Novertis AG v. Union of India
AIR 2013 SC 1311
Judges: Aftab Alam and Ranjana Prakash Desai, JJ.
Date of Decision: 1-4-2013
Jürg Zimmermann invented a number of derivatives of N-phenyl-2- pyrimidineamine, one of which is CGP 571481 in free base form (later given the International Nonproprietary Name ‘Imatinib’ by the World Health Organisation). These derivatives, including Imatinib, are capable of inhibiting certain protein kinases, especially protein kinase C and PDGF (platelet-derived growth factor)-receptor tyrosine kinase and thus have valuable anti-tumour properties and can be used in the preparation of pharmaceutical compositions for the treatment of warm-blooded animals, for example, as anti-tumoral drugs and as drugs against atherosclerosis. The N-phenyl-2-pyrimidine-amine derivatives, including Imatinib, was granted US Patent No. 5,521,184 on May 28, 1996. The Zimmermann compounds (i.e., derivatives of N-phenyl-2-pyrimidine-amine) were also granted a European patent under Patent No. EP-A-0 564 409.
The appellant claims that beginning with Imatinib in free base form, in a two-stage invention they first produced its methanesulfonic acid addition salt, Imatinib Mesylate, and then proceeded to develop the beta crystalline form of Imatinib Mesylate and named it as Glivec used for the treatment of chronic myeloid leukemia and certain kinds of tumors.
Evergreening of patents. What is the true import of section 3(d) of the Patents Act, 1970?
“Evergreening” is a term used to label practices that have developed in certain jurisdictions wherein a trifling change is made to an existing product, and claimed as a new invention. The coverage/protection afforded by the alleged new invention is then used to extend the patentee’s exclusive rights over the product, preventing competition.
Section 3(d) of the Patents Act, 1970 bars patent protection for all incremental inventions of chemical and pharmaceutical substances. The patent application submitted by the appellant contain a clear averment that all the therapeutic qualities of beta crystalline form of Imatinib Mesylate are also possessed by Imatinib Mesylate in free base. Beta crystalline form of Imatinib Mesylate is thus clearly a new form of a known substance. Regarding the therapeutic efficacy, it is clear that the physico-chemical properties of beta crystalline form of Imatinib Mesylate may be otherwise beneficial, but theses properties cannot even be taken into account for the purpose of the test of section 3(d), since these properties have nothing to do with therapeutic efficacy. Therefore, the beta crystalline form of Imatinib Mesylate fails the test of section 3(d). The appeal preferred by the appellant thus, failed and was dismissed with costs.