The European Patent Office Regulations provide that if a microorganism or other biological material involved in an invention is neither already available to the public nor capable of sufficient description to enable one skilled in the art to perform the invention, then a culture of the microorganism or (since October 1, 1996) other biological material must be deposited with one of a number of a specified culture depositories on or before the date of filing the European patent application and details of the deposit are filed no later than sixteen months of filing or of the priority date, whichever is earlier, or in certain rare cases even earlier. Failure to provide the information within the 16 month term can not be remedied.[1] Originally, it was necessary that the applicant for the patent and the deposition of the organism should be the same, although strict compliance with the requirement may be excused if one of the parties was a subsidiary of the other and the applicant for the patent had effective control over the biological material deposit as a result of this relationship.[2] The October 1996 rule change overruled this decision. Under new Rule 28 (1) (d) this is no longer required as long as the application identifies the depositor and the EPO is satisfied that the depositor has consented to the deposit being mentioned in the application and agrees to comply with the EPO's rules as to the making available of samples of the deposit to third parties.

Initially, the regulations also required that microorganisms so deposited had to be freely available to the public as of the date of the early publication of the European patent application. This rule was, however, changed after protests by industry that it made theft of their inventions too easy.

Under Rule 28 (4) as it was amended with effect from June 1, 1980 and again with effect from October 1, 1996, a compromise situation exits. From the earliest date of publication of the European application, samples of the culture must be available to EPO no later than the date from which preparation for publication is complete (normally about 15 months from the priority date.) It is possible to confine the provision of samples to persons on a list of independent experts promulgated by the EPO until the notice of grant of the European Patent has been made. If the application is refused or withdrawn, supply of samples can be confined to experts for a period of twenty years from filing the application.[3] It is hoped that this regulation will prevent competitors from being able to take unfair advantage of the requirement for release of samples. In a change of rules that became effective on October 1, 1996, the rules relating to microorganisms were extended to cover all "biological materials". These are defined as "any material containing genetic information and capable of self-reproducing or being reproduced in a biological system".[4]

Care must be taken, however, in relying on deposits in culture collections to meet the sufficiency requirement. In Monoclonal antibody/Ortho[5] it was held that the disclosure was insufficient in a case where a deposit number for a particular hybridoma was given. The invention -- production of antibodies having particular properties-- was reproducible only after repeated requests to the depository institution, discussions with the staff of the depository institution, and use of techniques beyond the common skill in the art.