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    Novartis vs. Union of India

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    GS Maggy
    This case involved Novartis seeking a patent for the beta crystalline form of imatinib mesylate, the active ingredient in their cancer drug Gleevec. The Supreme Court of India ruled against granting the patent. It determined that while the beta form had improved properties, it did not increase the therapeutic efficacy of the drug. As section 3(d) of India's Patent Act prohibits patents for new forms of known substances that do not enhance efficacy, Novartis' application was rejected. The ruling aimed to balance innovation and access to affordable medicines.

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    Novartis vs. Union of India

    Uploaded by

    GS Maggy
    21 views2 pages
    This case involved Novartis seeking a patent for the beta crystalline form of imatinib mesylate, the active ingredient in their cancer drug Gleevec. The Supreme Court of India ruled against granting the patent. It determined that while the beta form had improved properties, it did not increase the therapeutic efficacy of the drug. As section 3(d) of India's Patent Act prohibits patents for new forms of known substances that do not enhance efficacy, Novartis' application was rejected. The ruling aimed to balance innovation and access to affordable medicines.

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    Novartis vs union of India

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    This case involved Novartis seeking a patent for the beta crystalline form of imatinib mesylate, the active ingredient in their cancer drug Gleevec. The Supreme Court of India ruled against granting the patent. It determined that while the beta form had improved properties, it did not increase the therapeutic efficacy of the drug. As section 3(d) of India's Patent Act prohibits patents for new forms of known substances that do not enhance efficacy, Novartis' application was rejected. The ruling aimed to balance innovation and access to affordable medicines.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    21 views2 pages

    Novartis vs. Union of India

    Uploaded by

    GS Maggy
    This case involved Novartis seeking a patent for the beta crystalline form of imatinib mesylate, the active ingredient in their cancer drug Gleevec. The Supreme Court of India ruled against granting the patent. It determined that while the beta form had improved properties, it did not increase the therapeutic efficacy of the drug. As section 3(d) of India's Patent Act prohibits patents for new forms of known substances that do not enhance efficacy, Novartis' application was rejected. The ruling aimed to balance innovation and access to affordable medicines.

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    Novartis vs.

    Union of India

    Parties:
    Novartis International AG is the plaintiff and Union of India and others are the defendants.

    Issue:
    The issue in this case was whether Novartis could patent the beta crystalline form of Imatinib
    mesylate.

    Facts:
    The plaintiff, Novartis International AG filed an application before the Chennai Indian patent
    office for the grant of a patent for the “Beta crystalline form of imatinib mesylate” (the mesylate
    salt of imatinib) in 1998. It is used to make an anticancer drug ‘Gleevec’ that helps in the
    treatment of certain types of cancer such as Acute Lymphoblastic Leukemia, Chronic Myeloid
    Leukemia, Gastrointestinal Stromal Tumors, and myeloproliferative diseases.

    At the time of filing the application, in accordance with section 5 of the Patent Act 1970, the
    patent grant was limited to inventions where only methods or processes of manufacture could be
    patented; thus it was rejected. But later in 2005, after the Patent (Amendment) Act 2005 repealed
    section 5 and products could be patented, the application of Novartis for the drug Gleevec was
    taken up again.

    Yet again, the Madras patent office rejected the application on grounds of novelty and non-
    obviousness, further stating that this product was non-patentable as per section 3(d) of the
    Patents Act 1970 that prohibits patent grants to ‘inventions that are a mere “discovery” of a “new
    form” of a “known substance” and do not result in increased efficacy of that substance’.

    Following this, Novartis filed multiple appeals before Madras High Court in 2006. But before the
    High Court could’ve decided on the matter, the Intellectual Property Appellate Board (IPAB) was
    formed and the case was transferred in line with section 117G of the Indian Patent Act. Revising
    the earlier judgment, IPAB concluded that “novelty” and “non-obviousness” were present but the
    drug did not qualify as a new substance, it was just an amended version of a known compound
    that did not show any significant increase in efficacy of the drug, and therefore rejected the
    application under section 3(d) of the Indian Patent Act.
    In a separate and concurrent litigation, before the Madras High Court, Novartis claimed that
    section 3(d) of the Patent Act, 1970 violated article 14 of the Indian Constitution as “enhanced
    efficacy” was too vague a term, and it also disregarded WTO’s TRIPS Agreement. The High
    Court adjudicated that section 3(d) aimed to prevent Evergreening and make lifesaving drugs
    more accessible for the general public; it agreed with the counsel for Indian Government that the
    law wasn’t vague, and complied with TRIPS.

    Post rejection from IPAB and the Madras High Court, Novartis finally appealed directly to the
    Supreme Court through a Special Leave Petition.

    Issue:
    1. What would qualify as an “invention” under the Patents Act?

    2. Was the “beta crystalline form of imatinib mesylate” an advanced version of the preexistent
    ‘known’ substance “imatinib mesylate”?

    3. What exactly did section 3(d) of the Indian Patent Act mean by “efficacy”?

    Judgment:
    The court analyzed and inferred that imatinib mesylate, the primary drug was not new in itself, as
    was clear from the Zimmerman patent. It acknowledged that the beta crystalline form of Imatinib
    Mesylate had 30% increased bioavailability, but as it’s a pharmaceutical substance, it must be
    compared and judged on the basis of “efficacy” and not bioavailability. It decided to interpret
    “efficacy” as “therapeutic efficacy” as the compound has medicinal value. Finally, the court
    concluded that although the “Beta Crystalline form of Imatinib Mesylate” has better flow
    properties, better thermodynamic stability and lower hygroscopicity, none of these properties
    contribute to increase in therapeutic efficacy. Thus, as per section 3(d) of the Patent Act
    1970, the “Beta Crystalline form of Imatinib Mesylate” is a new form of the known substance
    “Imatinib mesylate” and hence not eligible for a patent.

    Conclusion:
    The honorable Supreme Court gave a well thought, nuanced judgment that prevents the rent-
    seeking practice of Evergreening without hindering the beneficial practice of incremental
    innovation, concomitantly aiding the common people by ensuring the availability of affordable
    medication.

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