Tuesday, 27 September 2016

Innovation & health

From Félix Rozanski, Director Ejecutivo del Centro de Estudios para el Desarrollo de la Industria Químico Farmacéutica Argentina, we heard that the 7th LATIN-AMERICAN SEMINAR ON: “INNOVATION AND HEALTH” took place last 21-23 September 2016. The event took place at two venues: the Federal Court of Administrative Justice in Mexico City and the Mexican Industrial Property Institute (IMPI).

Image result for medicines biosimilar cartoonsNot only the agenda has to be praised but the quality of the speakers is to be commended. The agenda cover topics such as: Challenges to Promote Innovation and Development in Latin America; Biomedicines: Regulations and access in Latin America; Correct Identification of ‘Biosimilar’; Data Exclusivity; the Linkage between Patents and Health.

Debates and experiences were heard from Judges and lawyers in the handling of technical and controversial cases; Voluntary vs. Compulsory licenses; Medicine Counterfeiting; and the experts from different National Industrial Property Institutes were also engaged in discussions and revealing the experiences and strategic plans in Latin America. Speakers such as Félix Rozanski (Argentina); Sergio Rodríguez Soria (Director Innovation at Production Ministry, Peru); Elke Simon (Patent Division, Boehringer-Ingelheim, Germany); David R. Gerk: Patent Prosecution Highway (USPTO); Albert Keyack (EPO); Freddy Arias Mora (Costa Rica), Professor School of Pharmacy and Patent Judicial Expert; Laura M. Vargas Sanchez (Director, Regulation of Health Products in Costa Rica); Corey Salsberg (NOVARTIS, Switzerland); Eladio Torres Moreno (Pfizer, USA); Francisco Gomez, (Sanofi, México); Luz María Anaya Domínguez (Judge, Specialized I.P. Chamber Administrative Federal Court, Mexico); Ramon Ignacio Cabrera Leon (Judge, Administrative Federal Court, Mexico); Francisco de las Carreras (Judge, Federal Civil and Commercial Second Instance Court, Argentina); Marcia Flores (Judge in the Quito Court of Justice, Ecuador); Jaime Enriquez ( Judge, Administrative Litigations Court, Ecuador); Rubí Lucrecia Gamboa Barrera de Valvert (Judge, First Instance Civil Court, Guatemala); Mónica Rosell (Expert in the Andean Community Court of Justice); Eric Velasco (Panama’s Supreme Court); Lic. Matías Schweizer (INPI, Argentina); Claudia Baez and Belen Cubilla (Patent Office, Paraguay); Nubia Chedid (INPI, Brazil); as many other judges, officials, and experts.

According to Félix Rozanski the most debated issues were:
(a) How to attract private investments to R&D? How to promote cooperation? How to develop regional R&D projects - mainly in the Pacific Alliance?
(b) The international cooperation and the new agreement signed to speed up patent examinations;
(c) The decision making process in the difficult IP litigation with contrasting views between Chilean and Argentine judges as to the role of the judge;
(d) The value of incremental innovations for the national industries and researchers. Example in Argentina where the nationals do not obtain Argentine patents but do patent the incremental innovation in the US;
(d) The compulsory licenses in Colombia and Ecuador and in the latter case the proposed new code on inventions which in practice mean no patents at all;
(e) The drama of counterfeit medicines with Dominican Republic taking the most severe measures in spite of all the difficulties;
(f) The new plans of the Argentine INPI to promote innovation and take into account the examinations in other national patent offices; and
(g) What the new TTP means for the Pacific nations participating and the chances that it will be ratified.
Felix is open to answer any query you may have at cedieduca@cedi.org.ar

Here you can also find a highlight written by the Federal Court for Administrative Affairs, Mexico about the Seminar.

Monday, 26 September 2016


Una de las soluciones de las oficinas de Propiedad Industrial del mundo para mejorar la calidad y eficiencia de la relación con sus usuarios es el trabajo colaborativo de intercambio.  La existencia de un gran número de solicitudes que se presentan en varias oficinas genera duplicidades innecesarias que pueden evitarse  compartiendo información de exámenes de patentes.

Con el objetivo de alcanzar esta colaboración, la Organización Mundial de la Propiedad Intelectual – OMPI, desarrolló WIPO CASE, que es un sistema que permite a las Oficinas interactuar entre sí, bajo dos modalidades. (a) Una de ellas permite el acceso a la plataforma de documentos de examen, lo que permite beneficiarse del trabajo de otras oficinas y (b) un segundo rol consiste en que además de acceder, las oficinas puedan hacer disponible su propia documentación.

Desde enero de 2016 que INAPI es oficialmente "oficina de acceso", lo que significa que puede visualizar el trabajo ejecutado por las oficinas proveedoras a través de esta plataforma. Pero con la idea de ser un aporte al sistema internacional de patentes, hoy está en condiciones de ser "oficina proveedora". Por tanto, fueron "disponibilizados" un importante número de documentos chilenos en WIPO CASE, para que las restantes oficinas puedan trabajar con esta información.

El sistema es utilizado por las oficinas de Australia, Brunei, Camboya, Chile, China, Estados Unidos, Filipinas, India, Indonesia, Israel, Japón, Malasia, Mongolia, Nueva Zelandia, la Oficina Europea de patentes (EPO), la Oficina Euroasiática de Patentes (EAPO), Papúa Nueva Guinea, República Democrática Popular Lao,  Singapur, Tailandia, Reino Unido y Vietnam.

Con este mecanismo de poner a disposición de otras oficinas documentos propios, Chile se trasforma en el primer país de Latinoamérica en incorporarse a este grupo, con el objetivo de lograr una tramitación más eficiente de las solicitudes de patentes. 

Fuente: Constanza Zülch (Comunicaciones INAPI)

Friday, 16 September 2016

A Presidential candidate that finished in a copyright infringement battle - welcome to Peru

Back in February 2016 the blog reported about a suspected plagiarism case (s) blaming Mr César Acuña Peralta who was running at the time for the Peruvian Presidency.

Mr Acuña was accused of copying his doctoral thesis (submitted at the Universidad Complutense, Madrid, in 2009) as well as his master’s thesis (submitted at the Universidad de los Andes, Colombia) and a whole book (authored in fact by Peruvian Professor Otoniel Oyarce Alvarado). As these accusations were so strong the Peruvian National Institute for the Defence of Competition and Protection of Intellectual Property (Indecopi) decided to investigate the accusations (Organization and Functions Act and Decree Legislative 822 gives INDECOPI the powers to investigate acts affecting copyright and related rights within the country).

Image result for right copyLast week INDECOPI finally came to a conclusion sanctioning Mr. César Acuña Peralta and the Universidad César Vallejo (UCV) for copyright infringement in relation to the authorship of the book “Política Educativa – concepto, reflexiones y propuestas”. INDECOPI also sanctioned Mr César Acuña Peralta for his the doctoral thesis “Competencia Docente y Rendimiento Académico del Estudiante de la Universidad Privada en el Perú”.

In the procedure, INDECOPI’s Copyright Commission concluded that:
• Mr Acuña Peralta infringed the moral right of paternity: claiming to be co-author of the book although the only author is Otoniel Alvarado Oyarce.
• The UCV infringed the moral right of paternity since it published the book, attributing sole authorship to Mr César Acuña; and so giving authorship to the book to a third party other than its creator.
• The UCV made another publication which although correctly attributed authorship to Otoniel Oyarce Alvarado, on the credits page of that book the copyright sign ( © ) was added next to Mr Acuña Peralta name, who is also mentioned as an author in the preface. By this the publisher granted authorship to the book to a third party other than its creator.
• In these two published books the Commission noted that the moral right of integrity of the author was also infringed since at least one paragraph of that work was mutilated.
• The patrimonial right of distribution was also infringed since both publications are kept and loaned at the Resource Center for Learning and Research of the UCV. The INDECOPI has ordered to withdraw from circulation such copies.
• In the proceedings against the UCV INDECOPI also found that there was infringement of the moral right of paternity of the author of the prologue of such books. The prologue was written by the priest Otoniel Ricardo Morales Basadre for Oyarce Alvarado. Both publications were altered and so, changing the name for the person for whom he wrote the foreword.
Image result for doctoral thesis• As the prologue of the infringing copies were distributed for loan in the Resource Center for Learning and Research of the UCV, the Commission determined that the patrimonial right of distribution was infringed.
In regards to the doctoral thesis the Copyright Commission sanctioned with fines to Mr Acuña Peralta due to reproducing fragments of works of others without acknowledging the authorship of them; therefore the Commission concluded that Mr Acuña Peralta infringed the moral right of paternity of those authors.

INDECOPI notes that this “decision may be appealed to the Special Branch Intellectual Property of INDECOPI, which is the second and final administrative authority” of the INDECOPI.

Monday, 5 September 2016

Invenciones de Chile en un programa de televisión

Según informa el INAPI, 24 inventores chilenos están siendo protagonistas de un nuevo programa de televisión llamado "Inventado Chile" (Canal 13C). El espacio ofrece una mirada al desarrollo de nuevas tecnologías desarrolladas en Chile y que han logrado ser protegidas

La iniciativa fue ideada por INAPI, con el objetivo de acercar la ciencia y los inventos a los telespectadores, de manera de contribuir a la educación del país en materia de propiedad industrial.

La apuesta televisiva será relatada por los propios inventores, que abrirán las puertas de sus talleres para contar en detalle cómo una buena idea, se terminó convirtiendo en un producto con alto potencial. En muchos casos, se trata de soluciones que ya están presentes en el mercado.

La primera temporada del programa se extenderá por 12 capítulos y será conducido por Verónica Calabi. 

El primer capítulo se exhibió el miércoles 17 de agosto e incluyó el desarrollo de una tecnología que busca obtener y acumular energía proveniente del mar. Además, se mostró cómo funciona un nuevo manillar para bicicletas, que ofrece la posibilidad de seleccionar dos diferentes posiciones de conducción, sin detener la marcha.

Para más información: http://bit.ly/2c5z52T
Fuente: Constanza Zülch (Comunicaciones INAPI)

Friday, 26 August 2016

Compulsory licence and parallel import: what is happening in Latin America?

A trend or a right? These are the two sides that we can hear when a government is negotiating or authorizing a compulsory licence or parallel import. But very plainly we could see that some of the Latin American countries are using TRIPS flexibilities in their own favour [wasn’t this the aim?].

Article 31 TRIPS recognizes the right of countries to grant compulsory licences for patented medicines in order to combat illnesses. Moreover, the Doha Declaration on TRIPS and public health, states that each WTO member state "has the right to grant compulsory licences and the freedom to determine the bases upon which such licences may be granted".

Back in 2007 this blog was reporting the news that the Brazilian government tried to reach an agreement with MERCK SHARP & DOME, for the antiretroviral EFAVIRENZ proposing the payment of a price comparable to the one it has in Thailand, i.e., US$ 0,65 per pill, instead of paying US$ 1,59 per each pill. As there was no a satisfactory outcome, the Brazilian government published the Decree no. 6,108 noting the compulsorily licence of EFAVIRENZ on the grounds of public interest principle. This licence was destined only to the public and non-commercial use of the drug, and aimed to attend local HIV/AIDS Program. The time frame of the licence was set to be 5 years.
Image result for brazilEFAVIRENZ would be manufactured by laboratories of governmental institutions but this was going to be at the end of 2008 and in the meantime Brazil was to import a generic version of EFAVIRENZ from India, to supply the internal need.

At the end of 2015 we heard from one of our Brazilian friends that Politicians were getting ready to vote for new Pharma Laws. If the law were to pass, the country’s generic industry was to certainly benefit from it. One of the proposal was to expand the grounds of Government non-commercial use of patents and patent applications on the basis of public interest.

Image result for ecuadorBy the end of 2009 the Ecuadorian government created public pharmaceutical and Drug Company called ENFARMA PA (executive Decree (No 181)).  Decree 118 was also passed declaring that it was in the public interest to have access to medicines used for the treatment of illnesses affecting the Ecuadorian people.

In 2014 we noted that Ecuadorian Intellectual Property Institute (IEPI) had received 32 applications for compulsory patent licences. Some of which were refused or abandoned, but nine resulted in the grant of licences for the production of drugs such as Ritonavir, Lamivudine and Abacavir. In the Ritovanir case, which was the first compulsory licence granted in the country, the licence was to be run until the expiry date of the patent i.e. 30 November 2014. ENFARMA PA had applied for the compulsory licences for 9 cases.

In 2010 we were made aware of Colombia's position. It seemed to prevent parallel imports of pharmaceutical unless they were listed in the ‘Compulsory Health Plan’. However, it was making it possible to allow the importation of medicines without permission from the manufacturers which were in the Compulsory Health Plan. The Colombia’s Government announced that the list aims was to get medicines at lower prices. For instance it recalled that Products Roche SA was already offering to reduce the prices of nine of its medicines. Therefore, the Ministry of Health excluded these nine drugs from the list of subject of parallel imports, but the Ministry left the door open to come to this facility if the prices increased again.

Image result for gleevec2016 and we received the information that for several weeks, the Colombian Health Minister Mr Alejandro Gaviria had tried to find a way to force Novartis to lower the price for its leukemia treatment drug Gleevec (due to expire in 2018). [Back in 2010 Laboratory Novartis was hearing a case in a Latin American court in regards to the same drug. The case was decided by the Supreme Court in Brazil and it was regarding extending for almost a year the patented drug through the pipeline system. (for more information see post here)]. Mr Gaviria, failing to negotiate with Novartis, has decided unilaterally to “lower the price the government will pay for the medicine.” …we need to rewind in here…why such an unusual and controversial measure?

It appears, as my teenagers daughters would say, the Minister of Health ‘got a beef’ with Novartis. In 2012, the patent registration of Gleevec was denied but Novartis successfully went to court and a patent was granted. This meant that generic versions could not be produced. In 2015, Novartis sent a letter to the Minister of Health warning that any trace of Gleevec that appears in a generic would be considered a patent infringement.

This issue has brought many into this debate. For instance both the US Senate Finance Committee and the US Trade Representative’s office met with Colombian embassy officials and suggested that Washington might withdraw support for bringing Colombia into the Trans-Pacific Partnership, as well as removing monetary support in backing for the peace initiative between the Colombian government and Marxist rebels.

Novartis in a statement noted that while they support the Declarations of Public Interest which is a legitimate tool, it ought to be used in exceptional circumstances and it considered that it was not the case of Colombia. Novartis further elaborating saying that there were no shortages of Gleevec and that it does not have a monopoly. Something that caught my attention from the statement is that Novartis says that “There are already noninfringing generic versions on the market, which the government could purchase instead of Gleevec in order to reduce its costs.” The question is: how can it be a generic drug that does not infringe? Generic drugs are identical--or bioequivalent--to a brand name. However, the news stated that there are two forms or versions of the drug, one of which is available as a generic (no Gleevec’s version of course). Novartis then insisted that Colombia can have access to the generic version.
Image result for battle
As it is usual when IP rights crosses or is in the border line with human rights, the task of setting the right balance keeps us debating. Indeed a heated discussion will follow in cases of drugs, genetic resources, and traditional knowledge and even in cases of geographical indications.

While TRIPS and the Doha Declaration and public health, permits WTO member the right to grant compulsory licences and the freedom to determine such ‘flexibility’, I think this news is a first…don’t have a compulsory licence, just unilaterally lower the price!

Friday, 19 August 2016

A network to attend: calling SMEs

No many times we receive news from Costa Rica and every time I see something in this country I get very excited [perhaps it’s because of its richness in fauna and flora: I definitely would like to visit the sloth sanctuary and indulge myself with their famous pineapples).

Image result for sloth tango
Sloths do tango.
An invitation was in my inbox from ELAN (European and Latin America Technology based Business Network) which I have the fortune to work with early in the year. For the 19th to the 21st September 2016 ELAN will be in San Jose, Costa Rica. The workshop is a great opportunity for small and medium enterprises (SMEs) to “create strong networks and durable relationships and business opportunities characterized by being technology and innovation related.” The flyer notes that “ICT is one of the most dynamic technological areas in Costa Rica. It includes more than 900 companies, 95% of which are SMEs, becoming an interesting sector which important challenges related to international collaboration and partnership.”

In regards to intellectual property, the Latin American IPR SME Helpdesk will be present in the event. Day 2 will see Silvia Salazar speaking on how to manage intellectual property in the ICT sector focusing on patents in Central America. The event is free of charge.

More information here.