Questionnaire on the patent system in Europe
Novo Nordisk is a research based Danish healthcare company with a strong commitment within diabetes care. We file a considerable number of European patent applications per year. Furthermore the European market is important to us. Thus the patent system in Europe is of high importance to our company and we welcome this opportunity to respond to the questionnaire from the European Commission.
Please find our comments enclosed.
Yours sincerely,
Anne Secher
Senior Patent Counsel
Novo Nordisk is a healthcare company and a world leader in diabetes care. The company has the broadest diabetes product portfolio in the industry, including the most advanced products within the area of insulin delivery systems. In addition, Novo Nordisk has a leading position within areas such as haemostasis management, growth hormone therapy and hormone replacement therapy. Novo Nordisk manufactures and markets pharmaceutical products and services that make a significant difference to patients, the medical profession and society. With headquarters in Denmark, Novo Nordisk employs more than 22,000 employees in 79 countries, and markets its products in 179 countries.
Response to the questions raised by the Commission
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?
We agree with these statements. A transparent, effective and credible patent system ensuring the grant of high quality patents is necessary in order to encourage innovation and promote competitiveness in Europe compared to e.g. the US and Japan.
The legal system should operate in a cost efficient way and should be flexible. Predictability and speed are important elements in dispute resolution. However, achieving this should never be at the expense of quality.
As a general matter, the patent system should be framed so as to promote innovation and dissemination of knowledge.The patent system is a vehicle to promote innovation, not other policy objectives. Public policy issues are difficult to incorporate in patent legislation and should preferably be dealt with in other legislation. This applies in particular to ethical issues. Our company is of the opinion that ethical issues have been adequately dealt with by e.g. the “order public” provision. The purpose of the patent system is to promote competition and innovation, also in the field of environment and healthcare.
The purpose of the patent system was never to promote political correctiveness.
Existing law already provides an appropriate balance between the interest of the industry (the main stakeholders) and the society.
1.2 Are there other features that you consider important?
We finds it very important that the patent system offers users flexibility and choice. National patents and the EP patent should continue to coexist even if a community patent is eventually introduced.
The costs of validating EP patents should be reduced e.g. by not requiring translations into national languages. With 25 countries now as members of EU the translation costs will be rather significant.
Our company consider the London Protocol as a step in the right direction and strongly urge the Commission to have this protocol introduced as soon as possible.
Our company language is English and English is the far most used language within science. In particular within medicineEnglish is the predominant language. Thus, from the pharmaceutical industry’s point of view a single language (English) system will be the most attractive and cost effective system.
High quality of both the grant and enforcement process is very important. If granted patents in general meet the substantive requirements of patentability the presumption of validity will be maximised reducing the need for, and cost of, litigation on validity issues. Furthermore, the confidence in and the effectiveness of the litigation system will be improved. Again, attempts to reduce the cost litigation should be at the expense of the quality.
A unitary patent litigation system should be established in the form of a specialist court with judges who are qualified within patent law assisted by technical experts within specific fields (who are also preferably conversant with patent law).
However, also in the case of legal disputes a freedom of choice as to the forum for applying for and enforcing patents is important. Patentees should not be forced to litigate in only one system. Therefore, national courts should continue to have jurisdiction of e.g. national patents.
1.3 How can the Community better take into account the broader public interest in developing its policy on patents?
We should explain that the present patent system already takes into account the broader public interest. Efforts should be focused on developing an excellent system with high quality patents and a reliable and cost efficient court system. This would enhance society’s trust into the system.
We should also make it clear that the present system already takes prevention of misuse of patents into account, e.g. through the option to get a compulsory license to patents not being commercially exploited.
Section 2 – The Community patent as a priority for the EU
The creation of a Community patent is an important initiative in the IPR field for the pharmaceutical industry. The community patent system should meet the industry’s need for a patent system being cost efficient and providing legal certainty and it should be an improvement of the present which, apart from costs issue, is a rather well functioning system (EPC). Otherwise there is no reason to develop a new system. However, the common political approach is unacceptable and definitely not an improvement in relation to EPC in particular from a cost point of view.
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?
We have been supportive of the original three language Community patent proposal made by the Commission. However, it should be emphasized,as mentioned above, that a single language (English) community patent optionally with translation of claims in case of a dispute is still the most agreeable solution to the pharmaceutical industry. The common political approach adopted by the Council would make little difference to the EP patent system. The common political approach is in particular unattractive both in terms of cost and legal certainty. Translations into all languages add substantive costs to the applicants. Furthermore, legal uncertainty is generated because of uncertainties as to what constitutes the authentic text. If translations are required they should have no legal effect.
A reliable jurisdictional system for Community patent litigation should include the following:
- Judges and parties of different nationalities should be allowed to communicate directly without requiring unrealistic language skills among judges or extensive translations. The language of proceedings for a European patent court should be the language of the litigated European patent or preferably English only.
- All judges both in first and in second instance should be experienced and specialised patent judges, in order to ensure a reliable and timely litigation. In the case of complex technical matters technical experts should be available to the court.
Section 3 – The European Patent System and in particular the European Patent Litigation Agreement
Wesupport the EPLA, as an optional system, and urge the Commission to put its efforts and resources into achieving this as quickly as possible.
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?
Pros:
- A common court system should harmonise praxis leading to greater legal certainty
- Costs of litigation before one court instead of 25 courts should be substantial lower
- Depending on the composition of the court we may see better quality decisions
- More efficient and fast procedure
Cons:
- “All or noting” - You either win or loss a case for the entire EU. With the present system you may win in some countries even though you may loss in others.
- The system is highly dependent on highly qualified judges
3.2Given 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?
It is important that the system is flexible. Thus a centralized EU patent court as discussed earlier should coexist with national courts.
Section 4 – Approximation and mutual recognition of national patents
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?
It is a potential problem that the individual EU countries implement the EPC, EU directives and EU regulations in a non uniform way into national patent law. One example is the implementation of the Biodirective into national patent law. Another very recent example is implementing of directive 2001/83/EUre human pharmaceuticals into national patent law.
Non uniform interpretation of patent clauses, e. g. the experimental use exemption clause in national patent law and the protection awarded for the product of a patented process (indirect product protection) may also give rise to distortion of competition.
Finally, the lack of a uniform patent litigation system may lead to distortion of competition.
4.2.To what extent is your business affected by such differences?
Our company may certainly be affected by such differences. The divergent interpretation of what falls under the experimental use exemption definition is one example. Furthermore, the non uniform implementation of various directives may have an impact on our business operation. Patenting subject matter within biotechnology is not uniformed defined in the European landscape and at present we have at least two versions of the so called “bolar” provision. This may certainly have an impact on e.g. were to place research centres between the individual European countries and were to conduct clinical trials.
4.3.What are your views on the value-added and feasibility of the different options (1) – (3) outlined?
(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.
(1) We see no need for bringing the main patentability criteria into Community law. Introduction of EPLA will eventually ensure uniformity in legal decisions.
(2) We see no need for such activities.
We are is strongly against this proposal. A number of European countries grant national patent without substantive examination. Other countries have a substantial patent examination. It is unrealistic to believe that the quality of examination at all national patent offices could be brought up to a uniform standard.
4.4. Arethere any alternative proposals that the Commissionmight consider?
No.
Section 5 – General
On a scale of one to ten (10 is crucial, 1 is negligible) :
5.1.How important is the patent system in Europe compared to other areas of legislation affecting your business?
The Patent system is very important to our company. However, other legislation may also be important, e.g. the approval system for new medicines and the data protection.
5.2Compared 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?
Patents are the most important type of IPR for our company.
5.3.How important to you is the patent system in Europe compared to the patent system worldwide?
As an international company being present in more than 100 countries all patent systems in the major markets such as the US, Japan, Europe, India and Chinaare important. The importance of one country’s or region’s patent system over another depends on the individual products and market share and competition. However, there is no doubt that the patent system in Europe is extremely important to our company
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?
5.5Are there other issues than those in this paper you feel the Commission should address in relation to the patent system?
Try to create an understanding among EU politicians that the patent system is essential to support innovation and development within technology areas with high growth potential to support the competiveness of EU in a globalized world.
Furthermore, it is important to develop a system which is coherent and easily understood by all the stakeholders.
(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?
As an individual company
(b)The name of your organisation/contact person: Novo Nordisk( Anne Secher)
(c)Your email address:
(d)Your postal address: Novo Alle, 2880 Bagsvaerd, Denmark
(e)Your organisation’s website (if available):novonordisk.com.
(1)Please help us understand the range of stakeholders by providing the following information:
(a)In which MemberState do you reside / are your activities principally located?
Denmark
(b)Are you involved in cross-border activity? Yes
(c)If you are a company: how many employees do you have? 22000
(d)What is your area of activity? Pharmaceuticals
(e)Do you own any patents?
–Yes
(f)If yes, how many? More than 2400
(2)Are they national / European patents? both
(a)Do you license your patents? yes
(b)Are you a patent licensee? yes
(c)Have you been involved in a patent dispute? yes
(d)Do you have any other experience with the patent system in Europe?
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