Budapest Treaty

Basis of the treaty

 Biotechnology inventions have a greater burden of description

 Difficult to describe and

 Inherently unpredictable

 Patents that deal with the use of biological material would need to
explain in detail the structural and functional details to meet the
requirements of ‘enablement’

 Budapest treaty deals with the bringing in uniformity with respect to

deposits, furnishing and maintenance of deposits for the purpose of
patent procedure
• It is a WIPO administered treaty and has the
following documents:
• Text of the treaty
• Regulations
• Guidelines
• http://www.wipo.int/about-
ip/en/budapest/guide/pdf/budapest_forms.p
df
• If deposited material is inviable or inadequate to meet demand, it may be
replaced or supplemented as long as the “new deposit” meets the
requirement for the original deposit.
– A replacement or supplemental deposit must include the filing of a certificate
of correction under 37 CFR 1.323.
• If the deposit becomes inviable during prosecution the examiner must
treat the application or reexamination proceeding as if no deposit existed.
(MPEP 2407).
• If the depository can supply samples of the original material, the Office
will not recognize the replacement deposit.
• 37 CFR 1.801 states:

– “For the purposes of these regulations pertaining to the

deposit of biological material for purposes of patents for
inventions under 35 USC 101, the term biological material
shall include material that is capable of self-replication
either directly or indirectly.” (emphasis added)
 Is a Deposit Necessary for
Enablement?
• An examiner considers both what is known and readily
available to those in the art, and what is disclosed and made
available via the patent application.

• The concepts of “known and readily available” are considered

to reflect a level of public accessibility to a necessary
component of an invention disclosure that is consistent with
an ability to make and use the invention.
- (MPEP 2404.01)
• To avoid the need for a deposit, biological material must be
both known and readily available -- neither concept alone is
sufficient.
– A material may be known in the sense that its existence has been
published, but is not available to those who wish to obtain it.

– Likewise, a biological material may be available in the sense that those

having possession of it would make it available upon request, but no
one has been informed of its existence.
- (MPEP 2404.01)
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• The reference to biological material in a specification disclosure or the
actual deposit of such material by an applicant or patent owner does not
create any presumption that such material is necessary to satisfy 35 USC
112, or that deposit in accordance with these regulations is or was
required.
– A deposit has been stated to have been made under conditions which make it
available to the public if;
• the deposit was necessary to overcome a rejection under 35 USC 112.
• there is, in the record, a statement by the examiner that a rejection would have
been made “but for” the deposit, or
• The record otherwise clearly indicates that the deposit was made under the
Budapest Treaty, and all restrictions (37 CFR 1.808(b)) imposed by the depositor on
the availability to the public of the deposited material will be irrevocably removed
upon the granting of the patent.
• The Rules clearly state that a biological deposit for the purpose of
satisfying statutory requirements may be made either under the Budapest
Treaty or independent of the treaty.
• Both Budapest Treaty and non-Budapest Treaty deposits must provide
assurances that:
• (1) Access to deposited material will be available, during pendency of a patent
application making reference to it, to anyone determined by the Director to be
entitled to access under 37 CFR 1.14 and 35 USC 122 (see In re Lundak, 227 USPQ
90, 94-95 (Fed. Cir. 1985) (citing 35 USC 114)); and

• (2) Subject to paragraph (b) of 37 CFR 1.808, all restrictions imposed by the
depositor on the availability to the public of the deposited material will be
irrevocably removed upon the granting of the patent.
Non-Budapest Treaty deposits must include the assurance noted
on the previous slide, as well as a viability statement
addressing:
• The name and address of the depository;
• The name and address of the depositor;
• The date of deposit;
• The identity of the deposit and the accession number given by the
depository;
• The date of the viability test;
• The procedures used to obtain a sample if the test is not done by the
depository; and
• A statement that the deposit is capable of reproduction.
• The depositor may contract with the depository
to require that samples of a deposited biological
material shall be furnished during the term of
the patent only if a request for a sample:
(1) Is in writing or other tangible form and dated;
(2) Contains the name and address of the
requesting party and the accession number of the
deposit; and
(3) Is communicated in writing by the depository to
the depositor, along with the date on which the sample
was furnished and the name and address of the party
to whom the sample was furnished.
• Currently there is no provision for an applicant to withdraw a deposit from
the public when the deposit was made to satisfy the requirements for
patentability.
– Reexamination is not available to address 112 issues.
– Applicant may file a reissue application.
• If an applicant fails to authorize release of biological material upon the
issuance of the patent the party requesting the biological material may
seek redress to invalidate the patent.
• An applicant’s agreement with an IDA concerning the conditions of
deposit is independent from any agreement regarding the deposit of
biological material necessary for patentability of an invention.
– All restrictions on the deposit must be irrevocably removed upon issue.
• Only IDAs which are certified by the USPTO are
acceptable for compliance with statutory
requirements in patent applications filed in the
United States.

• Deposits for the purpose of satisfying statutory

requirements are based on agreements between
the USPTO and the applicant, not the IDA.

• IDAs are independent from the USPTO and play

no regulatory role in determining compliance
with statutory requirements.
• Timing of the deposit is addressed in 37 CFR 1.804.

– “(a) Whenever a biological material is specifically identified in an application

for patent as filed, an original deposit thereof may be made at any time
before filing the application for patent or, subject to § 1.809, during
pendency of the application for patent.” (emphasis added)

– “(b) When the original deposit is made after the effective filing date of an
application for patent, the applicant must promptly submit a statement from a
person in a position to corroborate the fact, stating that the biological material
which is deposited is a biological material specifically identified in the
application as filed.”

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• Access to the deposited material will be available during
pendency of the application to a person who has been
determined by the Director to be entitled thereto under 37
CFR 1.14 and 35 USC 122.
• If the deposit was necessary for compliance with statutory
requirements, and has been stated to have been made
under conditions which make it available to the public as of
the issue date of the patent, then the Office will certify that
the deposit is available. The Office will provide a BP/12
form to submit to a depository for release the sample,
assuming that the requestor meets any other requirements
to receive a sample. (37 CFR 1.808(c))