In a very important ruling, the Supreme Court of India rejected a patent application by Novartis for a major cancer drug on the ground that the application was not an invention per Section 3(d) of the Patent Act.
The Court observed that Novartis patent application for the drug Glivec or Gleevec involved two steps, namely i) formation of an intermediate compound Imatinib Mesylate from Imatinib (free base form) and ii) producing beta crystalline form of Imatinib Mesylate (Glivec).
The Court held that step i) is neither an invention nor an inventive step per Patent Act and rejected Novartis argument that the Imatinib Mesylate is not a prior art (Zimmermann Patent). The Court observed “We certainly do not wish the law of patent in this country to develop on lines where there may be a vast gap between the coverage and the disclosure under the patent; where the scope of the patent is determined not on the intrinsic worth of the invention but by the artful drafting of its claims by skillful lawyers, and where patents are traded as a commodity not for production and marketing of the patented products but to search for someone who may be sued for infringement of the patent.”
Regarding step ii), the Court ruled that Imatinib Mesylate was a known substance from Zimmermann patent and thus beta crystalline form of Imatinib Mesylate is clearly a new form of a known substance, i.e., Imatinib Mesylate, of which the efficacy was well known. Therefore, it fully attracts section 3(d) and must be shown to satisfy the substantive provision and the explanation appended to it.
Interpreting ‘efficacy’ as mentioned in Section 3(d) and its explanation, the Court said “Therefore, in the case of a medicine that claims to cure a disease, the test of efficacy can only be ‘therapeutic efficacy’. The question then arises, what would be the parameter of therapeutic efficacy and what are the advantages and benefits that may be taken into account for determining the enhancement of therapeutic efficacy? With regard to the genesis of section 3(d), and more particularly the circumstances in which section 3(d) was amended to make it even more constrictive than before, we have no doubt that the ‘therapeutic efficacy’ of a medicine must be judged strictly and narrowly…….What is evident, therefore, is that not all advantageous or beneficial properties are relevant, but only such properties that directly relate to efficacy, which in case of medicine, as seen above, is its therapeutic efficacy.”