Novartis case ANALYSIS

The Novartis was denied of patent protection by SC is a most probable way to maintain a balance between IP Protection and Public Interest. The maintenance of balance is a fundamental duty of state. The Analyst by fully agreeing to what SC held. SC denied novelty and nonoviousness of Glivec (Imatinib Methaylate) by saying that prior art was present in USA. The treatment of Cancer using alpha crystalline form is commonly used in USA and UK. The three modes of manufacturing beta crystalline form by using alpha crystalline form is given in case as an example which clearly shows that a person who is ordinary skilled in that field may produce beta form. Thereby SC denied novelty as it was earlier used for the same purpose in other countries and India started following absolute novelty. The Supreme Court rejected a patent plea by Swiss drug maker Novartis AG for cancer drug Glivec, it was seen as being one of Novartis flagship drugs, and a crucial weapon in the fight against cancer of white blood cells and for the treatment of a rare form of stomach cancer called gastrointestinal stromal tumor (GIST). It is one of the first cancer drugs that validate rational drug design, based on an understanding of how some cancer cells function, it costs a patient about $2,600 (Rs 1, 30,000) a month. Its generic version was available in India for around $175 (Rs 8,750) per month. Novartis altered their old drug in a new form called beta crystalline form and filed an application on July 17, 1998, for grant of a patent for Imatinib Mesylate in beta crystalline form at the Chennai Patent Office. Patent application was rejected. The company then challenged Assistant Collectors orders and approached the Intellectual Property Appellate Board which subsequently dismissed Novartis plea. Novartis approached Madras High Court, where its appeal was dismissed and subsequently it approached Supreme Court.

Supreme Court rejected the plea on various grounds:-

1. Glivec was not new, not innovative and did not satisfy the criteria under section 3(d) which states that inventions that are a mere discovery of a new form of a known substance do not result in increased efficacy of that substance are not patentable. 2. They can add some additional elements and dress up the same drug in a new formulation and claim a new patent. Their aim is to keep the generic manufacturers at bay and continue to make a lot of money. 3. That imatinib mesylate was anticipated by prior art and that it existed before the claimed invention and was hence a known substance and Novartis had allegedly described imatinib mesylate as a necessary step to produce the beta crystalline form of the drug from imatinib. 4. It held that efficacy in Section 3(d) means only therapeutic efficacy. What is evident, therefore, is that not all advantageous or beneficial properties are relevant, but only such properties that directly relate to efficacy, which in case of medicine, is its therapeutic efficacy. 5. In this case, imatinib mesylate was presumed to be the known substance. The court then defined the scope of efficacy, for the purpose of comparing the known substance with the claimed invention and therefore patent was not granted. 6. The various grounds on which Supreme Court rejected the patent plea are absolutely right. When there is a substance which is already existing in a prior art and the similar substance is made just by adding something which is also obvious for the phosita to made then patent should not be granted.

The SC on the other ground i.e. to keep public health unharmed delivered a best judgment. The SC sad that by looking to historical development of Patent Law in Indian context will enable Court to determine whether patent protection can be granted to Novartis. The Doha Declaration of 2001 was also said the same thing that if the public health of a country is at stake than Municipal law should be adopted by country in such a manner wherein public health is protected. The Justice Ayyangar report on whose recommendations the Act of 1970 was enacted also emphasized that public interest should be protected. 1 The Indian legislature set out with a specific purpose in adopting section 3(d), and the patent office is implementing the express objectives of the legislature. This includes preventing pharmaceutical companies from securing patent monopolies without making a contribution to society worthy of imposing the social cost.2 This Sec was inserted only to stop granting of patent protection in case there is a slight improvement in the efficiency of the product. Sec 3(d) demands for the sufficient improvement in the efficacy of the product. The Novartis has set price of one month medication about Rs 1,20,000 Whilst same treatment is available at Rs 8,000 by other generic drug manufacturers. The SC said that a middle class Indian is also unaffordable to pay much and hence, protection should not be granted to Novartis by harming public health. Even with so many critics of judgment, I personally feel that court has rightly decided the case by rejecting Novartis of Patent protection.

Sec 3(c), of Indian Patent Act also include PUBLIC HARM as a ground for deniel of patent protection. SC verdict on Novartis Plea: What it means, published on Apr 1,2013, 01:36 PM IST. (http://www.livemint.com/Opinion/TQkiymlozHeVDfB4Sjn0gN/SC-verdict-on-Novartis-plea-what-itmeans.html)
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