United Kingdom Statutory Instruments

(a) in the heading, for "Micro-organisms" substitute "Biological material";

(b) in the rule, for "require for their performance the use of micro-organisms" substitute "involve the use of or concern biological material".

(a) which is not available to the public at the date of filing the application; and

(b) which cannot be described in the specification in such a manner as to enable the invention to be performed by a person skilled in the art,

shall, in relation to the biological material itself, be treated for the purposes of the Act as disclosing the invention in such a manner only if one of the conditions set out in subparagraph (2) below is satisfied and the application as filed contains such relevant information as is available to the applicant on the characteristics of the biological material.

    (2) The conditions referred to in subparagraph (1) above are - 

(a) a condition that, - 


(i) not later than the date of filing of the application, the biological material has been deposited in a depositary institution which is able to furnish a sample of the biological material; and

(ii) the name of the depositary institution and the accession number of the deposit are given in the specification of the application; and

(iii) where the biological material has been deposited by a person other than the applicant, the name and address of the depositor are stated in the application and a document is filed satisfying the comptroller that the depositor has authorised the applicant to refer to the deposited 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 this Schedule; and



(b) a condition, in the case of a European patent (UK), an application for a European patent (UK) or an international application for a patent (UK) which is treated, by virtue of section 77, 81, or 89 as a patent under the Act, or, as the case may be, an application for a patent under the Act, that the corresponding provisions of the Implementing Regulations to the European Patent Convention or, as the case may require, the Patent Co-operation Treaty have been complied with,

and, where paragraph 5 below applies, a further condition that a new deposit has been made in accordance with that paragraph and the applicant or proprietor has made the request referred to in subparagraph (2)(b) of that paragraph within the period referred to in subparagraph (2) or, if applicable, (4) of that paragraph.

    (3) Where the information specified in subparagraph (2)(a)(ii) or (iii) above is not contained in an application for a patent as filed, it shall be added to the application - 

(a) before the end of the period of 16 months after the declared priority date or, where there is no declared priority date, the date of filing of the application;

(b) where a request is made by the applicant to the comptroller to publish the application before the end of the period prescribed for the purposes of section 16(1), on or before the date of that request; or

(c) where the comptroller sends notification to the applicant that, in accordance with subsection (4) of section 118, he has received a request by any person for information and inspection of documents under subsection (1) of that section, before the end of one month after his sending to the applicant notification of his receipt of the request,

whichever is the earliest.

    (4) The giving of the information specified in subparagraph (2)(a)(ii) above shall constitute the unreserved and irrevocable consent of the applicant to the depositary institution with which biological material (including a deposit which is to be treated as having always been available by virtue of paragraph 5(2) below) is from time to time deposited making the biological material available on receipt of the comptroller's certificate authorising the release to the person who is named therein as a person to whom the biological material may be made available and who makes a valid request therefor to the institution.

General availability of biological material
     2.  - (1) Save where paragraph 3 below has effect, a request may be made to the comptroller to issue a certificate authorising a depositary institution to make available a sample of biological material - 

(a) before publication of the application for a patent, to a person who has made a request under section 118(1) in the circumstances mentioned in paragraph 1(3)(c) above; and

(b) at any later time, to any person (notwithstanding revocation or cancellation of the patent).

    (2) A request under subparagraph (1) above shall be made on Patents Form 8/77 (which shall be filed in duplicate together, in the case of biological material which is deposited under the Budapest Treaty with an international depositary authority, with the form provided for by the Regulations under that Treaty).

    (3) On receipt of a valid request under subparagraph (1) above, the comptroller shall send copies of the form or forms lodged with him under subparagraph (2) above and of his certificate authorising the release of the sample - 

(a) to the applicant for, or proprietor of, the patent;

(b) to the depositary institution; and

(c) to the person making the request.

    (4) A request under subparagraph (1) above shall comprise, on the part of the person to whom the request relates, undertakings for the benefit of the applicant for, or proprietor of, the patent - 

(a) not to make the biological material, or any material derived from it, available to any other person; and

(b) not to use the biological material, or any material derived from it, otherwise than for experimental purposes relating to the subject matter of the invention,

and both undertakings shall have effect - 

(i) during any period before the application for a patent has been withdrawn, has been taken to be withdrawn, has been treated as having been withdrawn, has been refused or is treated as having been refused (including any further period allowed under rule 100 or rule 110(1) or (4) but excluding, where an application is reinstated under either of those rules, the period before it is reinstated);

(ii) if a patent is granted on the application, during any period for which the patent is in force and during the period of six months referred to in section 25(4).

    (5) For the purposes of enabling any act specified in section 55 to be done in relation to the biological material for the services of the Crown, the undertakings specified in subparagraph (4) above - 

(a) shall not be required from any government department or person authorised in writing by a government department for the purposes of this paragraph; and

(b) shall not have effect in relation to any such person who has already given them.

    (6) An undertaking given pursuant to subparagraph (4) above may be varied by way of derogation by agreement between the applicant or proprietor and the person by whom it is given.

    (7) Where, in respect of a patent to which an undertaking given pursuant to subparagraph (4) above has effect,

(a) an entry is made in the register under section 46 to the effect that licences are to be available as of right; or

(b) a compulsory licence is granted under section 48,

that undertaking shall not have effect to the extent necessary for effect to be given to any such licence.

    (8) In subparagraph (4) above, references to material derived from deposited biological material are references to material so derived which exhibits those characteristics of the deposited biological material essential for the performance of the invention.

Restriction of availability of biological material to experts
     3.  - (1) Subject to subparagraph (3) below, where before the preparations for publication under section 16 of an application for a patent have been completed, the applicant gives notice to the comptroller on Patents Form 8A/77 of his intention that a sample of the biological material should be made available only to an independent expert, the provisions of this paragraph shall have effect.

    (2) The comptroller - 

(a) shall publish, with the application, notice that the provisions of this paragraph have effect; and

(b) notwithstanding paragraph 2 above, shall not:


(i) until the grant of the patent; or, where applicable,

(ii) for 20 years from the date on which the patent application was filed if the application for the patent has been withdrawn, has been taken to be withdrawn, has been treated as having been withdrawn, has been refused or is treated as having been refused,



issue any certificate authorising release of a sample otherwise than under paragraph 4 below.

    (3) Where an applicant for an international application for a patent (UK) gives notice in writing to the International Bureau under rule 13bis.3 of the Regulations under the Patent Co-operation Treaty before the technical preparations for international publication of the application are complete of his intention that a sample of the biological material should be made available only to an expert, he shall be treated by the comptroller for the purposes of this paragraph as having complied with the conditions in subparagraph (1) above and subparagraph (2)(a) above shall not apply.

Request for a sample to be made available to an expert
     4.  - (1) Where the availability of samples is restricted to independent experts by paragraph 3 above, any person wishing to have a sample of the biological material made available ("the requester") - 

(a) shall apply to the comptroller on Patents Form 8/77 (which shall be filed in duplicate together, in the case of biological material which is deposited under the Budapest Treaty with an international depositary authority, with the form provided for by the Regulations under that Treaty) nominating the person ("the expert") to whom he wishes the sample to be made available; and

(b) shall at the same time file undertakings by the expert as set out in subparagraph (4) of paragraph 2 above and the provisions of that paragraph relating to undertakings shall also apply to the undertakings given by the expert.

    (2) The comptroller shall send a copy of Patents Form 8/77 filed under subparagraph (1) above to the applicant for the patent and shall specify the period within which the applicant may object, in accordance with subparagraph (3) below, to a sample of the biological material being made available to the expert.

    (3) Unless, within the period specified by the comptroller under subparagraph (2) above (or within such longer period as the comptroller may, on application made to him within that period, allow), the applicant for the patent sends notice in writing to the comptroller that he objects to a sample of the biological material being made available to the expert and gives his reasons for his objection, the comptroller shall send a copy of any form lodged with him under subparagraph (1)(a) above and of his certificate authorising the release of the sample - 

(a) to the applicant for the patent,

(b) to the depositary institution concerned,

(c) to the requester, and

(d) to the expert.

    (4) Where, in accordance with subparagraph (3) above, the applicant for the patent sends notice to the comptroller of his objection to the issue of a certificate in favour of the expert, the comptroller - 

(a) shall decide, having regard to the knowledge, experience, independence and technical qualifications of the expert and to any other factors he considers relevant, whether to issue his certificate in favour of the expert; and

(b) if he decides to authorise the release of the sample to the expert, shall send to the persons referred to in subparagraph (3) above a copy of any form lodged with him under subparagraph (1)(a) above and of his certificate authorising the release of the sample to the expert.

    (5) Before making a decision in accordance with subparagraph (4) above, the comptroller shall afford the applicant and the requester the opportunity of being heard.

    (6) If the comptroller decides under subparagraph (4) above not to issue his certificate in favour of the expert, the requester may, by notice in writing to the comptroller and the applicant, nominate another person as the expert for the purposes of this paragraph; and the comptroller shall give such directions as he shall think fit with regard to the subsequent procedure.

    (7) Nothing in this paragraph or paragraph 3 above shall affect the rights under section 55 of any government department or any person authorised in writing by a government department.

New deposits
     5.  - (1) This paragraph applies where - 

(a) biological material ceases to be available from the institution with which it was deposited because - 


(i) the biological material is no longer viable, or

(ii) for any other reason the institution is unable to supply samples, or



(b) the depositary institution - 



(i) ceases to be a depositary institution for the purposes of this Schedule, either entirely or for the kind of biological material to which the deposited sample belongs, or

(ii) discontinues, temporarily or permanently, the performance of its functions as regards deposited biological material,



and no sample of the biological material has been transferred to another depositary institution, from which it continues to be available.

    (2) An interruption in availabilty of the biological material shall be deemed not to have occurred if within a period of three months from the date on which the depositor was notified of the interruption by the depositary institution - 

(a) the depositor (or applicant or proprietor if different) makes a new deposit of a sample of that biological material; and

(b) the applicant or proprietor makes a request for amendment of the specification under section 19 or section 27, as the case may be, so as to indicate the accession number of the new deposit and, where applicable, the name of the depositary institution with which the deposit was made.

(a) Rules 3, 4, 5 and 6 make consequential changes to references and terminology in the 1995 Rules,

(b) Rule 7 substitutes updated versions of forms 8/77 and 8A/77 for those forms currently in Schedule 1 to the 1995 Rules,

(c) Rule 8 substitutes a new Schedule 2 to the 1995 Rules.

Schedule 2 to the 1995 Rules contains detailed provisions dealing with the deposit, access and re-deposit of biological material.

A regulatory impact assessment is available, copies of which have been placed in the libraries of both Houses of Parliament. Copies of the assessment are also available from the Intellectual Property Policy Directorate of the Patent Office, Room 3B38, Concept House, Cardiff Road, Newport NP10 8QQ.