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Patent deposits

NCTC and ECACC are long established International Depository Authorities (IDAs) for the deposit of pathogenic bacteria, cell lines and viruses for the purposes of patenting under the Budapest Treaty.  

NCTC accepts bacteria (including ACDP Hazard Group 3) as patent deposits. The bacteria can be preserved by freeze-drying without significant change to their properties and should be free-living and grow on ordinary laboratory culture media.

ECACC accepts human and animal cell lines including genetically modified lines up to GMO2, hybridomas and eukaryotic DNA as patent deposits. ECACC also accepts viruses, including ACDP Hazard Group 3 pathogens and viral recombinant DNA either as naked DNA or cloned into a host. The viruses are processed on behalf of ECACC by the National Collection of Pathogenic Viruses (NCPV) which is operated under the same management structure as ECACC and NCTC.

As IDAs, NCTC and ECACC are required to provide services on the same terms to every depositor. We will accept and store microorganisms deposited with us for the full period specified in the Treaty (at least 30 years or five years after the most recent request for a sample whichever is the later). Furthermore, we will release (furnish) samples of deposited microorganisms only to those entitled to receive them.

Every deposit is strictly confidential until the relevant patent is issued. It is assigned a unique accession number on arrival at NCTC or ECACC.  Accession numbers are provisional until the patent has proved viable and a pure culture (NCTC) or passed QC testing (ECACC).

 

Submit these forms:

1. Patent Deposit Submission Form

2. Biohazard Risk Assessment Form (a legal requirement in accordance with the UK Health and Safety Laws. Ensure the possible pathogenicity of the microorganism to humans is stated as well as the including the Genetically Modified Organism (GMO) status).

Biohazard Risk Assessment Form - Cell Lines

Biohazard Risk Assessment Form - Viruses

Biohazard Risk Assessment Form - Bacteria

The Public Health England Genetic Modification Safety Committee (GMSC) will review the Biohazard Risk Assessment. Any deposit classified as GMO category 2 or higher category cannot be accepted unless approved by both the Health and Safety Executive (HSE) and GMSC. Upon approval we will notify the depositor to arrange receipt of the patent deposit. Similarly, if a patent submission is not approved we will contact the depositor to explain the reason why.

 

Await notification 

If approved, we will contact you to provide a reference number for receipt. Ensure you have read the Guidelines for Acceptance of Patent Deposits (below) and you understand that a patent deposit cannot be accepted unless twelve (12) identical ampoules are received.

 

Package correctly and send

Packages should be clearly labelled with the storage temperature, sender’s contact information and the reference number. Packaging and transportation must be used in accordance with UN 602 regulations. Approved UN 602 packaging may be obtained from several suppliers, the details of which are available from any Royal Mail Sales Centre. If you use a courier service to deliver your samples, please contact the company involved for advice on their own approved packaging. 

The depositor is entirely responsible for the costs of transportation of deposits to the Culture Collections.

Our current prices:

NCTC Patent Depository

Price

Bacterial strain

 £450

Issue of a Viability Statement (Rule 10.2)

 £60 per statement

Supply (furnishing) of a bacterial patent deposit (excluding delivery)

 £45 per ampoule

30-year declaration for already-deposited Collection bacterial strains

 £50 per declaration

ECACC Patent Depository

Price

Cell line

 £950

Virus

 £1100

DNA

 £600

Supply (furnishing) of a patent deposit (excluding delivery)

 £100

Unsuccessful patent deposits are subject to a fee to cover quality control and administration

Once a certificate of acceptance of a patent deposit has been issued, the deposit can be released to the depositor, or to a third party, provided certain release conditions are met, as per Rule 11 of the Budapest Treaty. Release conditions include either authorisation from the depositor or completion of the relevant European Patent Office (EPO) release forms which NCTC and ECACC are able to provide.

The depositor is kept informed of any applications for the furnishing of a patent at all times. However, for patents published in the USA/Canada, EPO authorisation may not be required if documentary evidence for the publishing of the patent is available. If this evidence is not available then authorisation from the EPO should be sought.

When the conditions for release have been met, the samples requested can be dispatched.

The format for furnished products depends on the recipient’s requirements:

  • NCTC patents are furnished frozen or freeze-dried, depending on the format deposited by the customer. NCTC can also provide a custom freeze-drying service for those who would like to preserve their frozen strains in the freeze-dried format
  • ECACC will dispatch cultures either in a frozen format or as a growing culture following 2-3 passages in the serum used routinely in the  ECACC laboratory

Note: For dispatch to the USA/Canada and Australia/New Zealand an Import Permit may be required due to the nature of the materials. For dispatch of hazardous pathogens outside the EU an export licence may be required at an additional cost.

All deposits must be preceded by: 

1. Patent Deposit Submission Form

2. Biohazard Risk Assessment Form 

 

A patent deposit cannot be accepted if:

(i) the package is damaged in any way that could compromise containment
(ii) appropriate shipping temperatures have not been maintained
(iii) ampoules are not completely sealed
(iv) ampoules are not clearly labelled
(v) twelve identical ampoules prepared from a single batch have not been provided

 

The twelve ampoules must be prepared from a single batch so that QC procedures carried out on one ampoule represent all ampoules. If this has not been followed the Culture Collections will request a new deposit or, alternatively, the Culture Collections may be able to re-bank the patent deposit. If a deposit is unacceptable or fails the QC tests the ampoules will be returned to the depositor for destruction. The Culture Collections will not destroy patent deposits. If a new deposit is required this will result in a new accession number.

 

Upon successful completion of the Quality Control (QC) testing the patent depositor is issued with a Certificate of Acceptance confirming the date the deposit was received. The depositor will be informed if the patent fails the QC tests.

Depending on the type of patent deposit the following QC tests are performed on one of the 12 deposited ampoules:

Type of patent deposit

QC test 

Human cell line

Animal cell line

Hybridoma cell line

  • cell count

  • viability check

Virus

  • viability of virus patent checked according to instructions provided by the depositor on the patent deposit form

Bacteria

  • viability check

  • purity check

Plasmid DNA

Naked DNA

  • purity and condition check – DNA is assessed by agarose gel electrophoresis

 

Remember: A patent deposit cannot be accepted unless 12 identical ampoules prepared from a single batch are supplied.