Direitos Especiais de Comercialização

1. Direitos Especiais de Comercialização TRIPs 70.9

2. Direitos especiais de Comercialização • Developing countries which do not at present give product patent protection to certain areas of technology have 10 years from the entry into force of the WTO Agreement to do so, except that for pharmaceutical and agricultural chemical products all countries must allow patent applications to be filed from the entry into force of the Agreement.

3. Direitos especiais de Comercialização • If authorisation for the marketing of the relevant pharmaceutical or agricultural chemical is obtained during the transitional period, the developing country concerned must offer an exclusive marketing right for the product for five years, or until a product patent is granted or refused, whichever is the shorter. • KRAUS, John. The GATT negotiations – A business guide to the results of the Uruguay round. Geneva: ICC, 1994, p. 58-59.

4. Direitos especiais de Comercialização • CORREA, Carlos. Intellectual property rights, the WTO and developing countries. Malaysia: TWN, 2000, p. 248-251. • Transitional Periods and Provisions • As mentioned earlier, developing countries can delay until 1 January 2000 the implementation of the Agreement, except for obligations concerning national treatment and most-favoured-nation treatment.

5. Direitos especiais de Comercialização • CORREA, Carlos. Intellectual property rights, the WTO and developing countries. Malaysia: TWN, 2000, p. 248-251. • Transitional Periods and Provisions • In addition, a further period of five years is contemplated for developing countries that did not grant product patent protection in certain areas of technology on the general date of application of the Agreement for hose countries (i.e., 1 January 2000). In the case of least developed countries, the transitional period is 11 years. An extension of this period can be granted by the Council for TRIPS (Article 66.1).

6. Direitos especiais de Comercialização • CORREA, Carlos. Intellectual property rights, the WTO and developing countries. Malaysia: TWN, 2000, p. 248-251. • Transitional Periods and Provisions • All these transitional periods are automatically applicable. However, in some countries, foreign patent-holders have attempted to obtain an anticipated application of the Agreement. In order to avoid his situation, a specific clause in the law to this effect may be included.

7. Direitos especiais de Comercialização • CORREA, Carlos. Intellectual property rights, the WTO and developing countries. Malaysia: TWN, 2000, p. 248-251. • Transitional Periods and Provisions • According to Article 70.7, if there is a patent application pending approval at the time the Agreement becomes enforceable in a Member country (i.e., 1 January 2000 for developing countries), it will be possible to amend the application to claim "any enhanced protection under the provisions of this Agreement". Such a conversion cannot include "new matter". Hence, a process claim cannot be transformed into a product claim.

8. Direitos especiais de Comercialização • CORREA, Carlos. Intellectual property rights, the WTO and developing countries. Malaysia: TWN, 2000, p. 248-251. • Transitional Periods and Provisions • Despite the transitional periods, Members have been obliged to receive applications for pharmaceutical and agricultural chemical products since the date of entry into force of the Agreement, i.e., 1st. January 1995 (Article 70.8). Patents are to be granted after the expiration of the transitional period, and for the remaining patent term.

9. Direitos especiais de Comercialização • CORREA, Carlos. Intellectual property rights, the WTO and developing countries. Malaysia: TWN, 2000, p. 248-251. • Transitional Periods and Provisions • "Exclusive marketing rights" (EMRs) must be granted during the transitional period under Article 70.9 of the Agreement. Such rights can be claimed if the following conditions are met: • a) a patent application has been filed in a Member after the entry into force of the Agreement; • b) a patent application has been filed in another Member entry into force of the Agreement and a patent has been granted • c) marketing approval for the protected product has been obtained in _the said other Member; • d) marketing approval has been obtained in the Member mentioned in (a) above.

10. Direitos especiais de Comercialização • CORREA, Carlos. Intellectual property rights, the WTO and developing countries. Malaysia: TWN, 2000, p. 248-251. • Transitional Periods and Provisions • EMRs should be conferred for five years after marketing ap­proval has been obtained. These rights will be terminated if: i) the corresponding patent is finally granted, or ii) the patent application is rejected. • Since the effects of EMRs are not specified in the Agreement, different options for implementing them are open to developing countries.

11. Direitos especiais de Comercialização • CORREA, Carlos. Intellectual property rights, the WTO and developing countries. Malaysia: TWN, 2000, p. 248-251. • Transitional Periods and Provisions • If EMRs were interpreted as the provision of a right to exclude third parties from marketing the relevant product, the EMRs should be subject to the exceptions that apply to the exclusive rights granted by patents, as well as to compulsory licences. However, a reasonable interpretation of EMRs, in the light of the negotiations and general context of the Agreement, is that they are meant to confer fewer rights than a patent. It is thus clear that EMRs cannot be used to prevent production for export to third countries (since EMRs only refer to "marketing" in the domestic market).

12. Direitos especiais de Comercialização • CORREA, Carlos. Intellectual property rights, the WTO and developing countries. Malaysia: TWN, 2000, p. 248-251. • Transitional Periods and Provisions • A possible option is to interpret that the EMRs confer the right to receive compensation from those that commercialize the invention, rather than a right to forbid their activities. The infringement of EMRs would only allow a claim for compensation (that may be equivalent to a reasonable royalty rate or one based on actual damages). But infringement would not prevent commercialization by third parties

13. Direitos especiais de Comercialização • CORREA, Carlos. Intellectual property rights, the WTO and developing countries. Malaysia: TWN, 2000, p. 248-251. • Transitional Periods and Provisions • Recommended option • The exclusive marketing rights (granted in accordance with Article 70.9 of the TRIPS Agreement) shall confer the right to request a just compensation from third parties that commercialize the inven­tion during the transitional period in the domestic market. • The final interpretation of the scope of EMRs shall be given by relevant WTO bodies, if the issue is brought to their consideration.

14. Direitos especiais de Comercialização • CORREA, Carlos. Acuerdo TRIPs. Buenos Aires: Ciudad Argentina, 1996, p.232-235. • El Acuerdo nada dice sobre el contenido y alcance de los "derechos exclusivos de comercialización". La introducción de este concepto fue producto de un compromiso de última hora, y no existe documentación para rastrear su fundamento ni origen. Parece claro, empero, que el titular de tales derechos no puede ser colocado en igualo mejor posición que el titular de una patente. Pues, si así fuera, el plazo de transición sería letra muerta.

15. Direitos especiais de Comercialização • CORREA, Carlos. Acuerdo TRIPs. Buenos Aires: Ciudad Argentina, 1996, p.232-235. • Cabe interpretar, por tanto, apelando a una distinción propia del derecho de patentes, que los "derechos exclusivos de comercialización" confieren un ius exclusivum, pero no un ius prohibendi. Este último es, precisamente, el que caracteriza de modo esencial a una patente (Mas­saguer,1989, p. 38). Ello significa que el titular de tales derechos podría comercializar su producto y requerir eventualmente una remuneración de terceros que tam­bién lo comercializaren, pero no podría excluirlos de tal comercialización.

16. Direitos especiais de Comercialização • CORREA, Carlos. Acuerdo TRIPs. Buenos Aires: Ciudad Argentina, 1996, p.232-235. • Por otra parte, los recursos penales están reservados para procedimientos basados en el ejercicio de derechos • de patentes ya concedidas; para hacer valer los "derechos exclusivos de comercialización" sólo estarían disponibles recursos de naturaleza civil.

17. Direitos especiais de Comercialização • CORREA, Carlos. Acuerdo TRIPs. Buenos Aires: Ciudad Argentina, 1996, p.232-235. • El impacto económico del articulo 70.9 variará según el tiempo que se necesite para obtener las aprobaciones y los registros requeridos para acceder a los derechos exclusivos de comercialización de un producto dado. • En el campo farmacéutico, la realización de pruebas clínicas y preclínicas para demostrar la utilidad y seguridad de una droga, además del tiempo requerido por los procedimientos gubernamentales particularmente prolongado en Estados Unidos y otros países industrializados- suele demorar varios años la- introducción de un nuevo producto. • Existen indicios, empero, de un acortamiento de ese lapso, especialmente en el caso de los productos de la biotecnología.

18. Direitos especiais de Comercialização • O Caso do Egito • Implementation of this program is accomplished through the Ministry of Health and Population, the Ministry of Higher Education and State for Scientific Research, and the Office of the Prime Minister. When all conditions are met, the Ministry of Health and Population should refuse marketing approval for the product to any other party than the owner of the mailbox patent application, since a party that is entitled to exclusive marketing rights clearly does not have exclusive rights if another party has permission to market the same product.

19. Direitos especiais de Comercialização • O Caso do Egito • Exclusive marketing rights must be implemented during any period when a Member exercises the right to defer implementation of full subject matter patent protection for pharmaceutical and agricultural chemical products. If a Member implements patent protection sooner than the end of that transition period, the obligation to offer exclusive marketing rights would terminate as to new applications, and the term of exclusive marketing rights for existing mailbox applications would end when a patent is issued or the patent application rejected.

20. Direitos especiais de Comercialização • O Caso do Egito • Implementation of this program is accomplished through the While the patent system offers exclusive rights only to inventions that meet certain requirements, including novelty, the system of exclusive marketing rights does not include any such provisions. That is, there is no basis on which a WTO Member may refuse exclusive marketing rights for any invention that meets the TRIPS requirements.

21. Direitos especiais de Comercialização • O Caso do Egito • This raises two policy issues. One is the fact that exclusive marketing rights may be required even if marketing approval has already been granted to another party. In such a case, the Member may be required to terminate marketing approval that has been granted to a party other than the owner of the mailbox patent application.

22. Direitos especiais de Comercialização • O Caso do Egito • The other policy consideration is that unexamined mailbox applications may refer to subject matter that would not be granted a patent in the Member for reasons other than being excluded subject matter, e.g., for lack of novelty. This risk is somewhat minimized by the fact that in order to obtain exclusive marketing rights, the applicant must have received a patent in another WTO Member and also marketing approval in that Member. However, not all WTO Members examine patent applications, so there is a risk of offering exclusive marketing rights to a product that would not be entitled to them under a TRIPS-consistent patent law.

23. Direitos especiais de Comercialização • O Caso do Egito • This risk is eliminated when the Member adopts full subject matter patent protection, which may be sooner than the end of the transition period. The risk can be minimized if the Patent Office examines applications that are in the mailbox. In the latter case, the Patent Office could reject applications that failed to meet other standards of patentability, such as novelty, inventive step, or industrial applicability, even though the Office would not be able to issue the application as a patent until permitted under national law or the end of the transition period, whichever is sooner.

24. Direitos especiais de Comercialização • Exclusive Marketing Rights — A monopoly without a right? Feroz Ali K. • THE grant of Exclusive Marketing Right (EMR) to Novartis ("Exclusive Marketing Rights — Novartis gets stay against 6 firms", Business Line, January 24) and the delay in granting EMR to Eli Lilly ("Eli Lilly's ED drug likely to face clone's onslaught", Business Line, February 15, 2004) have raised several controversial issues.

25. Direitos especiais de Comercialização • Exclusive Marketing Rights — A monopoly without a right? Feroz Ali K. • For Novartis, the grant means that it can exclusively sell or distribute its patented anti-cancer drug Glivec containing the active ingredient Imatinib mesylate, which is the subject matter of EMR. This move has affected six Indian pharmaceutical companies which have been manufacturing Imatinib mesylate at one-tenth its price, under different trade names. For Eli Lilly, the delay would result in the loss of profits over its patented drug, Cialis.

26. Direitos especiais de Comercialização • Exclusive Marketing Rights — A monopoly without a right? Feroz Ali K. • The Dunkel Draft — the predecessor to the Trade Related Intellectual Property Rights (TRIPS) Agreement — proposed that all countries that did not offer product patents for pharmaceutical and agricultural chemical products as on January 1, 1995 have to provide a means for accepting applications for such inventions (called the `mailbox'), apply applicable priority rights and provide exclusive marketing rights (EMRs) for such products.

27. Direitos especiais de Comercialização • Exclusive Marketing Rights — A monopoly without a right? Feroz Ali K. • The developing countries had a choice between EMR and product patents and many opted for the latter. As one of the chief opponents of TRIPS, India opted for the interim arrangements of `mailbox' and EMR.

28. Direitos especiais de Comercialização • Exclusive Marketing Rights — A monopoly without a right? Feroz Ali K. • Under Article 65.4 of the TRIPS, developing countries that did not have product patents were to get 10 years to comply with patent provisions in the pharmaceutical and agricultural chemical sectors. But in view of Articles 70.8 and 70.9, these countries did not get even one day's transition, as they had to accept product patent applications through the `mailbox' and EMR.

29. Direitos especiais de Comercialização • Exclusive Marketing Rights — A monopoly without a right? Feroz Ali K. • The concept of EMR has its origin in a US legislation — the Hatch-Waxman Act, 1984, which granted a five-year market exclusivity period for an innovative drug. This provision was meant to protect drugs that either enjoyed no patent protection or had less than five years of protection left at the time of approval.

30. Direitos especiais de Comercialização • Exclusive Marketing Rights — A monopoly without a right? Feroz Ali K. • Not surprisingly, the issue of EMR was brought up by the US before the panel of the WTO's Dispute Settlement Body. The issue in United States vs. India (1997) was whether the Indian Patents Act, 1970 (Act) had established a mechanism that adequately preserved novelty and priority with respect to patent applications covering pharmaceutical and agricultural chemical inventions, given that under the Act substances classified as "food, medicine or drug" were entitled to process patent and not product patent protection.

31. Direitos especiais de Comercialização • Exclusive Marketing Rights — A monopoly without a right? Feroz Ali K. • The WTO panel concluded that India did not comply with its obligations under Article 70.8(a) of the TRIPS Agreement and violated its obligation to provide EMR during the transitional period under Article 70.9. The WTO Appellate Body upheld the panel's conclusions. • Consequently, the Act was amended in 1999 granting product patents for pharmaceuticals from January 1, 2005. As a prelude to full implementation in 2005, the Act provided that applicants may immediately receive EMR, a patent-like right governed by conventional patent doctrines.

32. Direitos especiais de Comercialização • Exclusive Marketing Rights — A monopoly without a right? Feroz Ali K. • EMRs were introduced as an effective way to stall imitation of patented products by the local industry. It is only a privilege granted in anticipation of a patent right. EMRs offer rights similar to that of patents. • The right to make or use an invention may not be commercially viable without the right to sell or distribute the product. EMRs are even stronger than patents as the right of a national patent office to grant or reject the right is severely circumscribed.

33. Direitos especiais de Comercialização • No caso de aplicação diferida de TRIPs, quando um produto for objeto de uma solicitação de patente num Membro, na forma do 70.8...

34. Direitos especiais de Comercialização • serão concedidos direitos exclusivos de comercialização por um prazo de cinco anos, contados a partir da obtenção da aprovação de comercialização nesse Membro ou até que se conceda ou indefira uma patente de produto nesse Membro - se esse prazo for mais breve,

35. Direitos especiais de Comercialização • serão concedidos direitos exclusivos de comercialização por um prazo de cinco anos, contados a partir da obtenção da aprovação de comercialização nesse Membro ou até que se conceda ou indefira uma patente de produto nesse Membro - se esse prazo for mais breve,

36. Direitos especiais de Comercialização • desde que, posteriormente à data de entrada em vigor do Acordo Constitutivo da OMC, uma solicitação de patente tenha sido apresentada e uma patente concedida para aquele produto em outro Membro e se tenha obtido à aprovação de comercialização naquele outro Membro.

37. Direitos especiais de Comercialização • Pois na LEI No 10.603, DE 17 DE DEZEMBRO DE 2001, que dispõe sobre a proteção de informação não divulgada submetida para aprovação da comercialização de produtos e dá outras providências inclui-se um artigo pelo menos dúbio: • Art. 14. Esta Lei não exclui os direitos exclusivos de comercialização de produtos farmacêuticos e produtos químicos para a agricultura, estabelecidos em acordos ou tratados internacionais em vigor no Brasil.

38. Direitos especiais de Comercialização • Ora, a lei não exclui - nem inclui....porque tais direitos não foram assegurados em nenhum texto de legislação interna  em vigor no Brasil, e nem os mais encarniçados defensores da aplicação direta de TRIPs podem entrever a constituição de tais direitos através do disposto no art. 70.9 de TRIPs. • No entanto, o INPI recentemente emitiu documento "para efeitos do disposto" no art. 70.9 de TRIPs.