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Call For Transparency In The Trans-Pacific Partnership Negotiation

In this post, three US law professors explain a recent call by over 30 legal scholars for the US Trade Representative to increase transparency for the Trans-Pacific Partnership Agreement intellectual property chapter, and their response to Ambassador Kirk’s response that he is “strongly offended” by the suggestion that the negotiation is not adequately transparent already.





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    Novartis Persists In Challenge To Indian Patent Law; India Rejects More AIDS Drugs Patents

    Published on 2 September 2009 @ 1:42 pm

    By for Intellectual Property Watch

    Undeterred by two previous decisions by Indian authorities holding that under Indian Patent Law, its leukaemia drug – Glivec is not patentable, Novartis now wants to take the fight to the Indian Supreme Court. Meanwhile, also this week, Indian authorities were said to reject applications for patents on two HIV/AIDS drugs, opening the way for cheaper generic versions to be developed and marketed.

    In the Glivec (or Gleevec) case, the Swiss drug company filed a special petition, available here, seeking leave to appeal to the Supreme Court. The petition was to be heard on 31 August, but according to news and blog sources in India, the matter was adjourned until later after the presiding judge recused himself.

    In its case, Novartis is mainly seeking to challenge the validity and interpretation of a provision under Indian patent law which disqualifies from patentability “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,” according to the petition.

    This is a provision that various advocacy groups, such as Médecins Sans Frontières and the Swiss-based Berne Declaration, claim has been effective in preventing the evergreening of patents on pharmaceutical drugs.

    The Berne Declaration said it “strongly condemns” Novartis’ appeal as demonstrating that the company is “relentlessly” trying to challenge the Indian law, in particular its section 3(d), which Berne called “a crucial safeguard against the multiplication of patents around the same substance.”

    “A Glivec monopoly situation would deprive thousands of blood cancer patients from access to a vital drug, in India and beyond,” Berne said in a release.

    But Novartis argues in its petition that the provision was misinterpreted and is not applicable to their drug owing to the enhancements made from the original substance.

    On 26 June, the Indian Intellectual Property Appellate Body (IPAB) while upholding the denial by the Chennai Patent Office decided that Novartis was not entitled to a patent on Glivec, which is a beta crystalline form of imatinib mesylate, as the claimed product did not meet the requirement of increased therapeutic efficacy, according to sources. This was despite the fact that IPAB found Glivec to meet the requirements for novelty and inventive step, they said.

    The latest move by Novartis runs against international pressure to drop the suit (IPW, Developing Country Policy, 15 February 2007).

    The petition was remitted to India’s Chief Justice for reassignment, sources said, which may sit within a week, according to Indian blog SpicyIP, and will determine whether Novartis will have their appeal heard by the Indian Supreme Court and set new the direction for this decade-long battle.

    AIDS Drugs Patents Rejected

    Separately, this week MSF announced that India’s patent office rejected patents on new AIDS drugs tenofovir and darunavir, which the nonprofit group said are expensive but needed for AIDS patients failing on their existing treatments. Brand-name producer Gilead also previously failed to win a patent for tenofovir in Brazil, according to MSF (IPW, Public Health, 4 July 2008).

    Intellectual Property Watch has not yet confirmed the rejection of the patents with official sources. MSF credited Indian Law Section 3(d) with preventing the evergreening of drug patents and opening the way for generics competitors to enter the market. India is the leading producer of generics in the world.

    Robinson Esalimba may be reached at info@ip-watch.ch.

     

    Comments

    1. SC issues notices to Pharma in the Novartis Glivec appeal « Patently Yours says:

      [...] For those interested in the appeal, a copy of the Special Leave Petition filed by Novartis at the Supreme Court in the Glivec case is available here from the IP Watch website. [...]

    2. Patently Yours says:

      SC issues notices seeking reply from Centre, Generic Pharma in the Novartis Glivec appeal…

      Further to Justice Katju recusing himself from hearing the Novartis Glivec appeal, the Special Leave Petition (SLP) was listed today (11 September) before the Bench consisting of Justice Dalveer Bhandari and Dr. Justice. B.S. Chauhan.
      The Supreme Court…

    3. richardjones says:

      Good to hear India isn’t allowing the big drug companies to run riot.

    4. Indian Supreme Court To Hear Novartis Challenge To India’s Patent Law | Intellectual Property Watch says:

      [...] India passed its patent law in 2005 in compliance with its World Trade Organization commitments. The legal battle goes back to 2006, when the Indian patent office rejected a patent application for imatinib mesylate (sold as Gleevec), a cancer medicine. A legal challenge by Novartis lost in 2007, as did an appeal in 2009 (IPW, Public Health, 2 September 2009). [...]


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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.

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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.