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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.

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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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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.

The Politicization Of The US Patent System

The Washington Post story, How patent reform’s fraught politics have left USPTO still without a boss (July 30), is a vivid account of how patent reform has divided the US economy, preempting a possible replacement for David Kappos who stepped down 18 months ago. The division is even bigger than portrayed. Universities have lined up en masse to oppose reform, while main street businesses that merely use technology argue for reform. Reminiscent of the partisan divide that has paralyzed US politics, this struggle crosses party lines and extends well beyond the usual inter-industry debates. Framed in terms of combating patent trolls through technical legal fixes, there lurks a broader economic concern – to what extent ordinary retailers, bank, restaurants, local banks, motels, realtors, and travel agents should bear the burden of defending against patents as a cost of doing business.


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    Patent On AIDS Medicine Denied In India; Seen Unlocking Market

    Published on 4 January 2011 @ 11:56 pm

    By , Intellectual Property Watch

    A decision by the Indian Patent Office to reject a patent on an AIDS drug last week has drawn acclaim from civil society and Indian generic pharmaceutical industries. The decision was not based on a controversial article of Indian law aimed at preventing patent extensions but rather on the grounds of non-inventiveness. Abbott Laboratories, meanwhile, presented Intellectual Property Watch with justification for its Indian patent request.

    The HIV combination drug ritonavir/lopinavir was manufactured by Abbott, a United States-based company, which submitted several patent requests in India. The rejected patent was for “a method of preparing solid pharmaceutical dosage form,” according to the decision [pdf], a heat-stable form of rinotavir and lopinavir, according to sources.

    The patent application was filed in March 2006 under the Patent Cooperation Treaty managed by the World Intellectual Property Organization. It was opposed in August 2008 by Initiative for Medicines, Access, & Knowledge (I-MAK), a US-based non-governmental organisation working on access to medicines. Three Indian pharmaceutical companies also opposed the patent.

    On 30 December, the Indian Patent Office decided not to grant the patent to Abbott, on the grounds that the subject matter did not involve an inventive step and did not constitute an invention.

    “This groundbreaking victory for patients sets an important precedent to stop pharmaceutical companies from gaming the patent system, making a new era of hope for millions of people living with HIV all over the world,” I-MAK said in a statement.

    About 130,000 lives could be saved from “opening up the market for this drug alone,” the group said, adding that Abbott Laboratories holds at least 75 patents on lopinavir/ritonavir alone in the US.

    Article 3(d) of Indian patent law patents disallows modifications of existing compounds, so-called patent “evergreening,” often used by companies to extend patent monopolies. This article has been cited by industry several times as being non-compliant with India’s international trade obligations, and in particular with the World Trade Organization Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement.

    The opponents of the patent claimed that Abbott’s drug fell under Article 3(d) of the Indian patent law, which states “the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant.” However, the decision discarded this claim.

    According to Brook Baker of the US-based, non-governmental Health Global Access Project, it seems there is “growing evidence that the India Patent Office is not being uniformly rigorous in applying its strict patentability standards under Section 3(d), and thus is incorrectly allowing occasional patents on new uses, chemical variations, new formulations, and new combinations … it seems more important that there be resources devoted to expert opposition procedures in India.”

    A December WIPO economics seminar series presentation by Bhaven Sampat, a professor at the School of International and Public Affairs at Columbia University in New York, came to a similar conclusion (IPW, WIPO, 17 December 2010).

    Abbott Defends Inventiveness

    According to Dirk Van Eeden, director of public affairs for Abbott, “new formulations of Kaletra [the combination drug] have provided physicians and patients with real improvements in its use, dosing and convenience.”

    “The heat stable tablet,” he told Intellectual Property Watch, “solves specific convenience limitations of Abbott’s earlier version, which required refrigeration and had to be taken with food. These challenges have been resolved with the new tablet, and there is significant benefit for patients in developing countries and resource limited settings.”

    Abbott is “reviewing this decision and determining its next steps,” Van Eeden said.

    I-MAK Director Tahir Amin, meanwhile, said other Abbott patents on the drug are being challenged in India.

    Although the Indian Patent Office decision is presented as a landmark, and will unlock the market for Indian generic companies, the ability of those companies to export to developing countries will depend on the patent status of the drug in those countries.

    According to intellectual property lawyer Peter Maybarduk of Public Citizen, a US advocacy group, the Indian decision is highly significant.

    In cases where there are patents on any components of the drug in a recipient country, one of the solutions could be for that country to issue a compulsory licence. This “would be much simpler” than going through the so-called paragraph 6 decision of the WTO, an exception within TRIPS meant to ease access to generic versions of patented medicines in countries that lack the manufacturing capacity to make the drugs themselves, Maybarduk said.

    If there is no patent in the drug exporting country, such as in this case India, a compulsory licence can be issued by the importing country without using the paragraph 6 mechanism, which implies a more burdensome mechanism, he told Intellectual Property Watch.

    Separately, according to news source Livemint, the Indian government is considering capping foreign direct investment allowed in the pharmaceutical industry in an effort to prevent its drugmakers from being taken over by foreign interests.

    Catherine Saez may be reached at info@ip-watch.ch.

     

    Comments

    1. Patent On AIDS Medicine Denied In India – Intellectual Property Watch | Daily India News Update says:

      [...] posted here: Patent On AIDS Medicine Denied In India – Intellectual Property Watch Share Home abbott, drug-ritonavir, hiv, preparing-solid, rejected-patent, [...]

    2. Biotech Convention Pays Homage To IP, Pledges To Increase Access To Medicine | Conservation Commons says:

      [...] Patent On AIDS Medicine Denied In India; Seen Unlocking Market [4] [...]


    Leave a Reply

    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.

    6. You understand and agree that the discussion forums are to be used only for non-commercial purposes. You may not solicit funds, promote commercial entities or otherwise engage in commercial activity in our discussion forums.

    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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