YEARBOOK 2008 / I - AIPPI

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Bezug auf experimentelle Verwendung mag unausgesprochen enthalten sein, obschon sich bisher kein australisches Gericht zu dieser Frage aussprechen musste. Parallelimport mag gestattet sein, wenn der Patentinhaber keinen Vertrag abgeschlossen hat, um ihn zu verhindern; dies ist aber keine ausdrückliche Ausnahme. Ausnahmen für einzelne Verschreibungen und medizinische Behandlung werden nicht anerkannt. Die australische Gruppe geht davon aus, dass die Harmonisierung des Patentrechts allgemein wünschenwert ist. Die australische Gruppe ist der Ansicht, dass das Patentgesetz ausdrücklich den experimentellen Gebrauch und den Parallelimport patentierter Erfindungen gestatten sollte. Die australische Gruppe ist der Ansicht, dass der Umfang der übrigen Ausnahmen des australischen Rechts einen angemessenen Ausgleich zwischen den Rechten des Patentinhabers und den Interessen anderer Parteien schafft. 50 041-050_Q202_Australia.indd 50 17.07.2009 09:37:30
Questions Austria Autriche Österreich Report Q202 in the name of the Austrian Group by Christian GASSAUER–FLEISSNER 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? If so, under which conditions? What is the scope of the research exception? Specifically, is research or experimental use permitted for commercial purposes? Austrian Law does not feature a general research or trial exception in its patent law. 2) Is a Bolar-type exception recognised under your patent law? If so, under which conditions? What is the scope of the Bolar exception? Specifically, is it limited to drugs or does it also apply to other products, including biological products, research tools, etc.? If your patent law does not provide for a Bolar exception, will using an invention without the patentee’s consent for the purpose of obtaining approval of a generic product be covered by the research exception? Section 22 of the Austria Patent Act 1970 (Federal Law Gazette 1970/259 – ‘Patentgesetz 1970’ or ‘PatG’) outlines the effects of a patent, giving the patentee the exclusive authority to produce, to circulate, to keep for sale, to use and to import for any of the aforementioned actions or to own goods according to the patent granted. Even though the patent confers exclusive authority, a patentee is in the execution of the patent pursuant to Sec. 30 PatG still bound by substantive Austrian law, for example, covering drugs and medicines. “Use” as understood by Austrian Patent law, is every use within a business enterprise; solely use for personal purposes, home use and use for teaching purposes1 is not covered by the provision. Austrian Patent law does recognise a Bolar-type exception as put forth in Sec. 22 para. 3 PatG, clearly exempting clinical studies and related tests as well as practical requirements evolving out of them from the scope of a patent, as far as they are necessary to obtain an authorisation for a product under pharmaceutical laws. 3) Are parallel imports of patented medicines, medical devices or similar permitted? If so, under which conditions? Do the same principles apply if the products originate from markets where they were made available under a compulsory license? Parallel imports into Austria are permitted when, and only when, the respective products have already been introduced into the market of the EEA by the patentee2 . There is no case law whether this also applies in the case of compulsory licenses. 1 Friebel/Pulitzer, Patentrecht 2 , 213. 2 Urlesberger, Gibt es einen gemeinsamen Markt für Arzneien?, ÖBl. 2006, 4. 051-054_Q202_Austria.indd 51 17.07.2009 09:38:44 51
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 and 40: 2) Do you see other ways than by li
Page 41 and 42: Questions Australia Australie Austr
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: The Australian Group considers that
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
Page 93 and 94: Questions Denmark Danemark Dänemar
Page 95 and 96: swiss pharmaceutical company J.R. G
Page 97 and 98: The Danish group rejects the genera
Page 99 and 100: Questions Ecuador Equateur Ecuador
Page 101 and 102:
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
Page 107 and 108:
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
Page 173 and 174:
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
Page 197 and 198:
A particular complusory license can
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Questions Japan Japon Japan Report
Page 201 and 202:
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
Page 215 and 216:
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
Page 237 and 238:
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
Page 253 and 254:
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
Page 261 and 262:
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
Page 285 and 286:
L’harmonisation des exceptions de
Page 287 and 288:
Questions Switzerland Suisse Schwei
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in light of Swiss antitrust legisla
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- expropriation; the Swiss group is
Page 293 and 294:
ist. Versuche im Hinblick auf einen
Page 295 and 296:
Questions Thailand Thaïlande Thail
Page 297 and 298:
- 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
Page 305 and 306:
is not allowed although customs uni
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erstens durch die Behauptung begrü
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United Kingdom Royaume-Uni Vereinig
Page 311 and 312:
Medical treatment methods are not i
Page 313 and 314:
ss.55-59 PA 77 provide in effect fo
Page 315 and 316:
It would be useful if such rules we
Page 317 and 318:
Questions United States of America
Page 319 and 320:
7) Has new Article 31bis TRIPS been
Page 321 and 322:
Summary Report Question Q202 The im
Page 323 and 324:
France and Germany the Bolar except
Page 325 and 326:
country for the domestic manufactur
Page 327 and 328:
In Brazil two compulsory licenses h
Page 329 and 330:
The Bulgarian and Spanish Groups st
Page 331 and 332:
Individuals prescriptions exception
Page 333 and 334:
3) Should any of the limitations of
Page 335 and 336:
Rapport de Synthèse* Question Q202
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sont membres de l’Union Européen
Page 339 and 340:
Une exception pour les prescription
Page 341 and 342:
Le droit américain des brevets pr
Page 343 and 344:
8) Votre gouvernement est-il autori
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Portugal, République de Corée, Ro
Page 347 and 348:
Certains Groupes (Argentine, Bulgar
Page 349 and 350:
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
Page 357 and 358:
Peru, Portugal, den Philippinen, de
Page 359 and 360:
In den meisten berichterstattenden
Page 361 and 362:
- Irgendwelche anderen Beschränkun
Page 363 and 364:
Die Gruppe aus Australien (das das
Page 365 and 366:
Die mexikanische Gruppe merkt an, d
Page 367 and 368:
AIPPI Resolution Question Q202 The
Page 369 and 370:
6) Concerning public health: a) the
Page 371 and 372:
AIPPI Observant que: Résolution Qu
Page 373 and 374:
5) Dans la mesure où le droit des
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AIPPI Feststellend: Entschliessung
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3) Die Barcelona Entschliessung bet
Page 379 and 380:
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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