Supreme Court Judgement: Impact on Novartis
NOVARTIS CASE STUDY
BRIEF HISTORY OF THE CASE:
Novartis is a Swiss drug maker which produces and sells an anti cancer drug called ‘Glivec’.
It had filed an appeal before the Honorable Supreme court of India for the grant of patent of the same. The appellant had first filed an application for patent in Chennai Patent office on July 17, 1998. The appeal was filed for grant of patent for Imatinib Mesylate in beta crystalline form which they claimed to be an invention on the following grounds:
• It has more beneficial flow properties.
• It possesses better thermodynamic stability.
• Compared to alpha crystal form of Imatinib Mesylate, it has lower hygroscopicity.
It claimed that the above property made it a new and superior product as it increased its property of storage and process. Its claim for patent was rejected by Chennai Patent Office on grounds of lacking novelty, innovative step and being unpatentable in view of Section 3(d). Then Novartis challenged the decision before the Honorable Madras High court in a writ petition. It claimed before the High Court that Indian Patent law is not consistent with World Trade organization (WTO) Rules. It appealed the court to invalidate Section 3(d). The High Court rejected this plea and transferred the matter to the ‘Intellectual Property Appellate Board’ which also rejected its patent as it found it to be unpatentable under Section 3(d) of the Indian Patents Act. IPAB observed that the drug does not have a new molecule but has a modified version of a known compound for which Novartis failed to show any increased efficacy. But IPAB had also observed that Novartis satisfied the other requirements for patent, i.e. ‘novelty’ and ‘non obviousness to person skilled in art ‘. Based on its observations, IPAB rejected the application on 26 June, 2009.
Dejected by the rejection of its appeal, Novartis approached the Honorable Supreme court of India challenging the
BRIEF HISTORY OF THE CASE:
Novartis is a Swiss drug maker which produces and sells an anti cancer drug called ‘Glivec’.
It had filed an appeal before the Honorable Supreme court of India for the grant of patent of the same. The appellant had first filed an application for patent in Chennai Patent office on July 17, 1998. The appeal was filed for grant of patent for Imatinib Mesylate in beta crystalline form which they claimed to be an invention on the following grounds:
• It has more beneficial flow properties.
• It possesses better thermodynamic stability.
• Compared to alpha crystal form of Imatinib Mesylate, it has lower hygroscopicity.
It claimed that the above property made it a new and superior product as it increased its property of storage and process. Its claim for patent was rejected by Chennai Patent Office on grounds of lacking novelty, innovative step and being unpatentable in view of Section 3(d). Then Novartis challenged the decision before the Honorable Madras High court in a writ petition. It claimed before the High Court that Indian Patent law is not consistent with World Trade organization (WTO) Rules. It appealed the court to invalidate Section 3(d). The High Court rejected this plea and transferred the matter to the ‘Intellectual Property Appellate Board’ which also rejected its patent as it found it to be unpatentable under Section 3(d) of the Indian Patents Act. IPAB observed that the drug does not have a new molecule but has a modified version of a known compound for which Novartis failed to show any increased efficacy. But IPAB had also observed that Novartis satisfied the other requirements for patent, i.e. ‘novelty’ and ‘non obviousness to person skilled in art ‘. Based on its observations, IPAB rejected the application on 26 June, 2009.
Dejected by the rejection of its appeal, Novartis approached the Honorable Supreme court of India challenging the