Pages 573-582

INFORMATION FROM THE EPO

Notice dated 1 July 1999 concerning the amendment of the Implementing Regulations to the European Patent Convention¹

The new provisions relating to biotechnological inventions

1. In its decision of 16 June 1999 the Administrative Council inserted a new Chapter VI entitled "Biotechnological inventions" in Part II of the EPC Implementing Regulations and amended the wording of Rule 28(6) EPC. The new provisions enter into force on 1 September 1999 and implement the requirements of the EU Biotechnology Directive in European patent law. Details and the new provisions are given below.

Implementing the EU Biotechnology Directive in European patent law

2. Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 (hereafter the Directive)2 on the legal protection of biotechnological inventions entered into force on 30 July 1998. EU member states are required to implement it in national law by 30 July 2000.

3. The European Patent Organisation itself is not subject to this formal requirement. However, European patent law does need to be brought into line with the Directive, primarily in order to comply with the requirement for uniformity in harmonised European patent law.

4. The substantive provisions for the protection of biotechnological inventions are laid down in Chapters I-IV of the Directive. Chapter V contains the final provisions governing in particular when the Directive enters into force and when it must be implemented. The Directive is preceded by a comprehensive list of recitals to be taken into account in interpreting and implementing the Directive and in applying the provisions adopted in accordance with it.

5. At the level of European patent law the only possible and acceptable way to implement the Directive was within the framework of the EPC. Where the Directive relates to subject-matter for which European patents are governed by national law, implementation must be regulated nationally. This applies in particular to Chapters II (Scope of protection) and III (Compulsory licensing) of the Directive. The requirements of Chapter IV (Deposit of biological material) of the Directive are already satisfied in full by the relevant provisions of the Convention (Article 83, Rules 28 and 28a). To that extent no adjustment of European law was required.

6. However, that applied to Chapter I (Patentability) of the Directive with certain restrictions only. Although the principles set forth there regarding the patentability of biotechnological inventions are based on the relevant provisions of the EPC and essentially reflect current practice as developed by the Office and its boards of appeal in applying the Convention, some extensions and clarifications appear to be required in this area to ensure that the patentability provisions of the EPC also continue to be interpreted in keeping with the Directive.

7. The Directive expressly makes it clear that the protection of biotechnological inventions must be accomplished within the framework of and in accordance with general provisions of patent law, it being assumed that biological matter can in principle be protected under national patent law and the EPC (Recital 15). Since the early eighties the Office has received around 15 000 patent applications associated with the field of biotechnology. Some 1 500 of these applications relate to transgenic plants, 600 to transgenic animals and around 2 000 to DNA sequences.

On the basis of applicable law the Office has to date granted about 3 000 patents for biotechnological inventions which fall within the scope of the Directive.

8. That shows that the patentability provisions of the EPC - Articles 52 to 57 in particular - essentially take account of the requirements of modern biotechnology. That is confirmed by the case law of the boards of appeal on biotechnology issues. Hence the European Parliament and the Council of the EU essentially based the provisions in Chapter I of the Directive on the deliberations of the boards and on their interpretation of the relevant provisions of the EPC.

9. Hence implementation of the Directive in European patent law primarily entailed framing an interpretation of the applicable provisions of the Convention specifically designed to comply with the Directive. In the provisions relating to the deposit of biological material (Rules 28 and 28a), the EPC has long included rules governing the detailed application of the general provisions of the EPC in cases where an invention concerns biological material. Thus in terms of the legal system the route to follow in implementing the Directive in European law was already mapped out.

10. The implementing regulations to international treaties are often used for more precise definition, interpretation and development of the provisions of the treaty itself. The legally binding force of these supplementary provisions is based on the legislative powers that such treaties confer on the competent bodies. Under the EPC the Administrative Council is fully competent to adopt and amend the Implementing Regulations (Article 33(1)(b) EPC). This is not simply an authorisation to regulate specific issues more closely, such as is provided for in national legal systems, but full power to pass supplementary legislation for the treaty. The PCT provides the PCT Assembly with comparably wide powers. The wide legislative authority of the Administrative Council or the PCT Assembly is intentional and is essential in order to ensure that the treaties can be swiftly adjusted and developed.

11. The Implementing Regulations to the EPC were thus the appropriate instrument for implementing the requirements of the Directive in European patent law quickly and with binding force. Under Article 164(1) EPC the Implementing Regulations are an integral part of the Convention and hence are equally binding on the EPO's boards of appeal (Article 23(3) EPC) and on national courts. Hence, for practical application of the Convention, only the interpretation of its provisions laid down in the Implementing Regulations is binding. A different interpretation of the Convention would be possible only if it is specifically demonstrated that a particular rule of interpretation is inconsistent with the Convention itself.

12. The practice of making general provisions of the Convention specific in the form of implementing regulations is accepted as an essential instrument for the development of legislation. Thus Rule 30 EPC, for example, gives a binding interpretation of the notion of unity of invention referred to in Article 82 EPC. The same applies to Rule 28 EPC, which gives specific forms to the disclosure requirements referred to in Article 83 EPC.

13. At the same time, the addition of rules of interpretation for biotechnological inventions to the Implementing Regulations emphasises that the general provisions of the Convention apply unrestrictedly to such inventions as well and helps prevent the creation of a separate body of law.

THE NEW PROVISIONS OF THE IMPLEMENTING REGULATIONS

14. The following new Chapter VI has been inserted in Part II of the Implementing Regulations:

"CHAPTER VI

Biotechnological inventions

Rule 23b

General and definitions

(1) For European patent applications and patents concerning biotechnological inventions, the relevant provisions of the Convention shall be applied and interpreted in accordance with the provisions of this chapter. Directive 98/44/EC of 6 July 1998 on the legal protection of biotechnological inventions shall be used as a supplementary means of interpretation.

(2) "Biotechnological inventions" are inventions which concern a product consisting of or containing biological material or a process by means of which biological material is produced, processed or used.

(3) "Biological material" means any material containing genetic information and capable of reproducing itself or being reproduced in a biological system.

(4) "Plant variety" means any plant grouping within a single botanical taxon of the lowest known rank, which grouping, irrespective of whether the conditions for the grant of a plant variety right are fully met, can be:

(a) defined by the expression of the characteristics that results from a given genotype or combination of genotypes,

(b) distinguished from any other plant grouping by the expression of at least one of the said characteristics, and

(c) considered as a unit with regard to its suitability for being propagated unchanged.

(5) A process for the production of plants or animals is essentially biological if it consists entirely of natural phenomena such as crossing or selection.

(6) "Microbiological process" means any process involving or performed upon or resulting in microbiological material.

Rule 23c

Patentable biotechnological inventions

Biotechnological inventions shall also be patentable if they concern:

(a) biological material which is isolated from its natural environment or produced by means of a technical process even if it previously occurred in nature;

(b) plants or animals if the technical feasibility of the invention is not confined to a particular plant or animal variety;

(c) a microbiological or other technical process, or a product obtained by means of such a process other than a plant or animal variety.

Rule 23d

Exceptions to patentability

Under Article 53(a), European patents shall not be granted in respect of biotechnological inventions which, in particular, concern the following:

(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.

Rule 23e

The human body and its elements

(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."

EXPLANATORY NOTES

Rule 23b General and definitions

15. Rule 23b affirms the principle that inventions in biotechnology are already patentable under existing law (see also Directive Recital 15), defines the area to which the provisions of Chapter VI apply and gives definitions of the basic terms. Paragraph 1 establishes that the provisions relate to the application and interpretation of the Convention and further specifies that the Directive itself is also to be used to interpret the provisions. The aims in particular are to ensure that the recitals preceding the provisions of the Directive are also taken into account and to promote a uniform Europe-wide interpretation of the relevant provisions.

16. Rule 23b(2) defines the concept of "biotechnological invention" on the basis of Rule 28(1) EPC and with reference to Article 3(1) of the Directive. In that sense inventions are to be considered biotechnological if they concern or use biological material.

17. Rule 23b(3) gives the definition of "biological material" which was previously contained in Rule 28(6)(a) EPC and was incorporated in the Implementing Regulations in 1996, as now formulated in Article 2(1)(a) of the Directive (see Administrative Council decision dated 14 June 1996 - OJ EPO 1996, 390). For the sake of clarity the definition has now been moved to the new Rule 23b. Rule 28 EPC had to be adjusted accordingly (see point 28 below).

18. Rule 23b(4) adopts the definition of the concept of "plant variety" from Article 5(2) of Regulation (EC) No. 2100/94 on plant variety rights, which is binding in accordance with Article 2(3) of the Directive. The definition follows the wording of the concept of variety as set forth in Article 1(vi) of the 1991 UPOV Convention. The EPO boards of appeal have hitherto always used the UPOV Convention's concept of variety as the basis for interpreting Article 53(b) EPC (see T 49/83, T 320/87 and most recently T 356/93). Paragraphs 1, 3 and 4 of Article 5 of the EU Plant Variety Rights Regulation have not been adopted, as they relate specifically to variety rights issues and are not required for the definition of those plant varieties which are not patentable under Article 53(b) EPC.

19. Rule 23b(5) in keeping with Article 2(2) of the Directive specifies more precisely when a process for the production of plants or animals is "essentially biological". This in particular gives a more specific meaning to Article 53(b) EPC and establishes that only production processes based entirely on natural phenomena are excluded from patenting. Although the EPO boards of appeal have hitherto not given an explicit decision to that effect (see T 320/87, T 19/90, T 356/93), the interpretation developed by the boards falls within the framework of the definition given in the new rule.

20. Rule 23b(6) defines the concept of a microbiological process within the meaning of Article 53(b) EPC somewhat more broadly than is indicated by the case law of the boards of appeal (T 356/93). Thus, in keeping with Article 2(1)(b) of the Directive, the definition in particular also covers processes which as claimed include both microbiological and non-microbiological steps.

Rule 23c Patentable biotechnological inventions

21. Rule 23c establishes that biotechnological inventions are in principle patentable under the EPC. It includes a non-exclusive list of items which are explicitly considered patentable.

22. Rule 23c(a) relates to the demarcation between invention and discovery under patent law and to the concept of novelty. In keeping with the applicable provisions of the Convention and with previous Office practice, as well as with Article 3(2) of the Directive, it is explicitly stated that biotechnological material may be considered patentable even if it already occurs in nature. This particularly applies to genes which are isolated from their natural environment by means of technical processes and made available for industrial production. Such genes are also new, because they were previously not technically available to the public.

23. Rule 23c(b) does not affect the exclusion of plant and animal varieties from patentability under Article 53(b) EPC. Rather, it indicates that a plant grouping characterised only by a particular gene - but not by its whole genome - is not covered by the protection of new varieties and therefore is in principle patentable. This also applies if such plant grouping comprises plant varieties. The provision complies with Article 4(2) of the Directive and clarifies the scope of Article 53(b) EPC (see also Recitals 29 to 31 of the Directive).

24. Rule 23c(c) affirms the principle laid down in Article 53(b) EPC, whereby a microbiological or other technical process or a product obtained by such a process is in principle patentable. It also makes explicitly clear however that product claims for plant or animal varieties cannot be granted even if the variety is produced by means of a microbiological process. That does not affect the derived protection of such a variety as the direct product of a patented process. The rule is in keeping with generally accepted principles as to the effect of product or process protection such as have been developed in particular in conjunction with bans on the protection of chemical substances. The Directive includes a provision to that effect in Article 4(3).

Rule 23d Exceptions to patentability

25. Rule 23d lists a number of exceptions to patentability under Article 53(a) EPC. The list is non-exhaustive and is to be seen as giving concrete form to the concepts of "ordre public" and "morality". Letters (a)-(d) adopt the wording of Article 6(2) of the Directive and require no further clarification.

Rule 23e The human body and its elements

26. Rule 23e adopts the exact wording of Article 5 of the Directive. Paragraph 1 excludes from patentability the human body at all stages of its formation and development, in particular the human germ cells. As paragraph 2 specifies, however, this exclusion does not apply to elements isolated from the human body or otherwise produced by means of technical processes. These, particularly a sequence or partial sequence of a gene, are consequently patentable even if their structure is identical to that of naturally occurring elements.

27. In paragraph 3, the general requirement already present in Rule 27(1)(f) EPC that the description should where appropriate indicate the way in which the invention is capable of exploitation in industry is given specific form in relation to sequences and partial sequences of genes. Thus where such sequences are the subject-matter of an invention, it is necessary to indicate in particular what function is performed by the sequence and the protein built from it.

AMENDMENT OF RULE 28(6) EPC

28. Rule 28(6) now reads as follows:

"(6) For the purposes of paragraph 3, derived biological material shall mean any material which still exhibits those characteristics of the deposited material which are essential to carrying out the invention. The undertaking referred to in paragraph 3 shall not impede any deposit of derived biological material necessary for the purpose of patent procedure."

29. The deletion of Rule 28(6)(a) is a consequence of incorporating the definition of biological material into the new Rule 23b(3) (see point 14 above). The new rule gives a binding definition of biological material for the purposes of the Convention, so there is no need for Rules 28 and 28a EPC to refer to it explicitly.