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    Brazil HIV Drug Patent Ruling Allows Generics, Sends Pipeline Process Into Doubt

    Published on 21 March 2012 @ 12:05 am

    By , Intellectual Property Watch

    Word is spreading of a recent decision by a Brazilian judge to annul a patent on a key AIDS drug, effectively allowing less expensive generic versions into the country, and calling into question other such patents. [Update: decision added.]

    The decision is available here [pdf, in Portuguese]

    According to a statement by the Working Group on Intellectual Property of the Brazilian Network for the Integration of Peoples (GTPI/Rebrip), a coalition of non-governmental organisations, the judge granted a request by Cristália, a Brazilian generic producer, to annul a patent held by Abbott Laboratories.

    The patent was on the drug ritonavir and lopinavir (lop/r), which is marketed under the brand name Kaletra and used to treat HIV infection. [Clarification: the patent was on lopinavir, so the decision allows the Brazilian company to make a generic lop/r combination, according to a source.]

    The decision was issued on 23 February in the Federal Court of Rio de Janeiro, GTPI said. The decision was first reported in Brazilian newspaper Folha de São Paulo. An English language version of the decision is not yet available.

    Sources said it is likely that Abbott will appeal the decision. An Abbott spokesperson was not reached for this story. No press release appeared to be issued on the Abbott website. [Update: a source said it has been reported that Abbott asked that the nullification order be made pending a decision on the appeal but that the appeal has been denied.]

    A leading feature of the case is that the patent was granted under the “pipeline” process, which allowed “revalidation” of patents granted in other countries while Brazil was modifying its patent law for certain new areas including pharmaceuticals.

    The judge in this case ruled that the pipeline process was unconstitutional, according to sources.

    The pipeline process in Brazil had already come into question in recent years (IPW, Public Health, 13 May 2010; IPW, Public Health, 22 January 2008) and this decision furthers that movement.

    But according to sources, the judge ruled that there was not a question in this case of the absence of review of the drug by the health ministry’s Health Surveillance Agency (ANVISA). This has been a sensitive issue in recent years in Brazil as it has given a say in drug patent decisions to the health authorities.

    The judge found that the patent was granted (“revalidated”) by the Brazilian IP office (INPI) before the prior consent rule entered into effect in Brazil, a source said.

    A global campaign by NGOs was launched last autumn to open rinotavir/lopinavir to generic competition (IPW, Public Health, 16 November 2011).

    A patent on the same drug was rejected in India last year (IPW, Public Health, 4 January 2011).

    GTPI said the Rio decision could save Brazil millions of dollars through its national anti-HIV programme as the patent meant it could not allow sale of generics despite their availability on the international market.

    “The price paid by Brazil is US$763 per patient/year, but there are generic versions of approved quality by the World Health Organization (WHO) sold for US$402 per patient/year, a price 47% lower,” the group said.

    Abbott and the Brazilian government had reached an agreement in 2005 for the company to lower its prices on the drug, after the Brazilian government issued a decree declaring it to be of public interest, the first step to a compulsory licence.

    At that time, the drug consumed some 30 per cent of Brazil’s national budget on antiretroviral treatment, GTPI said. Now it represents some 16 per cent of such spending.

    William New may be reached at wnew@ip-watch.ch.

     

    Comments

    1. Another Boost For Generics: Brazilian Judge Annuls Patent On Key AIDS Drug – - TechNewsX - Technology News AggregatorTechNewsX – Technology News Aggregator says:

      [...] Last week Techdirt reported on an important decision in India to allow the production of a generic version of a kidney and liver cancer drug, with huge savings for the Indian health system, and major effects in terms of lives likely to be saved. Now Intellectual Property Watch has news of a court case in Brazil that could have equally important consequences for the local use of generics: [...]

    2. YARIAN.COM - Technology and Support Site – (888) 265-9330 » YARIAN.COM says:

      [...] and major effects in terms of lives likely to be saved. Now Intellectual Property Watch has news of a court case in Brazil that could have equally important consequences for the local use of generics: Word is spreading of a recent decision by a Brazilian judge to annul a patent on a key AIDS [...]

    3. Another Boost For Generics: Brazilian Judge Annuls Patent On Key AIDS Drug « waweru.net says:

      [...] and major effects in terms of lives likely to be saved. Now Intellectual Property Watch has news of a court case in Brazil that could have equally important consequences for the local use of generics: Word is spreading of a recent decision by a Brazilian judge to annul a patent on a key AIDS drug, [...]

    4. Most-Read IP-Watch Stories Of 2012: India Pharma, Europe, ACTA, WIPO Technical Assistance, Gene Patents | Intellectual Property Watch says:

      [...] Brazil HIV Drug Patent Ruling Allows Generics, Sends Pipeline Process Into Doubt http://www.ip-watch.org/2012/03/21/brazil-hiv-drug-patent-ruling-allows-generics-sends-pipeline-proc… [...]


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    We welcome your participation in article and blog comment threads, and other discussion forums, where we encourage you to analyse and react to the content available on the Intellectual Property Watch website. By participating in discussions or reader forums, or by submitting opinion pieces or comments to articles, blogs, reviews or multimedia features, you are consenting to these rules.

    We welcome your participation in article and blog comment threads, and other discussion forums, where we encourage you to analyse and react to the content available on the Intellectual Property Watch website.

    By participating in discussions or reader forums, or by submitting opinion pieces or comments to articles, blogs, reviews or multimedia features, you are consenting to these rules.

    1. You agree that you are fully responsible for the content that you post. You will not knowingly post content that violates the copyright, trademark, patent or other intellectual property right of any third party or which you know is under a confidentiality obligation preventing its publication and that you will request removal of the same should you discover that you have violated this provision. Likewise, you may not post content that is libelous, defamatory, obscene, abusive, that violates a third party's right to privacy, that otherwise violates any applicable local, state, national or international law, that amounts to spamming or that is otherwise inappropriate. You may not post content that degrades others on the basis of gender, race, class, ethnicity, national origin, religion, sexual preference, disability or other classification. Epithets and other language intended to intimidate or to incite violence are also prohibited. Furthermore, you may not impersonate others.

    2. You understand and agree that Intellectual Property Watch is not responsible for any content posted by you or third parties. You further understand that IP Watch does not monitor the content posted. Nevertheless, IP Watch may monitor the any user-generated content as it chooses and reserves the right to remove, edit or otherwise alter content that it deems inappropriate for any reason whatever without consent nor notice. We further reserve the right, in our sole discretion, to remove a user's privilege to post content on our site. IP Watch is not in any manner endorsing the content of the discussion forums and cannot and will not vouch for its reliability or otherwise accept liability for it.

    3. By submitting any contribution to IP Watch, you warrant that your contribution is your own original work and that you have the right to make it available to IP Watch for all purposes and you agree to indemnify IP Watch, its directors, employees and agents against all damages, legal fees and others expenses that may be incurred by IP Watch as a result of your breach of warranty or of these terms.

    4. You further agree not to publish any personal information about yourself or anyone else (for example telephone number or home address). If you add a comment to a blog, be aware that your email address will be apparent.

    5. IP Watch will not be liable for any loss including but not limited to the following (whether such losses are foreseen, known or otherwise): loss of data, loss of revenue or anticipated profit, loss of business, loss of opportunity, loss of goodwill or injury to reputation, losses suffered by third parties, any indirect, consequential or exemplary damages.

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    7. You acknowledge and agree that you use and/or rely on any information obtained through the discussion forums at your own risk.

    8. For any content that you post, you hereby grant to IP Watch the royalty-free, irrevocable, perpetual, exclusive and fully sub-licensable license to use, reproduce, modify, adapt, publish, translate, create derivative works from, distribute, perform and display such content in whole or in part, world-wide and to incorporate it in other works, in any form, media or technology now known or later developed.

    9. These terms and your posts and contributions shall be governed and interpreted in accordance with the laws of Switzerland (without giving effect to conflict of laws principles thereof) and any dispute exclusively settled by the Courts of the Canton of Geneva.

     

     
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