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Arnaud Michel

Bogota, 27 April 2009. WIPO - Successful Technology Licensing for R&D Networks in Columbia Theme 1: Intellectual Property in the Research Environment Topic 1: d) Research exemption and e) Exhaustion of IP rights. Arnaud Michel. Exceptions to Patent Rights – Research Exemption.

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Arnaud Michel

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  1. Bogota, 27 April 2009 WIPO - Successful Technology Licensing for R&D Networks in ColumbiaTheme 1: Intellectual Property in the Research EnvironmentTopic 1: d) Research exemption and e) Exhaustion of IP rights Arnaud Michel

  2. Exceptions to Patent Rights – Research Exemption • Balance of interests • Patent owners • Scientific and technical development • Exception in favor of research  experimental use exception

  3. Exceptions to Patent Rights – Research Exemption • TRIPs AGREEMENT, Article 30 • “Members may provide limited exceptions to the exclusive rights conferred by a patent, provided that such exceptions do not unreasonably conflict with a normal exploitation of the patent and do not unreasonably prejudice the legitimate interests of the patent owner, taking account of the legitimate interests of third parties.” • No specific provision on research • No international consensus

  4. Exceptions to Patent Rights – Research Exemption • Specific stake for the pharmaceutical industry • Research on new applications • Development of generic products • Length of regulatory approval process • How to be ready for the marketplace as soon as patent expires?

  5. Exceptions to Patent Rights – Research Exemption • « Bolar » exemptions • Specific safe harbour for clinical trials for regulatory data gathering • Exists in several countries with varying scope • The European example • General research exemption in almost all Member States • Uncertain scope due to variations in national case law • Difficulties concerning generic drugs  Harmonizing EC legislation – EC Directive No. 2007/27 of 31 March 2004

  6. Exhaustion of IP Rights – What is the Potential Impact on Protected IP Embodied in Research Results • The Exhaustion of Rights principle • First sale doctrine • May be applied more or less broadly • In terms of acts which the IP owner may oppose • In terms of geographic zone where exhaustion of rights applies (national/ international/regional exhaustion) • Practical interest for: • Distributors outside selective network • Parallel imports trying to take advantage of differences of segmentation on national markets

  7. Exhaustion of IP Rights – What is the Potential Impact on Protected IP Embodied in Research Results • Limitations to the Exhaustion of Rights doctrine • Protection of the IP owner when the use injures its legitimate interests • What kind of use injures the IP owner’s legitimate interests? • Issue of product repackaging, especially in the health and agrochemical sectors

  8. Exhaustion of IP Rights – What is the Potential Impact on Protected IP Embodied in Research Results • The European example: Trademark Directive, article 7 • “The trade mark shall not entitle the proprietor to prohibit its use in relation to goods which have been put on the market in the Community under that trade mark by the proprietor or with his consent. • Paragraph 1 shall not apply where there exist legitimate reasons for the proprietor to oppose further commercialization of the goods, especially where the condition of the goods is changed or impaired after they have been put on the market.”

  9. Exhaustion of IP Rights – What is the Potential Impact on Protected IP Embodied in Research Results • The European example: Trademark Directive, article 7 • § 1  European law applies a European exhaustion of rights principle • § 2  Even when a product has been put to sale for the first time in the European Economic Area by the IP owner or with his consent, the latter may, in principle, oppose future marketing of such product when it has been modified or repackaged. • BUT: Interpretation by case law : the 5 conditions (Bristol Myers Squibb)

  10. Exhaustion of IP Rights – What is the Potential Impact on Protected IP Embodied in Research Results • When repackaging has occurred, the IP owner may not oppose the resale of the product if the 5 following conditions are fulfilled: • Artificial partitioning of the markets (the « necessity » condition) • Original state of the product is preserved • Clear identification of manufacturer and entity having proceeded with the repackaging • No damage to the IP owner’s reputation or to his rights • Prior information of the IP owner with presentation of samples

  11. Abu Dhabi Alger Belgrade Bruxelles Bucarest Budapest Casablanca Dubai Hanoi Hô Chi Minh Ville Hong Kong Istanbul Kiev Londres Moscou New York Paris Pékin Prague Riyad Saint-Pétersbourg Shanghai Tunis Varsovie Contact(s) Arnaud Michel (partner) michel@gide.com GIDE LOYRETTE NOUEL A.A.R.P.I. ASSOCIATION D’AVOCATS À RESPONSABILITÉ PROFESSIONNELLE INDIVIDUELLE 26, cours Albert 1er 75008 Paris - France Tél. +33 (0)1 40 75 60 00 Fax+33 (0)1 43 59 37 79 E-mail : info@gide.com www.gide.com

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