World Intellectual Property Organization

PCT NEWSLETTER

www.wipo.int/pct/en

November 2014 | No. 11/2014

 

Practical Advice

The filing of international applications containing references to microorganisms (or other biological material)

Q: I will shortly be filing an international application in respect of an invention pertaining to the field of biotechnology and I would like to know whether it should contain any reference to the microorganism which was deposited with a depositary institution when I filed my national application. If so, what kinds of indications are required, and when must they be provided?

A: The PCT does not contain any express provision making it mandatory for an international application to include a reference to a deposited microorganism or other biological material (hereinafter “microorganism”) to which it relates. It merely prescribes that if such a reference is made, it shall be made in accordance with the provisions of Rule 13bis, and if so made, it will be considered as satisfying the requirements of the national law of each designated State with regard to the contents of such references and the time limit for furnishing them (PCT Rule 13bis.2).

It is nevertheless highly recommended to include a reference to the deposit of a microorganism in an international application whenever the national law of at least one of the designated States provides for making such a reference for the purposes of adequately disclosing an invention. Annex L of the PCT Applicant’s Guide lists those national/regional Offices of, or acting for, the Contracting States, the national laws of which provide for references to deposited microorganisms to be made for the purposes of patent procedure.

PCT Rule 13bis.3(a) requires the following indications to be included in a reference to a deposited microorganism:

– the name and address of the depositary institution with which the deposit was made; 

– the date of the deposit; 

– the accession number given to the deposit by that institution; and

– any additional matter that may be required as notified to the International Bureau (IB) under PCT Rule 13bis.7(a)(i) – some Contracting States require indications in addition tothose prescribed in Rule 13bis.3(a), such as a short description of the characteristics of the microorganism, to the extent available to the applicant. Annex L of the PCT Applicant’s Guide sets out, for each national (or regional) Office concerned, any additional indications that are required.

With regard to the time limit for including a reference to a deposited microorganism in an international application, PCT Rule 13bis.4(a) requires that any indications be furnished within 16 months from the priority date, or at the latest, before the completion of the technical preparations for international publication. However, earlier time limits may apply in the following circumstances:

– where a designated State has notified the IB that its national law requires the reference to be furnished at an earlier time (PCT Rule 13bis.4(b)); or

– where an early publication of the international application has been requested, in which case any reference to a deposited microorganism should be furnished by the time such a request is made (PCT Rule 13bis.4(c)).

It is important to note that a number of Offices (15 according to the information provided to the IB by designated (or elected) Offices, and as currently published in Annex L of the PCT Applicant’s Guide) have notified the IB, in accordance with PCT Rule 13bis.7(a)(ii), that they require that such indications be made at the time of filing. It is therefore a best practice to furnish the indications at the time of filing. Note that any reference to a deposited microorganism, if not furnished within the applicable time limit, may be considered by a designated Office as not having been furnished in time.

With regard to the form of the reference to a deposited microorganism, it is highly recommended that you include any such reference in the description, as is required under the national law applied by a number of designated Offices, for example, the Japan Patent Office and the Korean Intellectual Property Office (see Annex L of the PCT Applicant’s Guide for further details of the requirements of the Offices concerned). However, if the reference is not included as text in the description, it may be made on a separate sheet, preferably on Form PCT/RO/134 (Indications Relating to Deposited Microorganism or other Biological Material), available at: http://www.wipo.int/pct/en/forms/ro/editable/ed_ro134.pdf and numbered as a sheet of the description.

If the reference is included in the description, you should not mark the check-box in Box No. IX of the request form referring to “separate indications concerning deposited microorganism or other biological material”. However, if the form is submitted at the same time as the international application, but separately from the international application body itself, you would need to mark that check-box. Note, however, that it is recommended that you only do that if the reference to the microorganism has already been included in the description, but you wish to communicate further information in Form PCT/RO/134.

Where an international application is prepared using the PCT-SAFE software (see “Biology” tab), that software automatically generates a version of that form if the corresponding indications are made. Where the indications relating to the deposit of microorganisms have been included in the description and the international application has been prepared using the PCT-SAFE software, the page and line number or the paragraph number(s) of where such indications have been made should be entered in the appropriate fields.

When filing an international application using the ePCT-Filing function, you can, under the “Biology” tab, click a button marked “Add” to:

– prepare Form PCT/RO/134 online; or

– attach an existing Form PCT/RO/134.

When clicking the “Add” button, you will see a statement that the description of the international application as filed contains references to deposited microorganisms and/or other biological material.

A reference to a deposited microorganism shall be considered to be made for the purposes of all designated States, unless it is clearly indicated that it is being made for the purposes of some of the designated States only. Furthermore, references to different deposits of microorganisms may be made for different designated States.

Although no check is made in the international phase to determine whether a reference to a microorganism has been furnished within the prescribed time limit, where the indications are received after the technical preparations for international publication have been completed, the IB will notify the designated Offices of the date on which any indications not included in the international application as filed were furnished to it. Failure to include a reference to a deposited microorganism (or to include any particular indication required in such a reference) in the international application as filed, or failure to furnish it (or the indication) within the prescribed time limit, would have the same consequence before a particular designated Office as would apply under the national law applied by that Office.

For further information on the inclusion of references to microorganisms, see the PCT Applicant’s Guide, International Phase, paragraphs 11.075 to 11.087.  PCT Newsletter No. 09/2014 included general information on the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure, as well as statistics on the number of deposits and samples of microorganisms or other biological material furnished under the Treaty; see:

http://www.wipo.int/edocs/pctndocs/en/2014/pct_news_2014_9.pdf

For detailed information on, inter alia, the kinds of microorganisms accepted by the international depositary authorities (IDAs) under the Budapest Treaty, as well as the contact details and fees charged by the IDAs, please refer to the Budapest Treaty website at:

http://www.wipo.int/budapest

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