Novartis AG vs Union of India & Others
- ByPravleen Kaur --
- 05 May 2025 --
- 0 Comments
I. Introduction
This case revolves around the patent application filed by Novartis AG (the appellant) for the beta crystalline form of Imatinib Mesylate, a drug used in the treatment of certain types of cancer. The judgment discusses the interpretation of various provisions of the Patents Act, 1970, particularly Section 3(d), which was amended in 2005 to comply with the TRIPS Agreement. The case highlights the balance between promoting innovation and ensuring access to affordable medicines.
II. Background
A. The Zimmermann Patent and Imatinib Mesylate
• Jorg Zimmermann invented N-phenyl-2- pyrimidine-amine derivatives, including Imatinib, which can be used as anti-tumor drugs and in the treatment of atherosclerosis. The compounds were granted patents in the US and Europe. [Paragraph 5]
• The appellant claimed to have produced the beta crystalline form of Imatinib Mesylate from Imatinib free base in two ways. [Paragraph 6]
• The drug Gleevec, derived from the Zimmermann patent, came to market for commercial sale. The appellant claimed that Gleevec was part of the Zimmermann patent and obtained drug approval on that basis. [Paragraph 9]
B. India's Patent Regime and the TRIPS Agreement
• India's patent regime at the time of Independence was not beneficial for the country and mainly benefited foreigners. It did not promote scientific research or industrialization and limited the innovativeness of Indians. [Paragraph 31]
• The TRIPS Agreement required India to provide patent protection for pharmaceutical and agricultural products. India amended its Patents Act in 1994 to comply with these obligations. [Paragraph 61]
• India's patent law was taken to the WTO panel twice, first by the USA and then by the European Communities, regarding the lack of patent protection for pharmaceutical and agricultural chemical products. The WTO panel found India had not complied with its obligations under the TRIPS Agreement. [Paragraph 62]
• The Doha Declaration on TRIPS and Public Health was adopted at the fourth WTO Ministerial Conference in 2001, recognizing the flexibilities in the TRIPS Agreement to protect public health and promote access to medicines. [Paragraph 64]
C. Amendments to the Patents Act, 1970
• The Patents (Amendment) Act, 1999, was passed to comply with the TRIPS provisions, amending the Patents Act, 1970, retrospectively. [Paragraph 67]
• The Patents (Amendment) Act, 2002, brought large-scale amendments to the patent law in India, aiming to modernize and harmonize it with international practices. [Paragraph 20]
• The Patents (Amendment) Act, 2005, was passed to allow for product patents for pharmaceutical and agricultural chemical substances, as required by the TRIPS Agreement. [Paragraph 74]
III. Key Issues
A. Interpretation of Section 3(d)
• Section 3(d) of the Patents Act, 1970, as amended in 2005, states that the discovery of a new form of a known substance must enhance its efficacy to be considered an invention. [Paragraph 95]
• The amendment in Section 3(d) was meant to deal specifically with chemical substances and pharmaceutical products, setting up a second tier of qualifying standards. [Paragraph 26]
• The interpretation of Section 3(d) and its relationship with the definition of "invention" in Section 2(1)(j) and Section 2(1)(ja) was a crucial issue in the case. [Paragraph 99]
B. Patentability of the Beta Crystalline Form of Imatinib Mesylate
• The appellant's case was rejected, as the beta crystalline form of Imatinib Mesylate did not demonstrate enhanced efficacy over Imatinib in free base form. [Paragraph 48]
• The court held that the test of enhanced therapeutic efficacy must be applied strictly, with only properties directly related to efficacy to be considered. The appellant's arguments of enhanced efficacy were not convincing. [Paragraph 48]
• The court found that the beta crystalline form of Imatinib Mesylate is a new form of a known substance and must satisfy the relevant provisions, including Section 3(d). [Paragraph 16]
C. Access to Affordable Medicines
• The court acknowledged concerns about the impact of the product patent regime on access to affordable medicines, as highlighted by the high price of the drug Gleevec patented by Novartis. [Paragraph 82]
• The Parliamentary debate on the 2005 amendment focused primarily on medicines and drugs, with concerns about creating private monopolies in the pharmaceutical industry and the impact on affordable drug prices. [Paragraph 79]
• The court recognized the importance of the TRIPS Agreement and the Doha Declaration in addressing issues related to public health and access to medicines. [Paragraph 64]
IV. Conclusion
The Supreme Court dismissed the appeals filed by Novartis AG, upholding the decision of the Intellectual Property Appellate Board (IPAB) and the Assistant Controller of Patents and Designs. The court held that the beta crystalline form of Imatinib Mesylate failed the tests of "invention" and "patentability" under the Patents Act, 1970, as it did not demonstrate enhanced efficacy over the known substance, as required by Section 3(d). The judgment highlights the balance struck by the Indian patent law between promoting innovation and ensuring access to affordable medicines, in line with the TRIPS Agreement and the Doha Declaration on TRIPS and Public Health.
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