problems that need to be addressed by the Member States of the EU and the
Administrative Council:
1. The exclusion of plants and animals derived from conventional breeding must become
legally binding.
2. The definition of “essentially biological processes” should cover the whole area of
conventional breeding.
3. The scope of patents should be limited to avoid overlap between patentable and non-
patentable inventions.
The following sections outline some reasons and suggestions for changes in the text of the
Implementing Regulations to ensure that exclusions in Article 53(b) become more effective and to
ensure more legal certainty and clarity.
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2. The legal provisions
Article 4 of EU Directive 98/ 44/EC and Article 53(b) of the European Patent Convention (EPC)
exclude
“essentially biological processes for the production of plants or animals.”
The following definition was initially included in Article 2 (2) of EU Directive 98/44/EC and was
subsequently adopted as part of the Implementing Regulations of the EPC (Rule 26 (5)):
“A process for the production of plants or animals is essentially biological if it consists
entirely of natural phenomena such as crossing or selection.”
3. EPO interpretation: Patentability of the processes
The European Patent Office (EPO) forwarded several questions to the Enlarged Board of Appeal
(EBA) after finding that the definition in the EU Directive was very difficult to apply in legal
practice.
In 2010, in its decisions G1/08 and G2 /07, the EBA argued that processes containing or consisting
of the steps of crossing and selecting should be excluded from patentability as being “essentially
biological”:
“A non-microbiological process for the production of plants which contains or consists of
the steps of sexually crossing the whole genomes of plants and of subsequently selecting
plants is in principle excluded from patentability as being "essentially biological" within the
meaning of Article 53(b) EPC.
Such a process does not escape the exclusion of Article 53(b) EPC merely because it
contains, as a further step or as part of any of the steps of crossing and selection, a step of a
technical nature which serves to enable or assist the performance of the steps of sexually
crossing the whole genomes of plants or of subsequently selecting plants.”
It should be mentioned that this definition is not fully in line with the provisions of Article 2 (2) of
EU Directive 98/44/EC and Rule 26 (5), EPC. While the legal provisions exclude methods such as
“crossing
or selection”,
the decision of the EBA speaks about
crossing (…) and of subsequently
selecting”
which is likely to narrow the scope of the exclusion.
In addition, what is patentable was defined as follows:
“If, however, such a process contains within the steps of sexually crossing and selecting an
additional step of a technical nature, which step by itself introduces a trait into the genome
or modifies a trait in the genome of the plant produced, so that the introduction or
modification of that trait is not the result of the mixing of the genes of the plants chosen for
sexual crossing, then the process is not excluded from patentability under Article 53(b)
EPC.”
As a result, the EPO continues to grant patents on methods of genetically engineered plants and
animals because those processes are considered to be a
step of a technical nature, “which step by
itself introduces a trait into the genome”.
However, there are several grey areas. For example, random mutagenesis – from the perspective of
patent law - is not really 'technical' because the changes in the genome are not introduced by
specific technical means, but are random. Nevertheless, according to the definition implemented by
the EBA, it could be considered to be a
step in itself to introduce or modify a trait into the genome
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without crossing and selection.
Further processes that allow the propagation of plants (such as usage
of shoots) or the selection of plant characteristics without crossing (such as selection of native
traits) might still be considered to be patentable.
Two recent examples from EPO case law exemplify these grey areas:
EP 2134870 held by Monsanto covers selection of soybeans for the purpose of further
breeding. During the opposition procedure, the EPO, in December 2016, published a
preliminary opinion stating that the selection of plants for further breeding can be covered
by patents: “... the decision G1/08 does not allow to draw the conclusion that methods for
the selection … of plants based on markers (or any other feature such as oil content, or
pathogen resistance) would be excluded from patentability. ….”. According to the
examiners, only selection in combination with crossing will be excluded – this is not in
accordance with the wording of the EPC (see above).
Patent application EP 2571347 filed by Rijk Zwaan claims cucumbers derived from random
mutagenesis. During the examination, the EPO, in December 2016, suggested that the
company should explicitly state that the plants are derived from random mutagenesis
“otherwise, the proceedings may have to be stayed” because the processes would be
regarded as “essentially biological”.
These cases show that the examiners at the EPO are looking for loopholes and grey areas in
decisions G2/07 and G1/08 so that they can continue to grant patents on conventional plant
breeding. So far, it appears that the EPO has not finally decided how it will apply G2/07 and G1/08.
Whatever the case, there is, as yet, no legal certainty or clarity.
4. EPO interpretation: Patentability of products
In further decisions (G2/12 and G2/13), the Enlarged Board of Appeal at the EPO decided that
plants and animals derived from “essentially biological” breeding can be patented, even though the
process is excluded under Article 53(b), EPC.
5. EU Commission interpretation
In November 2016, the EU Commission drew up an explanatory notice on the interpretation of
Article 4 of EU Directive 98/44/EC. In its conclusion it states that:
“the Commission takes the view that the EU legislator’s intention when adopting Directive
98/44 /EC was to exclude from patentability products (plants/animals and plant/animal
parts) that are obtained by means of essentially biological processes.”
This explanatory statement is in clear contradiction to the decisions of the Enlarged Board of
Appeal at the EPO (G2/12 and G2/13).
Since 1999, when the EPO adopted the provisions of EU Directive 98/44/EC, the EPO has to some
extent been bound by the interpretation of the institutions of the EU in regard to its specific articles.
Consequently, there is now an expectation that the EPO should adapt its legal practice in accordance
with the interpretation presented by EU institutions.
Further, the EU Commission – based on the history and the text of the EU Directive - also presented
some guidance on what is regarded as patentable:
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“The trigger point for ensuring the patentability of either a plant or an animal is the
technical process, such as for instance the insertion of a gene into a genome. Essentially
biological processes are not of a technical nature and therefore, according to the position
taken by the legislator, they cannot be covered by a patent.”
This interpretation at least partially diverges from the one given by the EPA in G2/07 and G1/08.
In general, the definition provided by the EU Commission follows the distinction between genetic
engineering and conventional breeding. It clearly defines the technicality of methods which are
patentable: The meaning of the expression “insertion of a gene into a genome” as a method used in
genetic engineering can be understood historically (in regard to Directive 98/44/EC), and also
technically and legally, for example, EU Directive 2001/18 and its predecessor Directive
90/220/EEC are based on a similar definition for genetically modified organisms that need to be
regulated.
Indeed, Directive 98/44/EC in Recitals 1, 2, 52 and 53 as well as in Article 16 uses the expression
“genetic engineering”. Further, in Recital 32 the expression “genetic modification” is used and
Recital 9 and 10 deal with “biotechnology” in the sense of genetic engineering. This wording – and
the history of the Directive – clearly shows that the EU intent is to allow patents on methods of
genetic engineering, but not on methods applied in 'conventional' breeding. From the perspective of
patent law – which is not directly linked with the regulation of genetically engineered organisms – it
can be followed that the decision G2/07 and G1/08 of the Enlarged Board of Appeal should be
understood as follows: Only if material inserted from outside into the cell by itself introduces a trait
into the genome or modifies a trait in the genome of the plant produced, so that the introduction or
modification of that trait is targeted and not derived at random, then the process is not excluded
from patentability under Article 53(b) EPC.
Therefore, the guidance drawn up by the EU Commission provides more legal certainty and clarity
than the one previously developed by the EBA (G1/07 and G2/08). It is derived from the context
and the history of the EU Directive. Consequently, there now has to be an assumption that the EPO
will adapt its legal practice accordingly.
6. Further clarifications
There are further legal uncertainties that will need more clarification. In particular, both the scope of
patents and the prohibition relating to granting patents on plant and animal varieties need further
consideration.
a) Scope of patents
If 'absolute product protection' is provided for plant and animals produced by methods of genetic
engineering, then the scope of these patents can also cover plants and animals derived from
“essentially biological processes” with the same or similar characteristics.
Therefore, to make the exclusion in Article 53(b) effective, the scope of patents should be restricted
to the technical method used to produce plants or animals. This problem - to some extent - can be
resolved in national patent law. For example, Article 10 of French legislation on biodiversity (Loi
pour la reconquête de la biodiversité, de la nature et des paysages) prohibits the
extension of the protection conferred by patents on “a
biological material possessing specific
characteristics as a result of the invention”
to plants or animals derived from “essentially biological
processes” and naturally containing the same traits.
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Since national law might not lead to a harmonised approach and might, therefore, not provide
sufficient legal certainty and clarity, the EPO should generally avoid granting patents on inventions
concerning plants and animals that provide 'absolute product protection'. Instead, only 'process
claims' should be granted.
It is important to note that patent protection on products can also be derived from 'process claims',
since the result of the process is also covered by the patent. However, so-called 'absolute product
protection' is based on 'product claims' and goes beyond process-bound patent protection: If a
'product claim' is granted, the scope of the patent will cover all products (plants or animals) with
same or similar or identical characteristics as described in the patent – independently of the method
by which they were produced.
Consequently, if 'process claims' are granted on methods of genetic engineering, then plants and
animals obtained by these methods will fall within the scope of the patent as well as their offspring
as long as they contain the patented functions (traits). However, plants and animals with similar or
identical characteristics obtained by means of
essentially biological
breeding, will not fall within
the scope of the patents.
As the following analysis shows, the EU Directive and the EPC do not request 'absolute product
protection' for inventions concerning plants and animals. Especially relevant in this context is
Article 4 of Directive 98/44/EC, which is specific for the patents granted under Article 53(b) of the
EPC. Further, Article 3 of the EU Directive might be considered as being relevant, even though this
article is more important for material used for pharmaceutical purposes.
Article 4.2 of EU Directive 98/44/ EC (and Rule 27 (b) of the EPC) reads
“Inventions which concern plants or animals shall be patentable if the technical feasibility
of the invention is not confined to a particular plant or animal variety.”
While patent protection for inventions concerning plants and animals is requested, the wording of
this paragraph does not compel 'absolute product protection' for the resulting plants and animals.
Therefore, patentability can be fully satisfied by process claims. The same analysis can be applied
to Recital 32.
Further, Article 4.3 requests patent protection in regard to:
“inventions which concern a microbiological or other technical process or a product
obtained by means of such a process.”
This provision is related to the wording of Article 53(b), EPC, which reads in full length:
“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 shall not apply to microbiological processes or the products
thereof.”
In the past, this article has caused considerable confusion and uncertainty in regard to the
patentability of plant varieties. However, this was dealt with in the G1/98 decision of the Enlarged
Board of Appeal on the patentability of plant varieties: The EBA decided that the term
“microbiological processes” is not of relevance for the prohibitions under Article 53(b). In its G
1/98 decision the Enlarged Board of Appeal states:
“Genetically engineered varieties were covered by the prohibition on granting patents for
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plant varieties under Article 53(b) EPC even if the variety should in some sense be
considered the product of a microbiological process”
The reasoning for the decision G1/98 is somewhat loosely termed and can only be applied to plant
and animal breeding in general:
“At the time the Strasbourg Patent Convention and the EPC were drafted, it was
inconceivable that varieties could be obtained with the help of techniques including
microbiological steps. Thus, the legislator could not have intended that plant varieties
should be patentable as products of microbiological processes.”
There is no indication in the text of Directive 98/44/EC that would require a change in this legal
interpretation. On the contrary, Article 2 (b) of the Directive affirms the interpretation in the G1/98
decision:
“microbiological process` means any process involving or performed upon or resulting in
microbiological material.”
Thus again, Article 4 of EU Directive 98/44 EC cannot be interpreted in such a way that 'absolute
product protection' must be issued to cover plants and animals.
Further, Article 3.2 of EU Directive 98/44/ EC (and Rule 27 (a) of the EPC) reads
“Biological material which is isolated from its natural environment or produced by means
of a technical process may be the subject of an invention even if it previously occurred in
nature.”
Since the process of breeding plants or animals can hardly be considered to be 'isolating' biological
material, Article 3.2 cannot be applied to inventions concerning plants and animals. If, on the other
hand, biological material (plants or animals) is produced by a “technical
process”,
the patent
covering the process would also cover the plants and animals derived thereof, even if the
characteristics already existed in nature. However, Article 3.2 does not request the extension of
patent protection to plants and animals with the same characteristics that are derived by non-
technical (essentially
biological)
processes.
Consequently, there is no need to issue 'absolute product protection' for inventions concerning plant
and animal breeding. This interpretation of the provisions of EU Directive 98/44 is supported by
decision C-428/08 of the EU Court of Justice, which generally restricted product protection in
regard to biotechnological inventions.
In addition, if 'absolute product protection' is not issued for inventions that interfere with the
prohibitions of Article 53(b), this does not call into question product protection in other areas. Such
a provision would solely be justified by the necessity to make effective the prohibitions of Article
53 (b).
As a result, only process claims that are clearly based on technical processes should be granted in
relation to inventions that concern plants or animals.
b) Exclusion of plant and animal varieties
Article 53(b) also excludes plant varieties. However, in the past this exclusion has often been
circumvented by clever wording of the claims, even if the invention as described in the patent
application fell under exclusion.
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In its G2/06 decision (the so-called WARF-Decision), the EPO chose to apply a so-called 'whole
content approach' in the examination of patent applications that – because of ethical concerns -
might fall under the prohibitions of Article 53(a). The application of the 'whole content approach' in
regard to Article 53(a) was confirmed by the EUCJ in its decision C-34/10.
The 'whole content approach' is meant to prevent the circumvention of prohibitions in patent law by
inventive drafting of the claims in patent applications. Therefore, it requests that technically
unavoidable pre-process steps and technically unavoidable post-process steps and/or unavoidable
post-process uses of the products shall constitute part of the invention, even if they are not explicitly
disclosed in the specification and/or the claims of a patent application.
To make sure that none of the prohibitions in Art. 53, EPC can be circumvented by clever,
duplicitous drafting of the claims in patent applications, the whole content approach should also be
applied to exclusions under Article 53(b). This is in accordance with a resolution passed by the EU
Parliament in 2012 (“European Parliament resolution of 10 May 2012 on the patenting of
essentially biological processes”). Further legal arguments on the whole content approach can be
taken from Dolder, “Die Anwendung von Patentierungsausschlüssen nach dem whole content
approach”, Mitteilungen der Deutschen Patentanwälte, Heft 1/2017.
7. Summary: Tabled overview of suggested changes to the text of the Implementation
Regulation
The following table summarises the legal analysis and translates the most relevant findings into
suggestions for changes to the Implementation Regulation of the EPC.
Original text
Chapter V
Biotechnological inventions
Rule 26 General and definitions
….
(5) A process for the production
of plants or animals is
essentially biological if it
consists entirely of natural
phenomena such as crossing or
selection.
Proposed additional text
Comments
Methods concerning crossing,
or selection, or propagation, or
processes to introduce or
modify a trait at random are
regarded as essentially
biological.
Such processes are still
7
It can be inferred from the
explanatory notice published by
the EU Commission that
patentable inventions as
described in Article 4 of
Directive 98/44 solely concern
methods of genetic engineering.
Therefore, methods and
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Original text
Proposed additional text
considered essentially
biological even if they contain,
as a further step or as part of
any of the steps of breeding, a
step of a technical nature which
serves to enable or assist the
performance of the breeding
process.
Only if a material intentionally
inserted from outside into the
cell introduces a trait into the
genome or modifies a trait in
the genome of the plant or
animal produced, so that the
introduction or modification of
that trait is targeted and not
derived at random, then the
process is not considered as
essentially biological.
Further, if plants or animals
derived from non-essentially
biological processes are used in
breeding, the overall process is
not regarded as essentially
biological.
Comments
materials relevant for
conventional breeding have to
be excluded as they are
“essentially biological
processes”.
(6) "Microbiological process"
means any process involving or
performed upon or resulting in
microbiological material.
Breeding of plants and animals To avoid legal uncertainty.
is not regarded as
microbiological process.
Rule 27
Patentable biotechnological
inventions
Biotechnological inventions
shall also be patentable if they
concern:
(a) biological material which is
isolated from its natural
environment or produced by
means of a technical process
even if it previously occurred in
nature;
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Original text
Proposed additional text
Comments
Breeding of plants and animals To avoid legal uncertainty.
is not regarded as isolation of
biological material from its
natural environment.
(b) plants or animals if the
technical feasibility of the
invention is not confined to a
particular plant or animal
variety;
(c) a microbiological or other
technical process, or a product
obtained by means of such a
process other than a plant or
animal variety.
Breeding of plants and animals To avoid legal uncertainty.
is not regarded as
microbiological process.
Rule 28
Exceptions to patentability
Under Article 53(a), European Rule 28. 1
patents shall not be granted in
respect of biotechnological
inventions which, in particular,
concern the following:
abc d
Rule 28.2 (or Rule 29, new)
Under Article 53(b), the
following rules apply:
All products such as
This provision is mostly derived
plants/animals and plant/animal from the explanatory notice of
parts and genetic information
the EU Commission.
that are used in or obtained by
means of essentially biological
processes are excluded from
patentability.
Patentable plant- and animal-
related inventions can only be
covered by process claims. In
addition, the wording of the
process claims has to be
defined by the specific
technical methods as described
in the patent.
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This provision is necessary to
render the specific prohibitions
effective. If absolute product
protection is issued to cover
plants and animals, the scope of
patents granted covering plants
and animals derived from
methods of genetic engineering
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Original text
Proposed additional text
Comments
could cover those derived from
essentially biological processes
with same or similar
characteristics.
The EU Directive does not
require absolute product
protection to be issued for
plants and animals.
In regard to the exceptions of
article 53(b), the whole content
approach applies as developed
in G2/06.
This is necessary to prevent
applicants from escaping the
prohibitions by cleverly
wording the claims.
10