Authored Saya krishnan
Sastra Deemed University
Case Title & Citation
Novartis AG vs. Union of India & Others (2013) 6 SCC 1.
Court Name & Bench
Supreme Court of India, heard by a Division Bench comprising Justice Aftab AlamandJustice Ranjana P. Desai.
Date of Judgment
1 April 2013.
Parties Involved
Petitioner/Appellant: Novartis AG, a multinational pharmaceutical company, sought a patent in India for an anti-cancer drug (Glivec / Imatinib Mesylate in its beta crystalline form).
Respondents: Union of India, Controller General of Patents etc., and Indian generic drugmanufacturers who opposed the application.
Facts of the Case
Novartis filed a patent application in India in 1998 for the beta crystalline formof ImatinibMesylate (marketed as Glivec), which is used in treatment of chronic myeloid leukemia.
When Novartis filed the application, India’s patent laws did not allow product patents for medicines; only process patents were allowed. After the Patent (Amendment) Act, 2005(tocomply with TRIPS), product patents for pharmaceuticals became possible. The Novartis application was thus evaluated under the amended law.
The Indian Patent Office (Assistant Controller) rejected the patent application in 2006, primarily on Grounds of Section 3(d) of the Patents Act, 1970, for failure to show“significantly enhanced efficacy” in the beta crystalline form over the known substance (Imatinib Mesylate).
Novartis appealed to the Intellectual Property Appellate Board (IPAB), which also refusedtheapplication. Then Novartis took the matter to the Supreme Court.
Novartis had tried to show that the beta crystalline form had some improved properties (e.g., better bioavailability, better flow characteristics, more stability) over earlier forms. But criticsargued those improvements did not translate into therapeutic efficacy (i.e., better treatment outcomes in patients) and that Section 3(d) required therapeutic efficacy.
Issues Raised
Whether the beta crystalline form of Imatinib Mesylate qualifies as a patentable inventionunder the Patents Act, particularly under Section 3(d) (which prohibits patents on mere newforms of known substances unless enhanced efficacy is shown).
What is the meaning of “efficacy” under Section 3(d) — whether it includes improvementsinphysical properties, bioavailability etc., or whether it strictly means therapeutic efficacy(improvement in treatment outcomes).
Whether the patent application fails on novelty or other grounds when considered against prior art (publications, previous patent applications).
Arguments of the Parties
Novartis’Arguments:
They contended the beta crystalline form of Imatinib Mesylate is novel and involves inventive step. They argued that existing documented prior art (including Zimmerman’s patent and various scientific articles) did not disclose the beta crystalline form.
They claimed that the beta crystalline form showed enhanced properties: increased bioavailability, better stability, improved properties that justify patentability under Section3(d).
Novartis also argued that the rejection based on Section 3(d) violated its rights under TRIPSAgreement, that India should interpret Section 3(d) in such a way that product patent rightsare meaningful.
Respondents’Arguments:
The respondents contended that “efficacy” in Section 3(d) means therapeutic efficacy, i.e., actual better performance in treating disease, not just improved physical/chemical or pharmacokinetic properties.
They argued the improvements Novartis pointed to (flow, stability, bioavailability) didnot show demonstrable improvement in patient outcomes.
It was argued that allowing patents for such incremental modifications without enhancedefficacy would lead to evergreening— i.e. extension of patent monopolies without genuineinnovation, harming access to affordable medicines.
Judgment / Final Decision
The Supreme Court dismissed Novartis’ appeal and confirmed the rejection of the patent application. The Court held that the claims for the beta crystalline form do not satisfytherequirement under Section 3(d) because Novartis failed to prove enhanced therapeutic efficacy over the known substance.
Legal Reasoning / Ratio Decidendi
The Court interpreted “efficacy” under Section 3(d) of the Patents Act as therapeutic efficacy. It clarified that improvements in physical properties or in bioavailability alone are insufficient unless they result in better therapeutic effect.
The Court analyzed prior literature and patents (Zimmerman patent etc.) and found that Imatinib Mesylate in various forms was already disclosed, which set a high bar of what counts as novel or inventive under the Patents Act.
Section 3(d) was treated as a safeguard against the practice of evergreening. The lawdemands that if a known substance is modified, the modification must showsubstantial improvement in therapeutic efficacy to merit a separate patent.
The Court emphasized legislative intent — that the amended Patents Act (2005 amendment) intended to prevent grants of trivial patents for known substances, so that public healthconcerns are respected.
Conclusion / Observations
This judgment is a landmark for Indian patent law. It reinforced the principle that patent protection must be balanced with public health, especially in pharmaceuticals. The decisionprevented what many saw as abuses of patent law by granting patents for minor modificationsthat don’t significantly help patients in terms of therapeutic outcomes. As a result, access tolife-saving medicines remains more affordable in India, especially generic versions of drugs.
The case has had wide influence, both domestically (in how patent examiners evaluate Section 3(d)) and internationally (in discussions on TRIPS compliance, evergreening).
