The Section 3(d) of the amended Indian Patent Act of 2005 is a key safeguard against ever greening of a drug patent by the inventor companies by making some incremental changes to the original molecule. This section is specifically included in the Patent Act considering the practice of making minor modifications to the patented molecule by the MNCs to perpetuate the exclusive marketing rights of products after the expiry of patent. By obtaining patent rights the pharma companies can have a monopoly for that product and sell at very high prices. In spite of having this section, the Patent Offices in the country continue to receive hundreds of patent applications for products with no new therapeutic properties. As the global pharmaceutical industry is turning less and less innovative and is struggling to get new molecules, multinational corporations tend to re-jigger the same old drugs with the hope of getting new product patents. Novartis’ attempt to obtain patent for its cancer drug, Glivec, in India is well known. The company wanted a patent for Glivec, which is regarded just an incremental innovation of a known molecule. The patent office rejected the company’s application for the product in January 2006 but it moved the Madras High Court, IPAB and later the Supreme Court. Finally, the Supreme Court last year upheld the decision of Indian patent office of not granting the patent. In 2009, the Patent Office rejected patent application of Pfizer for its drug, Caduet, a therapeutic combination of amlodipine and atorvastatin. The decision against Caduet, a combination of Pfizer's Norvasc (amlodipine besylate) and Lipitor (atorvastatin calcium), is in favour of a pre-grant opposition filed by Torrent.
The decision of Patent Controller of India to release a set of revised draft guidelines last week for examination of patent applications for pharmaceuticals in this context is a step in the right direction. These guidelines could help the examiners and the controllers of the patent offices in achieving uniform standards of patent examination and grant of patents. On Section 3(d) of the Patent Act, the revised guidelines make clear 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 are not patentable. On Section 3(c), it explains that the mere discovery of a scientific principle or formulation of an abstract theory or discovery of any living thing or non-living substance occurring in nature is also not patentable inventions within the meaning of the Act. It is quite possible that international pharmaceutical companies may continue to try to get patents for worthless products in future as well and that calls for extreme vigilance on the part of patent offices in the country so as to not to issue any frivolous patents by default. Periodic review of the Patent Act and incorporation of necessary provisions are therefore necessary to ensure protection to the people from high drug prices and for maintaining steady growth of the pharmaceutical industry of the country.