IPTango

Wednesday, 2 December 2009

Venezuela to examine all pharmaceutical patents

Patricia Covarrubia December 02, 2009 No comments:

The forum titled "The patents as element of exclusion and limit to the health of the town", which was lectured in Venezuela, saw the head of different institutions united. Last Thursday, the Venezuelan Minister of Commerce, Eduardo Samán, the Servicio Autónomo de la Propiedad Intelectual (SAPI)’s director Arlen Piñate and the Cámara de Medicamentos y Afines (CANAMEGA)’s president , Jorge Rivas, declared their views regarding pharmaceutical patents.

Eduardo Saman, declared that “all pharmaceutical patents are to be examined to see if they have fulfilled the corresponding proceeding”. To this view, Jorge Rivas added that the SAPI needs to scrutinize all pharmaceutical patents that have been granted under Andean Community (CAN) Decision 311, 313, and 344.

The situation comes after two Bayer’s pharmaceutical patents were annulled by the government. As reported early in this blog here and here, the procedures under which these two patents were annulled caused controversy.

The crucial point of this is based on the fact that there is not clarity on how the examination is going to be done. In one hand, the Industrial Property Act of 1956 prohibits this type of patents. In the other, the Andean Declaration 344 does allow so. Venezuela withdrew from the Andean block in 2006 (a member since 1973). So that, the debate is: will it be scrutinized under the law in force at the time the application was filed or at the time it was examined?

As observed in the Bayer case, the government has a convenient way to declare that certain pharmaceuticals patents are ‘illegal’. Thus, it seems that if a pharmaceutical patent was filled or examined while the Industrial Property Act of 1956 was in force, then the patent will be annulled. From this statement, one can conclude that the Andean Community Declaration appears not to have existed! Or, is it a case that the Venezuelan government is not recognising general principles of law such as ‘non-retroactivity’ and the ‘protection of legitimate expectations’?

Peru: toys that play without a mark

Patricia Covarrubia December 01, 2009 No comments:

Christmas time appears to be a good moment for the National Institute for the Defence of Competition and Protection of Intellectual Property (INDECOPI) to launch a security check campaign. The institution is working on the street by doing inspections on different shops, specifically those that sell toys. The objective is to check the marks and labelling of these products. The mark is the one needed to identify the product and the latter, involves a sanitary authorisation.

This campaign is a clear reminder of what a mark signifies to consumers. Later on we have been absorbed by so many advertisers that marks have become a social status, a style of living, a representation of what we want to be or are. However, we must not put aside the principal function of a mark, that of origin. While I do agree that today’s function of a mark is more than origin and quality, I cannot stress enough the importance of recognising that a mark tells us that the product comes from a particular manufacturer.

That said, the INDECOPI rightly reports that with a mark, consumers indentify the importer, or manufacturer, or the responsible for the commercialisation of the product and so, the responsible, if a query and/or claim is brought.

Those toys that are found without a mark or labels, can be fined up to 1 million 65 thousand Peruvian Nuevos Soles (approx. 366 thousand American dollars)

To watch the INDECOPI working in this operation click here

Brazilian Government Tailors a Bill on Trade Sanctions

José Carlos Vaz e Dias November 30, 2009 No comments:

The Brazilian government is under strong internal pressure as the World Trade Organization (WTO) has recently upheld the Brazilian complaint against the United States due to the subsidies granted to cotton producers.

The concern has been the lack of a local law dealing with the applicability of commercial sanctions when Brazil wins complaints in WTO Settlement Disputes. A specific law in this regard has been recognized as of great use, since it will provide the weapons and the criteria to implement the sanctions.

As a result, the government concluded in a rush a draft of proposed law and delivered it to the Parliament on November 23, 2009. In a nutshell, the Bill establishes the weapons that may be used by the government. Among them is the intellectual property rights, which encompasses the suspension of royalty remittances derived from technology transfer and licensing agreement, the grant of compulsory licenses and the importation allowances of drugs and generic drugs still under local patent protection.

To secure the enforcement of the US$350 million in sanctions against the United States, recently issued by the WTO against the subsidies of cotton producers, the government is pressing hard the Parliament for approval of the Bill by Christmas. If Mr Lula feels that it will not get sufficient support in Parliament, he intends to immediately issue a Provisional Measure to make the contents of the Bill immediately enforceable.

For the general knowledge, a Provisional Measure is a type of law coming from an act of the President issued in case of urgency or extreme importance. The publication makes the Provisional Measure immediately effective for a period of 45 days (http://www.v-brazil.com/government/laws/laws.html).

The government is studying the options set by the Bill that may impact the most the American government. The identified preferences of the Brazilian government are as follows: (a) 1st Option – Suspension of intellectual property rights of American companies during the period of the sanction (until the American government phases out the condemned subsidies); (b) 2nd Option – Application of an additional tax or duty to royalty remittances; (c) 3rd Option – Suspension of royalty remittances and (d) 4th Option – Suspension of the internal rule that prohibits parallel importation, thereby allowing the entry of products without the prior and express authorization of the trademark/patent titleholder.

Such IP sanctions will be adopted further to the ‘normal’ commercial sanctions applicable on approximately 220 American products.

The Americans have been reacting against the Bill. They have been alleging that there is no reason for applying the sanctions, since the illegal cotton subsidies will be soon phased out. The Brazilian diplomacy has stated that such promise has been made but not fulfilled since 2005, when the WTO’s condemnation was issued for the first time.

The Bill or Provisional Measure will be posted on IP Tango soon after the final version is disposed to the press.

Instructing your society: how to avoid illegal medicines

Patricia Covarrubia November 27, 2009 No comments:

Peru - the National Institute for the Defence of Competition and Protection of Intellectual Property (INDECOPI in Spanish), destroyed almost two tonnes of expired and empty packaging of medicines (click here for the INDECOPI's news).

The campaign started back in 2007 by the INDECOPI together with pharmacies. It consists in installing special containers in pharmacies and chemist’s shops, where consumers can go and dispose of empty or unused packaging of medicines. This is the third time the destruction has taken place and, compared to previous years (1 ½ tonne in 2007 and the same in 2008), it appears that consumers are becoming more aware and involved in the campaign.

This is a cooperative effort that teaches consumers how to safely dispose medications, but to the INDECOPI, it is a situation of avoiding the reuse of packaging and thus counterfeit.

I give INDECOPI’s movement the thumbs up.

México: Es la piratería más rentable que el narcotráfico?

Gilberto Macias (@gmaciasb) November 26, 2009 No comments:

Según los cálculos de la American Chamber la respuesta no es solo afirmativa, sino qué, la piratería dobla prácticamente los ingresos del narcotráfico.

Difícil de creer, si, pero un claro reflejo de la realidad. Según la encuesta un 76 de cada 100 mexicanos compran mercancía pirata.

El impacto de las ventas de productos apócrifos causan en la industria se estimó en unos 74 mil 699 millones de dólares, cantidad que representa un 9% del Producto Interno Bruto, según la tercera “Encuesta de Hábitos de Consumo de Productos Pirata y Falsificados en México” que dio a conocer la cámara.

De acuerdo a los cálculos de la American Chamber, la piratería superó los principales rubros de ingreso nacionales, tales como el narcotráfico (40 mil millones de dólares), el petróleo (casi 25 mil millones), las remesas (21 mil millones de dólares) o el turismo (11 mil millones de dólares).

En porcentaje de compra los DVD y CD ocupan la primera posición con 94%; ropa con 14%; calzado con 13% y software 10%, entre otros productos. Mientras que, los encuestados por general expresaron su resistencia a adquirir medicinas, cigarros, alcohol y alimentos piratas.

You may ask: why is Venezuela in the Priority Watch List?

Patricia Covarrubia November 26, 2009 No comments:

Following yesterday’s news, Ricardo Antequera Parilli of Estudio Antequera Parilli & Rodriguez, has written to the blog with the following points:

“a) Despite of the Declaration of the Minister of Commerce by which it was informed that two Bayer patents, related to moxifloxacin were annulled, the fact is that the annulment procedures have been recently opened on November 23, 2009 through the resolutions issued by the same Minister;

b) In his resolution the Minister of Commerce notified Bayer that some irregularities had been found in the patent files Nos. A54057 and A58097. Hence, Bayer has to submit their defenses within the 15 working days. This time frame ends on December 14, 2009;

Regarding patent No. A54057, the Minister stated that they found that it was granted ignoring the corresponding procedure, among other facts. According to the Minister, even though the patent was examined and granted back in 1995 when Andean Community Decision 344 was supposedly to be in force (it allowed pharmaceutical patents), the application was filed in 1992 under the Industrial Property Act of 1956 which does prohibit pharma related patents;

As for the patent No. A58097, that claimed Convention Priority from DE 19546249.1, the Minister also stated that they found that it had been granted ignoring the corresponding procedure, since the claimed molecule lacks of novelty and non-obviousness.

According to the Venezuelan Administrative Procedures Act, decisions may be annulled when issued under absolute ignorance of the corresponding procedure, and hence, they can be reviewed ex officio. However, we can not find an absolute oversight of the procedure in the cases of patents A54057 and A58097, as informed by the Minister.

Also, it seems that the Minister is applying the Andean Community Decisions on a convenient form when he said that patent A54057 had to be examined under the law in force at the time the application was filed. However, recently the Venezuelan Patent Office started rejecting patent applications filed under Andean Decision 486, but which were examined in 2009 under the reinstated Industrial Property Act of 1956 which prohibits patents over pharmaceutical products.

Moreover, it seems very strange how this particular case is being prosecuted, since the Venezuelan PTO has nullity actions pending decision since 2000.”

There is not wonder why Venezuela remains in the Priority Watch list in 2009.

Venezuela Annuled Two Bayer's Pharmaceutical Patents

Patricia Covarrubia November 25, 2009 No comments:

The country’s Minister of Trade, Eduardo Saman, declared that the Government invalidated two registered pharmaceutical patents for the antibiotic moxiflocaxin produced by multinational Bayer.

The move comes after Bayer initiated civil lawsuits against two national companies that were producing generic copies of moxiflocaxin. The accused infringers alerted the Minister of Trade and the Servicio Autónomo de la Propiedad Intelectual (SAPI). Proceedings started challenging the validity of the patents.

The SAPI’s director Arlen Piñate declared that the requirements were not fulfilled. The requirements for granting a patent in Venezuela are 3: the invention must be new, no obvious and industrially applicable. Piñate said that the forms did not contain the reason why they were granted. She continues explaining that the first patent was registered in 1992. To this effect, she said that at the time, the Industrial Property Law 1956 excluded pharmaceutical patents. The second patent was granted in 1996 when the law was amended as to allow this type of patents. However, Piñate mentioned that the requirement of novelty failed because of the first patent (there was prior publication).

Criticism
Sadly, the Venezuelan view is political rather than explaining legal grounds. The declaration made by the Director appears to be focus on a socialist campaign (see SAPI’s declaration here – in Spanish). She starts by saying that ‘Bayer is putting into risk public health’. The thought that cross my mind was ‘side effects’ but I was wrong. Most of her statement is based on the dislike of transnational companies: they prevent generic alternatives, high prices for medications, and so on. However the blog is not about politics, therefore I need to proceed with IP.
Two points I have:
1.- Bayer’s first registration nullity; Bayer’s original registration fulfilled all requirements and was granted. Unfortunately, it does not have any legal ground because of the fact that pharmaceutical medicines could not be obtained under the said legislation. How this happens?
2.-Bayer’s second registration; novelty, clearly the invention was known and used in the country; there was also a printed publication (the one in the register). Therefore, there was, we can say, a prior publication. However, should not be a defence that relates to the malfunction of the system (in this case, the Patent Office). I am afraid I do not know any case, so please free to post any comments and ideas.

On a final note, ‘moxiflocaxin’ is not listed as an essential medicine by World Health Organisation (WHO), so I question, why is Bayer risking public health?

WHO model list of essential medicines here.

XIX Ibero-American Summit: ‘Innovation and Knowledge’

Patricia Covarrubia November 25, 2009 No comments:

The Ibero-American Heads of State and Governments are meeting for two days (30 November and 01 December) in Estoril, Portugal. The twenty two members are looking to promote, as the theme suggest, innovation and knowledge (see press release here)

Ibero-American Secretary General Enrique Iglesias, said that this forthcoming meeting looks better than previous years (in an informal note, perhaps he was referring to the XVII forum when the King of Spain demanded to the Venezuelan President to 'shut up'). Going back to the point, according to him, there is a healthier economic environment. He also adds that Latin America as well as any country in general, have learned to better manage economic affairs and are innovating in business structure and social policies.

Iglesias said that ‘innovation’ is very low in both Latin America and Spain and Portugal, but yet, they are ‘things that contribute’ (did not say what and how – I wonder if there is a hidden agenda). Anyway, he continues to explain that they are not starting from scratch and thus mentioned the Brazilian oil industry, biotechnology, the Ibero-American Science and Technology Education Consortium (ISTEC)and the Economic Commission for Latin American and the Caribbean (ECLAC).

Finally, Iglesias hopes that during the Spanish presidency of the Council of the EU (Jan-Jun 2010) the EU will sign association agreements with Central America, the Andean Community and Mercosur.

Point of concern
At the moment, innovation is the key to raise competitiveness for Latin America. However, it is understood that these countries have a very low level of innovation but are rich in biodiversity, so that what to do and what is the cost? Recently, I have been observing the negotiation agreements between the EU and countries such as Chile, Peru, Colombia and Ecuador and there is always a crucial point where talks appear to be on hold, that is, intellectual property (apart of course from the sensitive issue of the banana market).

Looking at the intellectual property clauses and table of negotiations, I sense that Latin American countries not only would like to protect but use their biodiversity themselves. Nonetheless, note that countries cannot give and get nothing in return - negotiations are focus in reciprocity. That said, Latin America countries are getting better quotas for products, which are not bad, but my concern is that they are not getting what is needed in this area.

I would finally say that negotiations in this issue should be considered if others make significant attractive offers in the innovation sector rather than a mere economical advantage.

Barrichello gana a Google.

Gilberto Macias (@gmaciasb) November 24, 2009 No comments:

Obviamente no se trata de una carrera de la F1, si no de un pleito iniciado por el piloto brasileño Rubens Barrichello en contra del buscador por lesiones a su honor, en concreto se trata de la existencia de más de 300 perfiles falsos en la red social de Google: Orkut

El piloto había avisado a Google desde julio de 2006 julio de 2006 que retirara esos perfiles, pero no obtuvo ninguna respuesta. Como no recibió respuesta alguna, Barrichello denunció el caso, tras lo cual, un tribunal de Sao Paulo le dio la razón.

Google ha sido condenado a pagar cerca de $700.000 USD en concepto de indemnización y además deberá además retirar los perfiles falsos y los comentarios ofensivos sobre Barrichello, y en caso de no poder hacerlo sufrirá una multa diaria de 590 dólares por día hasta la retirada de los perfiles

Si bien la sentencia condena a Google, seguramente la misma originará que el buscador busque la forma de controlar los contenidos de terceros…

La sentencia es de primera instancia y seguramente será recurrida por Google.

Bilateral agreement between the EU and both Peru and Colombia near to a closure

Patricia Covarrubia November 23, 2009 3 comments:

Last week, the Colombia’s capital has seen the EU and Peru and Colombia negotiating an Association Agreement. This Agreement concerns three issues: Free trade Agreement, cooperation and a form of political dialogue. However, according to Aguiar Machado (the EU negotiator in charge) the last two were put on hold because EU does not want to isolate the rest of the Andean block (the Andean Community is composed by Bolivia, Colombia, Ecuador and Peru; Venezuela withdrew in 2006).

The agreement has already closed half of the table of negotiations but yet, need to agree in other issues such as: reduction of import and export tariff in the banana industry and cars; an annual increase in the quota for sugar from the Andes to the EU; fishing and services; among others.

Regarding to Intellectual Property, Mr Santiago Pardo (Colombia’s main negotiator) affirmed that the negotiation regarding this area is ‘going well’ and that an agreement has been reached regarding patents. However, there are issues that are still of debate. For instance, on one hand Peru and Colombia are seeking for an agreement that ensures good use of its rich biodiversity. On the other hand, Europe is debating to protect their appellation of origin.

The EU and the Andean Community have been working towards a bilateral Agreement since 1993. By the fourth round (July 2008)the negotiations failed due to Bolivia and Ecuador causing tension. The Agreement block to block (Andean Community and EU) failed but two of the members continues with talks. The separated bilateral Agreement as it looks, seems that it is close to conclusion.

I would like to be optimistic. The reason being that the block to block agreement negotiation lasted more than ten years and it did not succeed. Last September, Peru and Colombia asked Brussels to continue bilateral negotiations and two month later they have managed to negotiate half of the 14 tables of negotiations. It seems pretty good to me.

For more information regarding the failed Andean Community and the EU Agreement (CAN - EU) click here.