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".

Brazil
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.

Ecuador
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.

Colombia
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.

Pisco: Chile vs Peru

Image result for piscoisperuvianThe Chilean Association of Producers of Pisco has heatedly reacted after a commercial banner located in a main area in Santiago de Chile remarking ‘#PISCOISPERUVIAN’.

Mr Hernandez, the Chilean Association Producers of Pisco’s president, said that this action is “an open campaign of provocation from the neighbouring country". The banner infringes national laws which protect the designation of origin of Pisco as a distilled drink only produced in the regions of Atacama and Coquimbo (see DFL 181, Law 18,455).

The association requested a hearing with the Minister of Agriculture, as well as contacting the Agriculture and Livestock Service (SAG). This set of events made SAG to bring a ‘Complaint and Summons’ (ADC) to the company's commercial advertising SUR S.A. (MASSIVA), which is the one that installed the banner – associated with the brand ‘PERUVIAN’.

SAG’s director informed that the reason “we have completed this ADC to the company have to do with the designation of origin of pisco…That is why the aforementioned company must go to the offices of SAG RM to provide background on hiring this ad space".

Added to the banner, there is also a video through Youtube produced by the brand ‘PERUVIAN’ which emits strong statements against the Chilean Pisco industry (to watch the video click here). For instance the video made remarks that “Pisco is 100% Peruvian due to geopolitical reasons, etymological, geographical and historical"; that the Chilean Pisco is a sign which “mislead the designation of origin”; and generally that the Peruvians need to react against this and need to claw-back the term Pisco as the Spaniards did with the term ‘Jerez’ and France with ‘Champagne’.

Image result for pisco chile peruThe Pisco Producers Association also reported this situation to regional parliamentarians, and now the Chilean Chamber of Deputies has published the discontent of not only the Producers but the Chileans. In this regard, Deputy Sergio Gahona said "it is unacceptable that in our own country the designation of origin of pisco is infringed". The MP argued that "in cases like this all public actors responsible for it should take a more active role in the defence of the Designation of Origin of the Chilean Pisco”.

The battle over this term is not something new. For instance, in 2013, the EU registered Pisco as a DO from Peru. However, this registration acknowledged a previous trade agreement between Chile and the EU in which Pisco was recognized as a DO from Chile. The note clarifies that the protection granted to "Pisco" as a DO to Peru does not hinder the use of that name for products originating in Chile. Other trade agreements also see the dispute over the term: Malasia recognizes Pisco as a DO from Peru; a trade agreement between Chile and Nicaragua recognizes Pisco as a DO from Chile; another trade agreement between Peru and Costa Rica recognized Pisco as a DO from Peru.

Thursday, 18 August 2016

Argentina: The sun come out tomorrow... and you will have to put extra money at the IPO

Image result for sun come out tFrom tomorrow onward the Argentina Instituto Nacional de la Propiedad Industral (INPI) will awake with new (increased) fees. The rise will be implemented in two stages and the second increase will take effect from October 2016.

For example, today to register a word mark cost you $ 760; tomorrow $1000 and in October will be $1200. A trade mark renewal costs $960, tomorrow $1300, and in October $1500. Collective marks remain free of charge.

The rationale behind the increase is intended to “facilitate management aimed at continuous improvement of the quality of its services, the relevant technological adaptation to new national and international parameters, taking into account its interaction with other regional industrial property offices, and the continued recognition of specialized technical level of its staff.”

The full Resolution (and new tariff) can be found here: Resolution 388-E/2016 (in Spanish).

Tuesday, 16 August 2016

Mexico: time to oppose to trade mark registration

At the end of this month (August 30, 2016) Mexico will implement an opposition system in trade mark.

Image result for roadshowIn May this year the Latin America IPR SMEs Helpdesk and the UK Intellectual Property Office (UKIPO) collaborated on a roadshow in the UK. Participating in one of this workshops in Reading we cover ‘Intellectual Property Rights in Latin America – sources of help and support’ and one of the issues covered was the (lack of) trade mark opposition in Mexico.

Mexico is one of the few countries which does not provide for trade mark opposition proceedings. The Instituto Mexicano de la Propiedad Industrial (IMPI) is the administrative authority legally authorized to conduct ex officio examinations of trade mark applications on absolute and relative grounds. As noted in the World Trademark Review, Mexico is not bound to introduce opposition proceedings as a result of its accession to the Madrid System, but this amendment would make the trade mark system more efficient. Colombia was the first Latin America emerging country to ratify the Protocol on the Madrid Agreement (2012), then Mexico (2013). Cuba signed in 1995.

On 23 August José Miguel Mena López, Legal Services Manager at Clarke, Modet & Cº Mexico will be holding a Webinar on the implementation of the opposition system in Mexico. Details of the Webinar and how to registry can be found here.

Friday, 12 August 2016

Samba, carnival...yep, you got it, we bring news from Brazil

Image result for Bordado Filé de Alagoas’From Brazil we looked at the number ‘57’ as a registered Geographical Indication (GI). The application came from the Instituto Bordado Filé das Lagoas de Mundaú-Manguaba (Inbordal) which is the representative of “local artisans who preserve the tradition and pass on know-how from one generation to another.” The product obtaining the GI is ‘Bordado Filé de Alagoas’, a non-agricultural product.

The Brazilian legislation does not differentiate between agricultural and non-agricultural products for the protection and registration of GIs. Yet, the legislation distinguishes between two GIs namely 1) denomination of origin (DO) and 2) indication of source (Indicação de Procedência). Another relevant issue under the Brazilian legislation is the recognition of services which is not common to see protected under GI – yet, they are not actually barred from registration e.g. PORTO DIGITAL (as an indication of source).

‘Bordado Filé de Alagoas’ is an “embroidery technique performed on a surface of woven wire.” While the technique’s origin can go back to ancient Egypt, its more recent location is found in the Iberian Peninsula. Inbordal noted that in the colony period it moved to Brazil and was consolidated and improved in the Lakes of Mundaú and Manguaba.

Image result for carnaval venezuela bombas de agua
If you are Venezuelan...you know that
this is the best part of  'the' Carnaval
For those that study Intangible Cultural Heritage (ICH), the publication made by the Brazilian Instituto da Propiedade Industriale (INPI) notes that ‘Bordado Filé’ is registered as ICH for the State of Alagoas. This however does not appear on the UNESCO list of ICH. Brazil has 8 elements registered in UNESCO and you can rightly speculate that some ICH that are in this list are: SAMBA de Roda of the Recôncavo of Bahia (RL) and the performing arts of CARNIVAL of Recife (RL).

A year has passed since I examined the different GIs that exist in Brazil and I notice that from Sept 2015 to August 2016 (almost a year later) 13 more GIs have been registered. There are in total 40 Indicação de Procedência and 17 DOs.

Source INPI.