Novartis AG v. Union of India
Supreme Court of India · 1 April 2013 · 2 judges
The Court refused Novartis a patent for the beta crystalline form of Imatinib Mesylate, holding that Imatinib Mesylate was known from the Zimmermann patent and that the beta form failed the enhanced therapeutic efficacy test of Section 3(d).
Facts
The Zimmermann patent (US, 1996) covered derivatives of N-phenyl-2-pyrimidine-amine, including Imatinib, an anti-tumour compound. Novartis applied in Chennai in 1998 for a patent on the beta crystalline form of Imatinib Mesylate (marketed as Glivec or Gleevec), claiming better flow properties, thermodynamic stability and lower hygroscopicity than the alpha form, and later filed affidavits on higher bioavailability. The application was kept in the mailbox until the 2005 amendments, and faced five pre-grant oppositions. The Assistant Controller rejected it in 2006. The IPAB found novelty and inventive step but held the product barred by Section 3(d). Novartis appealed to the Supreme Court under Article 136; NATCO Pharma and the Cancer Patients Aid Association also appealed against the IPAB's findings.
Questions before the Court
- What is the true import of Section 3(d) of the Patents Act, 1970, and how does it interplay with clauses (j) and (ja) of Section 2(1)?
- Is the beta crystalline form of Imatinib Mesylate a new product involving an inventive step over the Zimmermann patent?
- Does the beta crystalline form show enhancement of the known efficacy of Imatinib Mesylate under Section 3(d) and its Explanation?
What the Court held
- The 2005 amendment to Section 3(d) sets up a second tier of qualifying standards for chemical and pharmaceutical substances, leaving the door open for genuine inventions while checking repetitive patenting or extension of the patent term on spurious grounds.
- Imatinib Mesylate, and its pharmacological properties, were known from the Zimmermann patent, so it does not qualify as an invention under Section 2(1)(j) and (ja). The coverage of a patent cannot be allowed to go beyond its disclosure.
- Accepting for argument that the beta crystalline form is new, and without deciding inventive step, the Court held it a new form of a known substance with known efficacy, so Section 3(d) applies. For a medicine, 'efficacy' means therapeutic efficacy, judged strictly and narrowly.
- Better flow properties, thermodynamic stability and lower hygroscopicity have nothing to do with therapeutic efficacy. Increased bioavailability alone is not enough unless research data shows enhanced therapeutic efficacy, and none was produced.
- Section 3(d) does not bar patents for all incremental inventions of chemical and pharmaceutical substances. Novartis's appeals were dismissed with costs and the other two appeals allowed.
Why it matters
The judgment gives a detailed interpretation of Section 3(d) of the Patents Act as amended in 2005. It holds that a new form of a known pharmaceutical substance must show enhanced therapeutic efficacy, not merely better physical properties, to be patentable, and that patent coverage cannot exceed disclosure. It also clarifies that Section 3(d) does not exclude all incremental pharmaceutical inventions.
In the Court's words
Copied from the official judgment; each passage links to its page.
“The amended portion of section 3(d) clearly sets up a second tier of qualifying standards for chemical substances/pharmaceutical products 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.”
“Hence, 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".”
“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.”
“We have held that the subject product, the beta crystalline form of Imatinib Mesylate, does not qualify the test of Section 3(d) of the Act but that is not to say that Section 3(d) bars patent protection for all incremental inventions of chemical and pharmaceutical substances.”
Provisions interpreted
Case and bench
- Parties
- Novartis AG v. Union of India
- Case
- Civil Appeal Nos. 2706-2716 of 2013 (arising out of SLP (C) Nos. 20539-20549 of 2009), with Civil Appeal No. 2728 of 2013 and Civil Appeal Nos. 2717-2727 of 2013
- Decided
- 1 April 2013
- Bench
- Aftab Alam, J., Ranjana Prakash Desai, J.
- Opinions
- Unanimous. Judgment delivered by Aftab Alam, J.; Ranjana Prakash Desai, J. also signed. No separate opinion.
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