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Action Alert: Take Action to Protect the Pharmacy of the World

28. February 2012

    Join campaigners in India and worldwide, including members of the Ecumenical Advocacy Alliance, in calling on pharmaceutical company, Novartis, to drop its legal case over the Indian production of one cancer drug. The case begins in India’s Supreme Court today, 28 February 2012. If Novartis wins, the case is likely to have an impact on India’s ability to continue producing the cheap and quality-assured generic medicines, including anti-retrovirals, that millions of people around the world currently rely upon.


     

    Case Background

     

    Since 2006, Novartis has been suing the Indian government because its cancer drug, imatinib mesylate (marketed as Gleevac/Glivec elsewhere), did not get a patent. This decision was based on Section 3d of India’s Patents Act which states that patents should only be granted on medicines that are truly new and innovative. The Indian patent office ruled that imatinib mesylate was merely a new form of an old medicine, and therefore not patentable.


     

     

    After its patent application was rejected, Novartis mounted a legal challenge to have Section 3(d) declared unconstitutional in the Madras High Court. In 2007, the High Court rejected Novartis’s argument. In 2009, the Intellectual Property Appellate Board also rejected the company’s appeal against the rejection of its patent application.


     

     

    In 2009, Novartis launched fresh legal proceedings at the Supreme Court of India seeking to challenge the interpretation of the requirement for patent applicants to prove significant improved ‘efficacy’ of a new drug or new form of drug. In the first case in 2007, Novartis argued that increased bioavailability of the salt form of imatinib meant increased efficacy, but the Madras High Court clarified efficacy to mean ‘therapeutic effect in healing a disease’ and therefore rejected the patent application. The Supreme Court case will be heard from 28 February 2012.


     

    Case Implications

     

    The implications of a Novartis victory in weakening the interpretation of Section 3(d) would not be limited to the patenting of imatinib mesylate or on cancer patients alone. If Novartis wins the case, the precedent will have been established for patents to be granted in India as broadly as they are in wealthy countries, including for new formulations of known medicines already in use. Therefore, India’s current ability to provide the world with quality-assured and cheap generic medicines, including HIV drugs will be seriously jeopardized.


     

     

    The example of HIV and AIDS medicines is a good illustration of the potential impact of this decision. Even though first-line drugs to treat HIV have become affordable thanks to generic competition, the availability of second-line and improved formulations are crucial, as people gradually become resistant to their current combinations of HIV medicines and need to be switched to second-line regimens. Some of these key medicines have gone into generic production in India but if Novartis wins then this generic production will be endangered, as many more drug companies will push for their drugs to be patented in India.


     

     

    If Novartis wins the case, more and more treatments will remain priced out of reach for the duration of the patent term – twenty years or more – including those that are merely new forms of existing medicines.


     

     

    When Novartis applied for the patent on imatinib mesylate, the drug was sold at US$2,600 per patient per month in other countries with patents but, in India, generic versions were available for less than $200 per patient per month. Novartis applied for a patent so that it could sell the drug at higher prices in India. If it now wins in the Supreme Court, other drugs will also go up in price and many lives around the world will be put at stake.


     

    Act Now!

     

    Given the potentially huge ramifications for generic production and the availability of affordable medicines from India, treatment providers, patient groups and affected communities have long appealed to Novartis to stop its attacks on the pharmacy of the developing world. Join the campaign headed by MSF today to tell Novartis that people matter more than profits:


     

    1. Tweet 'Don't make life-saving drugs inaccessible' to @Novartis, and include ow/ly/92xYq and hastag #STOPNovartis
    2. Email Novartis via http://www.msfaccess.org/STOPnovartis/


     

    More Information



The Ecumenical Advocacy Alliance is a broad international network of churches and Christian organizations cooperating in advocacy on food and HIV and AIDS. The Alliance is based in Geneva, Switzerland. For more information, see http://www.e-alliance.ch/

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