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Access to essential medicines, patents and the lawPatent information on essential medicines and its use for public health

Alexandria

16th Mai 2013

Hans Georg Bartels, Global Challenges Division

New technical information worldwide

Source: WIPO Statistical Database (patent families); World Bank, World Development Indicators (journals)

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Scientific and technical journal articles Patent families

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A unique source of information

Much of the technical information revealed in patents is never published elsewhereOver 70 million patent documents have been published to datePatent documents provide various types of information in a highly standardized format

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I. Content of patent informationII. Sources of patent informationIII. Use of patent informationIV. Essential medicinesV. Discussion

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WIPO Standards http://www.wipo.int/standards/en/part_03.html

Standards relating to Patent Information and Docume ntationFor example:

Numbering of applications for IPRs and of published patent documentsIdentification of different kinds of patent documentsKind codes - a one letter code in the publication number followed by a one-digit numerical code, (e.g.

A – applications

B - granted patents

Bibliographical dataINID Codes - internationally agreed Numbers for the Identification of (bibliographic) data

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Plain language designation of the kind of document

office or organization publishing the document Identification of the patent, SPC or patent document

Publication of an unexamined document

International Patent Classification (IPC)

Application number

Application filing dateOriginal filing language

Publication Language

Data relating to priority

Name(s) of applicant(s)

Name(s) of inventor(s)

Name(s) of inventor(s) who is (are) also applicant(s)

Name(s) of attorney(s) or agent(s)

PCT Designated States

WO 2008/154813 A1

PCT/CN2008/001153

16.06.2008

15.06.2007

中文

中文

24.12.2008

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Publication of an unexamined document

International Patent Classification (IPC)

Application number

Application filing dateOriginal filing language

Publication Language

Data relating to priority

Name(s) of applicant(s)

16.06.2008

15.06.2007

中文

中文

Patent documents relating to the same invention or to several inventions sharing a common aspect

Priority application

Content

No single convention for defining a patent family

Patent documents of the same family may have different content and status

Patent families

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Legal status data

All data related to legal events:data change over the lifetime of patentsDefined by the respective patent law:different definitions limit comparabilityPatent registers record the most important events, such as grant, ownership, withdrawal, etc.

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Statistical Summary of WIPO Questionnaire on Availa bility of Patent Legal Status Datahttp://www.wipo.int/export/sites/www/patentscope/en/programs/legal_status/docs/statistical_summary_questionnaire_ls.pdf

9. Can data (e.g. dates) for the following legal events be recorded in the patent register and retrieved by the public if available for a particular patent application or granted patent?

Yes No9.1 Request for examination 33 359.2 Entry into national phase of PCT applications 50 19

9.3 Non-entry into national phase of PCT applications 12 56

9.4 Withdrawal of application 54 179.5 Rejection of application 56 149.6 Appeal to rejection 40 299.7 Grant of patent 73 09.8 Opposition to grant 38 329.9 Request for invalidation/revocation/nullification 45 259.10 Granted patent has been invalidated/revoked/nullified 65 7

9.11 Granted patent has expired, i.e. no further extension possible 59 14

9.12 Granted patent has lapsed, i.e. renewal fee not paid 64 9

9.13 Payment of fees (e.g. renewal) 57 14

9.14 Any events related to examination other than final decisions, e.g. a search report or examination report has been issued

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9.15 Change of ownership 69 39.16 Data related to licenses 57 15

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Patent Legal Status Data

WIPO study on availability of legal status data(CDIP/4/3 REV./INF 3)http://www.wipo.int/patentscope/en/programs/legal_status/index.html

87 patent authorities contributed information

Sometimes deficient situation regarding availability of reliable legal status data and their comparability

Committee on WIPO Standards (CWS)http://www.wipo.int/cws/en/Third Session, Geneva, April 15 to 19, 2013:Creation of a Task to establish requirements for the delivery of legal status information by industrial property offices (CWS/3/7)

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I. Content of patent informationII. Sources of patent informationIII. Use of patent informationIV. Essential medicinesV. Discussion

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Availability of information

Despite the standardization of patent documents Patent publication differs considerably from country to country. e.g.

no publication of patent applications, only granted patentspublication of only a short notice of the patent grant no publication of the full specification

TRIPS Article 29 (disclosure)Paris Convention Article 12 Each country establishes a central office for the communication to the public of patents, etc.: - the names of the proprietors of patents granted with

- a brief designation of the inventions patentedOn-line availability of information Additional documents:search reports, corrections, amendments, translations Legal status informationChallenges:

Availability and accessUpdating of databases Reliability

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Statistical Summary of WIPO Questionnaire on Availa bility of Patent Legal Status Datahttp://www.wipo.int/export/sites/www/patentscope/en/programs/legal_status/docs/statistical_summary_questionnaire_ls.pdf

Yes No

17. Does your patent legislation explicitly provide for a gazette or bulletin? 78 7

18. Is the gazette or bulletin published electronically, e.g. in PDF format? 71 12

18.2. Is the electronic publication accessible and/or available for download via the internet? 68 14

19. Is the gazette or bulletin published on paper? 45 38

20. If your answer to question 18 or 19 is “Yes”, please indicate whether the gazette orbulletin is published at periodical or non periodical time intervals:

weekly publications 22

bi-weekly 6

monthly publications 33

bi-monthly 6

quarterly 6

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http://www.wipo.int/patentscope/en/dbsearch/nationa l_databases.html

Access to Patent Information

Today’s situation:

32 national/regional collections including: ARIPO, Cuba, EPO, Kenya, Morocco,South Africa, US, Japan, Korea, Russia …

30 million biblio records, 20 million full text reco rds

Very soon China, Canada, Australia, UK

PATENTSCOPE, pursuing a global coverage

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EN_AB:("electric bicyle" OR “power bike” OR ”electri c bike”)OR DE_AB:"elektrisches Steuerungseinrichtung"OR FR_AB:("portage cycle électriques OR "bicyclette à assistance électrique") OR JA_AB:(" 電気電気電気電気 サイクルサイクルサイクルサイクル" OR "動力動力動力動力サイクルサイクルサイクルサイクル" OR "パワーパワーパワーパワーサイクルサイクルサイクルサイクル“)OR KO_AB:(" 자전거자전거자전거자전거전기전기전기전기" OR "자전거자전거자전거자전거전동식전동식전동식전동식")OR ZH_AB:(" 电电电电工装有" OR "电电电电子装有")

Search Forms – Cross Lingual Expansion

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http://www.wipo.int/tisc/en/

18http://www.wipo.int/tisc/en/search/

AlgeriaCosta Rica

CubaDominicanRepublic

GuatemalaHondurasMoroccoNigeria

Panama Philippines

RussianFederationUruguay

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I. Content of patent informationII. Sources of patent informationIII. Use of patent informationIV. Essential medicinesV. Discussion

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Uses and users of patent information

Legalavoid patent infringement – freedom to operatepartners for licensingTechnicaldetermine the patentability of inventionsgive direction to researchBusiness determine the validity of competitors’ patentspartnership buildingPolicy inform policy makers’ decisions

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The International Patent Classification (IPC)

Which IPC code? WIPO IPCCAT

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IPCCAT Suggestions…

F03D � wind motors

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Keyword vs. classification search

Keyword search:Pros � easier use, more flexible

(choice of fields to search, combination of fields)(P) � complex search techniques

(Boolean, proximity etc operators), language, synonyms/homonyms, misspellings

Classification search:Pros � independent from language(P) � IPC > 70.000 codes, complex for non-experts, not

universally applied

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I. Content of patent informationII. Sources of patent informationIII. Use of patent informationIV. Essential medicinesV. Discussion

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Essential medicinesDefinition: available within a functioning health system at all times in adequate amounts in the appropriate dosage forms, with assured quality and adequate information, and at affordable prices The WHO Model List of Essential Medicineshttp://www.who.int/medicines/publications/essentialmedicines/en/

First published in 1977 and updated every two yearsThe 17th EML (2011) contains 445 medicines and 358 molecules

Recommendation to be implemented by countries according to local needs and policies

Selection criteria relating to safety, quality, efficacy and total cost, not relating to patents

lists medicines by their international nonproprietary name (INN), also known as the generic name, without specifying manufacturer

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International Nonproprietary Names (INNs)

Unique, globally recognized generic name for an active pharmaceutical substanceWorld Health Assembly Resolution WHA3.11 (1950) Operational since 1953Selected names are published as proposed INNs 4 months period to raise objections (e.g. similarity to a trademark)If no more objection exists, publication as a recommended INNINNs are placed in the public domain (“nonproprietary”) -use without any restriction

INNs or parts thereof must not be used in trademarksPublic interest: clear distinction between new trade names and INNs Information on INNs circulated by WHO and WIPO

Use of INNs in patent documentsLink between INNs and chemical compounds

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Challenge: finding patents related to medicines

A product (including combination products, e.g. fixed-dose combinations), its manufacturing process and its use can be covered by several patents protecting various technological aspects. The manufacturers and sellers of a product are not obliged to disclose all pertinent patents. In addition, it is challenging to verify the legal status of all patent family members.

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Possible approachesSource:WIPO Patent Landscape Report on Atazanavir

(http://www.wipo.int/patentscope/en/programs/patent_landscapes/reports/atazanavir.html)

INN:INNs are adopted after the filingSupplementary Protection Certificate:

Up to five years medicines patent term extension in the EU application and registration is recorded in the INPADOC Legal Status field

US FDA Orange Book and Health Canada Patent Register (patent linkage):approved medicines and certain related patent informationChemical names:

Numerous chemical name conventionsOne frequently used system: CAS – Chemical abstract service (Atazanavir: CAS-198904313-31-3)

Clinical naming:Manufacturer name (Novartis: CGP-73547, CGP-75355, CGP-75136; BMS-232632)Generic name (atanazavir)Brand name (Reyataz®)

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I. Content of patent informationII. Sources of patent informationIII. Use of patent informationIV. Essential medicinesV. Discussion

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Some issues

Which information is useful for you? Why?Does a university need patent information?Does a company need patent information?Does a civil society organization needs patent information?Does a procurement agency need patent information? Think about procurement of medicines? Is there a role for patent information?Where can the information be obtained?Are there gaps?Who can help?

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http://www.medicinespatentpool.org/patent-data/patent-status-of-arvs/

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Hans Georg BartelsGlobal Challenges Divisionhansgeorg.bartels@wipo.int

http://www.wipo.int/globalchallenges/en/

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