Swiss International Depositary Authority for biological material

February, 2017

Culture Collection of Switzerland AG (CCOS) acquires the status of International Depositary Authority (IDA) under the Budapest Treaty

Since January 2017, Culture Collection of Switzerland AG (CCOS), a depositary institution where deposits of microorganisms and other biological material may be made, has acquired the status of International Depositary Authority (IDA) under the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure. The name and address of the depositary institution are:

Culture Collection of Switzerland AG (CCOS)
Einsiedlerstrasse 34
8820 Waedenswil
Switzerland

The purpose of an International Depositary Authority (IDA) under the Budapest Treaty is to help applicants to comply with the formal requirements for obtaining patent protection for inventions involving biological material (see below)

Patent protection for inventions involving biological material

Introduction

There are four basic requirements for patentability of an invention (Art. 52(1) European Patent Convention - EPC); (1) there must be an invention; (2) the invention must be susceptible of industrial application; (3) the invention must be new; and (4) the invention must involve an inventive step.

In addition to these four basic requirements, the following important requirement must be also considered when patentability of an invention is assessed: the invention must be such that it can be carried out by a person skilled in the art after proper consideration of information and instructions provided in the patent application (Art. 83 EPC). But how is this criteria satisfied for biotechnological inventions that involve biological material which cannot be properly described in the patent application?

Definitions

In principle, biotechnological inventions are patentable under the European Patent Convention (EPC) and are inventions that concern a product consisting of or containing biological material or a process by means of which biological material is produced, processed or used. According to the EPC, the biological material is any material containing genetic information and capable of reproducing itself or being reproduced in a biological system.

According to the practice of the European Patent Office, biotechnological inventions are also patentable if they concern biological material that is isolated from its natural environment or produced by means of a technical process even if it previously occurred in nature (Rule 26 EPC). However, this may not be the case according to the patent practice of other patent offices, such as the United States Patent and Trademark Office (USPTO).

Availability to the Public

As mentioned above, according to Article 83 EPC, the patent application shall disclose the invention in a manner sufficiently clear and complete for it to be carried out by a person skilled in the art. When biological material is involved, it has to be assessed whether or not the biological material is available to the public. There are several possibilities. The biological material may be known to be readily available to the public, for example baker's yeast or Bacillus natto, which is commercially available. It may be also a standard preserved strain, or another biological material which has been preserved in a recognised depositary institution and is available to the public without restriction. It is also possible to provide in the patent application sufficient information as to the identifying characteristics of the biological material and as to the prior availability to the public without restriction in a depositary institution recognised for this purpose (Guidelines for Examination (European Patent Office), Part F, Chapter III-6 Inventions relating to biological material).

Thus if an invention involves the use of or concerns biological material which is not available to the public and which cannot be described in the patent application in such a manner as to enable the invention to be carried out by a person skilled in the art, it is necessary (Rule 31 EPC) (1) to deposit a sample of the biological material with a recognised depositary institution on the same terms as those laid down in the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure of 28 April 1977 no later than the date of the filing of the patent application; (2) to provide such relevant information as is available to the applicant on the characteristics of the biological material; and (3) to state in the patent application the depositary institution and the accession number of the deposited biological material.

If, however, insufficient or no information on public availability of biological material is provided in the patent application, it can then be assumed that the biological material is not available to the public and the consequence can be that a person skilled in the art cannot carry out the invention (failure to comply with Art. 83 EPC and therefore failure to comply with one of the patentability conditions).

Deposit of biological material - Formal aspects

The deposit of biological material must be done with a depositary institution recognised as an International Depositary Authority under the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure of 28 April 1977. Useful information for deposits can be found at http://www.wipo.int/treaties/en/registration/budapest/

In order to ensure the valid deposit of a biological material it is highly recommended to do it as soon as possible, i.e. before filing the first (priority) patent application. Indeed, once a biological material is deposited, a viability test is carried out by the depositary institution and if this test is negative, the deposit is not acknowledged and a new deposit should be carried out. This may have a negative impact if the patent application has been already filed.

If the depositor and applicant of the patent application are not identical, it is necessary to provide a relevant document which indicates that the depositor has authorised the applicant to refer to the deposited biological material in the patent application and has given his unreserved and irrevocable consent to the deposited material being made available to the public. The depositor's authorisation for the applicant to refer to the deposit and his consent to the material being made available to the public must have existed as from the filing date of the patent application mentioning the deposit (Guidelines for Examination (European Patent Office), Part A, Chapter IV-4 Applications relating to biological material).

It is also necessary to consider transferring / changing the name of the depositor of a biological material in situations where the corresponding patents / patent applications are transferred to another owner or applicant.

For inventions based on biological material of plant or animal origin or using such material, it is recommended that the application should, where appropriate, include information on the geographical origin of such material, if known (Guidelines for Examination (European Patent Office), Part F, Chapter III-6 Inventions relating to biological material).

Andrea Manola - February 2017

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