Why deposit biological material?
If an invention is not sufficiently disclosed in a patent specification then a patent application may be refused. For many inventions, a sufficient disclosure can be provided by a detailed description of the invention. However, when inventions involve biological material, for example microorganisms, this can create some difficulties since it is not always possible to adequately describe the biological material using words or figures. When such biological material is not publicly available, a deposit of the material can be made at an approved depositary (in accordance with the Budapest Treaty) to help fulfil the requirement for a sufficient disclosure.
What biological material can/should be deposited?
Biological material should be deposited if it is central to the invention and it is not possible to otherwise describe the biological material, for example by including the full genomic sequence of a microorganism.
There are no hard and fast rules as to whether biological material should be deposited, but generally speaking, it is better to err on the side of caution. For example, if the invention claims a plasmid having a particular DNA sequence and the patent specification sufficiently discloses how to modify an existing plasmid to arrive at the claimed plasmid, then arguably the deposit of the plasmid is not required. However, the deposit of the plasmid may still be useful in case a validity attack from a third party is encountered or in order to satisfy the patent filing requirements in other countries.
A range of biological material can be deposited including cells (such as bacteria, fungi, cell lines, algae and plant spores), genetic vectors (such as plasmids, phages and viruses), host organisms (such as bacteria containing vectors or modified gene sequences) and expression systems (such as cell lines, hybridomas, plant cell tissues, organelles, chromosomes and nucleic acids).
Where should the deposit be made?
The biological material must be deposited in a depositary institution (or an International Depositary Authority) which is recognised under the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure (known as the Budapest Treaty).
In the UK, there are currently seven institutions which are authorised under the Budapest Treaty: National Collections of Industrial, Food and Marine Bacteria (NCIMB); European Collection of Cell Cultures (ECACC); CABI Bioscience, UK Centre (IMI); National Collection of Yeast Cultures (NCYC); National Collection of Type Cultures (NCTC); Culture Collection of Algae and Protozoa (CCAP); and National Institute for Biological Standards and Control (NIBSC). The type of material to be deposited may dictate which institution to use.
A comprehensive list of institutions which currently handle biological deposits in Europe, the US, Japan and further afield can be found on the World Intellectual Property Organization (WIPO) website: http://www.wipo.int/treaties/en/registration/budapest.
When should a deposit be made?
The timing of depositing the biological material is extremely important. In the UK and Europe, along with many other major jurisdictions, the deposit must be made before the filing date (or priority date) of the patent application. If the deposit is not made before the filing date and the biological material is not publicly available or sufficiently described in the patent application, the deposit will not be taken into account and the patent application may be refused for a lack of a sufficient disclosure.
In general, the filing of deposits can take a number of days or weeks and so the process of submission should be started in good time before a filing deadline. The deposit requirements vary depending on the depositary institution, but will generally require completion of various forms and the submission of the biological material along with information regarding how the biological material is cultured.
It is important when depositing the biological material that the depository is informed that the deposit is for patent filing purposes and that the correct fee is paid. Failure to do so may lead to problems when relying on the biological deposit.
The depositary institution will confirm the viability of the sample and issue a confirmation of viability and an accession number. The name of the depositary institute and accession number should be included in the patent application although this can be added up to sixteen months after filing the patent application. It is best practice to also include the date of filing the deposit and the address of the depositary institute as this may be required by other jurisdictions.
Who should make the deposit?
The biological material should ideally be deposited by the applicant of the patent application. However, if the biological material is deposited by a person or legal entity different from the applicant, then a statement is required which identifies the name and address of the depositor, authorises the applicant to refer to the biological material in the patent application and irrevocably authorises access to the material. It is particularly important for companies to check whether this is required as it is not uncommon for a subsidiary or other group company to deposit the biological material, with another entity being listed as the applicant.
Strategic considerations
One thing to consider is that in the UK and Europe, Budapest Treaty deposits are made available to the public, although this is restricted until after publication of the patent application. Therefore, if public access to the biological material is unacceptable to the applicant, they should consider whether there are alternative approaches by which the biological material can be sufficiently disclosed.
Access to the deposit can also be restricted to an expert, if desired. This allows the biological sample to be released only to a nominated third-party expert. However, this can only be done until the patent is granted, or until 20 years from the patent filing date if the patent is refused or withdrawn and so this would not prevent public availability indefinitely.
It is possible to rely on deposits made significantly before the filing date of the patent application. However, the biological deposits must be available for the lifetime of the patent. The Budapest Treaty stipulates that any microorganism deposited with an International Depositary Authority shall be stored for at least five years after the most recent request for the sample and for at least 30 years after the date of deposit. However, if an applicant relies on a deposit made more than 10 years before the filing date, it could be argued by a third party that the deposit will not be available for the entire lifetime of the patent and this could result in the validity of the patent being questioned. Therefore, it is often beneficial to have a deposit made near the time of filing the patent application.
If a deposit in accordance with the requirements of the Budapest Treaty has not or cannot be made, potential sufficiency objections may be raised either by the Patent Office or a third party, in opposition proceedings for example. If this is the case, and the patent application has not yet been filed, it should be considered whether the biological material can be considered to be publicly available or can be otherwise sufficiently disclosed in the patent application. If the biological material is publicly available, it is advisable to indicate this in the patent application. A sufficient disclosure of the biological material could also be achieved by including genetic information and/or sequence listings, for example.
If the patent application has already been filed, it may still be possible to argue that the biological material was publicly available at the filing date or that the skilled person could obtain the biological material using their common general knowledge along with the information contained in the patent application. Alternatively, it may be possible to re-cast the invention or amend the patent application such that the claimed invention is no longer reliant on the biological material. Withdrawal of the patent application and re-filing, following a Budapest Treaty compliant deposit is also an option. However, this would result in loss of the earliest priority date and any disclosures since the original filing date would become relevant prior art.
In general, the best approach is to consider whether a biological deposit is required in the early stages of drafting a patent application and, if required, ensure the deposit is made before filing. Including genetic information regarding the biological material in the patent application as filed could be beneficial as it may be considered to provide sufficient disclosure of the invention.
If you have any questions or would like any further information regarding biological deposits please contact rachel.mercer@appleyardlees.com.
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