INFORMATION FROM THE EPO
Notice dated 1 October 1996 concerning the main amendments to Rules 28 and 28a EPC
1. Introduction
In its decision dated 14 June 1996 (OJ EPO 1996, 390 ff) the Administrative Council amended Rules 28 and 28a EPC relating to the deposit and new deposit of biological material for the purposes of the European patent grant procedure with effect from 1 October 1996. The most important amendments, together with the main measures which have been or will be taken to implement them, are outlined below.
2. Main amendments to Rule 28 EPC
2.1 Replacement of "micro-organism" by "biological material"
The word "micro-organism" has been replaced by "biological material" - meaning any material containing genetic information and capable of self-reproducing or of being reproduced in a biological system (Rule 28(6)(a) EPC). The amendment thus uses the same terminology as the old and new draft EU directives on the legal protection of biotechnological inventions, which has not been controversial.
The term "micro-organism" as used in previous Rule 28 EPC and the Budapest Treaty is not defined, and was in line with the state of industrial microbiology at the time, which was based essentially on the use of bacteria and yeasts.
Technological advances soon made it necessary to expand the concept to include biological elements which are not strictly speaking micro-organisms, to permit sufficient disclosure within the meaning of Article 83 EPC of inventions which in themselves are perfectly patentable. Thus the Guidelines for Examination in the EPO (C-IV, 3.5) have already been amended to specify that "micro-organism" also covers plasmids and viruses - in line with the practice at numerous depositary institutions recognised by the EPO.
The amendment to Rule 28 EPC allows deposits, supplementing written disclosure of the invention, of types of biological material not covered by current EPO practice, eg seeds.
Although the term "biological material" in principle makes possible the deposit for disclosure purposes of macroscopic or multicellular material such as seeds or plants, a deposit's admissibility under Rule 28 EPC
- in no way prejudges the deposited matter's patentability under Articles 52 to 57 EPC;
- does not deprive EPO departments of their powers to interpret the definition of "biological material" with a view to the disclosure requirement of Article 83 EPC;
- presupposes that a recognised depositary institution is prepared to accept the deposit of a given type of biological material.
2.2 Applicant and depositor not identical (Rule 28(1)(d) EPC)
Following board of appeal decision T 118/87 (OJ EPO 1991, 474) EPO practice has in principle been to consider the requirements of previous Rule 28 to be met only if the applicant and depositor are one and the same (see Guidelines C-II, 6), because consent to the deposited culture being made available to the public in accordance with this rule (Rule 28(2), last sentence, EPC) can only be given by the depositor entitled to dispose of it.
In order to meet applicants' requirements, a sub-paragraph (d) has been added to Rule 28(1) EPC which specifies that the biological material may be deposited by a person other than the applicant if the name and address of the depositor are stated in the application and a document is submitted satisfying the EPO that the latter has authorised the applicant to refer to the deposited biological material in the application and has given his unreserved and irrevocable consent to the material being made available to the public in accordance with Rule 28.
The name and address of the depositor and proof of his consent must be submitted to the EPO within the periods laid down in Rule 28(2) EPC. No request for such information is issued by the EPO. Nor may such information be submitted after expiry of the relevant time limit (see G 2/93, OJ EPO 1995, 275).
2.3 Extension of the expert option (Rule 28(4) EPC)
Previous Rule 28(3) EPC limited access to deposited biological material by an expert nominated by the requester only until such time as a European patent had been granted or the application had been refused, withdrawn, or deemed to be withdrawn. User circles have argued this solution is inadequate where the application does not lead to a patent.
Rule 28(4) EPC now stipulates that the expert option used by the applicant will apply for twenty years from the date of filing if the application has been refused or withdrawn or deemed to be withdrawn. This amendment is also in line with the solution opted for in the draft EU directive on the legal protection of biotechnological inventions.
2.4 Certification of requests for issue of a sample after grant of the European patent (Rule 28(7) EPC)
In recent years, one or two problems have arisen about who - EPO or national offices - is responsible for certification at the post-grant stage. Although certification powers pre-grant lie exclusively with the EPO, it is not clear from the wording of the old version of Rule 28(7) EPC what the situation is as regards the post-grant period.
Under Rule 28(3) EPC, a sample is issued only if the requester has undertaken vis-à-vis the applicant or proprietor of the patent to observe certain obligations until such time as the application ceases to exist or the European patent has expired in all designated contracting states. It is therefore up to the EPO to verify the legal status of the application or patent, possibly over a long period of time. In addition, extension of the expert option will prolong the period in which certification will require verification of status.
The last sentence of Rule 28(7) EPC now stipulates that after grant of the European patent, the request for issue of a sample of the deposited biological material is also to be submitted to the European Patent Office.
3. Amendments to Rule 28a EPC
These amendments only involve replacing the word "micro-organism" by "biological material".
4. Main measures for implementing the amendments
4.1 The new version of the request for grant form (EPA/EPO/OEB Form 1001 10.96), published in issue No. 9/1996 of the Official Journal (OJ EPO 1996, 524), takes account of the amendments to Rule 28 EPC. These amendments will also be incorporated into the next edition of the form for Entry into the regional phase before the EPO as designated or elected Office (EPA/EPO/OEB Form 1200).
4.2 A new version of the forms to be used when requesting samples of the biological material deposited (EPA/EPO/OEB 1140/1141/1142) will be published shortly.
4.3 An updated version of the notice of the EPO dated 18 July 1986 (OJ EPO 1986, 269) concerning European patent applications and European patents in which reference is made to micro-organisms will be published in a forthcoming issue of the OJ EPO.
4.4 The Guidelines for Examination in the EPO will be amended at the next revision in order to take account of the amendments to Rules 28 and 28a EPC.