Supreme Court of India Rejects Novartis’ Patent Claim on Beta Crystalline Form of Imatinib Mesylate, Upholds Stringent Patentability Standards to Protect Public Health

Landmark verdict clarifies distinction between invention and patentability under Indian Patents Act, 1970, emphasizing strict interpretation of enhanced therapeutic efficacy and preventing “evergreening” of pharmaceutical patents.

In a landmark judgment dated April 1, 2013, the Supreme Court of India dismissed the appeal filed by Novartis AG seeking patent protection for the beta crystalline form of Imatinib Mesylate, a cancer drug marketed as “Gleevec” or “Glivec”. The Court held that the pharmaceutical compound does not meet the threshold of “invention” and “patentability” under the Indian Patents Act, 1970, as amended in 2005, especially under Section 3(d), which bars patents on new forms of known substances unless they demonstrate enhanced efficacy.

Background and Context:

The patent application filed by Novartis in 1998 claimed the beta crystalline form of Imatinib Mesylate, derived from Imatinib, a compound disclosed in the earlier Zimmermann patent (US Patent No. 5,521,184). While Novartis argued that the beta crystalline form involved two inventions — first, the creation of Imatinib Mesylate salt from Imatinib free base, and second, the crystallization into the beta form — the Indian Patent Office and later appellate bodies found the subject product anticipated by the Zimmermann patent and lacking the inventive step required under Indian law.

The case arose amid India’s transition from a process patent regime to a product patent regime in pharmaceuticals, driven by its obligations under the WTO’s TRIPS Agreement. The 2005 amendments to the Indian Patents Act introduced Section 3(d), aimed at preventing “evergreening” — the practice of obtaining multiple patents on minor modifications of existing drugs to extend monopoly periods and limit generic competition.

Key Legal Issues and Supreme Court’s Analysis:

1. Invention versus Patentability:

 The Court reaffirmed the dual concept under the Patents Act — a subject must be an “invention” as defined in Section 2(1)(j) and also satisfy patentability criteria under Section 3. It clarified that “invention” requires novelty, inventive step (technical advance or economic significance), and industrial applicability. However, even if these are satisfied, patentability can be denied under Section 3(d) for new forms of known substances that do not show enhanced efficacy.

2. Applicability of Section 3(d):

 Section 3(d) states that the “mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance” is not an invention. The Court held this provision to be a substantive and crucial test designed to prevent trivial modifications from being patented, thus safeguarding access to affordable medicines.

3. Known Substance and Efficacy:

 The Court found that Imatinib Mesylate (in any form) is a known substance disclosed in the Zimmermann patent, including its pharmacological properties. The beta crystalline form, although new as a polymorph, did not demonstrate enhanced therapeutic efficacy over Imatinib Mesylate. The claimed advantages — improved solubility, flow properties, thermodynamic stability, and lower hygroscopicity — were considered physico-chemical properties insufficient to establish enhanced “therapeutic efficacy” required under the law.

4. Interpretation of Efficacy:

 The Court emphasized that “efficacy” in pharmaceuticals means “therapeutic efficacy” — the ability to produce a desired therapeutic effect. It rejected the argument that improved bioavailability or other physical properties automatically translate into enhanced efficacy unless supported by convincing scientific data. Mere improvements in processing or storage do not qualify.

5. Disclosure and Coverage in Patent Claims:

 Novartis contended that the Zimmermann patent covered Imatinib Mesylate but did not disclose or enable it fully, hence justifying a separate patent. The Court disagreed, stating that the disclosure must be sufficient for a person skilled in the art to perform the invention. It refused to accept that coverage of a compound in a Markush patent claim without enabling disclosure justifies a new patent.

6. Public Health and Policy Considerations:

 The judgment extensively discussed India’s patent law history and policy, including the rationale behind Section 3(d) and the country’s constitutional obligation to ensure affordable healthcare. It recognized India’s role as the “pharmacy of the world” supplying generic medicines to developing countries and the importance of preventing monopolies on minor modifications.

7. Rejection of Evergreening:

 The Court underscored that the patent application appeared to be an attempt at evergreening, extending monopolistic rights on the same medicine under the guise of a new form. It rejected the patent to prevent abuse of patent rights that could result in unaffordable prices for life-saving drugs.

Outcome:

The Supreme Court dismissed Novartis’ appeal, affirming the rejection of the patent application for beta crystalline form of Imatinib Mesylate. The Court’s reasoning upheld the strict standards under Section 3(d) and reinforced the balance between rewarding genuine innovation and protecting public health.

Significance:

This decision is a milestone in Indian patent jurisprudence, clarifying the interpretation of “invention” and “patentability” in pharmaceuticals, and endorsing India’s TRIPS-compliant but health-sensitive patent regime. It provides a robust legal framework to prevent evergreening and supports access to affordable medicines without compromising innovation incentives.

The ruling also highlights the importance of examining the therapeutic efficacy of modifications in patented drugs and sets a precedent for evaluating future pharmaceutical patent claims in India.

Statutory provisions

Patents Act, 1970 - Sections 2(1)(j), 2(1)(ac), 2(1)(ja), 3(d), 5 (deleted), 10(4), 10(5), 25(1), 63, 64, 65;

Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS), Articles 7, 8, 27;

Doha Declaration on TRIPS and Public Health.

Novartis AG v. Union of India (SC) : Law Finder Doc Id # 421370