BUDAPEST TXE ATY ONTHE TNTERNATIONAL

RECOGNITION OF
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 INTRODUCTION TO THE BUDAPEST TREATY

(a) Deposit of Microorganismsfor the Purposes of Patent Procedure

(i) Disclosure and the Requirement for Deposit :-Afundamental requirement of patent law is
that the details of an invention must be fully discloscd to thepublic. For disclosure to be adequate,
an invention must be described in sufficient detail to permit a person skilled in the art to repat the
cffect of the invention: in other words, the disclosure should enable the average expert with access
to the appropriate fac1lities to reproduce the invention for himself. Disclosure is nonally achieved
by means of a written description supplemented where necessary by drawings. However, inventtons
involving the use of new microorganisnns (.e., those :not available to the public) present problems of
disclosure in that repeatability often cannot be cnsured by means of a written description alone. In
the case of an organism isolated fronm soil, for instancc, and perhaps "improved" by mutation and
further selection, it woald be virtuallv impossible to describe the strain and its selection sufficiently
to guarantee another person obtaining the same strain from soil hiumsclf. In snch a casc, the
microorganism itself might be considered to be an essential part of the disclosure. Morcover, if the
microorganism was not generally available to the public, the written disclosure of the invention
might be held to be insufficient. This line of reasoning led to the industrial property offices in an
increasing number of countries either requiring or recommending that the written disclosure of an
invenion ivolving the use of a new microoganism be supplemented by the deposit of the
mucrvorganist:a in a recognized culture collection. The culture collection would then make the
microorgr:isni available to the public at the appropriate point in the patenting procedure.
() Need for a Jnifor1n International Deposit System :-Although by the early i970s the
depo .ting of microorganisms in culture collections for patent purposes had become fairly common
there was no uniform system of deposit, or, perhaps more importantly, of recognition of depos.
Alost counries requiring or recommending deposit required it to be made in a "recog1ized
collection, but the minimum criteria to be met bysuch "recognized' collecions were vague and il
defined. in most cases, "recognized" probably equated with "internationaly known." The culture
collccions for their part, when confronted with the variety of national patent lavws, were often
unsure of howto proceed in respect of the furnishing of samples to requesting parties. Iack of firn
gidelines led some coliections to allow the depositor almost complete control over the furnishing,
of samples of his microorganism, believing this to be the surest way of protecüng themselves itom
the danger of releasing asample illegitimately.
Faced with the albove-mentioned uncertainties, many patent applicants saw no alternative but to
deposit the same microorganism in several collections in diferent countries to guard aganst the
poss1bility of any of their applications failing on the grounds of insufficient disclosure. Clearly this
practice was wasteful, time-consuming and sometimes expensive, and, taken to its logical conclusion,
would have resulted in applicants depositing the microorganism in every country in which they
WIshed to file a patent application referr1ng to that microorganism. In order to obviate the need for
such muluple deposits, therefore, the Governnment of the United Kingdom proposcd, in 1973, that
the World Intellectual Property Organization (WIPO) should srudy the possibilities of one deposit
serving the purposes of all the deposits that would otherwise be
by the nceded. This proposal was adopted
Governing Bodies of WIPO.
(u) The Budapest Treaty
In 1974, the Director General of WIPO convened a
Committee of Experts to discuss the
possibiliies of international cooperation over the deposit of microorganisms for patent purposes.
Ihe essence ot the solution prepared in discussions of this Committee was that certain culture
collections should be recognized as depositary authorities and that a deposit made with any one of
them should be recognized as valid for patent purposes by all the countries in which protection tor
the relevant invention was sought. The Committee of Experts also found that the conclusion of a
reaty would be necessary to put this proposed solution into effect. At two further sessions in 1975
and 1976 the Committee of Experts cxamined drafts prepared by the International Bureau of WIPO
of a Treaty and Regulations on the International Recognition of the Deposit of Microorganisns tor
the Purposes of Patent Procedure. A third draft of this Treaty and Regulations served as abasis for
the deliberations of a Diplomatic Conference, convened by the Director General of WIPO,
organized by him in cooperation with the Government of Hungary, and held in Budapest from
April 14 to 28, 1977./The Diplomatic Conference, which was attended by representatives of 2
States members of the Paris Union for the Protection of Industrial Propery and observers from tvo
non-member States of the Paris Union, the Interim Committee of the European Patent
Organisation, and 11 non-governmental international organizations, adopted a treaty with the title
Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the
Purposes of Patent Procedure," together with Regulations under the Treaty.
acceded to by the
I he Budapest ireaty came into effect in 1980 when it had been ratified or
requisite minimum number (five) of States. The Regulations under the Budapest Treaty were
modified in 1981 and in 2002.

(b) Main Features of the Budapest Treaty

() International Depositary Authorities and Recognition of Single Deposit

authorities"
U'nder the Treaty, certain culture collections are recognized as "international depositary
(IDAs). Any Contracting State which allows or requires the deposit of microorganisms for the
in any IDA,
purposes of patent procedure must recognize, for those purpOses, a deposit made
wherever that IDA may be. Similarly, if any intergovernmental industrial property organization (eg.
General of WIPO to the
the European Patent Office) files a formal declaration with the Director
Regulations,
effect that, for its own patent purposes, it accepts the provisions of the Treaty and the
then it too must recognize a deposit made in any lDA.
by the
Any culture collection can become an IDA provided that it has been formally nominated
furnished
Contracting State on whose territory it is located and that that Contracting State has
solemn assurances that the collection complies and will continue to comply with the requirements of
be avalable on
the Treaty and the Regulations. The most important of these are that the IDA will
the same terms to any depositor, that it will
accept and store
the full period specified by the Treaty, and that it vill furnish microorganisms deposited with it ror
only to those entitled to receive them. An
samples of deposited microorganisms
has fled the declaration referred to in intergovernmental industrial property organiizaou
paragraph 6 similarly may furnish assurances in respet a
culture collection located on the territory of one of its
member States.
(1) Deposit and Furnishing of Samples
Ihe Regulations under the Treaty lay down in detail the procedures which depositors and IDAs
must folow, the duration of storage of deposited microorganisms (at least 30 years or five years
after the most recent request for a sample. whichever is later), and the mechanisms for the
turnishing of samples. The Regulations do not address the timing of deposit, however; this is lett
entirely to therelevant national law. So., toa laroe extent. are the tming and conditions of furn1shing
of samples. Provision is made for samples to be furnished at any time to the depositor, to anyone
having the depositor's written authorization, and to any "interested" industrial property office (1.e-,
one dealing with a patent application concerning the deposited microorganism and which provides
the IDA wvith a declaation to that effect),but in all other cases national law determines when, to
whom and under what conditions samples are to be furnished. However, because IDAs may not be
familiar wih the national laws of different countries, the Regulations require that a third party
industrial
requesting a sample from an IDAmust make his request on aform on which the relevant
property office certifies that he is entitled to receive a sample of that particular microorgan1sm.
Alternatively, the industrial property office mav, from time to time, notify IDAs of the accession
case
numbers of those microorganisms referred to in patents granted and published by it, in which
for certification:
such miCrOorganisIms become available to anyone without the need

(u) Safeguard of Deposits

The Treaty and Regulations make various provisions to guard against the loss and conscquent non
expertise and facilities
availability of deposited microorganisms. Thus the lDA must have the
the storage period
necessary to keep the microorganism viable and uncontaminated 4 throughout
furnish samples of a
required by the Treaty. If for any reason an IDA is no longer able to
can benefit from the date of
mIcroorganism, a new deposit of the same organis1m can be made and
such, the Treaty provides for
deposit of the original. If for any reason an IDA ceases to function as
IDA.
the microorganisms deposited with it to be transferred to another
(iv)Meaning of the Term Microorganism"
interpreted in a broad
The termn 'microorganism" is not defined in the Treaty so that it may be
deposited under it. Whether an
sense as to the applicability of the Treaty to microorganisms to be
whether deposit of that
entity technically is or is not a microorganism matters less in practice than
will accept it Thus, for
entity is necessary for the purposes of disclosure and whether an IDA
though
example, tissue cultures and plasmids can be deposited under the terms of the Treaty, even
they are not microorganisms in the strict sense of the word.