The Directive 98/44 EC for the Legal Protection of Biotechnological Inventions: a commentary of its articles

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This article is divided in seven sections which present the different aspects of the patenting regime created by the directive 98/44 EC for the legal protection of biotechnological inventions. Certain relevant provisions of the directive are reproduced in order to better comment the words used, the meaning they have – or may have. The key words are bolded in the text or put in italic lettering.

A. Introduction

This article is divided in seven sections which present the different aspects of the patenting regime created by the directive 98/44 EC for the legal protection of biotechnological inventions. Certain relevant provisions of the directive are reproduced in order to better comment the words used, the meaning they have – or may have. The key words are bolded in the text or put in italic lettering.

B. The Definitions

Four definitions are laid down in the article 2 of the directive which is formulated as follows:
"Article 2
1. For the purposes of this Directive,
(a) ‘biological material` means any material containing genetic information and capable of reproducing itself or being reproduced in a biological system;
(b) ‘microbiological process` means any process involving or performed upon or resulting in microbiological material.
2. A process for the production of plants or animals is essentially biological if it consists entirely of natural phenomena such as crossing or selection.
3. The concept of ‘plant variety` is defined by Article 5 of Regulation (EC) No 2100/94."

The words "genetic information" have been the source of some confusion: indeed, it is not the genetic information contained in a gene – which is a part of the DNA – but the structure of the DNA sequence which determines, characterizes the production of a protein, for example. There is a difference if it is considered that the structure of the DNA sequence is more important than the genetic information, because it is more the information about this structure rather than the genetic information – which is a consequence of this – which would be necessary to know in order to produce a protein, for example.

C. The Patentability Conditions

The first paragraph of this section provides a commentary of the patentability conditions. The second and thirds paragraphs present the exceptions to this patentability regime and the eventual exceptions to these exceptions.

§1. The biological material

The article 3 defines the patentability conditions for biotechnological material in the following words:

"Article 3
1. For the purposes of this Directive, inventions which are new, which involve an inventive step and which are susceptible of industrial application shall be patentable even if they concern a product consisting of or containing biological material or a process by means of which biological material is produced, processed or used.
2. 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."

This article is rather controversial in the light of the classical distinction in patent law between discovery and invention. This is what Marie-Catherine Chemtob-Concé and Alain Gallochat identify as the first difficulty with the biotechnological inventions directive.This article concerns the patentability of biological material, with an extension to plant material. This is somehow contradictory with the recitals 22 to 25 of the directive which only refer to human genetic material.

The European Patent Convention defines in its article 52 (1) that : "European patents shall be granted for any inventions which are susceptible of industrial application, which are new and which involve an inventive step". These criteria are settled in the article 3 but they are subject to discussion in the case of biotechnologies.

The distinction between the discovery and the invention is a summa divisio in patent law, as Vincent Ost underlines it. The borderline between the two concepts is unclear in the case of biotechnologies because a distinction has to be done between the natural phenomenon discovered by the researcher and the invention resulting from the searcher’s work after the discovery of a natural phenomenon. The second paragraph of the article 3 is certainly a way to give more flexibility to the classical summa divisio, otherwise it would have been difficult to meet the patentability conditions in many cases involving biotechnologies. But some scholars disagree with the "sudden" patentability of a biological material once it has been isolated from its natural environment: there is according to this doctrinal opposition still the "naturalness of the element" which would mean that it is a discovery, because it is not "the result of a creative process" (G. VAN OVERWALLE, «Reshaping bio-patents: measures to restore trust in the patent system», in H. SOMSEN, u. d., The Regulatory Challenge of Biotechnology, Human Genetics, Food and Patents, 2007, p. 239.). But the concept of discovery is not used in the scientific meaning of the word but as a legal notion. This is why a certain degree of human intervention can be the condition which removes certain biological materials from the area of discoveries to the area of inventions. Only certain biological materials will be patentable because the verb "may" – in the second paragraph – means that not all isolated or replicated material will be therefore systematically patentable. In addition to this, the patent granted on such biological material isolated will not have a scope of protection extending to the natural form of the material.

The condition of novelty is not problematic in the case of biotechnologies since it is defined as the fact that the new invention is not part of the actual technique, covering every information that could have been provided about this. Modern biotechnologies are certainly a fertile field for novelty.

The inventive step condition implies that the invention is the clue of not a minor progress for the technique. Biotechnologies are often accomplishing a significant progress in sciences.

The industrial application is presented, in the case of biotechnologies, as a condition very close to the distinction between discovery and invention since the technical work done – in the perspective of making an industrial application – by the search after the discovery will be essential for the distinction.

Even if the recital 34 of the directive states that: "whereas this Directive shall be without prejudice to concepts of invention and discovery, as developed by national, European or international patent law", there is clearly an alteration of the classical distinction operated by patent law between these two concepts.

§2. The plants and the animals

Article 4 of the directive is devoted to the patentability of plants and animals. The first paragraph contains two exclusions from the patentability regime created under the directive:

"Article 4
1. The following shall not be patentable:
(a) plant and animal varieties;
(b) essentially biological processes for the production of plants or animals.
2. Inventions which concern plants or animals shall be patentable if the technical feasibility of the invention is not confined to a particular plant or animal variety.
3. Paragraph 1(b) shall be without prejudice to the patentability of inventions which concern a microbiological or other technical process or a product obtained by means of such a process."

This article 4, prima facie, echoes to the article 53 b of the European Patent Convention which says: "European patents shall not be granted in respect of: […](b) plant or animal varieties or essentially biological processes for the production of plants or animals; this provision shall not apply to microbiological processes or the products thereof;[…]". The same exclusions are settled in the first paragraph and the third paragraph of article 4, in the same way as the Munich convention, provides an exception to these exclusions for microbiological processes. But the article 4 provides, however, more exceptions to these exclusions.

As mentioned in article 2 of the directive, the definition of plant variety is provided by the article 5 of Regulation (EC) No 2100/94. Recital 30 of the directive says that the concept of plant variety "is defined by its whole genome and therefore possesses individuality and is clearly distinguishable from other varieties". Recital 31 stipulates that the concept of plant grouping – different from the concept of plant variety – "is characterised by a particular gene (and not its whole genome)". Even if a plant grouping has not the protection of a plant variety right, there is a question about its patent protection – whether it should be protected under the biotechnological inventions directive patent regime. Recital 31 brings, in fine, an answer: a plant grouping "is therefore not excluded from patentability even if it comprises new varieties of plants". This clarification has been made with regard to inventions modifying genetically a sole and particular plant variety which are, according to recital 32 of the directive, excluded from patentability. The fact that a plant grouping comprises new varieties of plants doesn’t, therefore, exclude it from patentability.

The "animal varieties" are, on the contrary, a non-defined concept. There is certainly here a gap to be filled, especially in a context of increasing animal biotechnology.

The paragraph 3 of article 4 provides an exception to the non-patentability of biological processes for the production of plants and animals which accordingly to article 2 paragraph 2 result entirely from a natural phenomena. This third paragraph doesn’t exclude – as mentioned above – from patentability microbiological processes, with the particularity that these microbiological processes are patentable even if they are essentially biological. Again, the classical distinction between discovery and invention is eroded: a certain degree of technical intervention – but undefined by the directive – can be the key for the patentability of certain biological processes.

§3. The human body

"Article 5
1. 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.
2. An element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element.
3. The industrial application of a sequence or a partial sequence of a gene must be disclosed in the patent application."

Marie-Catherine Chemtob-Concé and Alain Gallochat point out that this article represents a second difficulty with the directive. Besides the controversy about the non-respect of the distinction between discovery and invention which may arise with the ambiguous wording of this article, the principle of the non-commercial use of the human body – previously developed in section C of chapter one – is certainly violated.

There is a contradiction between the two first paragraphs of article 5: whilst the first paragraph prohibits the patentability of human body elements, the second one, through the criterion of the human intervention, opens the floodgates to the patentability of human body elements. Recitals 20 and 21 of the directive repeat that the technical intervention made on the human body material and the susceptibility of industrial application are the two main elements that draw the distinction between the discovery and the invention in the case of biotechnologies. The isolation of the element from the human body is a necessary condition for patentability, which involves the reproduction of the element isolated out of the human body. This appears quite logical and reasonable since the inventor could under patent law forbid the reproduction of the element – it is unconceivable to forbid the reproduction of a protein, for example, in the human body!

Article 5 (1) has, thus, no practical meaning, and was maybe only adopted in order to avoid ethical debates. The Netherlands criticized the harm caused to human dignity by the patentability of human body elements. The European Court of Justice, in the so-called "biotechnologies case", rejected their plea.

The third paragraph settles a procedural requirement about the industrial application which has to be disclosed in the patent application: this shows, again, that the industrial application is a determinant factor of the borderline between discovery and invention.

While recital 26 of the directive states that "whereas if an invention is based on biological material of human origin or if it uses such material, where a patent application is filed, the person from whose body the material is taken must have had an opportunity of expressing free and informed consent thereto, in accordance with national law", the directive doesn’t speak about the consent. The European legislator, maybe, didn’t want to add a limitation to patentability. Before the ECJ, The Netherlands objected, unsuccessfully, to the absence of any provision requiring "the verification of the consent of the donor or recipient [of biotechnological products].

D. Patentability Prohibitions

"Article 6
1. Inventions shall be considered unpatentable where their 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.
2. On the basis of paragraph 1, the following, in particular, shall be considered unpatentable:
(a) processes for cloning human beings;
(b) processes for modifying the germ line genetic identity of human beings;
(c) uses of human embryos for industrial or commercial purposes;
(d) processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes."

Article 53 (a) of the European Patent Convention is worded in similar terms as article 6 (1) of the directive: "European patents shall not be granted in respect of: (a) inventions the commercial exploitation of which would be contrary to "ordre public" or morality; such exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation in some or all of the Contracting States".

The second paragraph of article 6 is the result of a long parliamentary debate with numerous amendments brought to the directive proposals from 1988 – year of the original proposal which didn’t speak about "ordre public" and morality – to 16th July 1997, when a large majority of members of the European parliament approved the last and amended – sixty-five times – proposal of the Commission.

The unpatentability is nevertheless different from the exploitation of the patent. This is not because an invention is patented that it gives a right to exploit it, it simply excludes other people from its exploitation. By excluding some inventions from patentability, the European legislator chose to prevent any problem of exploitation of some controversial biotechnologies. It is a very careful way to ensure that these biotechnologies will not be exploited: when an invention is patented, it can be excluded from exploitation. But this doesn’t mean that the patenting is not necessary, because the inventor can wait for a change in the regulatory policies and then exploited the patented invention.

The Kingdom of the Netherlands argued in the "biotechnologies case" that the patents on biotechnological inventions should only be limited to biotechnological processes because the patentability of other inventions was considered by them as being against morality and human dignity. The Netherlands also invoked a breach of the principle of legal certainty because the directive "gives the national authorities a discretion in applying concepts expressed in general and ambiguous terms, such as ordre public and morality which appear in Article 6". The Court refused that argument and underlined that the concepts of "ordre public" – "public policy" in English – and morality are well-known concepts of law in the Member States. It held that "a directive cannot be considered contrary to the principle of legal certainty if it relies, as regards the conditions for its implementation, on concepts known to the laws of the Member States, specifying, as here, their scope and limits and taking account, in order to do so, of the specific nature of the subject-matter". This excerpt underlines that the discretionary margin that the Netherlands feared through the wording of article 6 is nothing else than a ghost.

However the Netherlands saw in article 6 (2) a non-complete list, the Court quotes recital 38 of the directive which specifies that the list is non-exhaustive. The Court, furthermore, held that "the grant of a patent does not preclude legal limitations or prohibitions applying to research into patentable products or the exploitation of patented products, as the 14th recital of the preamble to the Directive points out. The purpose of the Directive is not to replace the restrictive provisions which guarantee, outside the scope of the Directive, compliance with certain ethical rules which include the right to self-determination by informed consent". Indeed, the directive doesn’t’ preclude the application of provisions restricting, for example, the exploitation of certain inventions.

After all, the second paragraph of article 6 remains obscure. The wording mentions inventions excluded from patentability "in particular". The question is whether they are other inventions than are excluded. It can lead to the patentability of certain embryos for medical research, as recital 42 points it out. Some clarity will certainly have to be brought about this list.

A certain ethical regulation is supposed to occur before the patenting and after it. Article 7 of the directive states that: "the Commission’s European Group on Ethics in Science and New Technologies evaluates all ethical aspects of biotechnology". This group of ethicists doesn’t play a role in the procedure for the grant of patents, it only has an advisory power. Its role remains quite indefinite and limited to an evaluation of the conformity of biotechnologies to the "ordre public" and morality, without having regard to particular cases.

E. The Scope of Protection

Articles 8 to 11 of the directive bring some precision about the scope of protection of the biotechnological invention patented.

Article 8 extends the protection on biological material or a process to derived material obtained though the process patented or resulting of propagation or multiplication of that material, if it has the same characteristics. The successive and various generations of a product are therefore protected by the patent.

Article 9 also extends the protection in the following terms:

"Article 9
The protection conferred by a patent on a product containing or consisting of genetic information shall extend to all material, save as provided in Article 5(1), in which the product in incorporated and in which the genetic information is contained and performs its function."

The matter with this provision is that it can confer a patent protection protection even on plant and animal varieties, as long as a gene, for example, has been incorporated in a variety and its genetic information contained in it performs its function. It is only the human body which is excluded, according to article 5 (1). Nevertheless, the genetic information, even if it is contained in the hosting organism, may not perform its function. A DNA sequence can be incorporated in an organism and the genetic information contained in it can be latent, functionless. This will mean that even if a patented DNA sequence is incorporated, a claim from the holder of the patent right will be dismissed if the genetic information doesn’t or cannot perform its function. The industrial application described in the patent application form is a pertinent clue in order to determine the function of the genetic information in some cases, for example when a DNA sequence patented has been incorporated in an organism for the production of a determined protein.

Article 10 excludes from the protection of the patent all marketed biological material resulting from the propagation or multiplication of biological material, if the propagation or multiplication was aimed for the marketing of the biological material and nothing else. This provision is a way to protect farmers sowing genetically modified organisms. The holder of the patent must consent to this marketing.
Linked to article 10, article 11 permits farmers to multiply and sell for replanting patented plants. This gives a weaker protection to a plant patent than to a plant variety right. This is another difficulty with the directive, since this "farmer’s privilege" weakens the plant patents.

F. The Compulsory License

Article 12 regulates the compulsory license regime. As mentioned before – in section B of chapter 1 – a compulsory license is a precious tool for breaking "blocking patents". Article 12 (1) deals with the compulsory license that a breeder can ask, while article 12 (2) regulates the cross-licensing question which may apply when a plant variety right would be infringed if the holder of a patent on a biotechnological invention exploited it without having a compulsory license under that right. Article 12 (3) settles two conditions for obtaining the license: an unsuccessful attempt to obtain a contractual license and the significant technical progress and economic advantage of the invention or plant variety. The question about the authorities able to deliver the license is the object of article 12 (4).

G. The Directive, the National and the International Legislations

Two provisions are directly linked to the relationship between the directive, the national and the international laws: the articles 1 and 15.

Firstly, article 1 provides that:

"Article 1
1. Member States shall protect biotechnological inventions under national patent law. They shall, if necessary, adjust their national patent law to take account of the provisions of this Directive.
2. This Directive shall be without prejudice to the obligations of the Member States pursuant to international agreements, and in particular the TRIPs Agreement and the Convention on Biological Diversity."

The Netherlands tried, again unsuccessfully to convince the European Court of Justice, in the "biotechnologies case", that the directive was incompatible with their obligations under international treaties as the TRIPs agreement and the Convention on Biological Diversity. The Court didn’t see any incompatibility between the two international patent law sources and the directive.

Secondly, article 15 concerns the enforcement of the directive in the national legal orders before 30th July 2000. France (Case C-448/03 Commission of the European Communities v French Republic [2004]), Belgium (Case C-454/03 Commission of the European Communities v Kingdom of Belgium [2004]), Luxemburg (Case C-450/03 Commission of the European Communities v Grand Duchy of Luxembourg [2004]), Germany (Case C-5/04 Commission of the European Communities v Federal Republic of Germany [2005]), Austria (Case C-4/04 Commission of the European Communities v Republic of Austria [2005]) have all be condemned for the non-transposition of the directive within the time limit. Italy (Case C-456/03 Commission of the European Communities v Italian Republic [2005]) has been condemned for the non-compliance of its patent law regime with certain provisions of the directive – the more controversial having been set aside by Italy when it transposed the directive into the Italian patent law.

H. Procedural requirements

§1. Procedural requirements concerning the Deposit, the access and the re-deposit of a biological material

Articles 13 and 14 of the directive concern some procedural requirements concerning the deposit, the access and the re-deposit of biological material. Nothing controversial has to be underlined about these provisions.
Article 5 (3) – as said before – requires that the industrial application has to be disclosed in the patent application for a partial – or not – gene sequence.

§2. Procedural requirements binding the Commission

Article 16 defines the role of the Commission about the implementation of the directive, the evolution of patent law and the relationship between the directive and human rights international law. Reports from the Commission have to be send to the Parliament and to Council.

I. Conclusion

Ten years after its adoption, the directive 98/44 EC on the legal protection of biotechnological inventions remains controversial.

The controversies are ethical and the political and philosophical debates about the patentability of human body elements don’t seem to reach an end. The late transposition of the directive in certain countries illustrated this.

The notions of "ordre public" and morality which may exclude from patentability certain inventions are not convincing among the Member States.

The controversies are economical and linked to the debate about the existence of patents. Blocking patents are certainly refraining sciences from further progresses. The directive introduced the existence of a compulsory license.

But, all in all, the controversies are legal. The directive introduced confusion among the summa divisio between discovery and invention. Some provisions are quite contradictory in the directive and when some exceptions to the patentability regime exist, exceptions to these exceptions often annihilate the effects of these exceptions. This is the clue of a lack of courage of the European legislator to assume the patentability of controversial biotechnologies.

Clarity is certainly not the best word that fits the directive. Ambiguity is maybe the best.

Finally, a comparative law approach towards the national legislations of the Member States could provide a better understanding this regime that has been modestly commented in this paper.

Droit & Technologies


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