YEARBOOK 2008 / I - AIPPI

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keine direkt geschäftliche Anwendungen begrenzt werden. Zwangsmässige Lizenzierung und Zwangsenteignung sollten eingeengt ausgelegt sein damit das Recht von den Patentbesitzern präserviert ist. Parallelimport von patentierte Arzneimitteln sollte nicht erlaubt sein, weil es eine Wirtschaftliche Marktverzerrung vorbringt, der dadurch die Preise steigen und der dadurch die lokale Produktion vom Medizinprodukte betroffen wird, und folglich für die direkt aus dem Ausland herstammte Investierung einen Hindemis schafft. Es gibt andere Arte die nicht Patentrechte beschränken, und mit dem die Besorgung von Medizin, Diagnose, Medizinsapparate, usw., kann erleichtet sein. Es würde sehr ratsam die Patentrechtsbeschränkungen in Übereinstimmung zu bringen weil damit würde Gewissheit für den Patentbesitzern in vielen verschiedene Ländern erschafft. 40 035-040_Q202_Argentina.indd 40 17.07.2009 09:36:55
Questions Australia Australie Australien Report Q202 in the name of the Australian Group by Carolyn HARRIS, Sarah MATHESON, Wayne CONDON and Ben STRATE The impact of public health issues on exclusive patent rights I) Analysis of current law and case law 1) Is a research or experimental use exception recognised under your patent law? No express research or experimental use exception is available under the Patents Act 1990 (Cth). Many believe that an implicit exception for experimental use would be found to exist were the question to come before an Australian court. This has not yet happened. Nevertheless, researchers tend to act on the assumption that an exception exists. Whether a research exception exists and what its scope might be has been discussed in detail in recent years. The Australian Law Reform Commission (ALRC) released a report in 2004 recommending legislative clarification of the research exception. The Advisory Council on Intellectual Property (ACIP), an independent body established to provide policy advice to the Federal Government on issues relating to intellectual property, also recommended introduction of a statutory exception in 2005. Both groups discussed evidence supporting the existence of an experimental use exception, but in the absence of Australian court authority, neither could state with certainty whether the exception existed or what might be its scope. The Commonwealth Government released a response in August 2007 stating that it would amend the patent legislation to include an experimental use exception, reflecting Australia’s international obligations as closely as possible. The Government stated that the amendments will outline the research activities that can be done without infringing on a patent holder’s rights, including determining how an invention works, verifying the validity of patent claims, or improving the invention. No such legislation has been introduced into parliament as yet. Arguments supporting the exception tend to centre around definitions of the patentee’s exclusive right under the Commonwealth Patents Act 1990 (Patents Act) to ‘exploit’ their invention. The Explanatory Memorandum states that this exclusive right was not intended to ‘modify the present law relating to certain acts which have been held not to constitute infringement—for example, use of an invention for certain experimental or trial purposes’. ACIP supports this argument by observing that the fact that use for experimental or research purposes may not constitute an infringement is consistent with the scope and purpose of the Act as a whole. There is also an old line of English authority, beginning with the 19th century case of Frearson v Loe, 1 which has not been overturned in Australia. The decision in that case suggested that acts might not constitute ‘use’ of an invention where there is no commercial purpose. It is possible that this exception would continue to apply to allow experimental use of patented products and methods. 1 (1878) 9 ChD 48. 041-050_Q202_Australia.indd 41 17.07.2009 09:37:29 41
Page 1 and 2: YEARBOOK 2008 / I XXXXI TH CONGRESS
Page 3 and 4: XXXXI TH CONGRESS OF AIPPI BOSTON,
Page 5 and 6: I. THE QUESTIONS ON THE AGENDA LES
Page 7 and 8: The Questions on the Agenda On the
Page 9 and 10: II. QUESTION Q202 THE IMPACT OF PUB
Page 11 and 12: Working Guidelines by Jochen E. Bü
Page 13 and 14: 10) At the Congress of Montreal in
Page 15 and 16: The requirement that a licence be v
Page 17 and 18: - expropriation; - any other limita
Page 19 and 20: Orientation de Travail* par Jochen
Page 21 and 22: 8) Dans la résolution Q101 (Import
Page 23 and 24: limitée aux médicaments (et soumi
Page 25 and 26: 5) Prière de ne répondre à cette
Page 27 and 28: Arbeitsrichtlinien* von Jochen E. B
Page 29 and 30: 8) In Entschliessung Q101 (Parallel
Page 31 and 32: Parallelimport-Ausnahmen vor, jedoc
Page 33 and 34: 5) Bitte beantworten Sie diese Frag
Page 35 and 36: Questions Argentina Argentine Argen
Page 37 and 38: Yes, compulsory licenses are availa
Page 39: 2) Do you see other ways than by li
Page 43 and 44: 3) Are parallel imports of patented
Page 45 and 46: An examination of the circumstances
Page 47 and 48: If the patentee and the Commonwealt
Page 49 and 50: The Australian Group considers that
Page 51 and 52: Questions Austria Autriche Österre
Page 53 and 54: 7) Has new Article 31bis TRIPS been
Page 55 and 56: Questions Belgium Belgique Belgien
Page 57 and 58: The rule that patent rights shall b
Page 59 and 60: drugs to developing countries which
Page 61 and 62: ase nationale. Pour cette raison le
Page 63 and 64: Questions Brazil Brésil Brasilien
Page 65 and 66: obtained by Nortox Agro-Química S/
Page 67 and 68: une infraction de brevet. L’excep
Page 69 and 70: Questions Bulgaria Bulgarie Bulgari
Page 71 and 72: 9) Is the government allowed to exp
Page 73 and 74: Questions Canada Canada Kanada Repo
Page 75 and 76: seeking to copy a patented innovati
Page 77 and 78: If the patent is deemed to be abuse
Page 79 and 80: Terms of use 2) Subject to section
Page 81 and 82: Questions China Chine China Report
Page 83 and 84: 1) Where any entity which is qualif
Page 85 and 86: a view to implementing the WTO deci
Page 87 and 88: Questions Colombia Colombie Kolumbi
Page 89 and 90: Article 61 - At the expiry of a per
Page 91 and 92:
importation or exportation of pharm
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Questions Denmark Danemark Dänemar
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swiss pharmaceutical company J.R. G
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The Danish group rejects the genera
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Questions Ecuador Equateur Ecuador
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A compulsory license shall be grant
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II) Proposals for adoption of unifo
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Questions Egypt Egypte Ägypten Rep
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The compulsory license shall be iss
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5) The party to whom the compulsory
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- National security, health, enviro
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Questions Estonia Estonie Estland R
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- any other limitations of the excl
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Questions Finland Finlande Finnland
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Compulsory licenses have not been g
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Résumé en Finlande, la loi sur br
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France France Frankreich Rapport Q2
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Par un jugement en date du 20 févr
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législation d’un Etat membre ne
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Le droit communautaire ayant posé
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La réalisation de ces actes consti
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- le demandeur devra justifier qu
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7) L’article 31 bis TRIPS a-t-il
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Le propriétaire du brevet est info
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L’article L 3131-5 du même code
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toute mesure destinée à prévenir
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the general knowledge, but does not
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Die Europäische Gemeinschaft hat i
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Questions Germany Allemagne Deutsch
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3) Are parallel imports of patented
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forward as a defense against a pate
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order may be issued if the inventio
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II) Proposals for adoption of unifo
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it has to be considered that effect
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Germany Allemagne Deutschland Frage
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auch Versuche mit innovativen Arzne
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unten zu Frage 7). Bislang sind in
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Entschädigung zahlen. Die Wiederei
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mit urteil vom 04. Mai 1972 („Ker
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der armen Länder sowie die hierdur
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constitue une atteinte profonde aux
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Questions Hungary Hongrie Ungarn Re
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According to the Hungarian Patent A
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- are part of Hungarian patent law,
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Questions Indonesia Indonésie Indo
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- Bolar exception; (Article 135 (b)
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Questions Ireland Irlande Irland Re
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Simply put, this doctrine means tha
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as such. Service of the State is br
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Questions Israel Israël Israel Rep
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• In 1989 Agis Ltd. obtained a co
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Questions Italy Italie Italien Repo
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On 23 February 2005, the Authority
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A particular complusory license can
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Questions Japan Japon Japan Report
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The Japanese Patent Law has no “B
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5) Please answer this question only
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The provisions for awarding a non-e
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ut it should be provided within the
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license) was issued for the import
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Questions Malaysia Malaisie Malaysi
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) where the patent is granted in re
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Questions Mexico Mexique Mexiko Rep
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scope of the license, and the amoun
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Il serait souhaitable d´ avoir un
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Netherlands Pays-Bas Niederlande Re
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summary: No, the current Dutch Pate
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8) Is the government allowed to mak
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Questions Norway Norvège Norwegen
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Under the Civil Defense Act, the Mi
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Questions Peru Pérou Peru Report Q
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license in reasonable conditions, a
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the population has limited access t
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Questions Philippines Philippines P
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It may be instructive to likewise s
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8) Is the government allowed to mak
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9) Is the government allowed to exp
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Questions Portugal Portugal Portuga
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That is to say, exhaustion of the r
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though there are no practical cases
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In order both to resolve the abovem
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Questions Republic of Korea Républ
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If so, please provide details, incl
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Questions Singapore Singapour Singa
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• the name and particulars of the
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Questions South Africa Afrique du S
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This aspect was considered by the H
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c) where trade or industry in South
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It is also important to recognise t
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Spain Espagne Spanien Report Q202 i
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the Spanish Patent act foresees the
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- parallel import of patented medic
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c) dépendance entre brevets d) Exi
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Sweden Suède Schweden Report Q202
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are substantially related to the re
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very special reasons. In the litera
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prices for the generic drug to the
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L’harmonisation des exceptions de
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Questions Switzerland Suisse Schwei
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in light of Swiss antitrust legisla
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- expropriation; the Swiss group is
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ist. Versuche im Hinblick auf einen
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Questions Thailand Thaïlande Thail
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- that the patented product has not
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from the date of grant of license,
Page 301 and 302:
Questions Turkey Turquie Türkei Re
Page 303 and 304:
On the other hand, as thoroughly ex
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is not allowed although customs uni
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erstens durch die Behauptung begrü
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United Kingdom Royaume-Uni Vereinig
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Medical treatment methods are not i
Page 313 and 314:
ss.55-59 PA 77 provide in effect fo
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It would be useful if such rules we
Page 317 and 318:
Questions United States of America
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7) Has new Article 31bis TRIPS been
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Summary Report Question Q202 The im
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France and Germany the Bolar except
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country for the domestic manufactur
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In Brazil two compulsory licenses h
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The Bulgarian and Spanish Groups st
Page 331 and 332:
Individuals prescriptions exception
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3) Should any of the limitations of
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Rapport de Synthèse* Question Q202
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sont membres de l’Union Européen
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Une exception pour les prescription
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Le droit américain des brevets pr
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8) Votre gouvernement est-il autori
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Portugal, République de Corée, Ro
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Certains Groupes (Argentine, Bulgar
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Certains Groupes (Brésil, Portugal
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Zusammenfassender Bericht Frage Q20
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Mitgliedsstaaten der Europäischen
Page 355 and 356:
4) Ist in Ihrem Patentrecht eine Au
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Peru, Portugal, den Philippinen, de
Page 359 and 360:
In den meisten berichterstattenden
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- Irgendwelche anderen Beschränkun
Page 363 and 364:
Die Gruppe aus Australien (das das
Page 365 and 366:
Die mexikanische Gruppe merkt an, d
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AIPPI Resolution Question Q202 The
Page 369 and 370:
6) Concerning public health: a) the
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AIPPI Observant que: Résolution Qu
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5) Dans la mesure où le droit des
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AIPPI Feststellend: Entschliessung
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3) Die Barcelona Entschliessung bet
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Table of contents Congress (Boston,
Page 381 and 382:
Table des matières Congrès (Bosto
Page 383 and 384:
Inhaltsverzeichnis Kongress (Boston
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