Brazilian Politicians will vote for new Pharma Laws

Brazilian Politicians will vote for new Pharma Laws

Jeremy   October 04, 2015   No comments:

Last month IP Tango was delighted to host a guest post from our Brazilian friend Magda Voltolini, on the topic of sham litigation.  Now we are pleased to welcome her back with her perspective on the chances of Brazil applying the flexibilities of the Doha Declaration. This is what she writes:

Are Brazilian politicians applying the flexibilities on the basis of the Doha Declaration?  The Brazilian National Congress is apparently ready to reform Law N. 9279 of 14 May 1996 (Law 9279/96) regulating rights and obligations relating to industrial property.  In fact, the Committee on Constitution, Justice and Citizenship (CCJC) will soon vote Bill N. 139 of 2 February 1999 (Bill139/99) and its annexes, which aim at modifying the provisions concerning rights awarded by the patent and conditions that grant compulsory licenses including those relating to pharmaceutical products and processes.

On 17 September Deputy Andre Moura, Rapporteur of the Bill 139/99 voted to amend Law 9279/96 repealing the sole paragraph of art. 40, altering arts. 10, 13, 14, 31, 43, 68, 195 and 229-C and adding arts. 31-A and 43-A to art. 4 of the Law 9279/96. However, the Brazilian Fine Chemicals, Biotechnology and Specialty Industries Association (Abifina) and the Pharmaceutical Research Industry Association (Interfarma) support opposite views. If the proposed Bill passes, Abifina ideas will prevail and the Brazilian generic industry will certainly benefit from the new law.

For instance, the proposed Bill is also expanding the grounds of Government non-commercial use of patents and patent applications on the basis of public interest. In its article 43.A(6), it forbids the Judiciary Branch to decide on matters concerning whether the objectives of public interest were established to justify the Government authorization of the non-commercial use of the object of a pharmaceutical patent or patent application. However, as a fundamental right and guarantee,  the Brazilian Constitution stipulates that  “the law shall not exclude any injury or threat to a right from the consideration of the Judicial Power”. (art. 5, XXXV)

The table below illustrates a snapshot of the changes proposed by Bill 139/99 amending Law 9279/96.

Law 9279/96	Bill 139/99
40. An invention patent shall remain in force for a period of 20 (twenty) years, and a utility model patent for a period of 15 (fifteen) years from the date of filing. Sole Paragraph. The term shall not be less than 10 (ten) years for an invention patent and 7 (seven) years for a utility model patent, beginning on the date of granting, unless the INPI has been prevented from examining the merits of the application by a proven pending judicial dispute or for reasons of force fmajeure.
10. The following are not considered to be inventions or utility models: I. discoveries, scientific theories, and mathematical methods; ………………………………………………………	10. ........................................................................... ............................................................................................. X.  any new property or new use of a known substance or mere use of a known process, unless such known process results in a new product; XI. new forms of known substances, which do not result in the enhancement of the known efficacy of the substance. Single paragraph. For the purposes of this article, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations, and other known substance derivatives should be regarded as the same substance, unless they differ significantly in properties as regards efficacy. (NR)
13. An invention is endowed with inventive step provided that, to a technician versed in the subject, it is not derived in an evident or obvious way from the state of the art.	13.  An invention is endowed with inventive step provided that, to a person skilled in the art, it is not derived in an evident or obvious way from the state of the art, and since it represents a significant technical improvement over the state of the art. (NR)
14. A utility model is endowed with inventive act provided that, to a technician versed in the subject, it is not derived in a common or ordinary way from the state of the art.	14. A utility model is endowed with inventive act provided that, to a person skilled in the art, it is not derived in a common or usual manner from the state of the art, and since it represents a technical improvement over the state of the art. (NR)
31. After publication of the application and up to the end of the examination, interested parties may submit documents and data to assist the examination. Sole Paragraph. The examination shall not begin before 60 (sixty) days from the publication of the application.	31. After publication of the patent application and up to the end of the examination, any person may submit an opposition. (1) The applicant will be notified of the opposition, through publication in the official gazette, and may respond within sixty (60) days from the publication date of the opposition. (2) In cases where an opposition to a patent application has been submitted, INPI is allowed to request technical opinions from the Public Administration, organizations recognized by the Government as consultation bodies and members of the faculty and students of higher education universities. (3) After a complaint is filed, the examiner may, on the basis of a grounded requirement, request any further clarification as it deems necessary, as well as the submission of additional documents. (4) The examiner must necessarily give an opinion on every filed opposition, indicating the reasons why it accepts or rejects the information there presented ...................................
43. The provisions of the previous Article do not apply: ……………………………………………………… IV. to a product manufactured in accordance with a process or product patent that has been introduced onto the domestic market directly by the patentholder or with his consent;	43.  ................................................................................. ...................................................................... IV.  to a product manufactured in accordance with a process or product patent that has been introduced to the domestic or international market directly by the patent holder or with his consent;
68. The titleholder shall be subject to having the patent licensed on a compulsory basis if he exercises his rights derived therefrom in an abusive manner, or by means thereof engages in abuse of economic power, proven pursuant to law in an administrative or judicial decision. (1) The following also occasion a compulsory license: I. non-exploitation of the object of the patent within the Brazilian territory for failure to manufacture or incomplete manufacture of the product, or also failure to make full use of the patented process, except cases where this is not economically feasible, when importation shall be permitted; or II. commercialization that does not satisfy the needs of the market (2) A license may be requested only by a person having a legitimate interest and having technical and economic capacity to effectively exploit the object of the patent, that shall be destined predominantly for the domestic market, in which case the exception contained in Item I of the previous Paragraph shall be extinguished.	68. ............................................................................... ............................. (1) ......................... I. non-exploitation of the object of the patent within the Brazilian territory for failure to manufacture or incomplete manufacture of the product, or also failure to make full use  of a patented process; or II. ............................................................................. (2) A license may be requested only by a person having a legitimate interest and having technical and economic capacity to effectively exploit the object of the patent, that shall be destined predominantly for the domestic market.
195. A crime of unfair competition is perpetrated by anyone who: ............................................................................. XIV. divulges, exploits, or utilizes, without authorization, results of tests or other undisclosed data whose preparation involves considerable effort and that were submitted to government agencies as a condition for obtaining approval to commercialize products. Penalty—imprisonment, for 3 (three) months to 1 (one) year, or a fine.	195.  ........................................................................... ............................................................................................. (3) The provisions of item XIV do not apply to the use of results of tests or other undisclosed data, by government agencies, for marketing approval of equivalent products to the product for which they were originally presented.
229. The provisions of this Law shall apply to pending applications, except as regards patentability of substances, materials or products obtained by chemical means or processes, and alimentary or chemical-pharmaceutical substances, materials, mixtures or products, and medications of any kind, as well as the respective processes for obtaining or modifying them, which shall only be privileged under the conditions established in Articles 230 and 231.	229-C.  The granting of patents for pharmaceutical products and processes shall depend on the prior consent of the National Health Surveillance Agency - ANVISA, which shall examine the object of the patent application in the light of public health. (1) It is considered that the patent is contrary to public health, according to regulation, when: I. a product or pharmaceutical process contained in the patent application presents a risk to health; or II. an application for a product patent or pharmaceutical process is of interest to medicines or pharmaceutical care policies within the Unified Health System - SUS and does not meet the patentability requirements and other criteria established by this law (2) Following the examination of prior consent and published the result,  Anvisa shall return the request to the INPI, which shall carry out the technical examination of the approved application and shall shelve permanently the non-approved applications.
4. The provisions of treaties in force in Brazil are equally applicable to natural and legal persons who are nationals of or domiciled in this country.	31-A. The INPI must offer intuitive electronic channel, easily accessible, interconnected to the global computer network, wherewith anyone can, free of charge, present evidence or proof of previous existence, in Brazil or abroad, of the claimed invention or state of art. Single paragraph. Even after the possible grant of the patent, and especially during the process of opposition and administrative nullity proceedings, it is authorized the submission of evidence or proof of previous existence, in Brazil or abroad, of the claimed invention or state of art. 43-A. The Government, through an Ordinance of the Ministry of State concerned, may make non-commercial use of the object of patents or patent applications without the consent or authorization of the patent holder or the patent applicant, directly or by hiring or by authorization to third parties for the purposes of public interest, including those of national defense and social interest. (1) If the invention is a process, the public non-commercial use of the patent or patent application will cover the use in connection with any product that can be obtained by the process that is protected object  by the patent or patent application; (2) The Government shall notify the holder of the patent or patent application when making non-commercial use; (3) The non-commercial public use will meet the following conditions: I. it will not prevent the full exercise of other rights of the holder of the patent or patent application; II. it will not be exclusive, sublicensing not being permitted; III. it will be made exclusively to meet the objectives of the Ordinance that authorized the use, being forbidden any other use, not related to the non-commercial public use, matter contrary to Art. 42 of this Law; (4) The remuneration for non-commercial public use, which will be fixed by the Government according to the circumstances of each case, take into account the percentage that could be routinely determined in a voluntary license between independent parties, applied to the cost for the Government resulting from the use of the object of the patent or patent application and weighted by the contribution made by the holder in the transfer of technology of manufacturing or employment; (5) In the case of patent applications, the amount of compensation will be deposited in escrow until the grant of the patent; (6) The Judicial Branch is forbidden in the case of public non-commercial use to decide whether the purposes related to the general interest are established; (7) Non-commercial public use will not be suspended, limited or interrupted by a  judicial dispute concerning the fixed remuneration.

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How explicit a logo can be?

How explicit a logo can be?

Patricia Covarrubia   September 29, 2015   No comments:

Checking the Peruvian newspaper La Republica, I encountered with the recent registration (No 618011-2015) of the word mark ‘Guti’  and its respective logo in Class 10 of the Nice classification system (including in particular: hygienic rubber articles). The registration refers to condoms under the sub-title product. Now so far so good….but wait…who is Guti? What is the logo?

INDECOPI

Guty Carrera is a famous Peruvian model who has participated in modelling for underwear labels; he also has participated in reality tv shows, and even took part in a campaign celebrating the International Condom Day aiming to encourage the responsible use of condoms reducing sexually transmitted infections and unwanted pregnancies. He is renowned as a love rat and his lovers claim that he is ‘gifted’, alluding to his manhood. Then, appreciating Guty’s story we acknowledge the clever use of the ‘t’ in the logo.

The analysis comes towards Art 135 of Decision 486 CAN referring to signs that are not capable of been registered. In this case Art 135(p) refers to signs that are contrary to public order and morality. Is the logo against morals? This simple question open a Pandora box: who can actually determine if a sign breaches the public order and morality clause? Should it be a centralized definition of what is to be caught under this bar? In reality we open the debate:  what is considered to be profane or vulgar? The beauty of this blog is that we come from different backgrounds, religion, sexual orientations, ages (and eras) and what can be moral to me, it may be vulgar to you (or vice versa).

The logo

Is the logo vulgar? Offensive? Objectionable? One need to analyse who will be expose to the logo.  While the logo may contain quite a ‘graphic’ representation, it may be approved (as it was). Q&A go in the line that children and elderly are not the target market; they are not sold in toys shops; tv advertisements would be limited. A mere offence to a section of the public cannot be enough to bar a sign from registration. It has to be something that causes outrage, or it is considered by the society that it is against social values. In this case, the logo has sexual implications but it works for the goods applied for. A different story would be if the logo is for clothing, don’t you agree?

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La anomia marcaria

La anomia marcaria

Rodrigo Ramirez Herrera @ramahr   September 25, 2015   No comments:

La OAMI ha publicado el informe The economic cost of IPR infringement in sports goods donde nos habla del coste económico de la infracción de derechos de propiedad intelectual en el sector de artículos deportivos con pérdidas de ingresos para la industria, merma de empleos e impacto en las finanzas públicas, atribuyendo estos efectos a la presencia de productos falsificados en el mercado.

Este tipo de informes periódicos arrojan casi siempre similares resultados, lo que nos lleva a dos cuestiones: ¿Es la propiedad intelectual un bloque normativo de observancia más débil que otros? ¿Es la falsificación de productos un tipo de infracción que no tiene sanción social?

Uno de los rasgos de la moral es la autonomía manifestada por la aceptación de las normas por sus propios méritos, y no por haber sido dictadas por alguna autoridad, o por las circunstancias particulares en que deben ser aplicadas. No obstante, gran parte de nuestras acciones no tienen eficacia propia, sino como parte de prácticas sociales enmarcadas en un telón de fondo institucional. Una de esas acciones es el respeto a las normas de propiedad intelectual y más precisamente a las normas marcarias y de diseño.

En ese campo de acción (y principalmente de omisión) es perceptible a diario un constante incumplimiento del jus prohibendi marcario sin visos de sanción social. Es lo que podríamos denominar la anomia marcaria.

El término anomia es un concepto de raíz sociológica popularizado por Durkheim, aunque su sentido no es unívoco. Se puede entender – como lo hace Nino- como la falta de respeto a las normas. Y este desdén normativo, en sus distintos niveles, tiene agregadamente una incidencia directa en los niveles de productividad, eficiencia y crecimiento. Seguir leyendo...

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En Chile ratifican por un nuevo período a Maximiliano Santa Cruz a la cabeza del INAPI

En Chile ratifican por un nuevo período a Maximiliano Santa Cruz a la cabeza del INAPI

Rodrigo Ramirez Herrera @ramahr   September 22, 2015   No comments:

De acuerdo con la Ley Orgánica Constitucional Nº 20.254 de 2008 el Director Nacional del INAPI es el Jefe Superior del Servicio dependiente del Ministerio de Economía, Fomento y Turismo, y tiene la calidad de funcionario de la exclusiva confianza del Presidente de la República, y designado por éste. Tiene la calidad de alto directivo público, de conformidad con las normas pertinentes de la ley Nº 19.882, y le corresponde administrar, controlar y velar por el cumplimiento de los fines del Instituto. Para este cargo ha sido ratificado don Maximiliano Santa Cruz Scantlebury para un tercer período. Este nombramiento tiene lugar a casi un año de cumplirse la designación de INAPI como Autoridad Internacional de Patentes (ISA) por la Organización Mundial de la Propiedad Intelectual (OMPI). Hasta la fecha, INAPI en su rol de autoridad ISA, ha recibido 132 solicitudes internacionales PCT. 

El funcionario recién ratificado es un abogado de 45 años que le ha correspondido impulsar el proyecto de la nueva Ley de Propiedad Industrial, que busca reemplazar la actual normativa, vigente en Chile desde 1991. Durante el presente año INAPI llamó a una consulta pública sobre Estrategia Nacional de PI, a fin de recoger ideas y propuestas que apunten a mejorar el sistema. Además en los seis años anteriores el INAPI lanzó la plataforma de servicios en línea, que en la práctica permite la casi total tramitación de marcas y patentes vía internet; se trasladó a su nuevo edificio; lanzó InapiProyecta, plataforma con casi 20 herramientas para aprender, usar y transferir PI, además de ser una comunidad con alrededor de 3.000 usuarios inscritos; funciona con expedientes digitales; lanzó el programa Sello bajo el cual ya se han creado 16 denominaciones de origen; publicó las primeras directrices de marcas y de patentes; y es un activo participante en el sistema nacional de innovación.

Fuente: Francisco Carrasco/ Área de Comunicaciones INAPI

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Symposium: Geographical Indications in the EU -- Policy aspects and future regulation

Symposium: Geographical Indications in the EU -- Policy aspects and future regulation

Patricia Covarrubia   September 14, 2015   No comments:

Starting a new week and I am still not able to detach from a symposium that I attended last week. The reason could be that the high standard of the speakers and the friendly debate have woken up my Latin passion. While I am not an expert on GI, I followed every single speaker with such an understanding and desire that I may have found my topic for years to come [watch up Nick!]

Yet, you may wonder why I am covering GI in the EU since this blog is dedicated to Latin America. Well, for a start I was invited to speak in the symposium (I am not sure why if as I said I am not an expert on GI) but it was not until the end of the debate that I realised a key point (I will come to this later on). The majority of speakers while assessing the situation in the EU some extended as to cover international law, bilateral trade agreements, and the basic understanding of what is protected and why, and thus, relevant to any other jurisdiction. Generally, speakers when covering GIs provided opinions on: territorial development and the creation of public goods (Dev Gangjee – University of Oxford)); the principle of coexistence between trade marks and GIs (Gail Evans – Queen Mary University of London); insight field work and stories from farmers and the registration process (Funda Lancaster DEFRA); consumer confusion (Vito Rubino - Universita del Piemonte Orientale); the controversies between EU legislation and national protection (Nicola Coppola aka Nick – University of Bournemouth); the protection of non-agricultural products (Natasha Chick – UK IPO); and the Lisbon system and the Geneva Act (Matteo Gragnani - WIPO). While the speakers focused on these issues there were also some comments or remarks noting sustainable development, know-how, and biodiversity. Actually there were two questions from the audience that were identifying cultural heritage (one coming from a heritage consultant). By writing this remarks you can just grasp the different approaches that one system (GI) may have.

I was the last speaker and been not an expert on the area I was getting nervous by the minute. My topic was the protection of non-agricultural products in Latin America and perhaps what I brought to the table was something that maybe was not fully addressed by the previous speakers i.e. to preserve and safeguard culture. The point been that while it is important to ‘protect’ meaning preventing unauthorised or inappropriate use (IP negative right), it is also important to connect this protection to conservation of biological diversity and the rights of indigenous peoples. As I undertook to cover Latin America I gave examples from Brazil, Panama, the Andeans countries and Chile. I also indicated that GIs are not for everyone and gave the example of ‘chulucanas’ in Peru (see Rosemary Coombe). Other jurisdictions use IPs as a way to improve their quality of life (trade mark: Coopa Roca (Brazil)); or helping to reconstruct a region (Collective marks: Afloralta (Brazil)); adding value -tourism (Sello de Marca (Chile)); while for example Panama is using a specific sui generis right that helps protecting non-agricultural products GIs. Another issue that I needed to put across was that in some of the Latin American GI’s systems, the product/service become part of the goods of a nation i.e. become state property. This is an important issue since there exists amongst farmers, artisans and indigenous peoples mistrust -- resulting in having less GIs and more collective marks or nothing at all. Many of you may believe that actually when covering cultural heritage the IP regime is actually not appropriate at all, I may be of the same thought, however it is important to realise that for some products, it has helped. It has helped communities into social unity and it has helped us as citizens/consumers to create a sense of pride.

Indeed the conference raised a number of fascinating questions and I thank Nick for putting this symposium all together and for the generous sponsors that made it a reality (Grana Padano and CIIPM).

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Jornada sobre Propiedad Intelectual en Latinoamérica para PYMES

Jornada sobre Propiedad Intelectual en Latinoamérica para PYMES

Gilberto Macias (@gmaciasb)   September 11, 2015   No comments:

El próximo lunes 28 de septiembre, las PYMEs europeas interesadas en conocer cómo gestionar su Propiedad Intelectual en América Latina tendrán ocasión de ahondar en la materia de la mano del Latin America IPR SME Helpdesk.

El proyecto, de financiación europea, desarrollará en colaboración con la Cámara de Comercio, Industria y Servicios de Madrid un taller sobre las particularidades de la PI en Argentina, Brasil, Colombia, México y Perú bajo el título “Propiedad Intelectual en Latinoamérica: recomendaciones y experiencias”.

La jornada está dirigida a todas aquellas empresas con interés en hacer negocios en América Latina. En ella se explicarán las principales cuestiones relativas a la protección de propiedad intelectual e industrial en el momento de acometer su proceso de Internacionalización en estos países.

Tras las ponencias las empresas tendrán la oportunidad de concertar una reunión individual con alguno de los expertos del Latin America IPR Helpdesk para recibir asesoramiento gratuito en cuestiones relacionadas con la protección de los activos de Propiedad Intelectual.

La participación es gratuita, pero las plazas, limitadas.

Más información aquí. Agenda aquí. Inscripciones aquí.

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CADE rules in Eli Lilly Sham Litigation

CADE rules in Eli Lilly Sham Litigation

Jeremy   September 07, 2015   No comments:

Here's a guest post from our Brazilian friend Magda Voltolini, on the topic of what is termed "sham litigation" -- and which can be explained as a form of litigation which appears to be objectively unjustifiable in terms of protection of one's intellectual property. This is how she explains the topic:

Does anti-competitive conduct mean “don’t breach loyalty and diligence and don’t abuse your litigation rights”? 

Following an extensive investigation involving administrative and legal proceedings, leading to the assessment of serious harmful effects on competition, the Brazilian Competition Authority (CADE)’s answer is “yes”. In light of doctrine, legal opinions and jurisprudence, Reporting Commissioner Ana Razao held that Eli Lilly infringed competition rules by unduly obtaining a monopoly to commercialize Gemzar and by distorting market prices for gemcitabine hydrochloride. 

Eli Lilly, who had argued that the antitrust authority had no power to replace the judiciary or to recognize that there was an error in judgment and/or that the judge was wrong (see CADE ruling at [379]), will now apparently file an appeal to overturn CADE’s findings. 

This was the first time that CADE held a company liable on the ground of sham litigation in Brazil (Administrative Proceeding (AP) N.  08012.011508/2007-91), imposing a BRL 36.6 million fine on Eli Lilly calculated according to criteria established in Article 45 of Law 12.529 of 30 November 2011. The Advocate General still can examine consumer damages. 

Background and sham litigation analysis 

Eli Lilly filed patent application PI 9302434-7 in 1993 for the process of preparing gemcitabine hydrochloride, the active ingredient of cancer treatment medicine Gemzar, before the National Institute of Industrial Property (INPI); this application did not however relate to Gemzar itself.  In 1996, Eli Lilly presented the first request to examine the merit of its patent application on the basis of TRIPS, but INPI rejected this request on the basis that TRIPS was inapplicable.  Eli Lilly then filed a lawsuit, in result of which, in 2004, the 2nd Region Federal Regional Tribunal (TRF-2) set aside INPI’s decision. In December 1996 INPI published the continuation of its analysis of the patent concerning the process. This lawsuit was not considered sham litigation, as explained by the Reporting Commissioner Ana Razao at [252]. 

After INPI again rejected the patent application on the ground of the lack of inventive step, Eli Lilly provided technical opinions from university professors and added a new request, including claim 14 concerning the patent process. INPI denied this request in its technical opinion on the basis of lack of inventive step of claim 14.  In response Eli Lilly filed an administrative appeal before INPI, seeking to amend its second technical report concerning claim 14, and presenting two more claims -- 15 and 16: these dealt with the product gemcitabine hydrochloride, thus effectively changing the application from a process to a product. 

Additionally, in 2005, Eli Lilly had brought action N. 2005.51.01.506948-1 before the 39th Federal Court of Rio de Janeiro to overturn INPI’s opinion and validate the patent application, including claim 14; the court was also asked to assess claims 15 and 16 and to stay the INPI administrative proceedings in the INPI, seeking an order that the court to stay the INPI examination of claim 14 for inventive step until the issuance of the court decision. A stay of the administrative proceedings was ordered. 

Concerning the examinations of claims 15 and 16, INPI finally presented its conclusions to the court, explaining that claims 15 and 16 had not been subjected to its examination since the administrative proceedings had been stayed, and adding that the scope of the patent application could not be enlarged to include claims 15 and 16 since they concerned a product, not a process as initially disclosed. Consequently, the Court held that only INPI’s opinion concerning the analysis of the first 14 claims were the object of its judgment. 

Eli Lilly then filed an interlocutory appeal before the TRF-2, seeking inclusion in its judgment of claims 15 and 16, as if they had been part of INPI’s opinion concerning claim 14.  At this point, ProGenéricos joined the battle on INPI’s side. In 2007 the TRF-2 made its final decision on the Interlocutory Appeal and upheld refusal of the patent. The Federal Judge of the 39th Federal Court then refused to deal with claims 15 and 16. An expert nominated by that Court therefore only examined the requirements for patentability of the 14 process claims, finally determining the possibility of the grant of the patent as such. Claims 15 and 16 relating to product were not analyzed, following the TRF-2’s decision. 

Eli Lilly then filed another action before the Federal Justice of the Federal District against INPI, to reverse the TRF-2 decision, seeking a declaration that claims 15 and16 fulfilled all the requirements for patentability on the basis that there had been no change in the initially disclosed matter. 

The CADE investigation 

The CADE considered that Eli Lilly practised anti-competitive conduct by enlarging the patent’s scope to include matter which had not been disclosed at the time of the original patent application, and by submitting new matter after INPI had confirmed its refusal to register the patent in its administrative appeal, on the basis of Art. 32 of Law 9.279/96 which allow only changes in the patent application in relation to matter which is clear or already known before the final assessment of the patent registration [277].  Accordingly Eli Lilly acted strategically by adding claims 15 and 16. However, the CADE decided not to deem such conduct as sham litigation in light of the principle of in dubio pro reo (when in doubt, hold for the accused) [285]. Reciting that Art.70.9 TRIPS only admits grant of Exclusive Marketing Rights (EMRs) for patented products, not for patented processes, CADE found that the conduct in seeking to enlarge the scope of the patent was the first strategic step to obtain an undue degree commercialization of Gemzar in Brazil [286]. 

In Brazil, proceedings to obtain EMRs are less rigid than the process of obtaining a patent grant, in the sense that EMRs are based on a pending patent application request: the grant of exclusive rights stems purely from an expectation of rights, which is what Eli Lilly sought to obtain. 

The CADE decision also reports that in 2006 Eli Lilly brought a lawsuit before the Federal Justice of the Federal District against the National Health Surveillance Agency (ANVISA) to obtain EMRs for the product Gemzar on the basis of Article 70.9 TRIPS, affirming the patent was for a product but omitting pertinent information.  Eli Lilly disclosed that proceedings were stayed but not that claims 15 and 16 had been excluded from the patent’s scope. Indeed, it omitted pertinent information concerning the action before the 39th Federal Court, the TRF-2 and concerning the INPI opinion. In any event, the Federal Justice dismissed the case. 

However, an appeal was made before the TRF-1 asking for a preliminary injunction, which it obtained. This decision ordered ANVISA to refrain, until the end of proceedings, from granting EMRs for commercialization of a product similar to GEMZAR while INPI had not examined the object of the patent application, including those relating to the second amendment (claims 15 and 16). This action before the Federal Justice was deemed sham litigation. CADE took into account the abuse of the right to petition, considering that Eli Lilly demonstrated lack of good faith and diligence [345], based on the diversion of the purpose of the law, identified from the breach of duty of care and of objective good faith [348]. 

Sandoz intervened in the case to inform the TRF-1 of the TRF-2 decision of 2007, which had rejected the addition of claims 15 and 16 to the patent’s scope and to request the revocation of the preliminary injunction granted by the TRF-1. Importantly, the TRF-1 decision had authorized Eli Lilly to sell GEMZAR but exclusively for the treatment of cancer in Brazil. Subsequently, the Supreme Tribunal of Justice suspended the preliminary injunction considering there to be a distortion of market prices. Also, Sandoz brought a lawsuit before the Court of Sao Paulo requesting that Eli Lilly discontinue the fake accusations concerning the cancellation of its rights to commercialize the drug GEMCIT and indemnify Sandoz for incurred damages. However, for a period of three months the Sao Paulo Court prevented the commercialization of GEMCIT, which served to treat any type of cancer, on the basis of Eli Lilly’s responses. In December 2007 though, it overruled its decision on the basis of an acknowledgement of the TRF-1 judgment.

Against this background, CADE considered as sham litigation the filing of other lawsuits in different jurisdictions with the goal to circumvent the unfavourable decisions given earlier on.

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