INTRODUCTION

The exclusion from patentability on the ground of immorality specified in Article 53(a) of the European Patent Convention (EPC) and in Article 6(1) of Directive 98/44/EC on the Legal Protection of Biotechnological Inventions (Biotechnology Directive) has proved highly controversial. While, for example, UK trademark law excludes the registration of marks that are contrary to public policy or to accepted principles of morality (s. 3(3)(a) Trade Mark Act 1994), copyright law generally has no explicit immorality exclusions. However, we argue that commitment to human rights as conceived in the United Nations Declaration of Human Rights 1948 (UDHR) constitutes a commitment to the existence of morality conceived of as a system of practical rules governed by a categorical impartial imperative, the principle of generic consistency (PGC) of the American moral philosopher Alan Gewirth:

Thought of as the categorical imperative, the PGC is a principle with which all actions and rules for action must be consistent unconditionally, with the implication that no rules or actions inconsistent with the PGC may be regarded as valid by any legal system that professes adherence to human rights per the conception thereof in the UDHR.

This chapter has five main sections. In the first (section II), we discuss the concept of morality and provide reasons to focus on the conception of it as consisting of rules governed by a categorical impartial imperative in any system of rules that recognises that there are human rights per the UDHR. In section III, we briefly outline Gewirth’s argument for the PGC being the categorical imperative, and argue that, whether or not Gewirth’s argument is valid, the PGC must be taken to be the supreme principle of any system of rules built around the idea that there are human rights per the UDHR. In section IV, we explain the implications of this for the relationship between law and morality in any legal system that professes adherence to human rights per the UDHR.

A.1. CASE

Assume that your country has accepted GM food: the company CaMon is marketing seeds of a tomato plant that looks fresh on the shelf for longer than others. This feature of the tomato has been patented. Paul, a farmer of vegetables and legumes, is looking for better marketing opportunities. He heard about this plant and hopes to win more customers by expanding his distribution system. It seems that the new tomato plant has the potential to be a building block for his new strategy. He buys the seed – enough to plant 100 acres. However, the delivery of the seed is accompanied by a licence contract that obliges him to sell the whole harvest to a big food processing company (FPC), located 700 km away. Any violation will give rise to contractual penalties.

Paul ignores the licence and sells the harvested tomatoes to regional customers. In September, he receives a letter from CaMon reminding him only to sell to FPC and announcing a lawsuit. Since Paul pursues his own marketing strategies, they meet in court one year later.

Is CaMon entitled to contractual penalties?

A.2. COUNTRY REPORTS

(1) BELGIUM

I. Operative Rules

In case of breach of contract, CaMon would, in theory, be entitled to the agreed contractual penalties. However, some difficulties arise in this case.

We may ask whether Paul can be deemed to have consented to the licence contract. If not, the contract is not valid.

The contract clause containing the penalties might be invalid. Real penalty clauses, with the objective of private punishment instead of compensation for potential damages, are invalid.

The penalty clause could be invalid from a competition law perspective. Although the validity of the contract depends on the detailed circumstances, it seems probable in the present case that CaMon would not be entitled to the contractual penalties.

II. Descriptive Formants

• – Article 16 Regulation (EC) No. 2100/94 on Community plant variety rights;

• – Article 10 Biotechnology Directive 98/44/EC;

• – Article 27quater BPA (Art. XI.32 BCEL);

• – Article 21 Belgian Plant Variety Protection Act (the Belgian Plant Variety Protection Act of 1975 was replaced by the Plant Variety Protection Act on 10 January 2011, the latter implementing the UPOV Convention of 19 March 1991.

A.1. CASE

Dr Grey, the director of a private research institution, undertakes research projects with a variety of sponsors. She receives a licence for 100 EMC rats from White Corp. for a research project headed by her employee, Dr Black. The licence obliges the institute only to use the rat model in the identified experiment conducted by Dr Black. The use of the rat model in experiments sponsored by White’s competitor, Yellow Corp., is expressly forbidden.

Two years later, Dr Black is entrusted with an in-house research project sponsored by Yellow Corp. He continues using the rat model EMC 4 and patents his results.

Does White Corp. have a right to a share in profits as damages on the basis of breach of contract.

A.2. EDITORIAL NOTE ON THE EUROPEAN FRAMEWORK

The EU competition law framework is set by the Research and Development Block Exemption Regulation (Regulation (EU) No. 1217/2010) and the Technology Transfer Regulation (EC) No. 772/2004 (now Regulation (EU) No. 316/2014). In addition, Article 13 Directive 2004/48/EC (issued after the cases were designed in 2000) may play a role. Accordingly, courts can set damages by looking at different aspects like negative economic consequences, lost profits and unfair profits made by the infringer or, as an alternative, may set a lump sum on the basis of the royalties that would have been paid in the case of a valid licensing agreement between the parties (Art. 13(a) and (b) Directive 2004/48/EC). If the infringer did not knowingly, or with reasonable grounds to know, infringe the IP, member states may allow the courts to decide the recovery of profits (Art. 13(2)). Yet Case 12 asks for a share of profits based on the violation of a contract. Thus, Directive 2004/48/EC was not directly applicable, but may influence the reasoning.

A.3. COUNTRY REPORTS

(1) BELGIUM

I. Operative Rules

No, White Corp. does not have a right to a share in the profits as damages on the basis of breach of contract since the contract clause at stake will probably be invalid.

A.1. BASE CASE

Marc has a unique gene that makes him immune to a specific, but widespread, influenza virus. The Pharmaceutical Company (PhC) screens his genome. As a result of this information, PhC develops a (patented) vaccine against this type of influenza.

Is Marc entitled to veto research on the gene? Does he have a maiore ad minus the right not to give consent to experiments that he considers unethical? Could he object to commercial research and restrict the use to ‘academic research’?

A.2. EDITORIAL NOTE ON THE GDPR

When the case was draft ed and answered, the EC Directive 95/46/EC on Personal Data Protection was still in place, which has since been repealed by the General Data Protection Regulation (EU) No. 2016/679. This Regulation has strengthened patients’ rights to medical data. This subsequent fundamental change has to be kept in mind. Reports could not be updated.

The case was conceptualised after the Oviedo Convention on Human Rights and Biomedicine (1997), negotiated by the Council of Europe, came into force under public international law (1999) after five ratifications (Denmark, Slovakia, Slovenia, San Marino and Greece), and prior to Directive 2004/23/EC, Directive 2006/17/EC, and Directive 2006/86/EC. Depending on when the reports were submitted, transposing national regulations are reported or not.

A.3. COUNTRY REPORTS

(1) BELGIUM

I. Operative Rules

Due to the requirement of a prior informed consent and due to the revocability of it, we believe Marc:

• 1. would be entitled to veto research on the gene;

• 2. has the right not to give consent to experiments that he considers unethical; and

• 3. could object to commercial research and restrict the use to academic research.

CASE 1. ERICA’s IMPROVED BEER MARKET SOFTWARE

A.1. BASE CASE

Frank heads a major beer producing company. In the 1970s, he developed a computer programme which analyses regional patterns of beer distribution and beer consumption. Since then, he has constantly refined the programme and has freely distributed the programme to his traders, trade associations and market analysts. Over time, the programme became the standard instrument to analyse the beer market. Without using it, one cannot be active on this market. Therefore Erica, a former trader of Frank’s products and now director of a major competitor of Frank, started to model her own distribution system on Frank’s system. Does Frank have a right to an injunction arguing that the computer programme is his?

B.1. CASE MODIFICATION

Frank does license the programme to Erica under the obligation not to improve it and not to market the programme without his permission. Can Frank claim an injunction if Erica improves the programme and markets it without Frank’s prior consent?

CASE 2. MEDICAL RESEARCH (PUBLIC HEALTH – MODELLED ON BRCA1/2 AND CCR5)

A.1. CASE

Mary, owner of a small biotech company, was granted a patent on the gene BRAU-7. As a utility, the patent accounts for cardiovascular diseases. Five years after the patent was granted, her competitor John found out that the gene BRAU-7, in conjunction with the gene BLIB-5, is responsible for healing wounds.

The proportional relationship to which each gene accounts for the healing process is scientifically unclear. John is also granted a patent on his invention. He sets up a business and starts producing an ointment.

Does Mary have a claim for injunction against John?

CASE 3. CULTURE – THIRD PARTY ACCESS (MODELLED ON P2P FILE-SHARING)

A.1. BASE CASE

Carla, a 15-year-old teenager, downloads and uploads songs from the Internet and exchanges CDs with her girlfriend Karen. She is now sued by the record company ‘string’.

Will an injunction be granted ?

B.1. MODIFICATION

At the same time, ‘string’ is seeking an injunction against the Internet-based music provider ‘Keep Mov’n’, whose site has become the most popular music exchange site.

A.1. BASE CASE

Carla, a 15-year-old teenager, downloads and uploads songs from the Internet and exchanges CDs with her girlfriend Karen. She is now sued by the record company ‘String’. Will an injunction be granted?

A.2. EDITORIAL NOTE

This case analyses the national provisions implementing Article 5(2)(b) of Directive 2001/29/EC on Copyright and Related Rights in the Information Society. This provision in the Directive is not only optional, but its wording also left member states some latitude to decide on how to implement it. This explains the variations in the member states’ implementing legislation.

As the application of copyright rules is always very fact-specific, the simple wording of this question proved to be ambiguous for most country reporters. The question was formulated with the aim of giving respondents greater leeway to describe their national law and how it would apply to this general factual situation. Here, Carla downloads from the Internet, but the case is silent both on the technology she uses and on the source of her download. If Carla downloads songs from the Internet by using peer-to-peer file-sharing soft ware, it is not unreasonable to argue that most file-sharing soft ware nowadays involves not only an act of downloading but also an act of uploading. The source of Carla’s download may be legal or illegal. The case also does not specify whether the exchanged CDs are the result of the reproduction of the downloaded songs or if they were lawfully acquired from another (analogue) source. All these technical features matter and are likely to influence the outcome of the case. The answers to the question vary as country reporters have given their own interpretation of the facts and of the applicable law.

A.3. COUNTRY REPORTS

(1) BELGIUM

I. Operative Rules

Merely downloading songs would fall under the home copy exception. However, exchanging the CDs with a friend would go beyond the scope of this exception. Therefore, an injunction would probably be granted.

II. Descriptive Formants

• – Article 5(2)(b) Directive 2001/29/EC;

• – Articles 22§ 1 5° BCA (Art. XI.190 9° BCEL) and 46§4 BCA (Art. XI.217 7° BCEL).

A.1. CASE

Richard, a scientist with the renowned pharmaceutical company IPC, buys a computer programme, the top-selling product of IT-Company (ITC), which organises his article database. The programme has been written by the renowned Professor Higgens at Y-University. A specific algorithm, developed by him, is the core of the programme. This is widely known in the relevant community. In order to strengthen its marketing position, ITC markets the programme enclosing a licence agreement that obliges commercial users to cite the company’s name (ITC) when improving the programme; explicitly, any reference to Professor Higgens is forbidden. The contract between Higgens and ITC is silent about the original personality right of Prof. Higgens.

Does Prof. Higgens have the right to be named if Richard adapts ITC’s programme to the needs of pharmaceutical companies? Can Higgens claim an injunction if IPC markets the improved product making reference only to ITC?

A.2. COUNTRY REPORTS

(1) BELGIUM

I. Operative Rules

Yes, Prof. Higgens has the right to be named and can claim an injunction to stop marketing the improved product without mentioning his name.

II. Descriptive Formants

• – Article 6bis Berne Convention;

• – Software Directive 91/250/EC;

• – Articles 3 and 4 BSA (Arts. XI.296 and XI.297 BCEL);

• – Articles 1§2, 3, 86ter and 87 BCA (Arts. XI.165§2, XI.167, XI.334 and XVII.14 BCEL).

The starting assumption to solve the present case is that the algorithm developed by Prof. Higgens is protectable under copyright law, more particularly under the BSA, which implements the Soft ware Directive 91/250/EC (now Book XI, Title VI BCEL).

a) Does Prof. Higgens have the right to be named ?

According to Article 4 of the BSA (Art. XI.297 BCEL), the moral rights on computer programmes are regulated by Article 6bis of the Berne Convention. Article 6bis Berne Convention stipulates that: ‘Independently of the author’s economic rights, and even after the transfer of the said rights, the author shall have the right to claim authorship of the work and to object to any distortion, mutilation or other modification of, or other derogatory action in relation to, the said work, which would be prejudicial to his honour or reputation.’

A.1. BASE CASE

PXZ is a patient organisation representing 200 families with a disposition of a malignant form of cancer. Its mission is to sponsor wide research on this form of cancer. It raises money, obliges the researchers it sponsors to identify the director of PXZ as a co-inventor in any future filings for patents, and has a strong interest in having a say in future licensing negotiations.

The big pharmaceutical company BPC is close to coming up with a chemotherapy for this form of cancer. A gene-based therapy developed by a researcher sponsored by PXZ could cut profits on the final chemical cocktail. It considers a challenge to the gene patent as part of its business strategy. Can BPC challenge the patent on grounds of false inventorship?

A.2. COUNTRY REPORTS

(1) BELGIUM

I. Operative Rules

No, BPC cannot challenge this patent on the grounds of false inventorship.

II. Descriptive Formants

Inventorship, i.e. the right to be named as inventor, is a personal moral right, which cannot be transferred (this inalienability is not unanimously accepted, co-inventor will therefore be invalid, but only the real inventor will be able to object to this on the basis of Article 12 BPA (Art. XI.13 BCEL).

Whether or not the real inventor is identified in the patent has no influence on the validity of the patent itself.

Therefore, BPC cannot challenge this patent on grounds of false inventorship.

III. Metalegal Formants

Due to the personal bond between an inventor and his/her creation, the moral right to be named as inventor is personal, inalienable and absolute. This does not mean that the patrimonial right of ownership of an invention cannot be transferred. Indeed, PXZ might very well have validly obtained the ownership or co-ownership of any future inventions.

If, however, a patent is applied for without consent of the real inventor or his/her subsidiary, he/she can either reclaim the patent (Art. 9 BPA, now Art. XI.10 BCEL) or make a claim for its nullity (Art. 49§1 4° BPA, now Art. XI.57§1 4° BCEL).

A.1. BASE CASE

From 1980 to 2004, Dr Silver and his colleagues have published their scientific articles in the periodicals of ‘Big Publishing House, Inc.’. For the publication of each article, ‘Big Publishing House, Inc.’ required that the authors transfer ‘all rights with respect to modes of exploitation now known or to be discovered’ to the publisher. In 2004, Dr Silver, along with several of his colleagues, stopped publishing their scientific findings with ‘Big Publishing House, Inc.’ in reaction to the publisher’s very strict licensing conditions. They now decide to make all their publications available on their institute’s webpage under a Creative Commons Attribution-NonCommercial-ShareAlike licence. Not only do they make their most recent articles available on the website, they also include the full text of the articles that were previously published by ‘Big Publishing House, Inc.’. On the website, the papers are freely accessible, provided that the user accepts the licence conditions by clicking ‘I agree’ in the dialogue box on their screen. Contrary to the licence used by ‘Big Publishing House, Inc.’, the Creative Commons licence allows authors to publish their work on the Internet, and to use it for any purpose, including for educational purposes. The licence also allows anyone to reproduce, modify and communicate the paper freely for strictly non-commercial purposes, provided that proper credit is given, and that any redistribution of the paper occurs under the same licence conditions.

‘Big Publishing House, Inc.’ has got wind of Dr Silver’s action and claims an injunction against the making available of the articles on the website. Will an injunction be granted?

A.2. COUNTRY REPORTS

(1) BELGIUM

I. Operative Rules

‘Big Publishing House, Inc.’ will not be granted an injunction.

II. Descriptive Formants

The final paragraph of Article 3§1 BCA (Art. XI.167§1 6° BCEL) states: ‘Notwithstanding any provision to the contrary, the assignment of rights in respect of as yet unknown forms of exploitation shall be null and void.’ The clause obliging authors to transfer their rights on modes of exploitation yet to be discovered will therefore be null in Belgium.

It is a special pleasure to welcome the 21st book in the series The Common Core of European Private Law. This book is edited by four scholars, who together represent four different legal cultures: the German, the Belgian, the Netherlands and the English. Their works are already renowned and appreciated well beyond the ‘Common Core’ circles.

The Common Core project was launched in 1993 at the University of Trento under the auspices of the late Professor Rudolf B. Schlesinger. The methodology used in the Common Core project, then novel, is now a classic. By making use of case studies, it goes beyond mere description to detailed inquiry into how most European Union legal systems resolve specific legal questions in practice, and to thorough comparisons between those systems. It is our hope that these volumes will provide scholars with a valuable tool for research in comparative law and in their own national legal systems. The collection of materials that the Common Core project is offering to the scholarly community is already quite extensive and will become even more so as more volumes are published. The availability of materials attempting a genuine analysis of how things seem to be is, in our opinion, a prerequisite for an intelligent and critical discussion on how they should be. Perhaps in the future European private law will be authoritatively restated or even codified. As of today, the Common Core project is the longestrunning scholarly enterprise in the field. The analytical work carried out by the more than 300 scholars that have so far joined us in the Common Core project is also a precious asset of knowledge and legitimisation for any such a normative enterprise.

We must thank the editors and contributors for their work. With a sense of deep gratitude, we also wish to recall our late Honorary Editor, Professor Rudolf B. Schlesinger. We are sad that we have not been able to present him with the results of a project in which he believed so firmly.

No scholarly project can survive without committed sponsors. The International University College of Turin allows us to organise the General Meetings together with the Centro Studi di Diritto Comparato of Trieste. The European Commission has partially sponsored some of our past General Meetings, having included them in their High Level Conferences Program.

This book presents the results of a long-term comparative research project on information property which has accompanied us for 20 years (2001–2021). The project covers 16 European jurisdictions, and has brought us together with many collaborators with whom we are united in the spirit of a multinational research project, unfunded by third-stream money, powered exclusively by intrinsic scientific motivations.

The central research question is: How do boundaries to information property evolve? In the light of comparatively few legislative interventions in intellectual property law (IP), the following questions arise: Are boundaries set elsewhere? Do industrial practices or legal intervention in other fields of the law set boundaries? The methodology of the project (‘the Trento method’) and the research results are laid down in Part I. Our academic learnings have taken shape as four individual chapters, which form Part II of the book. They focus on regulatory theory, conflict configuration in IP law, the European Public Domain, and morality in IP Law.

Part III documents the empirical foundation of the project (cases and national reports). When, in individual cases, no answer is given by the country reporter(s), the lacuna is indicated.

We are grateful to numerous supporters. All the contributors of country reports are listed below. We have indicated the contributors’ affiliation at the time the respective country report was submitted. We are thankful to each one of them. Updates were invited, but only the editors used the option. Beyond our reporters, without the loyal research assistants who encouraged us while working on the project over the years, and who contributed valuable insights, the project would not have come to an end. In this respect, Dr Anja Balitzki deserves special gratitude. She prepared valuable texts which helped two of the editors to write their comparative remarks while she was employed at the University of Oldenburg (2010–2013). We are indebted to Jakob Rustige who supported us in 2018–2019 to master the technical side of the manuscript while we worked on revisions simultaneously; along the way, he made many corrections to the texts.

A.1.CASE

Mary, owner of a small biotech company, was granted a patent on the gene BRAU-7. As a utility, the patent accounts for cardiovascular diseases. Five years after the patent was granted, her competitor John found out that the gene BRAU-7, in conjunction with the gene BLIB-5, is responsible for healing wounds. The proportional relationship to which each gene accounts for the healing process is scientifically unclear. John is also granted a patent on his invention. He sets up a business and starts producing an ointment. Does Mary have a claim for injunction against John?

A.2. EDITORIAL NOTE

For EU member states, the patentability of human genes and the scope of such patents, as the gene patent regime, is predetermined by EU law since 1998. It determines the action radius of Mary.

1. Patent protection for genes

All selected jurisdictions provide patent protection for human genes. This approach is based on national legislation transposing the Biotechnology Directive of 1998. The approach is based on Article 3 Biotechnology Directive, which allows patentability of inventions which are new, which involve an inventive step and which are susceptible of industrial application even if they concern a product consisting of or containing biological material (e.g. Estonia). Alternatively, the approach is based on Article 5 Biotechnology Directive, allowing patentability of elements isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, even if the structure of that element is identical to that of a natural element (e.g. Belgium).

Given the fact that human genes are regarded as inventions in the jurisdictions at hand, and assuming that Mary’s invention further fulfils the criteria of novelty, inventive step and industrial application, Mary’s patent is not in question.

2. Scope of gene patents

The EU Directive gives leeway to member states as to the exact scope of gene patents. The BIP project is interested in how national legislatures have designed the scope, and how courts have adjudicated. Arguably, absolute patent protection for genes is suggested by Article 9 Biotechnology Directive. The basic idea is to conceive gene patents as product patents.

A.1. CASE

Amelie underwent gene therapy. As a result of the successful treatment, she is now producing a protein in her bone marrow that is patented by the company Cellgene. Does Cellgene have the right to prevent Amelie from giving her blood away for free?

A.2. COUNTRY REPORTS

(1) BELGIUM

I. Operative Rules

No, Cellgene cannot prevent Amelie from giving her blood away for free.

II. Descriptive Formants

It is not allowed for donors to make profit by donating their blood, on the basis of Article 5 of the Blood and Blood Derivatives Act.

Therefore, it is excluded in any case that Amelie would be allowed to commercially exploit her blood.

However, depending on the specific circumstances of the case, it might be conceivable that Amelie’s donations would fall under the private use and the research exemptions, as expressed in Article 28(1)(a) and (b) BPA (Art. XI.34§1 a) and b) BCEL). In addition, with regard to the proteins produced by Amelie’s body, Cellgene’s patent might be exhausted on the basis of Article 10 Biotechnology Directive (Art. 27quater BPA, now Art. XI.32 BCEL):

Even if Amelie’s donations fall outside the scope of the exemptions above, Cellgene could not forbid her to donate blood.

III. Metalegal Formants

The right to self-determination over one’s body is a widely accepted principle in Belgium. It means that nobody can control someone else’s body, or that everybody has the right to freely use his/her body. This right is in no way absolute, but it does include the possibility of blood transfer/donation. Everyone has the right to choose to donate blood or not, provided he/she respects the provisions of the Blood and Blood Derivatives Act.