YEARBOOK 2008 / I - AIPPI

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001-010_Intro-book1.indd 10 17.07.2009 09:33:01
Working Guidelines by Jochen E. BüHLING, Reporter General Dariusz SZLEPER and Thierry CALAME, Deputy Reporters General Nicolai LINDGREEN, Nicola DAGG and Shoichi OKUYAMA Assistants to the Reporter General Question Q202 The impact of public health issues on exclusive patent rights Introduction 1) The protection of public health is one of the most pressing issues in today’s world. The patent system is designed to promote scientific and technological innovation and, as a result, has contributed to significant improvements in the treatment of health conditions, as evidenced by the many medicines which have been invented and brought to the market. The patent system also contributes to public health and society at large by making available patent information which is freely available to other researchers to further improve existing technologies and products. Despite the public policy objectives inherent in the patent system, the relationship between patents and public health has been the subject of debate. Some consider that the current patent system does not adequately address public health issues. More specifically, there have been concerns about how patents may affect access to medicines, diagnostics, medical devices and medical treatment in view of possible future pandemics such as HIV/ AIDS, SARS or Avian flu. 2) Access to patented medicines, diagnostics and the like is a complex issue and may be affected by different factors such as pricing, availability, stock, and speed of manufacturing and supply. The exclusionary nature of patent rights has the effect that third parties are excluded from manufacturing or offering for sale products which are covered by the scope of the patents without the authority of the patent owner. By way of example, this may result in a shortage of adequate supplies of drugs capable of treating pandemic diseases if the patentee lacks sufficient manufacturing capacities or maintains high pricing. For instance, in the recent cases of anthrax attacks in the United States, some voices raised concerns that German pharmaceutical company Bayer would not be able to meet all of the demand of its anthrax drug Ciprobay and moreover would not be willing to provide it at affordable rates. 3) In general, the development of new drugs and medical devices requires substantial investment and long-term research, coupled with expensive clinical trials and regulatory approval procedures. The exclusive right conferred by a patent is one of the incentives for pharmaceutical companies to make the necessary investments into that research. To ensure access by third parties to patented technologies, the patent system is primarily based on a voluntary licensing mechanism. If the patent owner is not willing or able to provide access, this may be problematic. The patent system, therefore, provides for a number of limitations of the exclusive patent rights, such as, for example, provision for compulsory licensing in certain circumstances, recognition by some countries of the legality of parallel imports of patented medicines or – with a view to providing access on a longer term basis – research and Bolar exceptions. 4) The purpose of this question is to examine national and international legislation and case law in respect of limitations which may play a role in providing access to patented medicines and other medical or biological products so as to facilitate health care, notably in the context of public health crises such as those which may occur in any country, also in developed 011-018_WG_Q202_EN.indd 11 17.07.2009 09:33:25 11
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: II. QUESTION Q202 THE IMPACT OF PUB
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 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
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obtained by Nortox Agro-Química S/
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une infraction de brevet. L’excep
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Questions Bulgaria Bulgarie Bulgari
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9) Is the government allowed to exp
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Questions Canada Canada Kanada Repo
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seeking to copy a patented innovati
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If the patent is deemed to be abuse
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Terms of use 2) Subject to section
Page 81 and 82:
Questions China Chine China Report
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1) Where any entity which is qualif
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a view to implementing the WTO deci
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Questions Colombia Colombie Kolumbi
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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
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swiss pharmaceutical company J.R. G
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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
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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
Page 115 and 116:
- 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
Page 175 and 176:
According to the Hungarian Patent A
Page 177 and 178:
- are part of Hungarian patent law,
Page 179 and 180:
Questions Indonesia Indonésie Indo
Page 181 and 182:
- Bolar exception; (Article 135 (b)
Page 183 and 184:
Questions Ireland Irlande Irland Re
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Simply put, this doctrine means tha
Page 187 and 188:
as such. Service of the State is br
Page 189 and 190:
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
Page 199 and 200:
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
Page 207 and 208:
ut it should be provided within the
Page 209 and 210:
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
Page 217 and 218:
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
Page 239 and 240:
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
Page 251 and 252:
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
Page 263 and 264:
This aspect was considered by the H
Page 265 and 266:
c) where trade or industry in South
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It is also important to recognise t
Page 269 and 270:
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
Page 277 and 278:
Sweden Suède Schweden Report Q202
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are substantially related to the re
Page 281 and 282:
very special reasons. In the litera
Page 283 and 284:
prices for the generic drug to the
Page 285 and 286:
L’harmonisation des exceptions de
Page 287 and 288:
Questions Switzerland Suisse Schwei
Page 289 and 290:
in light of Swiss antitrust legisla
Page 291 and 292:
- 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
Page 299 and 300:
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
Page 307 and 308:
erstens durch die Behauptung begrü
Page 309 and 310:
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
Page 345 and 346:
Portugal, République de Corée, Ro
Page 347 and 348:
Certains Groupes (Argentine, Bulgar
Page 349 and 350:
Certains Groupes (Brésil, Portugal
Page 351 and 352:
Zusammenfassender Bericht Frage Q20
Page 353 and 354:
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
Page 375 and 376:
AIPPI Feststellend: Entschliessung
Page 377 and 378:
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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YEARBOOK 2008 / I - AIPPI

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