Q178 draft report.pdf - SFIR

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Sweden
Suède
Schweden
DRAFT Report Q 178 - Scope of Patent Protection
In the name of the Swedish Group by
Ulf DAHLGREN, Walo von GREYERZ, Åsa HELLSTADIUS, Ivan
HJERTMAN, Lennarth TÖRNROTH, Li WESTERLUND
1. Which are the technical fields involved?
1.1 Which are, in your view, the fields of technology in particular
affected by recent discussions concerning the scope of
patent protection?
The Swedish Group would like to emphasise that when answering the
questionnaire Q 178, we use the expression “scope of patent
protection” as indicating the field of patentable subject matter, and not
in its usual meaning of the breadth of protection awarded to a patent.
The Swedish Group understands the technical fields in particular
affected by recent discussions are, as stated, primarily biotechnology
and computer software/business methods. In the area of
biotechnology, the developments within the various fields of research
that are gathered under the expression “Life Sciences” and the
subsequent granting of patents in that domain raises questions. Both
genetic patents, for example the much discussed gene patents, patents
on stem cell inventions, and chemical patents are affected. The
protection of traditional knowledge by patents or other intellectual
property rights is also under discussion.
The Swedish Group believes that in the domain of computer software,
the protection of computer programs, including computer-implemented
business methods, is the prevalent field of discussion. Under European
Patent Convention (EPC) practice, business methods as such lack the
technical character which is necessary for patentability. We believe that
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the patent system with the current practice under the EPC fulfils the
existing needs for protection in this domain.
The Swedish Group believes that the value of the protection granted for
inventions in the domain of computer programs/business methods is
hard to estimate, which may cause future problems. The granting of
and subsequent enforcement of rights lead to questions of proper
scope and breadth of protection, and whether or not the legal system
can deal with this in a proper way.
1.2 What makes this field/these fields of technology special
compared to other fields of technology in the context of this
discussion?
The field of biotechnology can be technically more complicated than
others. In court proceedings, a high level of technical knowledge is
needed in order to reach a proper interpretation. The rapid
developments in research and the increasing patenting makes it hard
for legal experts to overlook the situation in a longer perspective, and to
establish a proper balance of protection for inventions in this domain.
The field of business methods, on the other hand, is said by some to be
characterised by the fact that the inventions are not so much the results
of research and development, but rather quite simple innovations.
Within the field of computer programs, the technique is not that
complicated, compared to, for example, biotechnology patents. Rather
it is the language in the technical descriptions that are sometimes
unfamiliar for others than experts in the field.
In the opinion of the Swedish Group, the usual criteria for determining
questions on patentability and breadth of patent rights have been
difficult to implement into the new areas of technology. The
patentability criteria may not have been implemented and interpreted
strict enough in the new domains, resulting in lowered thresholds for
patent protection.
Ethics and moral issues in biotech research is present at the legal
level. Inventions whose exploitation is contrary to ordre public or
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morality may not be patented under the EPC. However, ethical
considerations do – and should – play a larger role outside the narrow
field of patent issues. Nevertheless, many feel that it is wrong to allow
for exclusive rights to biological material of human origin. For instance,
the debate concerning patenting of human genes is ongoing in
Sweden, involving political, legal and ethical experts, but consensus is
not easily reached.
The Swedish Group is of the opinion that there is a lack of knowledge
and misunderstandings with the public on what exactly a patent right is.
These misunderstandings could in the long run pose a threat to the
existence of patent rights in biotechnology, as public perceptions
influences the political decisions.
The exceptions from patentability under the EPC are not clear. The
case law of the Boards of Appeal at the European Patent Office (EPO)
shows that the legal rules are difficult to implement in practice. This is
evident concerning the exceptions for plant varieties and inventions
contrary to ordre public and morality. The lack of clarity as to what
should be patentable and not causes problems of interpretation. See
supra question 2.3.
2. Practice of the patent granting authorities
2.1 What is the definition of patentable subject matter in your
jurisdiction?
European patent law is harmonized as to the granting of patents.
Patent protection in Sweden is regulated in the Swedish Patents Act
and the Patents Decree. Sweden, as a member of the EPC, has
implemented the convention’s requirements on patentability in the
Swedish legislation. Thus, the case law of the EPO Boards of Appeal
serves as a standard for interpreting Swedish law. The EU Directive
98/44 on the protection of biotechnological inventions (The Biotech
Directive) aims to establish some clarifications in the field of
biotechnology patents. The work of implementation of the Directive in
Swedish legislation is currently taking place (September 2003).
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The harmonisation of European patent law has lead to a situation
where the definition of patentable subject matter does not differ
between the European countries. The requirements in the EPC are
prevalent. The object of patent protection is an invention. An invention
must have technical character, i.e. present a technical solution to a
problem.
Do different definitions apply in various fields of technology?
If so, what are the differences?
The Swedish Group understands that there is no difference as to the
patentabillity requirements between various fields of technology.
However, the distinction between inventions and discoveries has been
questioned within the area of biotechnology, as many of the inventions
patented contains biological material existing in nature. It is therefore
stated in Article 3.2 of the Directive that “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”. Thus, natural biological material that is
either “isolated” or “produced by the means of a technical process” may
fulfil the basic criterion of technical character.
In theory, difference definitions are not applied between various fields
of technology. However, in the opinion of the Swedish Group, there is a
practical difference between biotechnology patents and patents in other
fields. We believe that the application of the patentability criteria (i.e.
inventive step) in biotechnology patenting has not been as strict as
required, compared to traditional fields of inventions.
2.2 What are exemptions/exceptions from patentability?
As indicated supra, the exemptions from patentability in Swedish law
are the same as in the EPC.
Some subject matter is never regarded as inventions according to
Swedish and European patent law. Discoveries, scientific theories and
mathematical methods, aesthetic creations, schemes, rules and
methods for performing mental acts, playing games or doing business,
programs for computers, and presentations of information are not
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patentable subject matter. A common characteristic of this subject
matter is that it is not perceived to have technical character and can
therefore not be regarded as inventions from a patent law perspective.
Hence, it is not patentable subject matter as such. Other subject matter
may be regarded as inventions and fulfil the necessary patentability
criteria, but nevertheless be expressly excepted from patentability on
other grounds. The following are the exceptions found in EPC and in
Swedish law:
* Methods for treatment of the human or animal body by surgery or
therapy and diagnostic methods. This exclusion does not apply to
products, in particular substances or compositions, for use of any of
these methods.
* Inventions whose commercial exploitation would be contrary to ordre
public or morality; however, exploitation shall not be deemed to be so
contrary merely because it is prohibited by law or regulation.
* Plant or animal varieties.
* Essentially biological processes for the production of plants of
animals.
2.3 What is the reasoning behind those exemptions/exceptions?
The Swedish Group believes that most of the exemptions have policy
grounds, and can be seen in an historical perspective.
* Methods for treatment of the human or animal body by surgery or
therapy and diagnostic methods.
These methods are excluded from patentability for policy reasons. It
has been regarded as unethical that medical or veterinarian personnel
should be affected by the effects of the patent system when carrying
out such methods as part of treatments of human or animals.
* Inventions whose commercial exploitation would be contrary to ordre
public or morality; however, exploitation shall not be deemed to be so
contrary merely because it is prohibited by law or regulation.
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The Swedish Group believes that the reason behind this exemption is
the idea that the ethical and moral principles recognised of the
countries in Europe should be prevalent and supplement the standard
legal examinations in patent law. The provision is only limited to
inventions of such a nature that they cannot at all be used in a moral or
legal way. Within the field of biotechnology, it has been emphasised
that this rule should be interpreted as to protect human, animal or plant
life, for example to prevent the patenting of processes whose use
would offend against human dignity.
* Plant or animal varieties.
* Essentially biological processes for the production of plants of
animals.
The Swedish Group understands that the exclusion of plant and animal
varieties as well as essentially biological processes for the production
of plants and animals from patentability originates from the historical
division between macro- and microbiology in patent law, and the
development of a separate sui generis protection system for plant
varieties as products of traditional breeding processes (The Plant
Variety Protection System). At the time of enactment of the EPC, a
distinction between macro- and microbiology was quite natural.
Microbiological processes such as fermentation had been used in
industry for a long time, and the knowledge of microbiological
substances such as for example antibiotics was nothing new. Plants
and animals were traditionally bred by crossing and selection.
The Swedish Group believes that the advent of biotechnology research
has changed the prerequisites for this exclusion. Biotechnology
processes are from a patent law perspective regarded as technical,
and thereby possible to patent, notwithstanding the fact that naturally
occurring material and processes are being used. Thus, the distinction
between macro- and microbiology is no longer upheld, resulting in
historical exclusions with no real basis in a modern patent system.
3. What is the effect of this definition on activities concerning
patent protection?
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3.1 Is the scope of protection sufficient or does it lack
opportunities for further protection? This includes economic
aspects for the users as well as for the public in general
regarding various technologies.
In the opinion of the Swedish Group, the patent system is flexible
enough to operate foreseeable needs for further protection, i.e.,
providing patents to inventions that may be developed in the future
within existing or new fields of technology.
The Swedish Group does not believe that the field of patentable subject
matter is overly broad, provided that the patentability criteria are strictly
applied and national courts interpret the claims consistently to
commensurate with the disclosure and not including prior art.
In Sweden, the Group believes the balance between protecting the
inventor without impeding the technical development, e.g. freedom to
operate, to be appropriate.
3.2 If the scope of protection is not sufficient, how does this
affect the users’ policy on patenting? Does this also have an
impact on research policy?
As indicated supra, the Swedish Group believes the balance for patent
protection with respect to patentable subject matter to be appropriate.
3.3 What are obstacles from political or social sources outside
the purely legal field which play a role in research and
patenting?
With respect to, in particular, life sciences, the Swedish Group believes
that the possibility for patent protection is necessary to foster research
and development by providing return for large investments.
That being said, public perceptions of patenting, specifically in the
biotech field with issues such as gene patents, receive unfavorable
response. Also within the research community itself, specifically from
researchers conducting much of the basic research at universities and
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other public institutions, there may be resistance towards accepting the
patent obstacles regarding research tools to freedom to operate.
In Sweden, the researchers themselves still principally own their
inventions conceived at public universities and other institutions with
public funding. Whether it be a favorable or unfavorable situation for
society is debatable. On the one hand it may arguably promote the
entrepreneurial aspect of the patent system. On the other hand it may
delay the release of new knowledge because of the secrecy
requirements in the early stages of patent processes. The Swedish
Group believes, however, that the same principal issues be present if
universities and other public institutions would instead own the
inventions.
3.4 How should new kinds or categories of inventions be
treated? Should there be an enlargement of patent
protection? If so, what are the reasons?
In the opinion of the Swedish Group, new kind of inventions and
categories of inventions should be evaluated within the framework of
the current patent system and that the traditional patentability criteria
be applied. Hence, if a new invention or category of inventions possess
technical character and is novel, if it is sufficiently disclosed and have
inventive step it should be granted a patent if it show industrial
applicability. The Swedish Group believes, however, that for new
inventions and categories of inventions it is important to still strictly
apply, for example, the criteria of inventive step and sufficient
disclosure.
3.5 If you find the field of patentable subject matter too wide,
how should it be limited? What would be the reasons for
such a limitation? What do you see as the positive effects of
such a limitation?
As set forth supra, the Swedish Group believes the balance to be
appropriate regarding the field of patentable subject matter. The
Swedish Group emphasizes again that it is the strict application of the
traditional patentability criteria that should be the focus.
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4. Further points of discussion
4.1 Which upcoming problems do you see specifically as a
result of a change of the scope of patent protection
regarding the requirements for patentability, in particular
novelty and inventive step?
We understand the question as referring to possible problems if
extending patentable subject matter. Given that the European patent
system for patentability has the requirement of technical character,
which also seems to be applied by the EPO and national courts, the
Swedish Group believes that the traditional patentability requirements
be adequate to control any extension of patentable subject matter. This
being said, The Swedish Group identifies the importance of a strict
application of the patentability criteria, specifically inventive step and
sufficient disclosure to commensurate with the scope of the granted
patent claim.
Because novelty is but one patentability requirement and the initial one
to meet, the Swedish Group does not believe that novelty is an issue. If
the invention was not in the prior art, i.e., every element of the claim, it
is and should of course be novel. The relevant threshold should be
inventive step, whose strict application will ensure that only inventions
having inventive merit will be granted a patent and, thus, allowed
patent protection. In addition, specifically regarding certain fields such
as, for example, the biotech field, the Swedish Group perceives that the
requirement of sufficient disclosure should be applied so that granted
claims commensurate with the disclosure and, hence, with the
protection granted to the inventor.
4.2 What are specific problems of the granting proceedings
(search, examination) if the scope of patent protection is
enlarged?
Conducting relevant searches can pose a problem if a technical field is
in its initial stage for the obvious reason that there will not be many
references published and, thus, be searchable. Another problem can
be that the Examiners lack the basic scientific knowledge within a new
area and, therefore, will not know how to search for and evaluate
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relevant references. The same concern of Examiner’s relevant
knowledge of course applies to the application of the traditional
patentability criteria to a field of technology not previously examined for
patentability and which is not altogether researched.
4.3 What do you see as possible solutions for these problems?
Would further harmonization of the laws help to solve such
problems and, if so, in which way?
Sweden follows the EPO case law and, thus, the granting and validity
aspects seem to be harmonized from a European perspective.
Therefore, it is not a harmonization of patentability requirement such as
that of inventive step that is an issue, but, if at all, it is the stringency of
the application of, for example, inventive step at the EPO that may be a
concern.
In this context, the Swedish Group would like to suggest that further
study be made on the effects which may result from the manner in
which the test for non-obviousness on basis of a combination of prior
art references is regulated in the USPTO, in the EPO and in the JPO.
Citation by a USPTO Examiner of a combination of prior art references
requires the Examiner to show the teaching or motivation to combine
these cited prior art references. This practice should be compared with
the corresponding rules in the examination procedures in the EPO and
in the JPO, in order to establish possible different effects on the
breadth of granted claims, for example in the biotechnology area. The
Swedish Group believes that a harmonization of the granting procedure
is desirable, including harmonization of the concepts non-obviousness
and inventive step.
Harmonization of infringement doctrines can help solving possible
problems regarding breadth of protection allowed to patentable subject
matter. Especially in situations when the patentee is granted the same
set of claims and specification in each designated member state under
the EPO-route and, therefore, is unable to tailor the claims to a specific
doctrine.
Regarding the search and examination stage, it is the opinion of the
Swedish Group that such problems mainly concern quality system
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issues. Further developments of documentation systems and sharing of
examination results between patent offices can therefore minimize
problems of this kind. Relevant training and hiring of specialists in the
various fields of examination are fundamental.
Summary
The technical fields involved are primarily biotechnology and computer
software/business methods. Also protection of traditional knowledge is
under discussion.
The Swedish/EPC patent system is considered to be appropriately
balanced, and flexible enough to operate foreseeable needs for further
protection within existing or new fields of technology.
Strict application of the patentability criteria, specifically inventive step
and sufficient disclosure, is necessary to commensurate with the scope
of granted claims.
Further development of quality system issues, documentation systems,
sharing of examination results between patent offices, training and
hiring of examination specialists, and harmonization of infringement
doctrines are examples of areas for further study.
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