The Supreme Court on Monday rejected Swiss pharma major Novartis’ plea for a patent on cancer drug Glivec, a verdict expected to facilitate Indian firms to provide affordable drugs to lakhs of cancer patients.
Novartis had filed an application on July 17, 1998, for grant of a patent for Imatinib Mesylate in beta crystalline form at the Chennai Patent Office. After the application was made and before it was taken up for consideration, several amendments were introduced in the Indian Patents Act, 1970, which brought about fundamental changes in the patent law of the country, noted Supreme Court judge Justice Aftab Alam, writing the judgment in the case.
The Assistant Collector of Patents and Designs heard all the parties in December 2005 and rejected its application of Novartis for a patent. After this, Novartis filed two petitions in the Madras High Court seeking a declaration that Section 3(d) of the Patent Act is unconstitutional. However, the High Court dismissed them. The Intellectual Property Appellate Board also dismissed the appeals of Novartis.
Challenging the orders of the Intellectual Property Appellate Board (IPAB), Novartis moved the apex court in 2009. Justice Aftab Alam wrote in his judgment, “In whatever way therapeutic efficacy may be interpreted, this much is absolutely clear: that the physico-chemical properties of beta crystalline form of Imatinib Mesylate, namely (i) more beneficial flow properties, (ii) better thermodynamic stability, and (iii) lower hygroscopicity may be otherwise beneficial but these properties cannot even be taken into account for the purpose of the test of Section 3 (d) of the Act, since these properties have nothing to do with therapeutic efficacy.”
Justice Alam further observed, “In whichever way Section 3(d) (The Indian Patent Act, 2005) may be viewed, whether as setting up the standards of “patentability” or as an extension of the definition of “invention”, it must be held that on the basis of the materials brought before this Court, the subject product, that is, the beta crystalline form of Imatinib Mesylate, fails the test of section 3(d), too, of the Act.”
“The case of the appellant appears in rather poor light and the claim for patent for beta crystalline form of Imatinib Mesylate would only appear as an attempt to obtain patent for Imatinib Mesylate, which would otherwise not be permissible in this country.”
“The appeals filed by Novartis AG fail are dismissed with costs,” Justice Alam added.