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 interpretation of Section 3(d) of Indian Patents act by IPAB which prohibited the patenting of new forms of known substances unless there is any significant increase in its efficacy. Supreme Court observed that the said compound Imatinib Mesylate was entirely represented by the Zimmermann patent (patented in US earlier) and so it already existed in public domain.
Supreme Court rejected the Novartis’ claim of patent of Gleevec on 1 April, 2013.
For passing the judgment on the Novartis case, Supreme Court based its decision on the below points: “a) What is the correct interpretation of section 3(d) of the Indian Patents Act, 1970? b) How is it related with clauses (j) and (ja) of section 2(1)? c) Is the claimed new product by Novartis fulfils the criteria of an invention which is not obvious to a person skilled in art? d) Does the product have an increased therapeutic efficacy?
ANALYSIS OF THE NEW PATENT LAW IN INDIA:
The Indian Supreme Court’s judgment on the much awaited patent application of Novartis has garnered a lot of views and opinions from the Indian as well as the International market for pharmaceutical industry as it is said to have set a stringent standard of non-obviousness and invention for patents. The Indian health aid groups have welcomed this decision of Supreme Court with open hands. It is hailed worldwide as a victory of public health.
The cause of concern for pharmaceutical industry in India is basically due to the newly amended Section 3(d) and clauses (j) and (ja) of Section 2(1) of the Indian Patent Act which specifies the meaning of ‘invention’ and ‘efficacy’.
What does not come into the category of inventions - the following criteria should be fulfilled for a product being called an invention according to clauses (j) and (ja) of Section 2(1): a) It should be ‘new’
b) It must be ‘capable of being made or used in an industry’ c) It must have been produced due to the result of an innovation which should not...
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