Case Law: Novartis AG v. Union of India & Others

1. Citation: Civil Appeal Nos. 2706-2716 of 2013 (arising out of SLP(C) Nos. 20539-20549 of 2009)
2. Court: Supreme Court Of India
3. Date of Judgement: 1 April 2013
4. Bench: Justice Aftab Alam and Justice Ranjana Prakash Desai

Relevant Statutes / Key Provisions

Indian Patents Act, 1970:

• Section 2(1)(j) (Invention)
• Section 2(1)(ja) (Inventive step)
• Section 3(d) (Patentability of new forms of known substances)
• Sections 5, 24A, and 25 (Transitional provisions, opposition to grant, etc.)

BRIEF FACTS  :

Novartis AG, a Swiss pharmaceutical company, applied for a patent in India on the beta crystalline form of imatinib mesylate, sold as Glivec (also known as Gleevec). This drug is used to treat chronic myeloid leukaemia (CML) and gastrointestinal stromal tumours (GIST). Novartis argued that its invention had better physical properties, such as greater stability, improved processability, and reduced hygroscopicity, compared to earlier forms. While Novartis obtained patents for Glivec globally, Indian law at that time allowed only process patents for pharmaceuticals. After complying with the TRIPS Agreement, India changed its law in 2005 to permit product patents but added Section 3(d) to limit “evergreening,” or getting patents for small changes to existing drugs.  

The Chennai Patent Office rejected Novartis’ application in 2006, stating that the new form did not demonstrate “enhanced efficacy,” as Section 3(d) required, but only had better physical properties. Novartis then filed writ petitions in the Madras High Court to challenge:  

– The rejection of its patent  

– The validity and constitutionality of Section 3(d), arguing it was unclear, arbitrary, and inconsistent with TRIPS. 

The Intellectual Property Appellate Board (IPAB) also ruled that the beta crystalline form was not patentable due to the lack of enhanced efficacy. Novartis took its case to the Supreme Court under Article 136.

ISSUES INVOLVED  :

1. Did the “beta-crystalline form of imatinib mesylate” claimed by Novartis show “enhanced efficacy” over the known substance “imatinib mesylate,” as required by Section 3(d) of the Patents Act?
2. How should we define efficacy in pharmaceuticals? Does it refer to any beneficial property, or specifically to therapeutic efficacy?  
3. Was Section 3(d) constitutional, or was it vague, arbitrary, and inconsistent with India’s obligations under the TRIPS Agreement?  
4. Did the Novartis product meet the standards of novelty, inventive step, and industrial applicability under Sections 2(1)(j) and 2(1)(ja) of the Patents Act? 

ARGUMENTS   :

Petitioner’s Arguments (Novartis AG)  

Section 3(d) was arbitrary and unclear; the phrase “enhanced efficacy” lacked precision, which led to arbitrary decisions.  

The Intellectual Property Appellate Board did not recognize that their product met all the requirements for “novelty” and “inventive step.”  They claimed their invention had better physicochemical properties (such as improved flow, stability, and processability), arguing that these properties represent enhanced efficacy.  

Section 3(d) violated the TRIPS Agreement, which India amended its laws to comply with, as well as Article 14 of the Constitution related to equality before the law.  

They argued that any improvement, including in physical properties, should qualify for a patent. 

Respondents’ Arguments (Union of India & Others; supported by Indian generics industry and civil society groups)  

“Efficacy” in the context of pharmaceuticals should be interpreted narrowly as therapeutic efficacy, not simply any enhanced property.  

Allowing small changes to existing drugs to be patented would permit “evergreening” and increase the costs of life-saving medications.  

The beta-crystalline form did not show a significantly better therapeutic effect.  

The “invention” was previously known or disclosed (in the “Zimmermann patent” and in scientific articles), thus failing both the “novelty” and “enhanced efficacy” tests.  

Section 3(d) represents a balance in national policy, permitted under TRIPS, aimed at preventing patent abuse in public health matters.  

JUDGEMENT   :

The Supreme Court dismissed Novartis’ appeal, stating that:  

The “beta-crystalline form of imatinib mesylate” was not patentable under Section 3(d) because Novartis did not prove that it provided enhanced therapeutic efficacy compared to known forms of imatinib mesylate.  

“Efficacy” in Section 3(d) should be understood as “therapeutic efficacy,” not just any improved physicochemical property.  

Section 3(d) was constitutional and not arbitrary or vague. The Court noted that its goal was to prevent ever greening by stopping the patenting of minor variations of known drugs to extend monopolies.  

Simply showing an improvement in physical properties (like stability or flow) does not satisfy the need for increased therapeutic effectiveness; higher bio availability does NOT automatically result in better treatment unless proven by outcomes.  

Novartis’ product was also already referenced in prior publications (such as the “Zimmermann patent”) and lacked the required novelty.  

The rejection of a product patent did not breach India’s TRIPS obligations, as TRIPS allows countries to balance innovation with public health considerations.  

RATIO DECIDENDI  :

Section 3(d) of the Patents Act, 1970, establishes a “therapeutic efficacy” standard for patenting new forms of known substances. Improved physical or physicochemical properties alone are not enough unless they clearly enhance treatment efficacy. 

OBITER DICTA  :

The Supreme Court clarified that incremental innovation is not completely excluded; Section 3(d) does not prevent all minor improvements, but such changes must enhance therapeutic effects for pharmaceuticals.  

This case should not be viewed as oppositional to all pharmaceutical innovation, but rather aimed at patent claims that do not meet the efficacy standard.  

FINAL JUDGEMENT : 

The Court dismissed Novartis’ appeal and upheld the IPAB’s and Patent Office’s decision to deny a patent for the beta-crystalline form of imatinib mesylate (Glivec).  

The constitutionality of Section 3(d) was confirmed, ensuring access to affordable generics in India. 

Section 3(d) emerged as an important precedent in Indian and global public health law, helping other developing countries balance pharmaceutical innovation with access to essential medicines. The section aims to prevent evergreening and rewards only true innovation in pharmaceuticals.  

A patent application that cannot prove greater therapeutic efficacy over previous forms does not meet the requirements and must be denied.  

REFERENCES USED:

1.  ESCR-Net, “Novartis AG v. Union of India, (2007) – ESCR-Net” (ESCR-Net, August 22, 2023) https://www.escr-net.org/caselaw/2020/novartis-ag-v-union-india-2007/
2.  Agrawal A, “Novartis AG v. Union of India: Critical Case Analysis” (LawBhoomi, August 14, 2025) https://lawbhoomi.com/novartis-af-v-union-of-india-critical-case-analysis/
3. Novartis vs Union Of India 2013: Landmark Case” (Testbook) https://testbook.com/landmark-judgements/novartis-vs-union-of-india
4.  UNCTAD’s Intellectual Property Unit, “Novartis AG v. Union of India & Others” (2013) https://unctad.org/ippcaselaw/sites/default/files/ippcaselaw/2020-12/Novartis%20AG%20v.%20Union%20of%20India%20&%20Others%20Indian%20Supreme%20Court%202013_0.pdf
5. WIPO Lex”https://www.wipo.int/wipolex/en/text/590006
6. NancyGarg, “Novartis V. Union of India (2013) 6 SCC 1.Pptx” (SlideShare) https://www.slideshare.net/slideshow/novartis-v-union-of-india-2013-6-scc-1pptx/254990984
7. LawFoyer and LawFoyer, “NOVARTIS v. UNION OF INDIA & OTHERS | LawFoyer” (LawFoyer | a Daily Doze for Inquisitors, August 3, 2022) https://lawfoyer.in/novartis-v-union-of-india-others/