Novartis v Union of India (Supreme Court of India, Civil Appeals 2706-2716/2013, 2013)

Dhenne Avocats · 11 October 2026

Our analysis

Summary

The Supreme Court of India (Aftab Alam and Ranjana Prakash Desai JJ) upheld the refusal of a patent for the beta crystalline form of imatinib mesylate, the active ingredient of Glivec (Gleevec). It held that imatinib mesylate was already known from the Zimmermann patent and was not an invention within section 2(1)(j) and (ja) of the Patents Act 1970 (para 157), and that the beta form, a new form of a known substance with known efficacy, failed the enhanced therapeutic efficacy test of section 3(d) (paras 180 to 190). The judgment establishes a strict reading of section 3(d) for polymorphs, salts and other forms of known active ingredients.

Facts and procedure

US Patent No 5,521,184 (the Zimmermann patent), granted on 28 May 1996, covered N-phenyl-2-pyrimidine-amine derivatives, including imatinib (para 5). On 17 July 1998 Novartis filed application No 1602/MAS/1998 in Chennai, claiming the beta crystalline form of imatinib mesylate, said to have better flow properties, better thermodynamic stability and lower hygroscopicity than the alpha form (para 8). The application sat in the « mailbox » during the transitional period and was examined only after the amendments in force from 1 January 2005 (paras 12 and 13). It drew five pre-grant oppositions, in answer to which Novartis filed expert affidavits asserting higher bioavailability than imatinib free base (paras 10 and 13). The Assistant Controller refused the application on 25 January 2006 for anticipation, obviousness, section 3(d) and a wrongly claimed Swiss priority (para 14). The Intellectual Property Appellate Board (IPAB), by decision of 26 June 2009, rejected anticipation and obviousness and allowed the priority claim, but upheld the refusal under section 3(d), also invoking section 3(b), while holding that a process patent could not be denied (paras 16 to 20). Novartis came directly to the Supreme Court; two opponents, NATCO Pharma and Cancer Patients Aid Association, challenged the IPAB’s findings in Novartis’s favour (paras 21 to 23).

The applicable law

Section 2(1)(j) defines an invention as a new product or process involving an inventive step and capable of industrial application, inventive step being defined in section 2(1)(ja) (paras 87 to 90). Section 3(d), as amended in 2005, excludes the mere discovery of a new form of a known substance which does not result in the enhancement of its known efficacy; its Explanation treats salts, esters, polymorphs, isomers and other derivatives as the same substance unless they differ significantly in properties with regard to efficacy (para 95). The Court read it as a second tier of qualifying standards for chemical and pharmaceutical products, designed to check repetitive patenting and extension of the patent term on spurious grounds (para 103).

Question

Is the beta form of imatinib mesylate an invention within section 2(1)(j) and (ja) and, if so, can its patentability still be denied under section 3(d) (para 3)?

Decision

The Court first rejected the case that imatinib mesylate was a new product arising from an invention beyond the Zimmermann patent: the substance and its pharmacological properties were known from it, as Novartis’s own US regulatory filings and patent term extension application confirmed (paras 121 to 133 and 157). It declined to separate the coverage of a claim from the teaching of the specification (paras 139 and 156). Accepting for the sake of argument that the beta form was new, it held it to be a new form of a known substance with known efficacy, caught by section 3(d) (paras 158 to 161). For a medicine, the relevant efficacy is therapeutic efficacy, to be judged strictly and narrowly (para 180); properties inherent in a given form do not qualify (para 181). Flow properties, stability and hygroscopicity have nothing to do with therapeutic efficacy (para 187). A 30 per cent increase in bioavailability does not by itself show enhanced therapeutic efficacy, which must be specifically claimed and established by research data, and none was offered (paras 188 and 189). The Court added that section 3(d) does not bar all incremental inventions (paras 191 and 192). Novartis’s appeals were dismissed with costs and the other two appeals allowed (para 195).

Key points for practice

• Under Indian law, a new form of a known active ingredient must satisfy, in addition to novelty and inventive step, the enhanced efficacy test of section 3(d) (para 192).
• For a medicine, only therapeutic efficacy counts; processing or storage advantages are irrelevant (paras 180 and 187).
• The comparison is with the known substance immediately preceding the claimed product, here non-crystalline imatinib mesylate (paras 171 and 174).
• Practical point: any enhancement of therapeutic efficacy, including one inferred from improved bioavailability, must be pleaded and supported by research data at the application or opposition stage (para 189).

Provisions applied

National law

Patents Act 1970 (India), sections 2(1)(ac), 2(1)(j), 2(1)(ja), 3(d) and its Explanation, 10(4) and 10(5), 25(1)

Case law cited

Monsanto Company v Coramandal Indag Products, (1986) 1 SCC 642; In re Hogan, 559 F.2d 595; Plant Genetic Systems v DeKalb Genetics, 315 F.3d 1335 (Fed. Cir. 2003); Chiron v Genentech, 363 F.3d 1247 (Fed. Cir. 2004); A.C. Edwards v Acme Signs & Displays, [1992] RPC 131; Astellas Pharma v Comptroller-General of Patents, [2009] EWHC 1916 (Pat)

Prepared by Dhenne Avocats from the text of the decision (WIPO Lex, English text), consulted on 11 October 2026. Only the official text is authoritative.