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Regulation on the deposit of biological material in patent and utility model procedures

Original Language Title: Verordnung über die Hinterlegung von biologischem Material in Patent- und Gebrauchsmusterverfahren

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Regulation on the deposit of biological material in patent and utility model procedures (Biomaterials deposit regulation-BioMatHintV)

Unofficial table of contents

BioMatHintV

Date of completion: 24.01.2005

Full quote:

" Biomaterials deposit regulation of 24 January 2005 (BGBl. 151) "

Footnote

(+ + + Text evidence from: 28.2.2005 + + +) 

Unofficial table of contents

Input formula

Pursuant to Section 34 (8) of the Patent Law, as amended by the Notice of 16 December 1980 (BGBl. 1981 I p. 1), which was last amended by Article 7 (16) (b) and (c) of the Law of 13 December 2001 (BGBl). 3656), and Section 4 (7) of the German Utility Model Act, as amended by the Notice dated 28 August 1986 (BGBl. 1455), most recently by Article 8 (1) (a), (c) and (d) of the Law of 13 December 2001 (BGBl I). 3656), respectively in conjunction with Section 1 (2) of the DPMA Regulation of 1 April 2004 (BGBl. 514), the German Patent and Trademark Office (Deutsche Patent-und Markenamt) is responsible for: Unofficial table of contents

§ 1 Need for deposit; biological material

(1) An invention relates to biological material which is not accessible to the public and which can not be described in the patent or utility model application in such a way that a person skilled in the art can carry out this invention afterwards, or includes the following: If the use of such a material is used, the description for the application of the patent or utility model right shall be deemed sufficient only if:
1.
the biological material has been deposited, at the latest on the date of notification or, if a priority has been claimed, on the priority date at a recognised deposit;
2.
the application contains the relevant information which is known to the applicant in respect of the characteristics of the deposited biological material; and
3.
in the application, the deposit and the file number of the deposit are indicated.
(2) Biological material within the meaning of this Regulation is a material which contains genetic information and which can itself be reproduced or reproduced in a biological system. (3) If the biological material is already from a third party, , no further deposit shall be required, provided that the first deposit ensures the exportability of the further invention for the time period laid down in § 7. Unofficial table of contents

§ 2 Recognizing deposit offices

The international deposit agencies are recognised as having this status under Article 7 of the Budapest Treaty of 28 April 1977 on the international recognition of the deposit of micro-organisms for the purposes of patent procedures (BGBl. 1104), and those scientifically recognised bodies which provide the guarantee for the proper storage and publication of samples in accordance with this Regulation, and are legally, economically and organizationally independent of the applicant and the backers. Unofficial table of contents

§ 3 Representing the file number of the deposit

(1) If, on the basis of the application documents, a clear assignment of the application to the deposited biological material is already possible, the file number of the deposit can be submitted to the following documents:
1.
in the case of utility model applications, within one month after the date of submission;
2.
in the case of patent applications, within a period of 16 months from the date of filing of the application or, if a priority has been claimed, after the priority date. The time limit shall be deemed to have been observed if the file number has been notified to the conclusion of the technical preparations for the publication of the disclosure document in accordance with § 32 (5) of the Patent Law.
(2) The time limit for submission shall, however, end no later than one month after the notification to the applicant that a right of access to the file exists in accordance with Section 31 (1) sentence 1 of the Patent Law, or in the case of early disclosure at the latest with the levy the declarant's declaration pursuant to section 31 (2) (1) of the Patent Act. Unofficial table of contents

§ 4 Release declaration

(1) The applicant has unreservingly provided the deposited biological material of the deposit office from the date of the application for the publication of samples in accordance with § 5 for the period of storage specified in § 7, by issuing an irrevocable declaration. To be made available. In the case of third parties, the applicant must prove, by submitting documents, that the deposited biological material has been made available by the depositor in accordance with the first sentence. (2) The applicant has to do so with regard to the deposit to make an irrevocable commitment to re-deposit or to have it carried out by a third party in accordance with § 9. Unofficial table of contents

§ 5 Access to biological material

(1) The biological material deposited shall be made available upon request by the publication of a sample.
1.
until the publication of the disclosure document in accordance with Section 32 (5) of the Patent Law or until the registration of the utility model only
a)
for the backers,
b)
for the German Patent and Trademark Office on request or
c)
for the applicant or any other third party, if the applicant is based on a decision of the German Patent and Trademark Office pursuant to Section 31 (1) sentence 1 of the Patent Act or § 8 (5) sentence 2 of the Utility Model Law or the decision of a a court has the right to obtain a sample or the depositor has consented in writing to the submission of the sample;
2.
from the publication of the disclosure document in accordance with Section 32 (5) of the Patent Act to the grant of the patent for everyone; at the request of the backer, access to the deposited biological material shall only be given by the issument of a sample an independent expert appointed by the applicant;
3.
after the grant of the patent or a supplementary protection certificate, or after the registration of the utility model, irrespective of a subsequent revocation or a declaration of invalidity of the patent or supplementary protection certificate or a later date of application of the patent Deletion of the utility model for everyone.
(2) In the event of a refusal or withdrawal of the application, access to the deposited biological material as referred to in paragraph 1 (1) (c) and (2) shall, at the request of the backer, be granted for a period of 20 years from the date of notification only by: Publication of a sample to an independent expert appointed by the applicant. (3) The expert referred to in paragraph 1 (2) and (2) may be appointed as an expert.
1.
any natural person to which the applicant and the depositor have agreed;
2.
any natural person who is recognised as an expert by the President of the German Patent and Trademark Office.
(4) The applicants ' applications under paragraph 1 (2) and (2) shall be submitted to the German Patent and Trade Mark Office and may only be submitted up to the date on which the technical preparations for the publication of the Disclosure notice pursuant to § 32 (5) of the Patent Act or for the registration of the utility model as concluded. (5) The application for access to biological material is to be made using the form issued for this purpose by the German Patent and Trademark Office. The German Patent and Trade Mark Office certifies on the form that a patent application or a utility model application has been filed, which refers to the deposit of the biological material, and that the applicant or the applicant He is entitled to issue a sample of this material. The application must also be submitted to the German Patent and Trademark Office after the grant of the patent or the supplementary protection certificate, or after registration of the utility model. (6) The German Patent and Trademark Office shall forward the deposit to the filing office and the applicant or the holder of the right of protection, and, in the case of third parties, a copy of the application with the confirmation provided for in the second sentence of paragraph 5, including the depositors. Unofficial table of contents

§ 6 Declaration of Commitment

(1) A sample shall be issued only if the applicant is also obliged to respect the applicant and, in the case of third parties, also to the depositor, for the duration of the effect of all the protective rights which have been laid down for the purpose of the filing of the test. biological material,
1.
to make no sample of the deposited biological material or any material derived therefrom accessible to third parties; and
2.
do not use any sample of the deposited biological material or any material derived therefrom, other than for experimental purposes, unless the applicant or the holder of the right of protection, in the case of third parties, in addition to the depositors, Expressly renounce such an obligation. The obligation to use the biological material only for experimental purposes shall lapse if the applicant uses this material on the basis of a compulsory licence or a state-of-the-art use order.
(2) Where the sample is issued to an independent expert, the independent expert shall make the declaration of commitment referred to in paragraph 1. The applicant shall be considered a third party within the meaning of paragraph 1 (1) to the expert. Unofficial table of contents

§ 7 Retention

The biological material deposited shall be retained for a period of five years from the date of receipt of the last application for the submission of a sample, but at least five years beyond the maximum period of protection of all the rights of protection laid down by law, which shall be subject to the following conditions: biological material, in addition. Unofficial table of contents

§ 8 Deposit in accordance with the Budapest Treaty

In the case of a deposit under the Budapest Treaty, the release declaration, the issuance of rehearsals, the declaration of commitment and the period of retention shall be governed exclusively by the rules of the Budapest Treaty and by the previous order of execution (BGBl. 1980 II p. 1104, 1122), as amended. Unofficial table of contents

§ 9 Re-deposit

(1) If the biological material deposited in accordance with this Regulation is no longer accessible at the recognised deposit, a new deposit shall be allowed under the same conditions as those of the Budapest Treaty and shall be subject to request (2) The biological material shall be re-deposited within a period of three months from the date of the request of the depositary body referred to in paragraph 1. (3) Each renewed deposit shall be one of the depositors shall be accompanied by a signed declaration confirming that the the biological material deposited is the same as the material originally deposited. Unofficial table of contents

§ 10 Cooperation with the German Patent and Trademark Office

The German Patent and Trade Mark Office gives the filing offices all the information necessary to carry out their duties. Unofficial table of contents

Section 11 Transitional regime

This Regulation shall not apply to applications for patent or utility model applications filed before their entry into force. Unofficial table of contents

§ 12 Entry into force

This Regulation shall enter into force on 28 February 2005.