India amended the patent Act in 2005 as a part of its obligation under TRIPS agreement but in the face of strong opposition from the Indian sector of the pharmaceutical industry. The fear of the Indian sector of the industry was that the powerful multinational drug companies will exploit the loopholes of the amended patent law and dominate the Indian pharmaceutical scene by obtaining patents for all kinds of modifications of known molecules. That is precisely what has happened during the last five years and the government could hardly do anything to stop it. MNCs have been filing applications for patenting different forms of the same drug, like salt, polymorphs, analogues, crystalline and combinations with other drugs. By doing this, they just tried to corner a broader spectrum of protection for commercially significant forms of the same compound. The patent offices in the country have thus granted patents to dozens of products which do not merit patent protection at all. Filing of multiple patent applications for various forms of the same drug is possible within the framework of the amended Patent Act. A study conducted by IPA in 2009 found that at least 86 cases of patents granted for pharmaceutical products were just minor variations of existing molecules. After 2005, about 13,000 patents have been already issued to various chemicals and pharmaceuticals until last year. And over 70,000 patent applications are pending for examination and process. Patent offices in the country are finding it extremely difficult to process such large number of patent applications because of manpower shortage and expertise.
Apart from filing frivolous applications, it has been now found that many MNCs are not complying with all the rules after patents are granted. A RTI query sought by Spicy IP relating to seven life saving drugs currently sold in India by MNCs, namely Pfizer, Bristol Myers, Roche, Bayer and Schering, has revealed that they have not made full disclosure for all these years since the grant of patents. In some cases, firms did not even file Form 27 at all for some years. The amended Patents Act stipulates that patent holder should file regular information to show how a patent has worked in India through Form 27. For imported drugs, details of the quantity and value of product need to be provided besides information on whether reasonable requirements of the public were met through the patent. The Patent Act also specifies that if the medicines are being imported and not manufactured domestically, they are liable for compulsory licensing. In other words, some quantity of the patented drug, sold in the country, has to be manufactured in the country within a time stipulated by the patent office. Otherwise, compulsory license can be issued under section of 84 of the Patent Act for the generic manufacture of the product. Section 122 of the Patents Act, 1970 also empowers the Patent Controller to slap a fine up to Rs 10 lakh on companies which do not file Form 27 or those who file incomplete information. It is shocking that despite such major lapses on the part of MNCs, no action was initiated against the offenders by any of the patent offices in the country.