The Budapest Treaty - 12th International Conference on Culture ...

<strong>The</strong> <strong>Budapest</strong> <strong>Treaty</strong>on the <strong>International</strong> Recognition ofthe Deposit of Microorganismsfor the Purposes ofPatent ProcedureE. Glantschnig, Patent DivisionSeptember 2010World Intellectual PropertyOrganization1

Why a specific treaty ?• Requirement of sufficient disclosure ofthe invention• How to disclose a microorganism?• Requirement of the deposit of themicroorganism• Usefulness of a single internationallyrecognized depositSeptember 2010World Intellectual PropertyOrganization2

What is a microorganism? (2)• Definition in Concise Oxford Dictionary:« an organism not visible to the nakedeye, e.g., bacterium or virus »September 2010World Intellectual PropertyOrganization4

Disclosure requirement• Patent law protection requires thedisclosure of inventions, usually by thepublication of a description• <strong>The</strong> public may use the information forexperimental purposes (depending onthe national patent law) and, once thepatent has lapsed, for commercialpurposesSeptember 2010World Intellectual PropertyOrganization5

Disclosure of a microorganism• Where an invention involves the use ofor concerns a new microorganism whichis not yet publicly available and whichcannot be fully disclosed in thedescription, it is necessary to deposit asample of that microorganism with aculture collectionSeptember 2010World Intellectual PropertyOrganization6

Multiplicity of deposits• Many national laws require the depositof microorganisms• Complex and costly procedures fordistinct deposits in various countries• Necessity of rationalization atinternational levelSeptember 2010World Intellectual PropertyOrganization7

<strong>The</strong> <strong>Budapest</strong> <strong>Treaty</strong>• Proposal by the United Kingdom to theExecutive Committee of the Paris Unionthat WIPO study the possibilities ofinternational treaty on deposits ofmicroorganisms• Decision to establish a Committee ofExpertsSeptember 2010World Intellectual PropertyOrganization8

Committee of Experts• <strong>The</strong> Committee held three sessions (in1974, 1975 and 1976) and prepared adraft of a <strong>Treaty</strong> and Regulations to besubmitted to a Diplomatic <strong>Conference</strong>September 2010World Intellectual PropertyOrganization9

Adoption and signature• Diplomatic <strong>Conference</strong>, held in<strong>Budapest</strong>, April 14 to 28, 1977• Adoption of the <strong>Treaty</strong> on April 28, 1977• Signature by 18 States: AT, BG, CH,DE, DK, ES, FI, FR, HU, IT, LU, NL,NO, SE, SN, SU, UK, USSeptember 2010World Intellectual PropertyOrganization10

Entry into force• Ratification by Hungary, Bulgaria, theUnited States and France• Entry into force on August 19, 1980, afterthe accession of Japan• Today:– 73 Contracting States– 39 <strong>International</strong> Depositary Authorities (IDA)September 2010World Intellectual PropertyOrganization11

Contracting States (1)Albania, Armenia, Australia, Austria, Azerbaijan,Belarus, Belgium, Bosnia and Herzegovina, Bulgaria,Canada, China, Costa Rica, Croatia, Cuba,Czech Republic, Democratic People’s Republic ofKorea, Denmark, Dominican Republic, El Salvador,Estonia, Finland, France, Georgia, Germany, Greece,Guatemala, Honduras, Hungary, Iceland, India, Ireland,Israel, Italy, Japan, Jordan, Kazakhstan, Kyrgyzstan,Latvia, Liechtenstein, Lithuania, Luxemburg, Mexico,Monaco,September 2010World Intellectual PropertyOrganization12

Declarations of acceptance (1)have been deposited by the followingintergovernmental industrial propertyorganizations:- European Patent Organisation (OEB)- Eurasian Patent Organization (EAPO)- African Regional Intellectual PropertyOrganization (ARIPO)September 2010World Intellectual PropertyOrganization14

Declarations of acceptance (2)• Article 9(1)(a):– recognition of deposit with any IDA(Art. 3(1)(a))– no additional requirements than thoseprovided in the <strong>Budapest</strong> <strong>Treaty</strong> (Art. 3(2))– possibility to require a copy of the receiptof the deposit (Art. 3(1)(b))September 2010World Intellectual PropertyOrganization15

Principal characteristics of the <strong>Treaty</strong>• All Contracting States recognize the depositof a microorganism with any IDA• Any deposit of a microorganism with an IDAshall be accepted for the purposes of patentprocedure by the patent offices of theContracting States and by any regional officewho filed a declaration of acceptanceSeptember 2010World Intellectual PropertyOrganization16

<strong>International</strong> Depositary Authority (1)• A scientific institution– located on the territory of a ContractingState– accepting deposits of microorganisms– storage of microorganisms– furnishing samples of any depositedmicroorganismSeptember 2010World Intellectual PropertyOrganization17

<strong>International</strong> Depositary Authority (2)• Status acquired after acceptance ofcommunication from the ContractingState to the Director General of WIPO(Art. 7)September 2010World Intellectual PropertyOrganization18

<strong>The</strong> subject matter of the deposit• <strong>The</strong> <strong>Treaty</strong> does not define the termmicroorganism thus allowing a broadinterpretation of the term• It includes unicellular and multicellularorganisms, bacteria, fungi, plant, animaland human cell cultures, murine embryos,plasmids, DNA sequences, enzymes,seeds, etc.• Today, the term « biological material » ismore commonly usedSeptember 2010World Intellectual PropertyOrganization20

Deposit procedure• Mandatory acceptance of themicroorganism by the IDA whenrequirements for deposit are met• Delivery of a receipt• Time limit for the deposit: depends onthe national law, in general, the filingdate of the patent application• Storage during at least 30 yearsSeptember 2010World Intellectual PropertyOrganization21

Rule 11: Access todeposited biological material• Any interested industrial property office• <strong>The</strong> depositor or third parties authorizedby the depositor• Any parties legally entitled under theapplicable legislation, with theprescribed form and certified by theindustrial property officeSeptember 2010World Intellectual PropertyOrganization22

Some Statistical Data• 69,546 microorganisms stored by IDAsfrom 1981 to 2009• 3,114 deposits made in 2009• 1,628 samples furnished in 2009September 2010World Intellectual PropertyOrganization23

Advantages of the<strong>Budapest</strong> <strong>Treaty</strong> (1)• Simplification and cost reduction ofpatent procedures• Prevention of certain risks in the field ofbiotechnology• Promotion of R&D through access todeposited biological material• Promotion of cooperation and exchangebetween IDAsSeptember 2010World Intellectual PropertyOrganization24

Documentation on the <strong>Treaty</strong>• <strong>Budapest</strong> <strong>Treaty</strong> and its Regulations• Guide to the Deposit of Microorganismsunder the <strong>Budapest</strong> <strong>Treaty</strong>• (www.wipo.int/budapest)September 2010World Intellectual PropertyOrganization26

Some other useful texts• Patent Cooperation <strong>Treaty</strong> (PCT),Rule 13bis• European Patent Convention (EPC),Rules 31 - 34• European Directive on the legal protectionof biotechnological inventions(Directive 98/44/EC)• TRIPS Agreement, Art. 27.3September 2010World Intellectual PropertyOrganization27

Where to get information?<strong>Budapest</strong> <strong>Treaty</strong> SectionPatent DivisionWIPOChemin des Colombettes, 341211 Geneva 20 (Switzerland)Ewald GlantschnigTel.: 00 41 22 338 84 80Fax: 00 41 22 338 88 30E-mail: ewald.glantschnig@wipo.intSeptember 2010World Intellectual PropertyOrganization28