End Of Novartis Saga: Supreme Court Rejects Novartis's Plea for Patent

 Putting an end to all the speculations and allaying the fears of millions of patients across the world, Supreme Court of India, on Monday, rejected the application of Novartis in the matter of the patentability of its cancer drug Glivec. Novartis had filed a patent application for the beta crystalline form of its drug Imatinib Mesylate (It is a therapeutic drug for chronic myeloid leukemia and certain kinds of tumours and is marketed under the names “Glivec” or “Gleevec”) claiming better bioavailability with the Indian Patent Office. The IPO had rejected the application on the ground of lack of efficacy under Section 3(d) of the Indian Patent Act. The same was challenged before the IPAB, which upheld the decision of the patent office. And Novartis, instead of approaching Madras High Court had directly approached Supreme Court against this decision. It had also challenged the validity of Section 3(d) of the Indian Patent Act. Hon’ble Supreme Court in its decision has considered the case de novo  and has given a detailed decision running to 112 pages, discussing in detail the patent in question and also the meaning and scope of the term ‘efficacy’ and Section 3 (d).

Supreme Court addressed Section 3(d) as the second tier of qualifying standards for the chemical substances and pharmaceuticals in particular in order to leave the door open for true and genuine inventions but, at the same time, to check any attempt at repetitive patenting or extension of the patent term on spurious grounds. The Court pointed out that,
"if clause (d) is isolated from the rest of section 3, and the legislative history behind the incorporation of Chapter II in the Patents act, 1970, is disregarded, then it is possible to see section 3(d) as an extension of the definition of “invention” and to link section 3(d) with clauses (j) and (ja) of section 2(1). In that case, on reading clauses (j) and (ja) of section 2(1) with section 3(d) it would appear that the Act sets different standards for qualifying as “inventions” things belonging to different classes, and for medicines and drugs and other chemical substances, the Act sets the invention threshold further higher, by virtue of the amendments made in section 3(d)"
It was pointed out that, the test of efficacy in the context of section 3(d) would be different, depending upon the result the product under consideration is desired or intended to produce. In other words, the test of efficacy would depend upon the function, utility or the purpose of the product under consideration. Therefore, in the case of a medicine that claims to cure a disease, the test of efficacy can only be therapeutic efficacy. The Court pointed out that the “therapeutic efficacy” of a medicine must be judged strictly and narrowly. It was laid down by the Court that the explanation to Section 3(d) indicates what is not to be considered as therapeutic efficacy. Though the Court considered in detail the opinions given by Mr. Anand Grover and Prof. Basheer on the scope of the term ‘therapeutic efficacy’, the Court left the question open for the future courts to decide.

It was also highlighted by the Court that, since the grant of the Zimmermann patent, the appellant has maintained that Imatinib Mesylate is part of the Zimmermann patent and had also obtained the drug approval for Gleevec on the basis. The U.S. Board of Patent Appeals, in its decision granting patent for the beta crystalline form of Imatinib Mesylate, had proceeded on the basis that Zimmermann patent had the teaching for the  making of Imatinib Mesylate from Mesylate and for its use in a pharmacological composition for treating tumors or in a method of treating warm blooded animals suffering from tumoral disease.  On the basis of these reasons the Supreme Court pointed out that the argument of developing Imatinib Mesylate from Imatinib is out of the scope of Zimmermann Patent is not valid and hence fails to satisfy the conditions for constituting an invention under the scope of Indian Patent law.

 The Supreme Court Judgment may be accessed here