Pages 230-245

D. PATENTABILITY

D.3 Biological material

Notice from the European Patent Office dated 7 July 2010 concerning inventions which involve the use of or concern biological material

OJ EPO 2010, 498

The present notice is intended to update and consolidate the information given in the "Notice of the EPO dated 18 July 1986 concerning European patent applications and European patents in which reference is made to micro-organisms" (OJ EPO 1986, 269) with the "Notice of the President of the EPO dated 28 July 1981 concerning the procedure for informing the EPO that the 'expert' option (Rule 28, paragraph 4, EPC) has been chosen, and the publication of that fact" (OJ EPO 1981, 358), the notice regarding "Conversion of deposits of micro-organisms made outside the purview of the Budapest Treaty to deposits made within the purview of the Budapest Treaty" (OJ EPO 1991, 461) and the "Notice dated 1 October 1996 concerning the main amendments to Rules 28 and 28a EPC" (OJ EPO 1996, 596).

A. Disclosure of biological material

I. European patent applications

1. Applications to which the special requirements with regard to biological material apply

1.1 "Biological material" means any material containing genetic information and capable of reproducing itself or being reproduced in a biological system (Rule 26(3) EPC).

1.2 If an invention involves the use of or concerns biological material which is available to the public - for example strains held in the public collections of recognised depository institutions and accessible without restriction - or which is described in the European patent application in such a manner as to enable the invention to be carried out by a person skilled in the art, the special requirements with regard to biological material do not apply (see Guidelines for Examination in the EPO (Guidelines) C-II, 6.2).

1.3 If, on the contrary, an invention involves the use of or concerns biological material which is not available to the public and which cannot be described in the European patent application in such a manner as to enable the invention to be carried out by a person skilled in the art, the invention shall only be regarded as being disclosed as prescribed in Article 83 EPC if the requirements set out in Rule 31 EPC have been fulfilled.

1.4 Where a European patent application claims the priority of a previous application in accordance with Articles 87 to 89 EPC, the invention is only considered disclosed in the previous application for the purposes of Article 87(1) EPC, if the deposit of the biological material was made no later than the date of filing of the previous application whose priority is claimed. The depository institution and the legal statute under which the biological material is deposited must comply with the requirements of the country in which the previous application was filed. The previous application must also refer to this deposit in a manner enabling it to be identified. For the purposes of disclosure of the invention in the European patent application claiming priority however, the requirements of Rule 31 EPC must be fulfilled, i.e. the deposit must have been effected with a recognised depository institution under the Budapest Treaty not later than the date of filing of the European patent application (see infra point 2.). Where the deposit of the biological material referred to in the European patent application is not the same as the deposit referred to in the previous application, it is up to the applicant, if the EPO considers it necessary, to provide evidence that the biological material is identical.

1.5 Where a European patent application is filed by reference to a previously filed application in accordance with Rule 40(1)(c) EPC and the previously filed application referred to already satisfied the requirements of Rule 31(1) EPC on its date of filing, these requirements will also be satisfied in respect of the European patent application (see Guidelines A-IV, 4.1.2).

2. Deposit, conversion and new deposit of biological material (Rules 31(1)(a) and 34 EPC)

2.1 To meet the requirements of Article 83 EPC in conjunction with Rule 31 EPC, a sample of the biological material must have been deposited with a recognised depositary institution on the same terms as those laid down in the Budapest Treaty1 not later than the date of filing of the European patent application.

2.2 Recognised depository institutions are the international depository authorities under the Budapest Treaty2 as well as depository institutions recognised by the EPO by virtue of a bilateral agreement. In accordance with Rule 33(6) EPC, the EPO regularly publishes in the Official Journal (usually in the April issue) an up-to-date list of the recognised depository institutions.3

2.3 Information regarding the general requirements for deposit as well as the specific requirements of individual international depository authorities, in particular with regard to the kinds of microorganisms accepted, fees etc., is contained in the "Guide to the Deposit of Microorganisms under the Budapest Treaty".4

2.4 Where a deposit was originally not made under the Budapest Treaty, it must be converted to a deposit made within the purview of the Budapest Treaty no later than the date of filing of the European patent application in order to fulfil the requirement of Rule 31(1)(a) EPC5 (see also supra point 1.4).

2.5. If biological material deposited in accordance with Rule 31 EPC ceases to be available from the recognised depository institution - either because the material has degraded such that it is no longer viable or due to the fact that the depository institution no longer qualifies for that kind of micro-organism - an interruption in availability shall be deemed not to have occurred if within the ruling period pursuant to Art. 4(1)(d) or (e) Budapest Treaty a new deposit is made with a recognised depository institution and if a copy of the receipt of the new deposit issued by the depository institution is forwarded to the EPO within four months of the date of the new deposit, stating the number of the European patent application or of the European patent concerned (see Rule 34 EPC and Guidelines A-IV, 4.1.1).

3. Information with regard to the biological material and the deposit to be given in the application, in particular in case of a deposit by a person other than the applicant

3.1 The application as filed shall give such relevant information as is available to the applicant on the characteristics of the biological material (Rule 31(1)(b) EPC). Further details on the relevant information under this provision are given in part C-II, 6.3 of the Guidelines.

3.2 Furthermore, the depository institution and the accession number of the deposited biological material are to be stated in the application (Rule 31(1)(c) EPC). This information may be submitted:

• within sixteen months after the date of filing of the European patent application or, if priority is claimed, after the priority date; this time limit is deemed to have been met if the information is communicated before the technical preparations for publication of the application are completed (Rule 31(2)(a) EPC);
• up to the date of submission of a request for early publication of the application under Article 93(1)(b) EPC (Rule 31(2)(b) EPC);
• within one month after the EPO has communicated to the applicant that a right to inspection of the files, pursuant to Article 128(2) EPC, exists (Rule 31(2)(c) EPC).

The ruling period is the one which is the first to expire.

3.3 Applicants are strongly advised to file the deposit receipt issued by the recognised depository institution in order to enable the EPO to ascertain whether the requirements laid down in Rule 31(1) EPC have been fulfilled. Where the accession number is not yet known to the applicant or not submitted to the EPO at the date of filing, the deposit must be identified in the patent application as filed in such a way that the later submitted accession number can be traced back without ambiguity. This can normally be done by indicating the identification reference given by the depositor to the biological material within the meaning of Rule 6.1(iv) of the Budapest Treaty (see Guidelines A-IV, 4.2 and G 2/93, OJ EPO 1995, 275).

3.4 Where the biological material has not been deposited by the applicant, the name and address of the depositor must be stated in the application and a document must be submitted to the EPO within the ruling period specified in Rule 31(2) EPC (see supra point 3.2) providing evidence that the depositor has authorised the applicant to refer to the deposited biological material in the application and has given his unreserved and irrevocable consent to the deposited material being made available to the public in accordance with Rule 33 EPC (Rule 31(1)(d) EPC).

3.5 The depositor's statement of authorisation and consent may be worded as follows:

"The undersigned, ... [name and full address of the depositor] has deposited with ... [name of recognised depository institution] under accession number ... biological material on the same terms as those laid down in the Budapest Treaty. The undersigned depositor authorises ... [name of applicant] to refer to the aforementioned deposited biological material in European patent application No. ... [where this is not available, applicant's/representative's reference number] and gives his unreserved and irrevocable consent to the deposited material being made available to the public in accordance with Rule 33 EPC as from the date of filing of the aforementioned European patent application."

3.6 In this context it is important to note that the applicant must have been authorised to refer to the deposited biological material and the depositor must have consented to it being made available to the public as from the date of filing, i.e. the authorisation and consent of the depositor must have been existent as from this date. It is only the corresponding information, i.e. the name and address of the depositor, and the proof of the consent and authorisation in the form of the statement from the depositor which may be submitted after the date of filing within the applicable period under Rule 31(2) EPC.

3.7 Attention is drawn to the fact that only under very restricted circumstances two legally independent entities (such as a parent and subsidiary company) may be considered the same person for the purpose of Rule 31(1)(d) EPC (see T 118/87, OJ EPO 1991, 474). In case of doubt, applicants are therefore strongly recommended to ensure the depositor's authorisation and consent as from the date of filing and to file the information and evidence required under Rule 31(1)(d) EPC within the time limit specified in Rule 31(2) EPC.

3.8 Where there are two or more applicants, it is sufficient for the purpose of Rule 31(1)(d) EPC if the deposit was made by one of the applicants or, if the deposit was made by someone else, that the depositor has authorised one of the applicants to refer to the deposited biological material.

3.9 Communication of the name of the depository institution and the accession number as well as, where applicable, of the information and evidence pursuant to Rule 31(1)(d) EPC within the applicable time limit constitutes the unreserved and irrevocable consent of the applicant to the deposited material being made available to the public in accordance with Rule 33 EPC (Rule 31(2), sentence 2, EPC).

3.10 Consequence of the failure to comply with the requirements of Rule 31 EPC, on the contrary, is that the biological material cannot be considered as having been disclosed pursuant to Article 83 EPC by way of reference to the deposit (see Guidelines C-II, 6.3). The information provided for in Rule 31(1)(c) and, where applicable, (d) EPC may not be submitted after expiry of the time limit set out in Rule 31(2) EPC since the time limit under Rule 31(2) EPC is excluded from further processing by Rule 135(2) EPC and because a lack of disclosure cannot be remedied by way of re-establishment under Article 122 EPC (see G 2/93, op. cit.).

3.11 In order for the EPO to be able to draw the applicant's attention to any deficiencies under Rule 31(1) EPC before the time limits laid down in Rule 31(2) EPC expire, it is of utmost importance that applicants duly complete sections 34 to 37 ("Biological material") of the Request for Grant form (EPO Form 1001). In addition, it is reiterated that applicants are strongly recommended to file the deposit receipt issued by the recognised depository institution, if available already at the date of filing.

4. Choice of the expert solution under Rule 32 EPC

4.1 Until completion of the technical preparations for publication of the application, the applicant may inform the EPO that, until the publication of the mention of the grant of the European patent or, where applicable, for twenty years from the date of filing if the application is refused or withdrawn or deemed to be withdrawn, the availability to the public of the deposited biological material referred to in Rule 33 EPC shall be effected only by the issue of a sample to an expert nominated by the requester (Rule 32(1) EPC).

4.2 The information under Rule 32(1) EPC must be supplied in the form of a written statement and separate from the description and the claims. It shall preferably be given in box 37 of EPO Form 1001. Alternatively, the statement that the expert solution has been chosen may be made on a separate sheet/letter and be phrased "Applicant makes use of Rule 32(1) EPC" or "Expert solution is requested".

4.3 The statement under Rule 32(1) EPC must be received before completion of the technical preparations for publication of the European patent application. If the declaration is admissible, it is mentioned on the front page of the published European patent application and the biological material will, in case of a request to the EPO from a third party, only be issued to an expert recognised by the President of the EPO or approved by the applicant (see infra B).

4.4 Information received under Rule 32(1) EPC after completion of the technical preparations for publication of the European application cannot be taken into account with the consequence that the biological material will be available to any person as provided for in Rule 33 EPC without an expert acting as intermediary (see infra B).

II. International patent applications designating or electing the EPO

5. The special requirements relating to the disclosure of inventions which involve the use of or concern biological material apply as well to international applications designating or electing the EPO, i.e. in order for biological material contained in an international application which is not available to the public and which cannot be sufficiently described to be considered disclosed for the purpose of the regional phase before the EPO, the application must comply with the requirements of Rule 13bis PCT in conjunction with Rule 31 EPC.

6. This means that a sample of the relevant biological material must have been deposited with a recognised depository institution not later than the international filing date, and to the extent available to the applicant, relevant information on the characteristics of the biological material must be given in the application.

7. In addition, pursuant to Rule 13bis.3(a) PCT6 the international application must contain a reference to the deposited biological material indicating:

(i) the name and the address of the depository institution with which the deposit was made

(ii) the date of deposit of the biological material with that institution

(iii) the accession number given to the deposit by that institution

(iv) where the biological material has been deposited by a person other than the applicant, the name and address of the depositor as well as the statement referred to supra points 3.4-3.6 (Rule 31(1)(d) EPC). In this context, attention is drawn to the fact that it is not sufficient if the depositor is one of the international applicants for a certain PCT member state (usually the US only as inventor-applicant) but not the applicant for the EPO. Rather the depositor must be (one of) the applicant(s) for the EPO, or else the requirements of Rule 31(1)(d) EPC must be fulfilled.

8. If any of the indications referred to in point 7 is not included in a reference to deposited biological material in the international application as filed, it may still be furnished to the International Bureau within a period of 16 months after the date of filing of the international patent application or, if priority is claimed, after the priority date; this time limit is deemed to have been met if the indication reaches the International Bureau before the technical preparations for international publication have been completed (Rule 13bis.4(a) PCT). Where the applicant makes a request for early publication under Article 21(2)(b) PCT, the indications must be furnished to the International Bureau at the latest before the completion of the technical preparations for international publication (Rule 13bis.4(c) PCT).

9. Where the EPO acts as receiving Office or International Searching Authority, it is intended to draw the applicant's attention to any deficiencies under Rule 13bis.3 PCT in conjunction with Rule 31(1) before expiry of the time limit pursuant to Rule 13bis.4 PCT. The applicant may not invoke the omission of such a reminder, though, which is a voluntary service from the EPO.

10. However, where the EPO does not act as receiving Office or International Searching Authority, the applicant's attention will generally not be drawn to any deficiencies with regard to the disclosure of inventions which involve the use of or concern biological material. Upon entry into the European phase, the time limit provided for in Rule 13bis.4 PCT will usually already have expired. The failure to meet the time limit cannot be remedied neither by re-establishment of rights nor by further processing. As a result, the application may have to be refused under Article 97(2) EPC in the course of examination proceedings for insufficient disclosure (Article 83 EPC). Applicants are therefore strongly recommended to file of their own motion a completed Form PCT/RO/1347 as well as the deposit receipt with the International Bureau before expiry of the applicable time limit (see supra point 8.). Where the deposit was made by a person other than the applicant, this should be indicated under point C of Form PCT/RO/134 and a "statement of authorisation and consent" should be filed in addition within the applicable time limit.

11. Until completion of the technical preparations for publication of the international application, the applicant may inform the International Bureau by a written statement that, until the publication of the mention of the grant of a European patent or for twenty years from the date of filing if the application is refused or withdrawn or deemed to be withdrawn, the biological material shall be made available as provided for in Rule 13bis.6 PCT and Rule 33(1) EPC only by the issue of a sample to an expert nominated by the requester (Rule 32(1) EPC). Such statement must be separate from the description and the claims of the international application and must preferably be made on Form PCT/RO/134. It will be published by WIPO on its Patentscope website.

12. If the international application was not published in an official language of the EPO (English, French, German), the statement under Rule 32(1) EPC can still be submitted in the European phase until completion of the technical preparations for publication of the translation of the international application under Article 153(4) EPC. The fact that the expert option has been chosen will then be published on the front page of the published translation of the application.

13. Information received under Rule 32(1) EPC after completion of the technical preparations for publication of the international application - or, where applicable, of the translation of the application pursuant to Article 153(4) EPC - cannot be taken into account with the consequence that the biological material will be available to any person as provided for in Rule 13bis.6 PCT and Rule 33(1) EPC without an expert acting as intermediary.

B. Availability of biological material deposited in accordance with Rule 31 EPC

14. Pursuant to Rule 33(1) EPC, biological material deposited in accordance with Rule 31 EPC is available upon request to any person from the date of publication of the application, and to any person having the right to inspect the files under Article 128(2) EPC prior to that date. By communicating the depository institution and the accession number as well as, where applicable, the information pursuant to Rule 31(1)(d) EPC to the EPO, the applicant has given his unreserved and irrevocable consent to the deposited biological material being made available to the public in accordance with Rule 33 EPC (Rule 31(2), last sentence, EPC).

15. Similarly, within the framework of the PCT, the communication of the indications referred to in point 7 is considered as constituting the unreserved and irrevocable consent of the applicant to the deposited material being made available to the public. In accordance with Rule 13bis.6, last sentence, PCT and Rule 33 EPC, biological material deposited with regard to an international application designating or electing the EPO is therefore available upon request to any person from the date of international publication or, where the international publication was not made in an official EPO language, from publication of the translation of the application under Article 153(4) EPC.

16. The availability of the biological material is not limited in time, i.e. it is not affected neither by the refusal or withdrawal of the application nor by the lapse of the patent or expiration of the patent term (Article 83 and Rule 33 in conjunction with Rule 32 EPC; Rule 9.1 Budapest Treaty). The depositor may not withdraw the deposit before the period specified in Rule 9.1 Budapest Treaty (see Rule 6.1(a)(i) Budapest Treaty).

17. The availability of the biological material is effected by the issue of a sample of the biological material to the requester. Where the applicant has made a declaration under Rule 32(1) EPC, the availability to the public is effected by the issue of a sample to a nominated expert until the publication of the mention of the grant of the European patent or, where applicable, for twenty years from the date of filing if the application is refused or withdrawn or deemed to be withdrawn.

18. Requests for the issue of samples of biological material must be submitted using EPO Forms 1140 and 1141 which can be downloaded from the EPO website.8

19. EPO Form 1140 constitutes the request proper whereas EPO Form 1141 contains the declaration under Rule 33(2) EPC vis-à-vis the applicant for or proprietor of the patent not to make the biological material or any biological material derived therefrom available to any third party and to use that material for experimental purposes only, until such time as the patent application is refused or withdrawn or deemed to be withdrawn, or before the European patent has expired in all the designated states, unless the applicant for or proprietor of the patent has expressly waived such an undertaking (which can be derived from box 36 of EPO Form 1001 or, in case of an international application, from section 8 of EPO Form 1200).

20. Both forms must be duly signed by the requester. If the requester appoints a professional representative under Article 134 EPC, the representative, who must be duly authorised by virtue of a specific or general authorisation, may only sign EPO Form 1140, whereas EPO Form 1141 must be signed by the requester himself since these undertakings are not entered vis-à-vis the EPO.

21. Where the applicant has made an admissible declaration under Rule 32(1) EPC and unless the mention of the grant of the European patent has been published or, if the application has been refused, withdrawn or was deemed to be withdrawn, twenty years from the date of filing have expired, access to the deposited biological material may only be effected by the issue of a sample thereof to an expert nominated by the requester.

22. As an expert may be nominated any natural person provided that the requester furnishes evidence when filing the request that the nomination has the approval of the applicant, and any natural person recognised as an expert by the President of the EPO. The EPO publishes in its Official Journal the list of experts recognised for the purposes of Rule 32(2)(b) EPC, giving their particulars and their fields of activity.9 Information on the recognition as expert for the purpose of Rule 32 EPC can be found in OJ EPO 1981, 359.

23. Where the expert solution applies, EPO Form 1142 must be used by the requester for the purpose of nominating an expert. EPO Forms 1140 and 1141 must be signed by the expert (see Rule 32(2), sentence 2, EPC) or, where the expert acts through a professional representative - which must be different from the requester's representative, if applicable - only EPO Form 1141 must be signed by the expert personally whereas EPO Form 1140 may be signed by the representative.

24. In order that the right forms be used and that they be correctly signed, requesters are therefore advised to check prior to the submission of a request under Rule 33 EPC whether the expert solution applies which is derivable from the front page of the published European patent application or, in case of an international application, from WIPO's Patentscope website.

25. EPO Forms 1140, 1141 and 1142 are provided with notes explaining how they are to be completed and the procedure that is to be followed, which should be read carefully. Only one form needs to be used to request samples of different biological material referred to in one and the same application or patent. After grant of the European patent, the requests must also be submitted to the EPO (Rule 33(4) EPC).

26. On receiving a request under Rule 33 EPC, the EPO verifies that the prescribed forms have been correctly completed and signed. If this is the case, the EPO certifies on the form that an application referring to the deposit of the biological material has been filed, and that the requester or the expert is entitled to the issue of a sample of that material (Rule 33(4) EPC). The EPO transmits a copy of the request, with the certification, to the depository institution as well as to the patent applicant or the proprietor of the patent (Rule 33(5) EPC). Where the request under Rule 33(2) EPC does not comply with the requirements, the EPO informs the requester and invites him to remedy the deficiencies.

27. The EPO does not charge a fee for the handling of requests under Rule 33 EPC. Fees levied by the recognised depository institutions for the issuing of samples are payable to these authorities and can be found in Part II, Section D of the "Guide to the Deposit of Microorganisms under the Budapest Treaty".10

C. Previous notices from the EPO superseded

28. The present Notice shall supersede as from 1 January 2011 the "Notice of the EPO dated 18 July 1986 concerning European patent applications and European patents in which reference is made to micro-organisms" (OJ EPO 1986, 269), the "Notice of the President of the EPO dated 28 July 1981 concerning the procedure for informing the EPO that the 'expert' option (Rule 28, paragraph 4, EPC) has been chosen, and the publication of that fact" (OJ EPO 1981, 358), the notice regarding "Conversion of deposits of micro-organisms made outside the purview of the Budapest Treaty to deposits made within the purview of the Budapest Treaty" (OJ EPO 1991, 461) and the "Notice dated 1 October 1996 concerning the main amendments to Rules 28 and 28a EPC" (OJ EPO 1996, 596).