EPO Response to EU Parliament Motion on Biotechnology Patents

Seth Johnson seth.johnson at RealMeasures.dyndns.org
Fri Oct 28 21:38:11 UTC 2005

(Well, the EPO responded.  Would they respond similarly to an EU
Parliament motion on software patents? -- Seth)

> http://www.european-patent-office.org/news/pressrel/2005_10_27_e.htm

"The EPO follows the EU’s Directive on biotechnology patents"

Munich, 27 October 2005 – The European Patent Office (EPO) has
noted the concern that several groups in the European Parliament
have expressed about the grant of European patent EP 1257168 B1.
However, the Office emphasises that it follows an extremely
cautious approach in patenting biotechnological inventions.

In motions communicated to the EPO, members of the European
Parliament have stated that, in their view, the grant of this
patent, which is entitled "Method of cryopreserving selected
sperm cells", constitutes a violation of the Directive on the
legal protection of biotechnological inventions (98/44/EC). The
MEPs maintain that the patent also covers non-patentable human
germ cells. They have therefore announced their intention to
contest the grant of this patent by initiating an opposition
procedure before the EPO. Other worries expressed in the motions
concern the future development of the EPO’s practice in patenting
human embryonic stem cells.

The President of the EPO, Alain Pompidou, has confirmed that such
a patent was granted to the US Company XY Inc. of Fort Collins,
Colorado, in February 2005, pointing out that the nine-month
period during which oppositions to the patent can be filed by
third parties will terminate on 2 November 2005: "The European
patent grant procedure allows anyone to formally oppose a patent
if they are of the opinion that it should not have been granted.
This is an inbuilt legal remedy for establishing legal certainty
on the patentability of an invention."

Opposition procedure

In view of the pending case, Mr Pompidou declined to comment on
the individual objections expressed in the motions: "We take the
concerns voiced by the MEPs very seriously. However, it will be
the task of a dedicated EPO body, the opposition division, to
consider the case in the light of the formal grounds brought
forward by opponents. To date, such a procedure could not be
opened as no oppositions have yet been filed." He added that
every year around 5% of the patents granted by the EPO are
contested in opposition proceedings. In two thirds of these
cases, the patent is changed or even revoked in its entirety.

The EPO grants patents by applying the European Patent Convention
The EPC forms the legal basis for the Office's institutional
structure and its activities and operations. It has been ratified
by the 31 member states of the European Patent Organisation
(http://www.european-patent-office.org/epo/members.htm), 24 of
which are also member states of the European Union. The EPC has
enabled the transnational protection of innovations by patents in
the European market and is seen by many countries as a model for
regional cooperation in the field of intellectual property.

Since September 1999, the EPO has applied the EU Directive in its
patenting practice. According to Mr Pompidou: "Following a
decision of our supervisory body, the Administrative Council,
this Directive has been incorporated into the EPC Implementing
Regulations. We thus strictly adhere to the provisions of the EPC
and the Biotechnology Directive."

Strict quality standards and transparency

Biotechnology is one of the technical fields in which large
numbers of patent applications are filed every year. In 2004, the
EPO received 6 581 patent applications in biotechnology and
granted some 4 000 patents. "We apply very strict standards in
examining these applications", the EPO President said. "The
provisions of the EPC and the Directive, together with the case
law of the Boards of Appeal, which are the EPO's judiciary,
demand a restrictive approach to patenting biotechnological
inventions. We are fully aware that this is a sensitive field of
technology and also has important ethical implications. However,
one should also bear in mind that obtaining a patent does not
imply permission to actually use an invention. This is the
responsibility of regulatory bodies, not of the EPO."

Inbuilt legal remedies

Mr Pompidou acknowledged that, despite all the quality controls
in place at the EPO, it is impossible to rule out the possibility
that some patents do not meet its high quality standards in all
aspects. For the current year the EPO expects to receive 190 000
patent applications. In 2004 the Office granted 60 000 patents,
each one of them after a rigorous three-step procedure involving
a comprehensive novelty search through more than 55 million
documents and a thorough examination for compliance of the
claimed invention with patent law. "The task of our 3 400 patent
examiners is extremely challenging. They work at the forefront of
technology and have to take difficult decisions within a complex
legal and ethical framework, knowing that there is always a risk
of inaccuracy. However, the European patent system takes that
risk fully into account and has inbuilt legal remedies to oppose
granted patents", the EPO President explained.

With the help of the EPO’s free patent information services such
as epoline® and esp at cenet®, it is possible for anyone to inspect
files pending before the EPO at all times: "The patent system
provides complete transparency on any case pending or granted.
Anyone who wishes to do so can monitor progress on any file at
all stages of the procedure and even send us observations without
getting legally involved in the case, and we will have to take
them to account."

Restrictive approach to human embryonic stem cells

On the question of human embryonic stem cells, President Pompidou
pointed out that the EPO has so far taken a very restrictive
approach to the patenting of human embryonic stem cells and cell
lines obtained from them. Following the "Edinburgh patent" case,
the EPO has not granted patents for such inventions. Moreover, it
has raised objections to the patentability of inventions
pertaining to human embryonic stem cells in a number of
applications that have been examined so far. The EPO's Technical
Board of Appeal is called upon to give a first decision on the
subject on 18 November. It has the option of referring the issue
to the EPO's highest instance, the Enlarged Board of Appeal, for
a definitive legal ruling.

Information for journalists:

1. European patent EP 1 257 168 B1 was granted on 2 February 2005
to XY Inc., Fort Collins, CO (USA), based on a corresponding
patent application filed with the EPO on 22 November 2002. The
title is "Method of cryopreserving selected sperm cells".

2. Implementation of Directive 98/44/EC

Directive 98/44/EC of the European Parliament and the Council on
the legal protection of biotechnological inventions was adopted
on 6 July 1998. In its decision of 16 June 1999, the
Administrative Council of the European Patent Organisation, which
supervises the activities of the EPO and is composed of
representatives of all the contracting states to the European
Patent Convention (EPC), incorporated the relevant provisions of
this Directive into European patent law. Though not legally
subject to this formal requirement, the European Patent
Organisation decided that European patent law needed to be
brought into line with the Directive, primarily in order to
comply with the requirement for uniformity in harmonised European
patent law.

3. Exclusion from patentability of inventions whose exploitation
would be contrary to ordre public or morality

The EPC expressly stipulates that the human body, at the various
stages of its formation and development, and the simple discovery
of one of its elements, including the sequence or partial
sequence of a gene, cannot constitute patentable inventions.
However, an element isolated from the human body or otherwise
produced by means of a technical process may constitute a
patentable invention, even if the structure of that element is
identical to a natural element.

Recital 16 of the Directive and the Guidelines for examination in
the EPO state that such stages in the formation or development of
the human body include germ cells. Moreover, Rule 23b(1) EPC
states that the Directive must be used as a supplementary means
of interpretation. This is intended in particular to ensure that
the recitals preceding the provisions of the Directive are also
taken into account and to promote a uniform Europe-wide
interpretation of the relevant provisions.

4. Article 53a EPC, in line with Article 6(1) of the Directive,
establishes a general principle of exclusion for inventions whose
exploitation would be contrary to ordre public or morality.
Article 6(2) of the Directive lays down an illustrative list of
exclusions from patentability which the EPO has implemented by
the introduction of Rule 23d EPC. Recital 38 of the Directive
confirms that this list is not exhaustive and that any process
whose application offends against human dignity is also excluded
from patentability. It thus follows from both the provisions of
the Directive and of the EPC that, as regards the human body and
its elements, the applicable legal framework rigorously ensures
that the human body effectively remains unavailable and
inalienable and that human dignity is thus safeguarded.

5. Patentability of human embryonic stem cells and cell lines
obtained from them

Rule 23d(c) EPC implements Article 6(2)c) of the Directive. It
stipulates that European patents may not be granted in respect of
biotechnological inventions which, in particular, concern uses of
human embryos for industrial or commercial purposes. The European
Group on Ethics considered in its opinion No. 16 that there was
no ethical reason for a complete ban on the patenting of
inventions relating to stem cells or stem cell lines, although
the normal requirements of patentability would have to be met.
The EPO's departments of first instance have a much more
restrictive practice on the patenting of human embryonic stem
cells and cell lines obtained therefrom. According to the
practice of the EPO examining and opposition divisions, Rule
23d(c) EPC excludes from patentability all claims to the
industrial or commercial use of human embryos and also all claims
to associated products which necessitate the direct and
unavoidable use of a human embryo, for example, embryonic cells.
Appeals have been filed against several first-instance decisions.
The EPO Boards of Appeal will now have to construe the wording of
Rule 23d(c) EPC themselves and form their own conclusions on what
falls within its scope. In their decisions, the members of the
Boards are not bound by any instructions and must comply only
with the provisions of the EPC.

6. Abuses and risks of a given technology

A patent is an industrial property right for an intangible asset,
the invention, which must represent a technological improvement.
The right which it accords is to prevent all others - not just
imitators but even independent devisers of the same idea - from
using the invention for the duration of the patent. A patent does
not authorise its holder to implement that invention, but merely
entitles him to prohibit third parties from exploiting it for
industrial and commercial purposes. In other words, the grant of
a patent does not confer a positive right to use the invention
without complying with all the applicable rules of the legal
system. Regardless of whether or not a patent is granted, the
inventor has to respect all legal provisions that might possibly
prohibit the working or marketing of the subject-matter of his
invention. Patent law is thus not a suitable tool for preventing
any abuses or risks associated with a given technology. It cannot
serve to replace or render superfluous national, European or
international law which may impose restrictions or prohibitions
or which concerns the monitoring of research and of the use or
commercialisation of its results, notably from the point of view
of the requirements of public health, safety, environmental
protection, animal welfare, the preservation of genetic diversity
and compliance with certain ethical standards.

7. Transparency

The practice of the European Patent Office adheres strictly to
the legal principles and high standards laid down by the European
Patent Convention. The EPO provides for a maximum of transparency
and information on its activities. Patent applications are
published 18 months after filing or after the priority date. Once
a European patent application has been published, the file
relating to it is open to inspection. This means that any member
of the public can view the communications between the Office, its
first and second-instance departments and the parties involved in
the procedure. Such file inspections can be made online and are
free of charge. Furthermore, all European patent applications and
patents can be accessed on the Internet at www.espacenet.com,
while any legal and procedural status information can be obtained
from the EPO’s epoline® server at www.epoline.org free of charge.
Procedural information on any patent can be retrieved from the
Online European Patent Register.

European patent law also provides for a highly developed system
of legal remedies. Any person may present observations concerning
the patentability of the invention in respect of which the
application has been filed. In addition, any third party can file
an opposition to a granted patent, without having to prove a
direct interest in the case. The possibility of appeal exists
both against the decisions of the examining and opposition
divisions. Furthermore, proceedings to revoke the patent, even if
its validity has been upheld in opposition proceedings and/or
subsequent appeal proceedings, can be instituted in any
designated contracting state.

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