Direitos Especiais de Comercializa

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Direitos Especiais de Comercialização

• TRIPs 70.9

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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.

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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.

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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.

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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).

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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.

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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.

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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.

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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.

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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.

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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).

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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

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.
  

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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...

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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,

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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,

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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.

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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.

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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.