UCB naire by celeste.bertha


									                   EUROPEAN COMMISSION
                   Internal Market and Services DG

                   Knowledge-based Economy
                   Industrial property

                                                      Brussels, March 29, 2006

                      REPLY BY UCB S.A., BRUSSELS, BELGIUM

Our replies appear in green in the text of the Questionnaire.


                               On the patent system in Europe

The field of intellectual property rights has been identified as one of the seven cross-sectoral
initiatives for the Union's new industrial policy as set out in the Commission Communication
launched on 5 October 2005. Stimulating growth and innovation means improving the
framework conditions for industry, which include an effective IPR system.

In 1997, the Commission launched the idea of a Community Patent in its Green Paper on
promoting innovation. This was taken up by Heads of State and Government in the
conclusions of the Lisbon European Council of March 2000, who called for a Community
patent to be available by the end of 2001. The Community Patent proposal, establishing a
unitary system of patent protection for the single market, has formally been on the table of the
Council since 2000 but overall agreement is yet to be achieved. The Commission remains
convinced that an affordable Community Patent would offer the greatest advantages for
business: we owe it to industry, investors and researchers to have an effective patent regime in
the EU. Commissioner McCreevy has stated his intention to make one final effort to have the
proposal adopted during his mandate. Until the time and conditions are ripe for that effort,
the interim period should be used to seek views of stakeholders on en effective IPR system in
the EU.

Views are therefore sought on the patent system in Europe, and what changes if any are
needed to improve innovation and competitiveness, growth and employment in the
knowledge-based economy.

Please note that this consultation focuses on the overall legal framework. Accompanying
measures, such as information, awareness raising or support training, are outside the scope of

The document that follows contains a number of questions: In answering them we would
invite you to be as detailed as you can. Supporting evidence and statistics are also welcome.
On the basis of the feedback the Commission intends to organise a hearing in Brussels in
early summer 2006.

This consultation is open to all, and will be closed on 31 March 2006.

The Commission services will publish a report on the outcome of this consultation. It will be
available on the Internal Market and Services Directorate's General website.

Please either email us at:
Or send your response by post to:
Mr Erik Nooteboom
Head of Unit
Industrial Property Unit
Internal Market and Services Directorate General
European Commission
1049 Brussels

Please be sure to indicate if you do not consent to the publication of your personal data or
data relating to your organisation with the publication of your response.
The contact data provided by the stakeholder make it possible to contact the stakeholder to
request a clarification if necessary on the information supplied.
By responding to this consultation you automatically give permission to the Commission to
publish your contribution unless your opposition to publish your contribution is explicitly
stated in your reply. The Commission is committed to user privacy and details on the personal
data protection policy can be accessed at:

For further information please contact Ms Grazyna PIESIEWICZ at
grazyna.piesiewicz@cec.eu.int or at +
            Section 1 - Basic principles and features of the patent system

The idea behind the patent system is that it should be used by businesses and research
organisations to support innovation, growth and quality of life for the benefit of all in society.
Essentially the temporary rights conferred by a patent allow a company a breathing-space in
the market to recoup investment in the research and development which led to the patented
invention. It also allows research organisations having no exploitation activities to derive
benefits from the results of their R&D activities. But for the patent system to be attractive to
its users and for the patent system to retain the support of all sections of society it needs to
have the following features:

      –            clear substantive rules on what can and cannot be covered by patents,
               balancing the interests of the right holders with the overall objectives of the
               patent system

      –           transparent, cost effective and accessible processes for obtaining a patent

      –            predictable, rapid and inexpensive resolution of disputes between right
               holders and other parties

      –            due regard for other public policy interests such as competition (anti-trust),
               ethics, environment, healthcare, access to information, so as to be effective and
               credible within society.

1.1        Do you agree that these are the basic features required of the patent system?

          The first three listed features are key to a well-functioning patent system. For
          innovation and competitiveness to survive and prosper in Europe, an effective and
          trustworthy patent system is essential.

          The current patent system in Europe, particularly as governed by the European Patent
          Convention (EPC) and administered by the European Patent Office (EPO), reflects to
          a great extent the above-mentioned features and has functioned most successfully for
          nigh on thirty years in relatively peaceful co-existence with National Patents filed
          under National Patent Laws offering those seeking patent protection a choice.
          Nevertheless there is still room for improvement, particulary in terms of costs and
          legal certainty in the grant and enforcement process which will in turn help to ensure
          the continued viability of the present system..

          Whilst it is clear that the patent system must be sensitive to public policy issues it is
          not the vehicle by which these should be regulated. Patent systems in one form or
          another have been in place for centuries with the goal of encouraging the fruits of
          intellectual and scientific creativity to be made available for the benefit of society at
          large by providing incentives for inventors to disclose their ideas and thus to promote
          innovation. Continually adapting the patent system to deal with constantly shifting
          public policy interests not related to that goal risks undermining its effectiveness.

          In its present form, the patent system is already flexible enough to accommodate those
          issues which are more fundamental to society by including such provisions as the
          “ordre public” and research exemptions of patent law.
1.2    Are there other features that you consider important?

      High and consistent quality in both the grant and enforcement processes are
      fundamental. A high quality grant procedure – both in terms of process and substance
      – is needed to ensure that patents are only granted on inventions which “deserve” them
      i.e. which meet the substantive requirements of patentability. Quality of grant will
      ensure a robust presumption of validity and create a secure environment for companies
      such as ours (patent holders and others) to conduct our business, be it directly or
      through licensing. It will also reduce the need for, and cost of, litigation on validity
      issues and the likelihood of conflicts between decisions of the granting instances and
      the courts, thus maximising business certainty.

      The quality and, above all, consistency of the judicial system is vital for similar

      Given the enormous resources that are invested in developing patented inventions by
      companies such as UCB, quality of grant and enforcement must not be sacrificed for
      other interests. Although there are certain concerns about the cost of enforcing patents
      in certain European jusrisdictions, these concerns should be dealt with by means
      which do not sacrifice quality.

      Finally, freedom of choice as to the forum for applying for and enforcing patents is

1.3    How can the Community better take into account the broader public interest in
       developing its policy on patents?

      Regular, in depth consultation and dialogue with all stakeholders is of prime
      importance in developing a policy which will find broad acceptance and support. It is
      however essential that the views received, which in some cases will be driven by
      ideologies or special interests inimical to the fundamental premises of the patent
      system, are evaluated in an informed and objective way by the Commission in order to
      arrive at a policy which truly does promote innovation to the good of society.

      It is an unfortunate fact that recent attempts to improve the patent system in Europe by
      taking into account more recent technological advances such as Biotechnology or
      Computer Implemented Inventions have failed or been diluted for political reasons
      which have little if anything to do with the patent system and its role in fostering
       Section 2 – The Community patent as a priority for the EU
The Commission's proposals for a Community patent have been on the table since 2000 and
reached an important milestone with the adoption of the Council's common political approach
in March 2003 [http://register.consilium.eu.int/pdf/en/03/st07/st07159en03.pdf; see also
costs_en.pdf]. The disagreement over the precise legal effect of translations is one reason why
final agreement on the Community patent regulation has not yet been achieved. The
Community patent delivers value-added for European industry as part of the Lisbon agenda. It
offers a unitary, affordable and competitive patent and greater legal certainty through a
unified Community jurisdiction. It also contributes to a stronger EU position in external fora
and would provide for Community accession to the European Patent Convention (EPC).
Calculations based on the common political approach suggest a Community patent would be
available for the whole of the EU at about the same cost as patent protection under the
existing European Patent system for only five states.


2.1 By comparison with the common political approach, are there any alternative or additional
    features that you believe an effective Community patent system should offer?

   To be effective a Community patent system must satisfy the demands of its many intended
   users in terms of quality, cost-effectiveness and legal certainty.

   A Community Patent (CP) must have effective unitary character for the whole EU
   territory. It must be affordable but at the same time of high quality, and should, where
   appropriate, make use of and coexist with the present European patent system. The CP
   should lead to legal certainty and high quality decisions on both infringement and validity
   matters by means of an appropriate court system.

   Whilst the original Commission proposal was a significant step towards achieving these
   goals, later proposals for amendment, particularly as to the langauage of enforcement
   proceedings undid the good work.

   Furthermore the affordability of the Community Patent was brought into serious question
   by the March 2003 agreement, which would have introduced an obligation on the
   applicant at the time of the grant of the patent, to file translations of the claims in all
   official Community languages. There was no objectively justifiable need for this and its
   value to users is obscure.

   UCB would favour an English-only approach for the language arrangements under a CP
   although the non-obligatory use of French or German to cover a majority of speakers and
   litigators in the EU could also be considered

   Even more disturbingly however, the March 2003 agreement seriously undermined the
   unitary character of the CP by proposing to give legal effect to the claim translations.

   In our opinion a reliable jurisdictional system for the litigation of CP’s must fulfill the
   following minimum standards:
          Judges in both first and second instance who have solid experience as specialised
           patent judges preferably with a tchnical background. The evaluation of both
           technical facts and law is central for patent litigation. Therefore, it is also crucial
           that the judges understand presentations of complex technical matters and that
           procedures allow for this in a way that ensures reliable and speedy litigation.

          A language regime that allows judges and parties of different nationalities to
           communicate directly without requiring unrealistic language skills and/or
           extensive translations. An appropriate regime for such a CP court would be at very
           least the language of the litigated patent or, preferably, English only.

          Simple, transparent, understandable procedural rules that are effective.

          Consistency with other European judicial systems.

The common political approach of 2003 fails to achieve these goals.
Section 3 – The European Patent System
and in particular the European Patent Litigation Agreement
Since 1999, States party to the European Patent Convention (EPC), including States which are
members of the EU, have been working on an agreement on the litigation of European patents
(EPLA). The EPLA would be an optional litigation system common to those EPC States that
choose to adhere to it.

The EPLA would set up a European Patent Court which would have jurisdiction over the
validity and infringements of European patents (including actions for a declaration of non-
infringement, actions or counterclaims for revocation, and actions for damages or
compensation derived from the provisional protection conferred by a published European
patent application). National courts would retain jurisdiction to order provisional and
protective measures, and in respect of the provisional seizure of goods as security. For more
information see [http://www.european-patent-office.org/epo/epla/pdf/agreement_draft.pdf]

Some of the states party to the EPC have also been tackling the patent cost issues through the
London Protocol which would simplify the existing language requirements for participating
states. It is an important project that would render the European patent more attractive.
The European Community is not a party to the European Patent Convention. However there is
Community law which covers some of the same areas as the draft Litigation Agreement,
particularly the "Brussels" Regulation on Recognition and Enforcement of Judgments
(Council Regulation no 44/2001) and the Directive on enforcement of intellectual property
rights through civil procedures (Directive 2004/48/EC). [http://europa.eu.int/eur-
lex/pri/en/oj/dat/2004/l_195/l_19520040602en00160025.pdf] It appears that there are three
issues to be addressed before EU Member States may become party to the draft Litigation
(1)    the text of the Agreement has to be brought into line with the Community legislation
       in this field

(2)    the relationship with the EC Court of Justice must be clarified

(3)    the question of the grant of a negotiating mandate to the Commission by the Council
       of the EU in order to take part in negotiations on the Agreement, with a view to its
       possible conclusion by the Community and its Member States, needs to be addressed.
3.1    What advantages and disadvantages do you think that pan-European litigation
        arrangements as set out in the draft EPLA would have for those who use and are
        affected by patents?

UCB is fundamentally in favour of a common litigation system including common rules of
procedure and a common court of appeal, for litigating infringement and validity disputes
with respect to European Patents as a means of achieving consistent and efficient enforcement

Currently, patent disputes in Europe are being handled differently in each country in terms of
procedures and evidence. This tends to lead to more litigation, higher costs, increased
likelihood of conflicting decisions on the same subject-matter in different countries and thus
higher legal uncertainty.
We need a judicial system that employs simple, transparent procedures, is affordable and
ensures legal certainty and consistency. The intent of EPLA is designed to bring to the
European patent system enhaced legal certainty while avoiding the potentially harmful effects
of divergent national proceedings as referred to above.

We would however urge the Commission to balance carefully and objectively the benefits and
risks of EPLA as presently proposed.

Although there are discrepancies in decisions as between jusrisdictions, in practice, a
company such as UCB would most likely litigate in a single country which is of key
importance to us and where we would expect to get a sound decision in a reasonable time
frame and at a affordable cost. Germany, France or possibly the UK spring to mind and we
would most likely take that decision, once rendered, into account in our dealings in other

The idea of an overarching, reliable system is attractive but the ability of EPLA to deliver its
promise from the outset is a leap of faith rather than a sure thing. Patents are an essential
business asset to research-based biopharmaceutical companies such as UCB as they represent
one of the most important means of protecting, and thus incentivising, enormous amounts of
high risk investment. We would not like to be forced into the position of putting those assets
at risk in an untested enforcement system.

A system such as EPLA should therefore, at least initially, permit the patentee at the time of
enforcement to have the choice of using the centralised system or the national route. Initiation
of nullity and declaratory judgement proceedings in the centralised court must only be
possible with the consent of the patentee.

Alternatively and similarly to the Court of Appeals of the Federal Circuit (CAFC) in the U.S.,
the EPLA court would be the mandatory second instance

3.2     Given the possible coexistence of three patent systems in Europe (the national, the
        Community and the European patent), what in your view would be the ideal patent
        litigation scheme in Europe?

Depending on the product, we can be and are faced with both national and multinational, in
some cases EU-wide, conflicts relating to our European Patents. In many cases the potential
exists for litigation to be directed against different defendants in different countries relating to
different products.

For these reasons and those mentioned above, we may wish to seek resolution in a national
court or, if such a day ever dawns, in a centralised court and should retain the option to

As discussed above a common judicial system acceptable to our industry would include a
workable language regime and experienced patent judges in both instances, including
technically trained judges. To be appropriate, the language regime must require neither
extensive translations nor unrealistic linguistic abilities on the part of judges.
      Section 4 –Approximation and mutual recognition of national patents
The proposed regulation on the Community patent is based on Article 308 of the EC Treaty,
which requires consultation of the European Parliament and unanimity in the Council. It has
been suggested that the substantive patent system might be improved through an
approximation (harmonisation) instrument based on Article 95, which involves the Council
and the European Parliament in the co-decision procedure with the Council acting by
qualified majority. One or more of the following approaches, some of them suggested by
members of the European Parliament, might be considered:
(1)     Bringing the main patentability criteria of the European Patent Convention into
        Community law so that national courts can refer questions of interpretation to the
        European Court of Justice. This could include the general criteria of novelty, inventive
        step and industrial applicability, together with exceptions for particular subject matter
        and specific sectoral rules where these add value.

(2)     More limited harmonisation picking up issues which are not specifically covered by
        the European Patent Convention.

(3)     Mutual recognition by patent offices of patents granted by another EU Member State,
        possibly linked to an agreed quality standards framework, or "validation" by the
        European Patent Office, and provided the patent document is available in the original
        language and another language commonly used in business.
To make the case for approximation and use of Article 95, there needs to be evidence of an
economic impact arising from differences in national laws or practice, which lead to barriers
in the free movement of goods or services between states or distortions of competition.


4.1      What aspects of patent law do you feel give rise to barriers to free movement or
         distortion of competition because of differences in law or its application in practice
         between Member States?

Apart from some of the inconsistencies in decisions and the opportunity for “forum shopping”
which this creates, we feel that substantive patent laws as such are well enough harmonised
across the EU as not to give rise to de facto trade barriers or to distort competition.

4.2      To what extent is your business affected by such differences?

Very little except for a few lingering differences such as reservations on compound per se
claims in countries such as Spain which will however no longer apply going forward.

4.3      What are your views on the value-added and feasibility of the different options (1) –
         (3) outlined above?

All three Options leave much to be desired and would presumably only be fallbacks if the
present initiatives were to fail. As such we believe they should best be left out of the present
discussion in order not to start down the road already contemplating defeat.

Option 1
This is least undesirable but in its present form the ECJ is not equipped to deal with questions
of patent law of the type mentioned. This would require creation of a special chamber with
esperienced judges which brings us back to a CP court or EPLA.

Option 2

To the extent that further harmonisation is needed (see above) this could be achieved under
the European Patent Convention through the European Patent Organisation. The two most
recent attempts to harmonise patent laws with respect to Biotech- and Computer Implemented
Inventions illustrate well the pitfalls of such an undertaking.

Option 3

Mutual recognition of national patents is neither viable nor desirable in view of vast
differences in the qualifications in national patent offices (there are Member States such as
our own, Belgium, where national patent offices never have conducted a material examination
on patentability). Mutual recognition would inevitably work to the detriment of the quality
standards so diligently achieved by the EPO under the EPC.

4.4     Are there any alternative proposals that the Commission might consider?

Passing an act which makes patents granted under the EPC effective in all member states
without the need for validation or translation. The issue of the creation of a suitable judiciary
could then be dealt wuith separately e.g. via an EPLA-like arrangement.
                                     Section 5 – General
We would appreciate your views on the general importance of the patent system to you.
On a scale of one to ten (10 is crucial, 1 is negligible):

As a general proposition, we see little value in assigning numerical value comparators to these

5.1     How important is the patent system in Europe compared to other areas of legislation
        affecting your business?

It is vital to protecting the fruits of our innovative efforts and for securing a fair return on our
investment in reasearch (25% of net sales in 2005!). We are heavily regulated and other
regulations are of very great significance to us as well. These are hurdles which we have to
take in the interests of patient safety, affordable health care and other considerations but
without the protection offfered by the patent system we would not have the wherewithal to do

5.2 Compared to the other areas of intellectual property such as trade marks, designs, plant
    variety rights, copyright and related rights, how important is the patent system in Europe?

All are important in providing protection. We note however that many of these are already
regulated in a pan-European way.

5.3 How important to you is the patent system in Europe compared to the patent system

Together with the U.S. the EU represents the second key market for us and is our home
market. The European patent system is therefore vital. However, for a global industry
working in an environment where competition from elsewhere is very significant, strong
patent systems in other countries are also of great importance and Europe can and should lead
by example.

5.4 If you are responding as an SME, how do you make use of patents now and how do you
    expect to use them in future? What problems have you encountered using the existing
    patent system?

Not applicable

5.5      Are there other issues than those in this paper you feel the Commission should
         address in relation to the patent system?

(1)   If you would like the Commission to be able to contact you to clarify your comments,
      please enter your contact details.

      (a)    Are you replying as a citizen / individual or on behalf of an organisation?
      On behalf of an organisation.
      (b)    The name of your organisation/contact person:

      UCB S.A./Allen Norris VP, Head Group IP

      (c)    Your email address: allen.norris@ucb-group.com

      (d)    Your postal address: Allée de la Recherche 60, 1070 Brussels, Belgium

      (e)    Your organisation’s website (if available): www.ucb-group.com

(2)   Please help us understand the range of stakeholders by providing the following

      (a)    In which Member State do you reside / are your activities principally located?

      Belgium/We are active in all member states with affiliates in major countries such as
      Germany, France, UK, Italy, Spain

      (b)    Are you involved in cross-border activity?


      (c)    If you are a company: how many employees do you have?

      About 8,500

      (d)    What is your area of activity?

      We are a leading Biopharmaceutical company

      (e)    Do you own any patents? If yes, how many? Are they national / European

      We own well in excess of 500 patent families the European branches of which are
      predominantly filed under the EPC.

      (f)    Do you license your patents?

      Sometimes, if it makes sound business sense.

      (g)    Are you a patent licensee?

       (h)     Have you been involved in a patent dispute?

       Yes, more than one

       (i)     Do you have any other experience with the patent system in Europe?

       Yes. Oppositions, third party observations and other interactions with the EPO through
       industry organisations.

Please either email us at:
Or send your response by post to:
Mr Erik Nooteboom
Head of Unit
Industrial Property Unit
Internal Market and Services Directorate General
European Commission
1049 Brussels

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