T 0272/95 (Relaxin/HOWARD FLOREY INSTITUTE) 23-10-2002

Admissibility of the opposition and appeal by the Appellants

1. A notice of opposition was filed on behalf of 26 named persons (9 January 1992) and one opposition fee was paid (10 January 1992). Subsequently, a common representative was authorized by 18 of the 26 named individuals (3 May 1993). The Opposition Division decided that the opposition was admissible under Article 99(1) EPC and Rule 55 EPC and pursuant to Rule 100(1) EPC (decision of 18 January 1995). After the patent was maintained as granted, 5 out of the 18 individuals lodged an appeal in the name of the group through a non-entitled person. Subsequently, upon invitation by the Board of Appeal, 17 out of the 18 named individuals (the eighteenth being deceased) signed the notice of appeal and authorized a new common representative to act on their behalf (13 July 1995).

2. To the questions asked by the Board of Appeal in its interlocutory decision (section VIII, supra), in relation to the common opposition, the EBA (decision G 3/99, supra) answered that:

"1. An opposition filed in common by two or more persons which otherwise meets the requirements of Article 99 EPC and Rules 1 and 55 EPC, is admissible on payment of only one opposition fee.

"2. If the opposing party consists of a plurality of persons, an appeal must be filed by the common representative under Rule 100 EPC. Where the appeal is filed by a non-entitled person, the Board of Appeal shall consider it not to be duly signed and consequently invite the common representative to sign it within a given limit. The non-entitled person who filed the appeal shall be informed of this invitation. If the previous common representative is no longer participating in the proceedings, a new common representative shall be determined pursuant to Rule 100 EPC.

"3. In order to safeguard the rights of the patent proprietor and in the interests of procedural efficiency, it has to be clear throughout the procedure who belongs to the group of common opponents or common appellants. If either a common opponent or appellant (including the common representative) intends to withdraw from the proceedings, the EPO shall be notified accordingly by the common representative or by the new common representative determined under Rule 100(1) EPC in order for the withdrawal to take effect."

3. Pursuant to Article 112(3) EPC, this decision is binding on the Board in assessing the admissibility of the opposition and appeal in the present case. A common representative was duly appointed (section VII, supra) and the further conditions set up by the EBA have also been met. For these reasons and taking into account that the further requirements of Article 99(1) and Rule 55 EPC for the filing of an opposition and, of Article 108 EPC and Rule 64 EPC for the filing of an appeal are fulfilled, the opposition and appeal are admissible.

Articles 53(a) and 52(2)(a) EPC, Rules 23(b) to (e) EPC

4. After the Directive 98/44/EC of 6 July 1998 was passed by the European Parliament, the Administrative Council of the EPO in its decision of 16 June 1999 amended the Implementing Regulations of the European Patent Convention by adding to Part II of these Regulations a Chapter VI - Biotechnological inventions - comprising Rules 23(b) to 23(e), for the purpose of applying and interpreting the provisions of the Convention relevant to European patent applications and patents concerning biotechnological inventions. Article 2 of this decision states that it shall enter into force on 1 September 1999; the decision itself does not contain transitional provisions. The Board concludes from the absence of transitional provisions that the Administrative Council must have been of the opinion that Rules 23(b) to 23(e) EPC only gave a more detailed interpretation of the meaning of Article 53 EPC as intended from its inception, and hence were also applicable to cases already pending before 1 September 1999 such as the present case.

5. Having regard to Article 164(2) EPC, the Board has to examine whether or not the new rules insofar as they relate to Article 53(a) EPC are in conformity with this article. In decision G 1/98 (OJ EPO 2000, 11, point 5.3) dealing with the interpretation of Article 53(b) EPC, the EBA stated that Article 4(1)b and (3) of the EU biotechnology directive 98/44 (see supra) was intended to be interpreted in the same sense as the EBA interpreted the scope of Article 53(b) EPC (G 1/98, points 3.10, 5 and 6, see supra). This latter interpretation corresponds entirely to the new Rule 23(c) adopted by the Administrative Council, which in turn is based on the EU directive. The EBA, thus, found this Rule related to Article 53(b)EPC to be only interpretative. The present Board adopts this view, considers that the same holds true for the new rules as far as they relate to the interpretation of Article 53(a) EPC and, thus, will apply Rules (e) and (d) to the present case.

Articles 53(a) and 52(2)(a) EPC; ordre public or morality; discoveries

6. The Appellants argued that the subject-matter of product claims 2 to 7, 10 to 14 and 18 to 21 fell within the category of exceptions to patentability or must be considered as a discovery of biological elements present in the human body which may not be patented.

7. To assess the validity of these arguments, Articles 53(a) and 52(2)(a) EPC are interpreted by the Board in accordance with the implementing Rules 23(d) and 23(e)(2)EPC. Rule 23(d) provides a list of processes and uses which are exceptions to patentability but does not mention any products. However, it is a non-exhaustive list, which implies that product claims relating to biological material may equally be found unallowable under Article 53 a) EPC. Rule 23(e)(2), however, defines which biological material originating from the human body may be patented. It states that:

"(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".

It follows from the text itself that the matter mentioned above is not to be considered as an exception to patentability under Article 53(a) EPC. Claims 2 to 7, 10 to 14 and 18 to 21 are, thus, allowable under this article.

8. Claims 2 to 7, 10 to 14 and 18 to 21 directly or indirectly relate to DNAs encoding the human protein preprorelaxin or to the human preprorelaxin per se, which are described in the patent in suit on pages 9 to 15. as having been obtained by technical processes. They, thus, answer the definition of patentable elements of the human body given in Rule 23(e)(2) EPC. Accordingly, they do not fall within the category of inventions which may not be patented for being discoveries (Article 52(2)(a) EPC).

9. Thus, the Appellants' arguments under Articles 53(a) and 52(2)(a) EPC (see section IV and XII, supra) are answered by the new implementing Rules 23(d) and 23(e) EPC.

Article 54 EPC; novelty

10. There are no documents on file where the existence of the H2-relaxin gene is mentioned, let alone the sequences of this gene and of the corresponding H2-relaxin protein. Novelty is acknowledged.

Article 56 EPC; inventive step

11. The closest prior art is document (1) which describes the molecular cloning of the DNA encoding rat relaxin and also mentions that "The peptide hormone relaxin is produced...in many mammalian species, including pigs, rats and humans,....".

12. The problem to be solved can be defined as isolating and characterising a DNA encoding a further relaxin.

13. The solution provided to that problem is the human DNA fragment encoding the H2-relaxin having the specific sequence given in Figure 2.

14. Lack of inventive step was argued on the basis that a technique well-known at the priority date had been used to isolate this DNA fragment. The Board agrees that it may, then, have been common practice to isolate a DNA fragment from a given species by hybridisation of the cloned DNA to a probe consisting in the DNA encoding the same protein in another species, when there was some reason to expect that the sequences of both DNAs may be somewhat homologous or at least when no reasons existed to suspect an absence of homology. Here, there is evidence on file (document (2), page 155, right-hand column) relating to the cloning of the gene encoding porcine relaxin, that no significant hybridisation occurs between the rat and the porcine relaxin cDNAs. Thus, the skilled person would have had reasons to doubt that such an homology would exist between the human and rat or porcine relaxin DNAs ie. that the cloning technique using a probe derived from rat or porcine DNA would work. Furthermore, the skilled person may not have found it obvious to use the same cloning technique as that described in documents (1) and (2) based on the protein sequences of rat or porcine relaxin since the sequence of human relaxin was not known. Thus, there existed no reasonable expectation of success that the claimed human relaxin encoding DNA may be isolated. Inventive step is acknowledged.