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Patents / Biotechnology / US Biotechnology Practice |
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4.6 Micro-organism Deposits One
potentially problematical area relating to sufficiency has been in relation to
inventions relating to microorganisms in cases where the microbe being claimed
or that is required to be used is not generally available to the public.
Provision in the specification of full details as to how to obtain the organism
in question from natural sources may suffice to meet the requirements of 35 USC
§ 112 even without a deposit.
[67]
In
re Argoudelis
[68]
it was held that a microorganism needed for the performance of a patented
invention must be permanently available to the public once the patent had
issued and that the microorganism must have been deposited in a culture
collection before filing the patent application. It has, however, been held
that in cases where deposit of a microorganism is necessary in order to meet
the sufficiency requirement, the depository in which the deposit is made need
not be independent.
[69]
The court further held that in this case one could add to the specification
information relating to the details of a deposit with an independent depository
after filing the application. For foreign applicants, it is common to rely on
the provisions of the Budapest Treaty to meet the deposit requirements.
However, care should be taken in doing this.
In
Ex
parte Hildebrand
[70],
the Board of Appeals was confronted with the question of whether a "simple"
Budapest deposit complied with the requirement that in cases where an invention
involves the use of a microorganism which is not generally available or which
cannot be adequately described in an application, the applicant must provide an
assurance that upon grant of any patent samples of a culture of that
microorganism shall be freely available. The Board concluded that it did not.
It reached this conclusion notwithstanding the provision in the rules attached
to the Budapest Treaty that in respect of patents granted and published by any
industrial property office, that office may from time to time communicate to
the international depositary where the microorganism is on deposit a list of
accession numbers given by that authority to deposits referred to in granted
patents. The Treaty itself requires that once such notification has been
given, the depositary has to release the organism to anyone who requests it.
The majority of the Board concluded that this rule did not impose a positive
obligation relating to granted patents on international depositaries and,
thus, there was no assurance that microorganisms would be released once the
U.S. patent was granted.
It,
therefore, seems that it would behoove applicants who are relying on deposits
of microorganisms under the Budapest Treaty to comply with U.S. enablement
requirements to take some positive steps to ensure that microorganisms will be
released to the general public once a patent has been issued. One way to do
this might be to insert into the declaration at the time of the original
deposit a statement that samples should be released to anyone who can show that
the deposit number was referred to in a granted United States patent.
No
deposit is necessary if the biological organisms can be obtained from readily
available sources or derived from readily available starting materials through
routine screening that does not require undue experimentation.
See
also
Ex
parte Rinehart,
10 USPQ2d 1719 (Bd of Apps 1989).
[68]
434 F.2d 1390 168 USPQ 99.
[69]
In
re Lundak,
773 F.2d 1216, 227 USPQ 90 (Fed. Cir. 1985).
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© Copyright 2002 John Richards - Posted July 2002
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