The Mayor Inc. is a company incorporated under the laws of United States of America (U.S.A.) consequent to its Research and Development (R&D) activities the company invented and developed its patented drugs to enable

The act of Mayor Inc. to evergreen its pre-existing patent for its pre- patented product is not according to law and the rejection-order of the controller of patents is valid in the light of following provisions of the Patent Act, 1970 and relevant case law mentioned below: Section 3(d) of Indian Patents Act, 1970 says that the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant, is not patentable. This section provides that the new form of the substance shall not be considered as patentable unless it shows enhancement in efficacy. For instance, new use of Aspirin for treatment of the cardio-vascular disease, which was earlier used for analgesic purpose, is not patentable. However, a new and alternative process for preparing Aspirin is patentable. For instance, the paracetamol has antipyretic property. Further discovery of new property of paracetamol as analgesic can not be patented. Similarly, ethyl alcohol is used as solvent but further discovery of its new property as anti knocking, thereby making it usable as fuel, can not be considered patentable. In order to distinguish the invention from the prior art, relevant prior art is also required to be given in the specification. It is always essential to analyze the invention in the light of what is described and the prior art, in order to identify the contribution to the art and hence determine whether this advancement resides in, or necessarily includes technological features and technical application or is solely intellectual in its content. Section 3(d) of the Indian Patent Act restricts grant of patent for "incremental innovations" in many drugs unless it provides significant therapeutic advantages to existing molecules. The Supreme Court's judgment in Novartis A.G v. Union of India [AIR (2013) SC 1311] whereby it dismissed the patent application filed by Novartis for a drug used to treat a type of blood cancer, was a much awaited decision for the patients. Even, in 2006, the Madras Patent Office refused the patent application of Novartis for its drug Glivec stating that the said drug did not exhibit any major changes in therapeutic effectiveness over its pre-existing form, which was already patented outside India. The said decision was based on Section 3(d) of the Indian Patents (Amendment) Act, 2005 which provides a known substance can only be patented if its new forms exhibit "enhanced efficacy". The Patent Office did not find any enhanced efficacy in the drug Glivec and, therefore, considered it incapable of patentable under Section 3(d) of 2005 Act. Countries in order to attain development while taking care of the needs of its citizens must go through a paradigm shift, now more than ever. And in order to maximize achievements of developmental goals, health is a parameter of utmost importance; healthy citizens can lead to overall growth of an economy. India is till present categorized as a developing nation owning a naïve Intellectual Property Law regime in contrast to a swiftly germinating population ranked second largest globally. But this disparity does not settle the classic case of commercialism versus larger public good in the form of human rights. The Indian law since long followed a 'process patenting system which was brought to a stop with TRIPS Agreement of the World Trade Organization (WTO) in 1995 that made 'product' patenting mandatory; thus opening a disputable area in India between the giant pharmaceutical sector and the larger goal of public health. The Apex Court rejected the contention stating that in the case of medicines, efficacy means "therapeutic efficacy" and these properties while they may be beneficial to some patients do not meet this standard. The Supreme Court also held that patent applicants must prove the increase in therapeutic efficacy based on research data in vivo in animals. The Supreme Court held that the true intention to enact section 3(d) was to prevent the concept of evergreening and thus if the invention does not fulfil the test of Section 3(d), it cannot be granted a patent. The court further specified that this case should not be interpreted to mean that Section 3(d) bars all incremental inventions. It is with regard to the field of medicine especially in cases of life-saving drugs, a great acre and caution needs to be taken so as to protect the right to life of the masses This section plays an important role to protect public health of teeming millions of our country. This provision is one of the most important safeguards under the Patents Act, 1970 to protect public health. This section contradicts the problem and claim of ever greening 17. This provision does not recognize ever greening and permits entry of generic drugs which in turn makes the price of life saving drug cheaper. It will definitely protect the public health of millions and millions of people in India who live in below poverty line and have a little financial power to purchase medicine.