NOVARTIS AG VS. UNION OF INDIA
This is one of the famous landmark cases for Patent in Intellectual Property Rights where the judgment was given by the two-judge bench of the Hon’ble Supreme Court of India in the case of Novartis AG vs. Union of India, where Novartis challenged the rejection of its patent application by IPAB.
Novartis AG was one of the largest international pharmaceutical companies, in 1998 they applied as per the TRIPS agreement in the Chennai patent office for the grant of a patent where the anticancer drug name is “Glivec” which is basically used to treat Chronic Myeloid Leukemia (CML) and Gastrointestinal Stromal Tumours (GIST) invented from Beta crystalline form of “Imatinib mesylate”. It was patented in more than 35 countries and famously used for the treatment of cancer.
When they filed a patent application, it was not for the process of the products in India but it was for the grant to restrict the methods as defined under section 5 of the Patent Act,1970. But after the amendment act 2005, it was repealed and patents came to be granted for methods or processes but also products.
Drug Glivec was taken into consideration, in 2005 for the application of Novartis but was rejected by Madras Patent Office, by saying that it failed to anticipate the drug by prior publication and they failed to satisfy the requirement of novelty and non-obviousness and it is an invention that is unpatentable under the provision of section-3(d) of Patent Act, 1970.
Two writ petitions were filed under Madras High Court by Novartis, in 2006 under Article 226 of the constitution of India. The appeal already stated that it is unconstitutional because it is not in compliance with the TRIPS agreement and also violates Article-14 of the Constitution of India and the other against the order passed by the Madras Patent Office. IPAB got the case transferred by the Madras High Court in 2007. There is also the application that got rejected. The judgment given by IPAB is to prevent the ever-greening of an already patented product by introducing minor changes and to provide easy access to the citizens of India to life-saving drugs.
-Whether the invention “Beta crystalline form of imatinib mesylate” claimed by Novartis is more efficacious than the substance that it was derived from i.e. “Imatinib mesylate”?
Supreme Court made it clear that in the case of medicine “Efficacy” in section-3(d) only means “Therapeutic Efficacy” and states that all properties of the drug are not relevant, the properties which directly relate to efficacy in the case of medicine is its therapeutic efficacy. The judgment given by the Hon’ble Supreme Court is to prevent the ever-greening of patented products and gives relief to those who can’t afford the lifesaving drug as these pharmaceutical companies sell such lifesaving drugs at a very high price hence unaffordable for the common man. Novartis failed to prove that the therapeutic efficacy of “Beta Crystalline form of Imatinib Mesylate” is more as compared to the therapeutic efficacy of “Imatinib Mesylate”. So that the application of Novartis for patent was rejected by Supreme Court.