direitos especiais de comercialização trips 70.9

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Direitos Especiais de Direitos Especiais de Comercialização Comercialização TRIPs 70.9 TRIPs 70.9

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Page 1: Direitos Especiais de Comercialização TRIPs 70.9

Direitos Especiais de Direitos Especiais de ComercializaçãoComercialização

TRIPs 70.9TRIPs 70.9

Page 2: Direitos Especiais de Comercialização TRIPs 70.9

Direitos especiais de Direitos especiais de ComercializaçãoComercialização

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

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Direitos especiais de Direitos especiais de ComercializaçãoComercialização

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

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Direitos especiais de Direitos especiais de ComercializaçãoComercialização

CORREA, Carlos. CORREA, Carlos. Intellectual property rights, the WTO and Intellectual property rights, the WTO and developing countries.developing countries. Malaysia: TWN, 2000, p. 248-251. Malaysia: TWN, 2000, p. 248-251.Transitional Periods and ProvisionsTransitional Periods and Provisions

As mentioned earlier, developing As mentioned earlier, developing countries can delay until 1 countries can delay until 1 January 2000 the implementation January 2000 the implementation of the Agreement, except for of the Agreement, except for obligations concerning national obligations concerning national treatment and most-favoured-treatment and most-favoured-nation treatment. nation treatment.

Page 5: Direitos Especiais de Comercialização TRIPs 70.9

Direitos especiais de Direitos especiais de ComercializaçãoComercialização

CORREA, Carlos. CORREA, Carlos. Intellectual property rights, the WTO and Intellectual property rights, the WTO and developing countries.developing countries. Malaysia: TWN, 2000, p. 248-251. Malaysia: TWN, 2000, p. 248-251.Transitional Periods and ProvisionsTransitional Periods and Provisions

In addition, a further period of five In addition, a further period of five years is contemplated for developing years is contemplated for developing countries that did not grant product countries that did not grant product patent protection in certain areas of patent protection in certain areas of technology on the general date of technology on the general date of application of the Agreement for hose application of the Agreement for hose countries (i.e., 1 January 2000). In the countries (i.e., 1 January 2000). In the case of least developed countries, the case of least developed countries, the transitional period is 11 years. An transitional period is 11 years. An extension of this period can be granted extension of this period can be granted by the Council for TRIPS (Article 66.1).by the Council for TRIPS (Article 66.1).

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Direitos especiais de Direitos especiais de ComercializaçãoComercialização

CORREA, Carlos. CORREA, Carlos. Intellectual property rights, the WTO and Intellectual property rights, the WTO and developing countries.developing countries. Malaysia: TWN, 2000, p. 248-251. Malaysia: TWN, 2000, p. 248-251.Transitional Periods and ProvisionsTransitional Periods and Provisions

All these transitional periods are All these transitional periods are automatically applicable. However, in automatically applicable. However, in some countries, foreign patent-some countries, foreign patent-holders have attempted to obtain an holders have attempted to obtain an anticipated application of the anticipated application of the Agreement. In order to avoid his Agreement. In order to avoid his situation, a specific clause in the law situation, a specific clause in the law to this effect may be includedto this effect may be included. .

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Direitos especiais de Direitos especiais de ComercializaçãoComercialização

CORREA, Carlos. CORREA, Carlos. Intellectual property rights, the WTO and Intellectual property rights, the WTO and developing countries.developing countries. Malaysia: TWN, 2000, p. 248-251. Malaysia: TWN, 2000, p. 248-251.Transitional Periods and ProvisionsTransitional Periods and Provisions

According to Article 70.7, if there is a According to Article 70.7, if there is a patent application pending approval at patent application pending approval at the time the Agreement becomes the time the Agreement becomes enforceable in a Member country (i.e., 1 enforceable in a Member country (i.e., 1 January 2000 for developing countries), January 2000 for developing countries), it will be possible to amend the it will be possible to amend the application to claim "any enhanced application to claim "any enhanced protection under the provisions of this protection under the provisions of this Agreement". Such a conversion cannot Agreement". Such a conversion cannot include "new matter". Hence, a process include "new matter". Hence, a process claim cannot be transformed into a claim cannot be transformed into a product claim.product claim.

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Direitos especiais de Direitos especiais de ComercializaçãoComercialização

CORREA, Carlos. CORREA, Carlos. Intellectual property rights, the WTO and Intellectual property rights, the WTO and developing countries.developing countries. Malaysia: TWN, 2000, p. 248-251. Malaysia: TWN, 2000, p. 248-251.Transitional Periods and ProvisionsTransitional Periods and Provisions

Despite the transitional periods, Despite the transitional periods, Members have been obliged to receive Members have been obliged to receive applications for pharmaceutical and applications for pharmaceutical and agricultural chemical products since agricultural chemical products since the date of entry into force of the the date of entry into force of the Agreement, i.e., 1Agreement, i.e., 1stst. January 1995 . January 1995 (Article 70.8). Patents are to be (Article 70.8). Patents are to be granted after the expiration of the granted after the expiration of the transitional period, and for the transitional period, and for the remaining patent term.remaining patent term.

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Direitos especiais de Direitos especiais de ComercializaçãoComercialização

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

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Direitos especiais de Direitos especiais de ComercializaçãoComercialização

CORREA, Carlos. CORREA, Carlos. Intellectual property rights, the WTO and Intellectual property rights, the WTO and developing countries.developing countries. Malaysia: TWN, 2000, p. 248-251. Malaysia: TWN, 2000, p. 248-251.Transitional Periods and ProvisionsTransitional Periods and Provisions

EMRs should be conferred for five EMRs should be conferred for five years after marketing ap proval has years after marketing ap proval has been obtained. These rights will be been obtained. These rights will be terminated if: i) the corresponding terminated if: i) the corresponding patent is finally granted, or ii) the patent is finally granted, or ii) the patent application is rejected.patent application is rejected.Since the effects of EMRs are not Since the effects of EMRs are not specified in the Agreement, different specified in the Agreement, different options for implementing them are options for implementing them are open to developing countries.open to developing countries.

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Direitos especiais de Direitos especiais de ComercializaçãoComercialização

CORREA, Carlos. CORREA, Carlos. Intellectual property rights, the WTO and Intellectual property rights, the WTO and developing countries.developing countries. Malaysia: TWN, 2000, p. 248-251. Malaysia: TWN, 2000, p. 248-251.Transitional Periods and ProvisionsTransitional Periods and Provisions

If EMRs were interpreted as the provision of a If EMRs were interpreted as the provision of a right to exclude third parties from marketing right to exclude third parties from marketing the relevant product, the EMRs should be the relevant product, the EMRs should be subject to the exceptions that apply to the subject to the exceptions that apply to the exclusive rights granted by patents, as well as exclusive rights granted by patents, as well as to compulsory licences. However, a to compulsory licences. However, a reasonable interpretation of EMRs, in the light reasonable interpretation of EMRs, in the light of the negotiations and general context of the of the negotiations and general context of the Agreement, is that they are meant to confer Agreement, is that they are meant to confer fewer rights than a patent. It is thus clear that fewer rights than a patent. It is thus clear that EMRs cannot be used to prevent production EMRs cannot be used to prevent production for export to third countries (since EMRs only for export to third countries (since EMRs only refer to "marketing" in the domestic market).refer to "marketing" in the domestic market).

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Direitos especiais de Direitos especiais de ComercializaçãoComercialização

CORREA, Carlos. CORREA, Carlos. Intellectual property rights, the WTO and Intellectual property rights, the WTO and developing countries.developing countries. Malaysia: TWN, 2000, p. 248-251. Malaysia: TWN, 2000, p. 248-251.Transitional Periods and ProvisionsTransitional Periods and Provisions

A possible option is to interpret that A possible option is to interpret that the EMRs confer the right to receive the EMRs confer the right to receive compensation from those that compensation from those that commercialize the invention, rather than commercialize the invention, rather than a right to forbid their activities. The a right to forbid their activities. The infringement of EMRs would only allow a infringement of EMRs would only allow a claim for compensation (that may be claim for compensation (that may be equivalent to a reasonable royalty rate equivalent to a reasonable royalty rate or one based on actual damages). But or one based on actual damages). But infringement infringement would would not prevent not prevent commercialization by third partiescommercialization by third parties

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Direitos especiais de Direitos especiais de ComercializaçãoComercialização

CORREA, Carlos. CORREA, Carlos. Intellectual property rights, the WTO and Intellectual property rights, the WTO and developing countries.developing countries. Malaysia: TWN, 2000, p. 248-251. Malaysia: TWN, 2000, p. 248-251.Transitional Periods and ProvisionsTransitional Periods and Provisions

Recommended optionRecommended option

The exclusive marketing rights The exclusive marketing rights (granted in accordance with Article 70.9 (granted in accordance with Article 70.9 of the TRIPS Agreement) shall confer of the TRIPS Agreement) shall confer the right to request a just compensation the right to request a just compensation from third parties that commercialize from third parties that commercialize the inven tion during the transitional the inven tion during the transitional period in the domestic market.period in the domestic market.The final interpretation of the scope of EMRs shall be given by relevant WTO bodies, if the The final interpretation of the scope of EMRs shall be given by relevant WTO bodies, if the issue is brought to their consideration.issue is brought to their consideration.

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CORREA, Carlos. CORREA, Carlos. Acuerdo TRIPs.Acuerdo TRIPs. Buenos Aires: Ciudad Buenos Aires: Ciudad Argentina, 1996, p.232-235.Argentina, 1996, p.232-235.

El El Acuerdo Acuerdo nada nada dice dice sobre sobre el contenido el contenido y y alcance de alcance de los "derechos los "derechos exclusivos de exclusivos de comercialización". La introducción comercialización". La introducción de este de este concepto fue producto concepto fue producto de de un un compromiso compromiso de última hora, y no existe de última hora, y no existe documentación documentación para para rastrear su rastrear su fundamento fundamento ni origen. ni origen. Parece claro, Parece claro, empero, empero, que que el el titular de titular de tales tales derechos derechos no no puede puede ser colocado ser colocado en en igualo igualo mejor posición mejor posición que que el el titular de una titular de una patente. patente. Pues, Pues, si si así fuera, el plazo así fuera, el plazo de de transición sería transición sería letra letra muerta.muerta.

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CORREA, Carlos. CORREA, Carlos. Acuerdo TRIPs.Acuerdo TRIPs. Buenos Aires: Ciudad Buenos Aires: Ciudad Argentina, 1996, p.232-235.Argentina, 1996, p.232-235.

Cabe interpretar, por tanto, apelando a una Cabe interpretar, por tanto, apelando a una distinción propia del derecho distinción propia del derecho de patentes, de patentes, que que los "derechos los "derechos exclusivos de exclusivos de comercialización" confieren un comercialización" confieren un ius ius exclusivum, exclusivum, pero pero no no un un ius ius prohibendi. prohibendi. Este Este último es, precisamente, último es, precisamente, el el que caracteriza que caracteriza de modo de modo esencial esencial a una patente (Mas a una patente (Mas saguer,1989, p. 38). saguer,1989, p. 38). Ello Ello significa que significa que el el titular de tales titular de tales derechos podría derechos podría comercializar comercializar su producto su producto y y requerir requerir eventualmente una eventualmente una remuneración remuneración de de terceros terceros que que tam bién lo tam bién lo comercializaren, pero comercializaren, pero no no podría excluirlos podría excluirlos de de tal tal comercializacióncomercialización..

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CORREA, Carlos. CORREA, Carlos. Acuerdo TRIPs.Acuerdo TRIPs. Buenos Aires: Ciudad Buenos Aires: Ciudad Argentina, 1996, p.232-235.Argentina, 1996, p.232-235.

Por otra parte, los recursos penales Por otra parte, los recursos penales están reservados para procedimientos están reservados para procedimientos basados en el ejercicio de derechosbasados en el ejercicio de derechosde patentes ya concedidas; para de patentes ya concedidas; para hacer valer los "derechos exclusivos hacer valer los "derechos exclusivos de comercialización" sólo estarían de comercialización" sólo estarían disponibles recursos de naturaleza disponibles recursos de naturaleza civil.civil.

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

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Direitos especiais de Direitos especiais de ComercializaçãoComercialização

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

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

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Direitos especiais de Direitos especiais de ComercializaçãoComercialização

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

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O Caso do EgitoO Caso do Egito

This raises two policy issues. One is This raises two policy issues. One is the fact that exclusive marketing the fact that exclusive marketing rights may be required even if rights may be required even if marketing approval has already been marketing approval has already been granted to another party. In such a granted to another party. In such a case, the Member may be required to case, the Member may be required to terminate marketing approval that has terminate marketing approval that has been granted to a party other than the been granted to a party other than the owner of the mailbox patent owner of the mailbox patent applicationapplication. .

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

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

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Exclusive Marketing Rights — A monopoly without a right? Exclusive Marketing Rights — A monopoly without a right? Feroz Ali K. Feroz Ali K.

THE grant of Exclusive Marketing THE grant of Exclusive Marketing Right (EMR) to Novartis ("Exclusive Right (EMR) to Novartis ("Exclusive Marketing Rights — Novartis gets stay Marketing Rights — Novartis gets stay against 6 firms", against 6 firms", Business LineBusiness Line, , January 24) and the delay in granting January 24) and the delay in granting EMR to Eli Lilly ("Eli Lilly's ED drug EMR to Eli Lilly ("Eli Lilly's ED drug likely to face clone's onslaught", likely to face clone's onslaught", Business LineBusiness Line, February 15, 2004) , February 15, 2004) have raised several controversial have raised several controversial issues. issues.

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Exclusive Marketing Rights — A monopoly without a right? Exclusive Marketing Rights — A monopoly without a right? Feroz Ali K. Feroz Ali K.

For Novartis, the grant means that it For Novartis, the grant means that it can exclusively sell or distribute its can exclusively sell or distribute its patented anti-cancer drug Glivec patented anti-cancer drug Glivec containing the active ingredient containing the active ingredient Imatinib mesylate, which is the subject Imatinib mesylate, which is the subject matter of EMR. This move has affected matter of EMR. This move has affected six Indian pharmaceutical companies six Indian pharmaceutical companies which have been manufacturing which have been manufacturing Imatinib mesylate at one-tenth its price, Imatinib mesylate at one-tenth its price, under different trade names. For Eli under different trade names. For Eli Lilly, the delay would result in the loss Lilly, the delay would result in the loss of profits over its patented drug, Cialisof profits over its patented drug, Cialis. .

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Exclusive Marketing Rights — A monopoly without a right? Exclusive Marketing Rights — A monopoly without a right? Feroz Ali K. Feroz Ali K.

The Dunkel Draft — the predecessor to The Dunkel Draft — the predecessor to the Trade Related Intellectual Property the Trade Related Intellectual Property Rights (TRIPS) Agreement — proposed Rights (TRIPS) Agreement — proposed that all countries that did not offer that all countries that did not offer product patents for pharmaceutical product patents for pharmaceutical and agricultural chemical products as and agricultural chemical products as on January 1, 1995 have to provide a on January 1, 1995 have to provide a means for accepting applications for means for accepting applications for such inventions (called the `mailbox'), such inventions (called the `mailbox'), apply applicable priority rights apply applicable priority rights andand provide exclusive marketing rights (EMRs) provide exclusive marketing rights (EMRs) for such products. for such products.

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Exclusive Marketing Rights — A monopoly without a right? Exclusive Marketing Rights — A monopoly without a right? Feroz Ali K. Feroz Ali K.

The developing countries had The developing countries had a choice between EMR and a choice between EMR and product patents and many product patents and many opted for the latter. As one of opted for the latter. As one of the chief opponents of TRIPS, the chief opponents of TRIPS, India opted for the interim India opted for the interim arrangements of `mailbox' arrangements of `mailbox' and EMR. and EMR.

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Exclusive Marketing Rights — A monopoly without a right? Exclusive Marketing Rights — A monopoly without a right? Feroz Ali K. Feroz Ali K.

Under Article 65.4 of the TRIPS, Under Article 65.4 of the TRIPS, developing countries that did not have developing countries that did not have product patents were to get 10 years product patents were to get 10 years to comply with patent provisions in the to comply with patent provisions in the pharmaceutical and agricultural pharmaceutical and agricultural chemical sectors. But in view of chemical sectors. But in view of Articles 70.8 and 70.9, these countries Articles 70.8 and 70.9, these countries did not get even one day's transition, did not get even one day's transition, as they had to accept product patent as they had to accept product patent applications through the `mailbox' and applications through the `mailbox' and EMR. EMR.

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Exclusive Marketing Rights — A monopoly without a right? Exclusive Marketing Rights — A monopoly without a right? Feroz Ali K. Feroz Ali K.

The concept of EMR has its origin in a The concept of EMR has its origin in a US legislation — the Hatch-Waxman US legislation — the Hatch-Waxman Act, 1984, which granted a five-year Act, 1984, which granted a five-year market exclusivity period for an market exclusivity period for an innovative drug. This provision was innovative drug. This provision was meant to protect drugs that either meant to protect drugs that either enjoyed no patent protection or had enjoyed no patent protection or had less than five years of protection left less than five years of protection left at the time of approval. at the time of approval.

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Exclusive Marketing Rights — A monopoly without a right? Exclusive Marketing Rights — A monopoly without a right? Feroz Ali K. Feroz Ali K.

Not surprisingly, the issue of EMR was Not surprisingly, the issue of EMR was brought up by the US before the panel of the brought up by the US before the panel of the WTO's Dispute Settlement Body. The issue in WTO's Dispute Settlement Body. The issue in United States vs. India United States vs. India (1997) was whether (1997) was whether the Indian Patents Act, 1970 (Act) had the Indian Patents Act, 1970 (Act) had established a mechanism that adequately established a mechanism that adequately preserved novelty and priority with respect preserved novelty and priority with respect to patent applications covering to patent applications covering pharmaceutical and agricultural chemical pharmaceutical and agricultural chemical inventions, given that under the Act inventions, given that under the Act substances classified as "food, medicine or substances classified as "food, medicine or drug" were entitled to process patent and drug" were entitled to process patent and not product patent protection. not product patent protection.

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Direitos especiais de Direitos especiais de ComercializaçãoComercialização

Exclusive Marketing Rights — A monopoly without a right? Exclusive Marketing Rights — A monopoly without a right? Feroz Ali K. Feroz Ali K.

The WTO panel concluded that India did not The WTO panel concluded that India did not comply with its obligations under Article comply with its obligations under Article 70.8(a) of the TRIPS Agreement and violated 70.8(a) of the TRIPS Agreement and violated its obligation to provide EMR during the its obligation to provide EMR during the transitional period under Article 70.9. The transitional period under Article 70.9. The WTO Appellate Body upheld the panel's WTO Appellate Body upheld the panel's conclusions. conclusions. Consequently, the Act was amended in 1999 Consequently, the Act was amended in 1999 granting product patents for pharmaceuticals granting product patents for pharmaceuticals from January 1, 2005. As a prelude to full from January 1, 2005. As a prelude to full implementation in 2005, the Act provided implementation in 2005, the Act provided that applicants may immediately receive that applicants may immediately receive EMR, a patent-like right governed by EMR, a patent-like right governed by conventional patent doctrines.conventional patent doctrines.

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Exclusive Marketing Rights — A monopoly without a right? Exclusive Marketing Rights — A monopoly without a right? Feroz Ali K. Feroz Ali K.

EMRs were introduced as an effective way to EMRs were introduced as an effective way to stall imitation of patented products by the stall imitation of patented products by the local industry. It is only a privilege granted in local industry. It is only a privilege granted in anticipation of a patent right. EMRs offer anticipation of a patent right. EMRs offer rights similar to that of patents. rights similar to that of patents. The right to make or use an invention may The right to make or use an invention may not be commercially viable without the right not be commercially viable without the right to sell or distribute the product. EMRs are to sell or distribute the product. EMRs are even stronger than patents as the right of a even stronger than patents as the right of a national patent office to grant or reject the national patent office to grant or reject the right is severely circumscribed.right is severely circumscribed.

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

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

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

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

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Pois na LEI No 10.603, DE 17 DE Pois na LEI No 10.603, DE 17 DE DEZEMBRO DE 2001, que dispõe sobre a DEZEMBRO DE 2001, que dispõe sobre a proteção de informação não divulgada proteção de informação não divulgada submetida para aprovação da submetida para aprovação da comercialização de produtos e dá outras comercialização de produtos e dá outras providências inclui-se um artigo pelo providências inclui-se um artigo pelo menos dúbio:menos dúbio:

Art. 14. Esta Lei não exclui os direitos Art. 14. Esta Lei não exclui os direitos exclusivos de comercialização de produtos exclusivos de comercialização de produtos farmacêuticos e produtos químicos para a farmacêuticos e produtos químicos para a agricultura, estabelecidos em acordos ou agricultura, estabelecidos em acordos ou tratados internacionais em vigor no Brasil.tratados internacionais em vigor no Brasil.

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