Novartis AG v. Union of India & Others
CITATION: (2013) 6 SCC 1
COURT: Supreme Court of India.
BENCH: Aftab Alam, J.; Ranjana Prakash Desai, J.
One of the predominant pharmaceutical companies, Novartis International (The Appellant) filed an application for patent registration of a drug called ‘Glivec’. This drug was invented using the Beta Crystalline form of "Imatinib mesylate" used to treat cancer.
Initially, the application in India was not considered because Section 5 of the Patents Act, 1970 restricted the grant of a patent for products. After the 2005 amendment, which included patents for products along with processes, the application for patenting Glivec was taken into consideration.
The application by the appellant, when first filed, was rejected by the Madras Patent Office as well as the IPAB, on the grounds that the drug in question is a known substance and does not induce any ‘enhanced efficacy’ than the previous drug ‘Zimmermann’ patented in the US. Thus, it cannot be considered to include an inventive step under Section 3(d) of the Act. The IPAB’s reasoning for the rejection involved the prevention of ‘evergreening’ of an already patented product which would eventually cause an obstacle in the provision of affordable medicines .
Thus, a SLP was filed by the appellants in the Supreme Court of India under Article 136.
Whether the ‘inventive step’ requirement under section 2(1)(j) is fulfilled by the appellant?
Whether Section 3(d) of the Act bars the registration of the appellant’s patent?
Section 2(1)(j), Indian Patents Act, 1970 – Defines Invention as a new product or process which includes an inventive step and is capable of industrial application.
Section 2(1)(ja), Indian Patents Act, 1970 – Defines Inventive step to mean a non-obvious feature which involves a technical advancement when compared to a previous product.
Section 3(d), Indian Patents Act, 1970 – New form of a known substance which does not result in an enhanced efficacy is not patentable.
Section 83, Indian Patents Act, 1970- The general principles applicable to the working of patented inventions.
The Appellant primarily argued that the Zimmerman patents registered in the US differ from Glivec in terms of the form of the substance used. The appellant’s product is in a beta crystalline form which satisfies the novelty requirement because the Zimmerman does not constitute the beta crystalline form of imatinib mesylate. It was contended that since the Zimmerman patent contains no mention of a crystalline structure or teach a person how to prepare a particular polymorph of the salt, the process of production of the salt and the synthesis of the relevant crystalline form would possess the characters to pass the Novelty test.
When the court analysed this contention, it concluded that since the substance in question was already a known substance, it does not qualify the test of invention as under section 2(1)(j).
Secondly, the appellant had stated that their product in the beta crystalline form has an enhanced efficacy over the imatinib mesylate used in the previously registered drug, thus it satisfies the test of selection under Section 3(d).
The Respondents denied these arguments and stated that imatinib mesylate in beta crystalline form is not original or non-obvious as there are pre-existing publications about the component in addition to the disclosures in the Zimmerman registration application. Further, in order to prove the novelty of the same, it was contended that ‘efficacy’ in Section 3(d) should be considered as a therapeutic efficacy and not merely physical efficacy.
The court accepted this argument and rejected the appeal filed by Novartis by stating that although the beta crystalline is a new form of a known substance (Imatinib Mesylate),the efficacy of the substance is already well known.
This is one of the Landmark judgments of the Supreme Court which ensured affordable access to medicines for all while defining the scope of the Patents (Amendment) Act, 2005. The Court, in effect, emphasised that while considering the efficacy in case of any drugs or medicine, the efficacy under section 3(d) always refers to ‘Therapeutic efficacy’ as contented. Further, it stated that the intention of the amendment provisions to the Patents Act, 1970 also includes ensuring that patented products do not get ‘evergreen’ protection. The Indian patent office does not take a liberal approach towards the grant of patent protection for pharmaceutical products to ensure prevention of unaffordability of life saving drugs. Section 3(d) by barring all incremental inventions achieves this objective. The Hon’ble Court in its judgement, clearly stated that since India is a developing country, the availability of medicines at affordable rates is a necessity.