Pese al fracaso de Chile para proteger apropiadamente la propiedad intelectual, hay razones para estar esperanzados. La legislaci\u00f3n a la que hace referencia la USTR incluye un proyecto de ley propuesto por el Gobierno del presidente Sebasti\u00e1n Pi\u00f1era que modificar\u00eda la Ley de Propiedad Industrial de Chile para aumentar la protecci\u00f3n de patentes para los principios activos en los f\u00e1rmacos.<\/p>\n
La legislaci\u00f3n, conocida como el proyecto de ley de linkage, fue ideada por una comisi\u00f3n gubernamental compuesta por los ministros de Hacienda, Econom\u00eda, Salud y Justicia, y fue enviada al Congreso en enero del 2012.<\/p>\n
No obstante, no todos est\u00e1n de acuerdo en que Chile necesita una legislaci\u00f3n de este tipo. En enero, un grupo de senadores encabezados por Fulvio Rossi y Francisco Chahu\u00e1n de la Comisi\u00f3n de Salud del Senado presentaron una demanda ante el Tribunal Constitucional de Chile alegando que el proyecto de ley es inconstitucional. Los senadores argumentaron que el proyecto incrementar\u00eda los precios de los medicamentos para los consumidores y que es innecesario dado que las patentes ya est\u00e1n protegidas al amparo de la legislaci\u00f3n chilena.<\/p>\n
Pero el presidente Pi\u00f1era design\u00f3 un equipo jur\u00eddico de excelencia para defender el proyecto de ley, grupo que es encabezado por el ex embajador de Chile en Estados Unidos, Arturo Fermandois. Como resultado el 22 de marzo el Tribunal Constitucional fall\u00f3 de manera un\u00e1nime (por nueve votos a favor y cero en contra) que el proyecto de ley es constitucional. La decisi\u00f3n allana el camino para que el Congreso apruebe el proyecto de ley, aunque hasta abril este segu\u00eda en el pleno.![](\"\/sites\/default\/files\/arturo_fermandois_0.jpg\")
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A juicio de Fermandois, el proyecto de ley es necesario para que Chile reforme su sistema de solicitud de patentes y facilite que las compa\u00f1\u00edas protejan su propiedad intelectual.<\/p>\n
\u201cEs importante porque proporciona la primera herramienta efectiva para detener la comercializaci\u00f3n y venta de productos farmac\u00e9uticos que no cuentan con patentes\u201d, explica Fermandois.<\/p>\n
En virtud del actual sistema judicial de Chile, es el due\u00f1o de la patente el responsable de demostrar en tribunales que la solicitud de una patente infringe la suya, pero los jueces a menudo son inexpertos en temas de salud y las demandas pueden prolongarse por meses antes de que se conceda un recurso de protecci\u00f3n.<\/p>\n
\u201cEs un \u00e1rea de conocimiento extremadamente sofisticada y t\u00e9cnica, y los jueces a menudo no est\u00e1n dispuestos a ordenar una medida de protecci\u00f3n\u201d, se\u00f1ala Fermandois.<\/p>\n
Parte del problema, explica Fermandois, es que la instituci\u00f3n responsable de registrar las patentes industriales en Chile, el Instituto Nacional de Propiedad Industrial (INAPI), est\u00e1 separado de la instituci\u00f3n responsable de certificar los principios de nuevos medicamentos: el Instituto de Salud P\u00fablica (ISP).<\/p>\n
El proyecto de ley de \u201clinkage\u201d aspira a resolver esto haciendo que el ISP sea responsable tanto de mantener un registro de principios activos patentados \u2013similar al Libro Naranja de la Administraci\u00f3n de Alimentos y Medicamentos (FDA, por su sigla en ingl\u00e9s) de Estados Unidos\u2013 y de detener las solicitudes de nuevas patentes cuando ellas contengan uno o m\u00e1s de estos principios. La combinaci\u00f3n de estas nuevas dos funciones \u2013mantener un registro p\u00fablico de patentes y suspender el proceso de registro cuando sea necesario\u2013 es lo que se conoce como \u201clinkage\u201d.<\/p>\n
En efecto, dado que un juez emitir\u00e1 de manera autom\u00e1tica un recurso si la solicitud contiene un principio activo ya registrado, el proyecto de ley pasa el peso de prueba del due\u00f1o de la patente a quien la est\u00e1 solicitando. \u201cExiste una presunci\u00f3n de infracci\u00f3n\u201d, sostiene Fermandois.<\/p>\n
Los laboratorios farmac\u00e9uticos de Chile afirman que esto es injusto y argumentan que subir\u00eda los precios para los consumidores. A juicio de Jos\u00e9 Luis C\u00e1rdenas, asesor jur\u00eddico del directorio de la Asociaci\u00f3n Industrial de Laboratorios Farmac\u00e9uticos (ASILFA) de Chile, un mecanismo autom\u00e1tico para bloquear los f\u00e1rmacos gen\u00e9ricos significa que los consumidores o el Estado chileno se ver\u00e1n obligado a pagar \u201cprecios monop\u00f3licos\u201d por los medicamentos.<\/p>\n
\u201cIncluso si el juez tiene la \u00edntima convicci\u00f3n que no hay infracci\u00f3n de patente, deber\u00e1 suspender el otorgamiento del registro sanitario del gen\u00e9rico. \u00bfRazonable? No\u201d, escribi\u00f3 C\u00e1rdenas en una columna publicada en el peri\u00f3dico Diario Financiero.<\/p>\n
Sin embargo, una medida de protecci\u00f3n no significa necesariamente que una patente no se entregar\u00e1 nunca. La suspensi\u00f3n es una medida preventiva por hasta un a\u00f1o y puede levantarse si el postulante presenta dos informes independientes que muestren que el medicamento no viola ninguna patente existente.<\/p>\n
En cuanto al argumento de quienes se oponen al proyecto de que este incrementar\u00e1 los precios de los medicamentos en Chile, Fermandois manifiesta que el gobierno de Pi\u00f1era ha comprometido recursos para asegurarse de que eso no suceda, al menos en el sistema de salud p\u00fablica.<\/p>\n
\u201cSi los precios son la consecuencia de un mercado injusto o distorsionado, entonces hay herramientas en nuestro sistema legal para corregir esa distorsi\u00f3n\u201d, asevera.<\/p>\n
Promover la Innovaci\u00f3n<\/strong><\/p>\n El proyecto de ley no solo apunta a proteger la propiedad intelectual de las compa\u00f1\u00edas farmac\u00e9uticas multinacionales. Tambi\u00e9n est\u00e1 dise\u00f1ado para promover la innovaci\u00f3n chilena, que es clave para el continuo desarrollo econ\u00f3mico del pa\u00eds.<\/p>\n \u201cCualquier pa\u00eds desarrollado requiere un fuerte poder de innovaci\u00f3n y no tendremos eso sin una protecci\u00f3n efectiva de la propiedad intelectual\u201d, asevera Fermandois.<\/p>\n Seg\u00fan Sandra Guazzotti, gerente general de Oracle Chile y directora del grupo de trabajo de AmCham sobre propiedad intelectual, el proyecto de ley es muy importante para la agenda de innovaci\u00f3n de Chile. \u201cPara que haya mayor innovaci\u00f3n en Chile es necesario que lo que los innovadores puedan crear tenga mayor seguridad jur\u00eddica en relaci\u00f3n a su propiedad intelectual\u201d, sostiene.<\/p>\n El proyecto de ley crear\u00eda estabilidad legal para la propiedad intelectual que es un requisito \u201cb\u00e1sico y fundamental\u201d para estimular la investigaci\u00f3n y el desarrollo, destac\u00f3.<\/p>\n Adem\u00e1s del tratado de libre comercio de Chile con Estados Unidos, el Art\u00edculo 19 de la Constituci\u00f3n de Chile establece un t\u00edtulo especial sobre la propiedad intelectual. Esto es respaldado por le Ley de Propiedad Intelectual, creada en el a\u00f1o 1970 y modificada en el 2010 bajo el gobierno de la ex presidenta Michelle Bachelet, que garantiza a los tenedores de patentes y derechos de autor el derecho exclusivo a beneficiarse de sus productos.<\/p>\n Pero esto es insuficiente. Chile necesita herramientas efectivas para asegurarse que este derecho se cumpla, asevera Fermandois. Al respecto, el fallo del Tribunal Constitucional es el primero en reconocer formalmente la obligaci\u00f3n de la Legislatura de Chile de cumplir con su mandato constitucional de proteger la propiedad intelectual.<\/p>\n De manera crucial, tambi\u00e9n podr\u00eda tener un impacto positivo en las relaciones internacionales de Chile. El tema del linkage en relaci\u00f3n con las farmac\u00e9uticas es uno de los temas que est\u00e1n analizando Estados Unidos y Chile como parte de las negociaciones del Acuerdo de Asociaci\u00f3n Transpac\u00edfico (TPP, por su sigla en ingl\u00e9s). Esta iniciativa multilateral de comercio en la regi\u00f3n del Asia-Pac\u00edfico aspira a ser un acuerdo de alto est\u00e1ndar y la protecci\u00f3n de la propiedad intelectual es un pilar clave.<\/p>\n Seg\u00fan Fermandois, el reciente fallo no est\u00e1 relacionado directamente con las negociaciones del TPP, pero la eventual aprobaci\u00f3n del proyecto de ley por parte del Congreso ser\u00eda un significativo avance al mostrar la voluntad del gobierno de Chile de impulsar una mayor protecci\u00f3n de la propiedad intelectual, afirma Sandra Guazzotti.<\/p>\n Queda por ver si existe la voluntad pol\u00edtica en el Congreso para aprobar el proyecto de ley de linkage antes de la elecci\u00f3n presidencial de Chile en noviembre de este a\u00f1o, pero ser\u00eda una se\u00f1al saludable que Chile sea serio en cuanto a la protecci\u00f3n de patentes. Y esa ser\u00eda una muy buena noticia para los innovadores tanto de Chile como de Estados Unidos.<\/p>\n Julian Dowling es editor de bUSiness CHILE<\/strong><\/p>\n <\/p>\n Pharmaceutical companies invest billions of dollars in developing new drugs every year. The United States is by far the world\u2019s leader in this regard as pharmaceutical companies there invested a total US$36.4 billion in research and development in 2011. Some of this research results in groundbreaking new drugs to treat afflictions like cancer, depression and Alzheimer\u2019s, many of which are available over the counter in Chile.<\/p>\n But in order for companies to recoup their investment in innovation, and thereby fund more innovation, their patents must be protected. Without protection any laboratory can, in theory, copy a drug and sell it, like a counterfeit CD or soft drink, without incurring the cost of research and development.<\/p>\n In Chile the pharmaceutical market is worth about US$2 billion annually. But, according to the Ministry of Health, patented brand name drugs only represented 41.3% of this market in 2012 and 12.3% by unit volume. The rest of the market is split between \u2018similar\u2019 drugs produced by a laboratory without a patent, private label drugs produced by a pharmacy\u2019s own laboratory and generic drugs.<\/p>\n Since brand name drugs are much pricier \u2013 around ten times the price of generic drugs \u2013 cost-conscious Chilean consumers often choose a cheaper version. When a patent expires, usually 20 years after it is filed, generic drugs certified as bioequivalent can be legally produced and sold in Chile. But there is a problem \u2013 some laboratories don\u2019t wait for the patent to expire and register new patents for drugs that contain identical active ingredients.<\/p>\n Understandably, big pharma is not happy about the situation. Under Chile\u2019s Free Trade Agreement with the United States, signed in 2003, pharmaceutical patents in Chile must be protected. But given the lengthy judicial process required for companies to prove patent infringement in Chile, this protection has proven to be ineffective.<\/p>\n Chile\u2019s shortcomings in intellectual property protection have not gone unnoticed. In May, the office of the United States Trade Representative (USTR) published its annual Special 301 Report and, for a seventh straight year, Chile appears on the Priority Watch List of countries that have failed to protect intellectual property adequately. The other countries on the list are: Algeria, Argentina, China, India, Indonesia, Pakistan, Russia, Thailand and Venezuela.<\/p>\n \u201cAlthough Chile took some steps in 2012 to propose legislation, the United States continues to urge Chile to implement an effective system for addressing patent issues expeditiously in connection with applications to market pharmaceutical products,\u201d said the report.<\/p>\n The problem is not limited to the pharmaceutical industry \u2013 the report also urges Chile to increase protection for encrypted satellite signals and to crack down on Internet piracy. But, according to the US industry association Pharmaceutical Research and Manufacturers of Americas (PhRMA), which recommended that Chile remain on the Priority Watch List this year, better protection of pharmaceutical patents and test data could prompt a review of Chile\u2019s inclusion on the list.<\/p>\n Linkage bill<\/strong><\/p>\n Despite Chile\u2019s failure to properly protect intellectual property, there is reason to be hopeful. The legislation referred to by the USTR includes a bill proposed by the government of President Pi\u00f1era that would modify Chile\u2019s Industrial Property Law to increase patent protection for active ingredients in pharmaceuticals.<\/p>\n The legislation, known as the Linkage bill, was drafted by a government committee consisting of the Ministers of Finance, Economy, Health and Justice, and was submitted to Congress in January 2012.<\/p>\n But not everyone agrees that Chile needs such a law. In January, a group of Senators led by Fulvio Rossi and Francisco Chahu\u00e1n of the Senate Health Committee presented a complaint to Chile\u2019s Constitutional Tribunal claiming that the bill is unconstitutional. They argued that the bill would increase prices of medication for consumers and is unnecessary since patents are already protected under Chilean law.<\/p>\n But President Pi\u00f1era appointed a crack legal team, led by Chile\u2019s former Ambassador to the US, Arturo Fermandois, to defend the bill. The result was that on March 22 the Constitutional Tribunal ruled unanimously (nine votes for, zero against) that the bill is constitutional. The decision clears the way for Congress the to pass the bill, although as of April it remains on the floor. According to Fermandois, the bill is needed for Chile to reform its patent application system and make it easier for companies to protect their intellectual property.<\/p>\n \u201cIt\u2019s important because it provides the first effective tool for stopping the marketing and selling of pharmaceutical products that are not supported by patents,\u201d explained Fermandois.<\/p>\n Under Chile\u2019s current legal system, the burden is on the patent-holder to prove in court that a patent application infringes its own, but judges are often inexperienced in health matters and lawsuits can drag on for months before an injunction is granted.<\/p>\n \u201cIt\u2019s an extremely sophisticated and technical area of knowledge and judges are often not willing to order an injunction,\u201d said Fermandois.<\/p>\n Part of the problem, explains Fermandois, is that the institution responsible for registering industrial patents in Chile, the National Industrial Property Institute (INAPI), is separate from the institution responsible for certifying the ingredients of new medications – the National Institute of Public Health (ISP).<\/p>\n The Linkage bill aims to solve this by making the ISP responsible for both keeping a registry of patented active ingredients \u2013 similar to the US Food and Drug Administration\u2019s Orange Book \u2013 and stopping new patent applications when they contain one or more of these ingredients. The combination of these two functions \u2013 keeping a public registry of patents and suspending the registration process when necessary \u2013 is what is known as \u201clinkage\u201d.<\/p>\n In effect, since a judge will automatically issue an injunction if the application contains an active ingredient already registered, the bill shifts the burden of proof from the patent-holder to the patent seeker. \u201cThere is a presumption of infringement,\u201d said Fermandois.<\/p>\n Chile\u2019s pharmaceutical laboratories say this is unfair and they argue it would hike prices for consumers. According to Jos\u00e9 Luis C\u00e1rdenas, a legal advisor to the board of the Chilean Association of Pharmaceutical Laboratories (ASILFA), an automatic mechanism to block generic drugs means that consumers or the Chilean State will be forced to pay \u201cmonopolistic prices\u201d for medication.<\/p>\n \u201cEven if the judge is convinced there is no patent violation, he must suspend the sanitary registration of the generic. Reasonable? No,\u201d wrote C\u00e1rdenas in a column published in the newspaper Diario Financiero.<\/p>\n But an injunction does not necessarily mean a patent will never be granted. The suspension is a preventative measure for up to one year and can be lifted if the applicant presents two independent reports showing the medication does not violate any existing patent.<\/p>\n As for the opposition\u2019s claim that the bill will increase prices for medication in Chile, Fermandois says the Pi\u00f1era government has committed resources to make sure this doesn\u2019t happen, at least in the public health system.<\/p>\n \u201cIf prices are the consequence of an unfair or distorted market, then there are the tools in our legal system to correct that distortion,\u201d he said.<\/p>\n Promoting innovation<\/strong><\/p>\n The bill is not only aimed at protecting the intellectual property of multinational pharmaceutical companies. It is also designed to promote Chilean innovation, which is key for the country\u2019s continued economic development.<\/p>\n \u201cAny developed country requires strong innovation power and we won\u2019t have that without effective protection of intellectual property,\u201d said Fermandois.<\/p>\n According to Sandra Guazzotti, CEO of Oracle Chile and director of AmCham\u2019s intellectual property working group, the bill is urgently needed to give Chilean researchers an incentive to develop new medications. \u201cThis is very important for the innovation agenda given that, in order for there to be more innovation in Chile, innovators need greater legal security regarding intellectual property,\u201d she said.<\/p>\n The bill would create the legal stability for intellectual property that is a \u201cbasic and fundamental\u201d requirement for research and development, she pointed out.<\/p>\n In addition to Chile\u2019s FTA with the US, Article 19 of Chile\u2019s Constitution establishes a special right to intellectual property. This is backed up by the Intellectual Property Law, created in 1970 and modified in 2010 under the government of former President Bachelet, which guarantees patent and copyright holders the exclusive right to benefit from their products.<\/p>\n But this is insufficient. Chile needs effective tools to make sure this right is enforced, said Fermandois. In this regard, the ruling by the Constitutional Tribunal is the first to formally recognize the obligation of the Chilean legislative to fulfill its constitutional mandate to protect intellectual property.<\/p>\n Crucially, it could also have a positive impact on Chile\u2019s foreign relations. The issue of linkage in regard to pharmaceuticals is one of the items being discussed by the United States and Chile as part of negotiations for the Trans-Pacific Partnership (TPP) agreement. This multilateral trade initiative in the Asia-Pacific region aims to be a high-standard agreement and protection for intellectual property is a key pillar.<\/p>\n According to Fermandois, the recent ruling is not directly related to the TPP talks, but the bill\u2019s approval could help negotiations by showing the will of the government to better protect intellectual property, said Sandra Guazzotti.<\/p>\n It remains to be seen if there is the political will in Congress to pass the Linkage bill before Chile\u2019s presidential election this November, but it would be a healthy sign that Chile is serious about protecting patents. And that would be welcome news for innovators in both Chile and the United States.<\/p>\n Julian Dowling is Editor of bUSiness CHILE<\/strong><\/p>\n <\/p>\n","protected":false},"excerpt":{"rendered":" <\/p>\n Las compa\u00f1\u00edas farmac\u00e9uticas invierten cada a\u00f1o miles de millones de d\u00f3lares en el desarrollo de nuevas drogas. Estados Unidos es por lejos el l\u00edder mundial en esta materia luego que las firmas farmac\u00e9uticas en esa naci\u00f3n invirtieran un total de US$36.400 millones en investigaci\u00f3n y desarrollo en el 2011. Algunas de estas investigaciones traen como resultado innovadores f\u00e1rmacos nuevos para tratar afecciones como el c\u00e1ncer, la depresi\u00f3n y el mal de Alzheimer, muchos de los cuales est\u00e1n a la venta sin receta en Chile.<\/p>\n <\/p>\n Pharmaceutical companies invest billions of dollars in developing new drugs every year. The United States is by far the world\u2019s leader in this regard as pharmaceutical companies there invested a total US$36.4 billion in research and development in 2011. Some of this research results in groundbreaking new drugs to treat afflictions like cancer, depression and Alzheimer\u2019s, many of which are available over the counter in Chile.<\/p>\n <\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"template":"","news_tax":[],"user_type":[],"class_list":["post-5019","news","type-news","status-publish","hentry"],"acf":[],"yoast_head":"\n![](\"\/sites\/default\/files\/Sandra_Guazzotti-secondary_0.jpg\")
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