Law - Deposit(s) of Biological Material

Although some national patent offices (e.g., the USPTO) allow the actual deposit of a biological material (access to which enables the practice of an invention) to be made at any time before the filing date of the patent application or during the pendency of the application, some require that the deposit be made before the international application is filed. It is always necessary that the application as filed include a "specific identification" of the biological material.

At a minimum, a reference in an international patent application as filed to deposits of biological materials should include at least the following: name and address of depository, date of the deposit and l deposit accession number. If available, a taxonomic description should be given. Information in the following sections of the PCT Applicant's Guide (PCTAG) is applicable to this task:

PCTAG Vol. I/A 402 - When must an international application include a reference to a microorganism and/or to its deposit with a depository institution?
PCTAG Vol. I/A 403 - What effect does the PCT give to such a reference?
PCTAG Vol. I/A 404 - May the reference be made for the purposes of only some of the designated States?
PCTAG Vol. I/A 405 - What are the indications which must be given in the reference with regard to the deposit of the microorganism?
PCTAG Vol. I/A 406 - What are the indications concerning the microorganism itself which must be given in the reference?
PCTAG Vol. I/A 407 - At what time must the reference (with the indications which must be contained therein) be made?
PCTAG Vol. I/A 408 - What is the consequence of failure to furnish an indication in time?
PCTAG Vol. I/A 409 - Where should the reference be made?
PCTAG Vol. I/A 410 - How does the applicant decide on the depositary institution with which to deposit the microorganism?
PCTAG Vol. I/A 411
PCTAG Vol. I/A 412 - Does a reference in an international application to the deposit of a microorganism involve the possibility of a sample being obtained by the International Searching Authority or the International Preliminary Examining Authority?
PCTAG Vol. I/A 413 - What possiblity is there, when a reference is made in an international application to the deposit of a microorganism, of third persons obtaining a sample?
PCTAG Vol. I/A 414

Information in the following USPTO Manual of Patent Examining Procedure (MPEP) sections is directly applicable to this task only if the international application will form the basis of a U.S. patent application. However, since PCT rules are somewhat similar in concept to U.S. rules, it is also included for general reference.

MPEP 2402 - The Deposit Rules
MPEP 2403 - Deposit of Biological Material
MPEP 2403.01 - Material Capable of Self-Replication
MPEP 2403.02 - Plant Material
MPEP 2404 - Need or Opportunity to Make a Deposit
MPEP 2404.01 - Biological Material that is Known and Readily Available to the Public
MPEP 2404.02 - Biological Material that Can be Made or Isolated Without Undue Experimentation
MPEP 2404.03 - Reference to a Deposit in the Specification
MPEP 2405 - Acceptable Depository
MPEP 2406 - Time of Making an Original Deposit
MPEP 2406.01 - Description in Application Specification
MPEP 2406.02 - Deposit after Filing Date Corroboration
MPEP 2406.03 - Possible Loss of U.S. Filing date in Other Countries
MPEP 2407 - Replacement of Deposit
MPEP 2407.01 - In a Pending Application
MPEP 2407.02 - After a Patent Has Issued
MPEP 2407.03 - Failure to Replace
MPEP 2407.04 - Treatment of Replacement
MPEP 2407.05 - Exemption from Replacement
MPEP 2407.06 - Replacement May Not be Recognized
MPEP 2408 - Term of Deposit
MPEP 2409 - Viability of Deposit
MPEP 2410 - Furnishing of Samples
MPEP 2410.01 - Conditions of Deposit
MPEP 2410.02 - Certification of Accessibility of Deposit
MPEP 2411.05 - Content of Application with Respect to Deposited Material

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