Availability of the deposited cell line to the public

Rule 27^ter of the Implementing Regulations to Patent Act provides the condition for Furnishing of Samples.

Rule 27^ter (internal citation omitted and emphasis added)
(1) A person who wishes to carry out the invention involving the deposited microorganisms for the purpose of examination or research may be furnished the sample of microorganisms under the following circumstances:
              i) the invention involving the deposited microorganisms is patented,
              ii) the person is given a warning that the person is carrying out the invention involving the deposited microorganisms which falls in the scope of claims of a published patent application, or
              iii) it is necessary for the person to obtain the sample of microorganisms in order to draft a Written Opinion in response to the Notice of Reasons of Refusal.
(2) The person who obtained the sample of microorganisms from the depositary authority shall not allow a third party uses the sample.

In this context, the term “examination or research” means “examination or research for i) assessing the patentability of or ii) the effect of the invention involving the deposited microorganisms, or iii) improving the invention involving the deposited microorganisms.” Examination or research in university or institution that utilizes the invention as a tool is not included. In other words, the deposited microorganisms itself must be the object of such an examination or research.

Of course, the depositary authority shall furnish a sample of any deposited microorganism:
              (i) to the depositor, on his request; or
              (ii) to the authorized party, on the request of such party, provided that the request is accompanied by a declaration of the depositor authorizing the requested furnishing of a sample.

With regard to the scope of claims supported by deposit, it is possible to obtain claims directed to a genus of cells that are broader than just the deposited cell line, if the applicant has deposited “enough” number of cell lines and disclosed them in the specification. If you have only one cell line deposited and disclosed in the specification, the examiner would pose a question of reproducibility and you will need a strong argument that a person skilled in the art would have been able to obtain additional cell lines that should fall in the claims with the guidance of the specification and the common knowledge in the art. If you have more than two cell lines deposited and disclosed in the specification, you should not have reproducibility problems, but the examiner might say that the two or more cell lines do not represent the entire scope of the broad genus claims. This argument is not specific to the deposited microorganisms but is universal to the issue of enablement in general. Attached please find schema explaining the relationship between the number of examples and enablement (filename: Requirement of enablement figure.pdf). Traditionally, the Japanese courts and the JPO have required that the applicant show, by way of examples or scientifically sound theories, that every single invention which is encompassed in the claims actually works or is reasonably expected to work. Consequently, the scope of claims allowed in Japan has been narrower than EPO and USPTO.