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Showing posts with label approval of pharmaceutical patents. Show all posts
Showing posts with label approval of pharmaceutical patents. Show all posts

Tuesday, 5 May 2015

Patricia Covarrubia

Peru: Patents vs Public Health (Part II)

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Building upon the previous post regarding the overview by Peruvian national press that patents restrict competition, the Peruvian Instituto Nacional de Defensa de la Competencia y de la Protection de Propiedad Intelectual (INDECOPI) answered back.

It starts by establishing that the Institute is in charge of ‘protecting intellectual property’ and as so “performs a thorough technical review of each patent application” done by specialists in the area who do have years of experience. The Institute follows “strictly defined legal requirements by current regulations (Decision 486 of the Andean Community Commission and Legislative Decree 1075) and by international treaties to which Peru is party.” By doing so it gives the example that between 2010 and 2014, half of pharmaceutical patent applications evaluated were denied. Andean Decision 486 provides that patents may be granted for inventions either product or a process, in ‘all fields’ of technology BUT not second uses [i.e. Swiss formula].

Moreover, INDECOPI notes that by administering this legal obligation it does recognize fundamentals right under the Peruvian Constitution. Its performance will always be in “safeguarding the judicial stability and rule of law in accordance with the Peruvian obligations in the Andean Community and the World Trade Organization.”

As you may recalled from the previous post (here), INDECOPI was encouraged to ask for technical opinion to the Ministry of Health before granting a patent on a drug (as the Colombian office does). This requirements was suggested as to protect the public interest. To this matter, INDECOPI notes that while there is no legal provision that established that for the granting of a patent in the pharmaceutical area, the prior technical opinion of another entity was sought, INDECOPI “recognizes the relevance to society's protection of the right to health” and also noted that under present patent legislation there are “measures that can be applied to access to medicines by the population”[i.e. compulsory license].

The exclusive rights generated a patent encourages investigations that lead to the creation of new products and procedures in the case of pharmaceutical development benefit the health of society and is one of the mechanisms that guarantees are made to continue investigating and investing in search for new drugs.

Then the note went on to target the criticism that in other Latin American products the same medicines have been denied protection. To this INDECOPI responds that the “granting or refusal of a patent in one country is not binding”. “ It then went to note that the compound Atazanavir bisulfate referred in the media while it a patent has been denied in countries like Brazil, Colombia, Uruguay and Venezuela, it has however been granted in countries like Chile, Argentina and Mexico.

Finally, INDECOPI “reaffirms its mission of protecting intellectual property, which includes legal measures which the competent authorities do have access to for safeguarding public health.”

Source INDECOPI.
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Friday, 16 September 2011

Patricia Covarrubia

Venezuela: a tormenting week

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This week we posted two notes from Venezuela: an IP reform is on its way and Empresas Polar transferred its mark to a Canadian company (also the post mentioned some other Venezuelan trade marks and brands (the majority well-known) that have been transferred to other companies abroad). To this info I would like to add that Venezuela has taken steps to pull out from the International Centre for the Settlements of Investment Disputes (ICSID) which, as its name stands for, is a global for dispute resolution. While this latter news appears not to have relation with IP I regret to disagree. The foreseeable future seems to be frightening for IP authors and owners. Let us consider some matters that have been happening in this country, lately: 1.- In 2006 Venezuela withdrew from the Andean Community block which did have an impact on IP. For instance, the government declared that certain pharmaceuticals patents granted under the Andean Community (CAN) Decision 311, 313, and 344 were ‘illegal’ because the Industrial Property Act of 1956 ( in force) prohibits this type of patents. 2.-Venezuelan Government has expropriated 988 companies (401 this year), nationalising even international companies. Additionally, we need to have a look at the information provided by the Venezuela Central Bank which reports that the government owes more than $40 billion for properties nationalised by it (ConocoPhillips US $30billion; ExxonMobil Corp US $7billion; Crystalles International Corp Canada $3.8 billion; Cemex Mexico $1billion; Holcim Switzerland $650 million, upon others). 3.- Venezuela not only has expropriated physical properties but also IPRs such as the case of Venezuelan coffee roasting company ‘Fama de America’. The government expropriated its trade mark. 4.- Last month academics and Scientifics called for the annulment of the Law of Science and Technology claiming that if the law is implemented it could abolish the existence of any IP protection which “would hinder further innovation process that the law says it wants to promote.” 5.- This year Venezuela was placed on the priority watch list released by the Office of the United States Trade Representative (special 301 Report) – the study focus on the adequacy and effectiveness of U.S. trading partners’ protection of intellectual property rights(IPRs). I am sure there has been much more news regarding these matters but I bring today these ones. Without bias, I can see and say that national and foreign companies are pulling out of this country which means investments, inventions, technologies are leaving. For example, the fact that Venezuela is withdrawing from the ICSID gives a warning to foreign investments especially investors and holders of Venezuelan debt bonds amid fears of having to resolve disputes in unreliable domestic courts. For these reasons I await the reform that the government is so promoting but I have to be honest and say that I am not holding my breath on this one (it is I believe quite predictable – this means no good news for IP authors and owners).
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Thursday, 23 June 2011

Patricia Covarrubia

Brazil: the case of pharmaceutical patent examination - a dual examination system?

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From Dr Ken Shadlen, Reader in Development Studies at London School of Economics and Political Science (LSE), the iptango received an interested article called “The political contradictions of incremental innovation: lessons from pharmaceutical patent examination in Brazil”.

I was planning to give you a summary or at least an inside of this article but it is so good that I do recommend reading it all. The article is very much focused on the situation of patent administration and its process and so, the situation experienced by the pharmaceutical industry when filing an application at the Brazilian Instituto Nacional da Propiedade Industrial (INPI). The article however covers some other interesting issues, such as:
  • It explains the so-called ‘neodevelopmental patent regimes’ which goals is to facilitate to nationals the access to knowledge and so encouraging innovations; yet, it also illustrates the political contradictions between these objectives.
  • It covers the fact that Brazil did not protect pharmaceutical products (patent was not granted to this type of products and/or processes) and so, it needed to reform its law and legislation due to its obligation as a member of the WTO. In the same line it tries to bring awareness between strong protection and its relation to high prices and hence, its effect on access to medicines.
Nevertheless, the main issue of this article is the situation called ‘prior consent’ which requires all pharmaceutical patent applications to be approved by INPI but also, prior to being granted, it needs to be approved by the country’s Health Surveillance Agency (ANVISA). Yes, a dual examination system!

The author goes on to study (in depth) this policy: how it is designated to operate and how it functions in practice. At the end he states that this health-oriented patent policy “has become fraught with tensions” and explains the conflict between these two institutions (INPI and ANVISA) and so, he refers to the fact that they have become weaker.

This article is a significant contribution made by Dr Ken to our IP Latin America community.
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Sunday, 1 November 2009

Jeremy

BPTO v ANVISA: pharmaceutical patents in Brazil

In what has become a classical issue in recent years, the battle between the examination of pharmaceutical patent applications by the Brazilian Patent and Trademark Office (BPTO) and the Health National Surveillance Agency, also known as ANVISA, we may probably have reached its highpoint.

This time, a new player is in the game: the Federal General Attorney and his recently-issued Opinion no 210, after a formal request brought by the BPTO.

The issue is this: what is the role of ANVISA, on the examination of patent applications related with pharmaceutical products and processes? Does it extend to the examination of patentability requirements or is it limited to dealing with public health matters?

At the centre of the discussion is the current draft of article 229º C of the Brazilian Intellectual Property Law that states:
“The granting of patents to pharmaceutical products and processes depends upon the prior approval of the Health National Surveillance Agency.”
Under this provision, ANVISA examines pharmaceutical patent applications and, if they meet the patentability requirements (novelty, inventive step and industrial application), as the BPTO currently does, this creates a double examination on the same invention.

The current legal framework has already led the BPTO and ANVISA to issue contradictory decisions, but the final wording belongs to ANVISA, to the despair of patent applicants. This also gave ANVISA the power to substantially interfere on IP policy matters, through an aggressive and effective policy regarding the protection and development of the generics industry, the promotion of the issuance of more compulsory licenses, and the support of Bills against the patentability of second medical use, leaving the BPTO in a less visible position.

Surprisingly, the issued Opinion goes completely in the opposite way, against ANVISA’s interests. The Federal General Attorney understands that ANVISA has indeed the power to examine pharmaceutical patent applications, but only under a public health perspective. Thus the patentability requirements of a pharmaceutical invention can only be examined by the BPTO.

This Opinion also focuses on the issue of the patents granted by the BPTO under the pipeline system and that were not previously forward to ANVISA’s examination. In this case, the Federal General Attorney recommends that ANVISA should be given the opportunity to examine these patents on a public health approach.

The Federal General Attorney submitted this Opinion to Presidential approval. For now, let us wait to see what will be the President’s decision on this matter and the respective consequences for both Agencies.

By Jorge Miguel Arruda da Veiga (Di Blasi, Parente, Vaz e Dias & Asociados); posted by Jeremy
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Wednesday, 2 July 2008

Jeremy

ANVISA to review Brazilian pharma patents -- but is this lawful?


On 23 June 2008 the Brazilian National Health Surveillance Agency (ANVISA) issued Resolution RDC 45 on the approval process for patent applications for pharmaceutical products and processes. This resolution is made under Article 229-C of the Law 9.279/96 (Industrial Property Law), according to which all patent applications for pharmaceutical products and processes must have the approval of ANVISA.

Under Resolution RDC 45, applies to all pending patent application filed from 15 December 1999 onwards, the Brazilian Patent Office will send the patent application files to ANVISA in order to obtain official approval, which will state reasons for giving or denying its approval. ANVISA may ask the applicant to submit documents, objections, searches as well as the results of examination in other countries. additionally, interested third parties will be able to submit documents so as to support ANVISA’s examination during the proceeding.

If ANVISA’s preliminary report concludes that the patent cannot be allowed, or if the agency raises an office action, the patent applicant has 90 days receipt of its decision in which to respond. Failing such a response, the decision is final. There is also a 60- day term, following the date of publication of the decision in the Brazilian Official Gazette, in which the patent applicant may file an appeal against the decision

According to the authors of this information, this resolution in their opinion exceeds ANVISA’s competence, since the patentability examination falls within the competence of the Brazilian Patent Office. Accordingly the legality of this resolution may be subject to court proceedings
[source: Di Blasi Parente, Vaz e Dias & Associados circular, 1 July 2008].
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