1 / 22

Building BRICs – the pharmaceutical industry in emerging markets

Building BRICs – the pharmaceutical industry in emerging markets. Eugene Arievich Partner Baker & McKenzie - CIS, Limited Moscow Russia . Baker & McKenzie | 1. RUSSIAN FEDERATION. BRAZIL. Presentation Plan. Customs Union: Challenges and opportunities Parallel imports: state of play

daktari
Download Presentation

Building BRICs – the pharmaceutical industry in emerging markets

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Building BRICs – the pharmaceutical industry in emerging markets Eugene ArievichPartner Baker & McKenzie - CIS, Limited Moscow Russia Baker & McKenzie |1

  2. RUSSIAN FEDERATION BRAZIL

  3. Presentation Plan Customs Union: Challenges and opportunities Parallel imports: state of play Trademarks v INNs – the balance Trademarks related issues of pharma legislation Eugene Arievich - Baker & McKenzie |3

  4. CUSTOMS UNION: CHALLENGES AND OPPORTUNITIES Customs Union went into force in July 2010 Eugene Arievich – Baker & McKenzie |4

  5. CUSTOMS UNION Expected economic gains: For Russia: $ 400 bln Belarus: $ 16 bln Kazakhstan: $ 16 bln Transit of good from China to Europe: 4 times faster Kyrgyzstan, Tadjikistan and potentially Ukraine are considering joining Over 40 multilateral agreements currently Eugene Arievich – Baker & McKenzie |5

  6. CUSTOMS UNION Administrative/criminal liability for illegal use of the trademarks in Customs Union member-states Russia: fines, mandatory confiscation, corrective labor, imprisonment. Customs are authorized to draw protocols of administrative offences Belarus: fines; confiscation as an option; customs are authorized to draw protocols of administrative offence Kazakhstan: fines, mandatory confiscation; customs are not authorized to draw protocols of administrative offenses; authorized authorities: prosecutor’s office; justice bodies and financial police Eugene Arievich – Baker & McKenzie |6

  7. CUSTOMS UNION Legal and practical differences in national protection regimes: Russia: effective customs; national exhaustion of rights Belarus: rather weak customs; national exhaustion of rights Kazakhstan: weak customs; unclear exhaustion regime Eugene Arievich – Baker & McKenzie |7

  8. CUSTOMS UNION Agreement on Unified Regulation Principles of Protection and Enforcement of Intellectual Property (adopted December 31, 2010) Article 13 From the date of entry into force of this Agreement the Parties shall introduce the following principle of exhaustion of exclusive rights in a trademark: use of a trademark with respect to goods that have been lawfully introduced into commerce in the territory of the Parties’ states by the right holder or by others at its consent shall not be deemed infringement of exclusive trademark rights [EA – regional exhaustion] Eugene Arievich – Baker & McKenzie |8

  9. CUSTOMS UNION AUTHORITY OF CUSTOMS OF THE CUSTOMS UNION IN TRADEMARK PROTECTION MATTERS: Trademarks included on the National Customs Register and/or Unified Customs Register – obligation to protect Trademarks non included on the Customs Register (ex officio) – measures to be taken are based on national legislation of member states (Article 328 Customs Code) Eugene Arievich – Baker & McKenzie |9

  10. CUSTOMS UNION Ex officio in Russia (Article 308 “Law on Customs Regulation”) Customs are authorized to suspend release of good containing IP objects, not included in the Register “when there are signs of IP infringement and information on the right holder (or its representative) in Russia is available” suspension for 7 days informing the declarant and the right holder about suspension extending suspension for 10 more days if the right holder initiates registration of its trade mark with customs deciding on arrest/confiscation or release of goods BUT the above shall not apply to goods with respect to which such measures were taken in the past Eugene Arievich – Baker & McKenzie |10

  11. CUSTOMS UNION Practical problems No uniform approach to trademark protection and orderly system of cooperation between customs authorities of the CU member states No mechanism of multijurisdictional trademark protection similar to CTM Varying degree of effectiveness of customs/border control in the CU member states Eugene Arievich – Baker & McKenzie |11

  12. PARALLEL IMPORTS CASE LAW Trademark PORSCHE – Supreme Abitrazh Court, case No. A40-9281/08-145-128 of 03.02.2009 (not an administrative offense) Civil case decided in favour of trademark owners Trademark KRUSOVICE, case No. A40-60322/10-12-360 Trademark PANASONIC, case No. A60-41915/2009 Trademark UVEX, case No. A56-20519/2009 adverse to trademark owner Trademark KAYABA, case No. A40-2250/09-51-27 of 28.09.2009 Eugene Arievich – Baker & McKenzie |12

  13. PARALLEL IMPORTS National exhaustion of rights, but Counterfeits are defined as goods, labels packaging onto which a trademark or a confusingly similar sign has been illegally placed (RF Civil Code, Article 1515.1) Before 2008 – parallel imports is an administrative and civil violation After 2008 – no longer administratively punishable, but civil litigation is still an option Eugene Arievich – Baker & McKenzie |13

  14. TRADEMARKS v INNs: the balance LAW ON CIRCULATION OF MEDICINES of April 12, 2010 No. 61 Article 18. For registration of a pharmaceutical the application must contain inter alia the name of the pharmaceutical (INN and trade name) Recommendations on Methodology on Rational Choice of Names for Pharmaceuticals (Ministry of Healthcare and Social Development, 05.10.2005) Eugene Arievich – Baker & McKenzie |14

  15. TRADEMARKS v INNs: the balance Main principles of choice of names under the Recommendations: must help to identify medicines with different composition and pharmaceutical activity must not be false and capable of misleading consumers as to the product or its manufacturer, must not contravene public interests, principles of humanity and morale should not be identical or similar to names of previously registered products with different activity and composition use of INNs in names should be discouraged should not be laudatory . . . . . . . . . . . . . . . difference between names should be 3 or more letters in any combination Eugene Arievich – Baker & McKenzie |15

  16. TRADEMARKS v INNs: the balance CASE LAW Trademarks ОКТРЕОТИД (OCTREOTIDE) and ОКТРЕОТИД ДЕПО(OCTREOTIDE DEPO); trademark owner – Pharm-Sintez, ZAO Pharm Sintez, ZAO v F-Sintez, ZAO, Ministry of Healthcare, trademark infringement Claims: enjoin from use; cancel product registration Satisfied: 15.12.2010 Novartis AG v Pharm Sintez, ZAO Claims: cancel trademark registration Satisfied: 27.12.2010 Pharm Sintez, ZAO v F Sintez, ZAO, reversed on appeal: 21.02.2011 appeal ruling sustained by Federal Court: 17.06.2011 Pharm Sintez, ZAO v Rospatent, Novartis AG: Appeals from trademark cancellation decision refused: 31.03.2011 refused on appeal: 24.06.2011 refused on cassation appeal: 26.09.2011 Eugene Arievich – Baker & McKenzie |16

  17. TRADEMARKS v INNs: the balance CASE LAW PIK-PHARMA, OOO v Rospatent, Accent,OOO; Akvion, OOO, 2011: Essence of Ruling: registration of КАРНИТОН (CARNITON) is legitimate despite existence of INN КАРНИТИН (CARNITIN) and Recommendations of Ministry of Health are of non-binding nature and by the way do not apply to dietary supplements Eugene Arievich – Baker & McKenzie |17

  18. TRADEMARK RELATED ISSUES OF PHARMA LEGISLATION LAW ON CIRCULATION OF MEDICINES Definitions: Falsified medicine – a medicine, accompanied with false information on its composition and (or) producer Counterfeit medicine – a medicine which is being commercialized with violation of civil legislation Article 47.5. It shall be forbidden to import into Russia falsified and counterfeit pharmaceuticals 6. Falsified pharmaceuticals shall be withdrawn from circulation and then destroyed or exported out of Russia; counterfeit pharmaceuticals shall be withdrawan from circulation and destroyed at the expense of the importer. Eugene Arievich – Baker & McKenzie |18

  19. TRADEMARK RELATED ISSUES OF PHARMA LEGISLATION LAW ON CIRCULATION OF MEDICINES Article 46. Marking of pharmaceuticals Marking must contain the name of a pharmaceutical (INN or chemical name and trade name) in legible script in Russian It is strongly advisable to register Russian equivalents of trademarks in Latin script! Eugene Arievich – Baker & McKenzie |19

  20. TRADEMARK RELATED ISSUES OF PHARMA LEGISLATION No statutory requirements to register Cyrillic equivalents of a foreign trademark, BUT ОЛФЕН[olfen] infringes OLFEN, OLPEN infringes OLFEN, ОЛПЕН infringes ОЛФЕН, but does ОЛПЕН[olpen] infringe OLFEN ?? Eugene Arievich – Baker & McKenzie |20

  21. TRADEMARK RELATED ISSUES OF PHARMA LEGISLATION LAW ON CIRCULATION OF MEDICINES Article 32. State registration of a pharmaceutical may be cancelled in cases when state registration of a pharmaceutical has been made under a trade name coinciding with the trade name of a medicine registered earlier when the same pharmaceutical of the same applicant has been registered under different trade names when there is a court decision on infringement of IP rights that occurred in the course of circulation of medicines Eugene Arievich – Baker & McKenzie |21

  22. Thank you! Eugene Arievich– Baker & McKenzie |22

More Related