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Indian Patents Act : Need for urgent review By B.K. Keayla The problem does not end with the need to modify the ?scope of patentability?. In a recent statement made by a concerned government official, it is observed that government is thinking of granting of patents for encouraging incremental innovations. Patents system has acquired a unique position in the industrial economy of each country. It is a system which has to be very carefully evolved to ensure that exploitation of the consumer does not take place through creation of absolute monopolies over the new products. The interests of the patent holders and the consumer have to be balanced to ensure achievement of objectives and smooth working of the patents system. Over a period, the objectives of the patents system for developing new knowledge for prosperity of the mankind is getting diluted. Instead, the system is helping monopolisation of new knowledge for exploiting the mankind. The TRIPS Agreement is mainly serving the interest of patent holders at the cost of ailing people of the world. There are flexibilities in the TRIPS Agreement as well as in the Doha Declaration on Public Health. These flexibilities have been rather ignored in the amending process of our Patents Act 1970, with the result that trivial / unusual patents are being granted. Government thinking of further liberalise the patentability will be totally against the public interest. In fact, patent frequency in USA is being criticised in that country. Even the UK IRP Commission and the WHO omission on IPR and Innovation are strongly favouring containing of patents to ensure public interest. Patents system was introduced in the legal system in the 19th Century with a view to : - promoting basic inventions; - to enable disclosure of inventions for further research; and - dissemination of fruits of new research for the benefit of general public. The broad idea behind the system was to ensure the availability of new knowledge for prosperity of mankind. The patent rights are formerly granted by the patent authority under the national law legislated through an enactment of Parliament. The rights are granted to both nationals and foreigners at par and are enforceable for a specified period within the territorial limits of the country. In order to be patentable, an invention needs to meet the criteria of : - novelty (previously unknown to the public); - Non-obviousness (containing sufficient innovativeness to merit protection) ; and - Industrial applicability (usefulness). Patents system has acquired a unique position in the industrial economy of each country. It is a system which has to be very carefully evolved to ensure that exploitation of the consumer does not take place through creation of absolute monopolies over the new products. The interests of the patent holders and the consumer have to be balanced to ensure achievement of objectives and smooth working of the patents system. Importance of scope of patentability Scope of patentability is a core component of the patents system. The definitions of ?patentable invention? and ?patentable pharmaceutical substance? in particular have to be carefully framed to ensure that only subject matter of basic research are patented. Since the patents system prevents the third parties not having owner?s consent from the acts of : making, using, offering for sale, selling, or importing for these purposes products, it is important to carefully frame the patentability as otherwise the system will deprive effective competition in new products by other industrial enterprises. This scenario will be against the public interest. The public health policy and laws, national drug policy and the patents system are intensely co-related. This aspect aught to have been kept in view while implementing the TRIPS Agreement in amending the Patents Act 1970. Our then Prime Minister, Mrs. Indira Gandhi, while speaking at the historic session of the World Health Assembly in Geneva on May 6, 1981 emphatically stated that ?My idea of a better ordered world is one in which medical discoveries would be free of patents and there would be no profiteering from life or death?. This statement was made not only for India but for the entire world at the World Health Assembly where an important resolution about ?Health for All by 2000 AD? was also unanimously adopted by all countries. Forgetting this resolved, the Uruguay Round of GATT Negotiations which concluded in December 1993 gave birth to the TRIPS Agreement containing high standards for a universally applicable new patent system to be implemented both by the poor and rich countries alike. The negotiations at the Uruguay Round on the TRIPS Agreement kept in view only the interest of the Multinational Corporations and not the ailing poor people particularly in the developing and the least developed countries. The present political regime seems to have totally forgotten the strong statement of their leader about the ?scope of patentability for the pharmaceutical products?. India being member of the WTO was required to amend its Patents Act 1970 to bring its provisions in line with the TRIPS Agreement. The process of amendment has been completed by amending our Act through three amendments during 1999, 2002, and 2005. During debate in Parliament in April 2005 on the final amendments of the Patents Act 1970, several important Members of Parliament raised issues about ?patentable subject matter for the pharmaceutical products? and ?exclusion of patenting of micro-organism?. The Minister for Commerce and Industry realised the importance of the issues raised, gave an assurance on the floor of Parliament that both the issues would be referred to a Technical Export Group for examination. The government constituted the Technical Export Group consisting of eminent experts. The Group submitted their Report to the government in December, 2006. It was found that the recommendations of the Group were biased and not based on cogent reasons. Some parts of the Report were even plagiarised from the submission made before the Group on behalf of the MNCs. Government has not taken any final decision so far on the rejection or acceptance of the Report and as such the critical issues relating to scope of patentability are still undecided. The assurance given on the floor of the Lok Sabha has also remained unfulfilled. Exploitation of patentability: In the absence of proper definition of patentable invention, it is observed that patent authorities in India are granting patents on trivial/unusual patents. Some of the examples are as follows : Patenting of a cigarette comprising with a tobacco rod. Patent No. 193777 granted to Philip Morris Products INC. A US Company on January 13, 2006. A process for the preparation of a novel composition useful for making parottas (fried chapatti). Patent No. 195187 granted to CSIR a semi government organisation on 7.3.2002. (Thus a semi-government organisation has also exploited the weak patentable subject matter provision). Sanitary napkin, Patent No. 195410 granted to UNI-Charm Corporation on 11.4.2005. A Broom, Patent No. 195912 granted to Jatin Tarachand Gala on 29.7.2005. A process of Making Fried Masala Banana Chips, Patent No. 198069 granted to M. Veeresh on July 7, 2006. Toilet Seat Cover, Patent No. 198000 granted to Dr. P.I. Mohandas on 23.2.2007. In addition to above, there are a number of other trivial product patents granted in the pharmaceutical sector during the last over three years. The question arises whether these are really subject matter of real patentable research. Who is responsible for granting such patents? It would not be proper to blame the Patent Authorities alone for grant of such patents. The real blame lies with the broad based provision on patentability stipulated in the amended Patents Act 1970. The crucial issue of importance is whether the patent system is meant for researchers/scientists or trading enterprises i.e. shopkeepers, Dhabas, Vendors, etc. Government must realise that the patent system in India should not become a joke where patents are granted for subject matter like sanitary napkin, parottas (fried chapatti), broom, etc. Government much act fast and refer the matter of ?scope of patentability? covering definition of patentable invention, patentable pharmaceutical substance and even patenting of microorganism to the concerned Parliamentary Committee so that time is not lost in amending our Patents Act. Patentability should be for the real basic invention and not for the trivial subject matter. Lakhs of patents on trivial matter will only create crisis and result in high cost of economy as in USA. Need for patentability rather than expanding: The problem does not end with the need to modify the ?scope of patentability?. In a recent statement made by a concerned government official, it is observed that government is thinking of granting of patents for encouraging incremental innovations. The statement, in question, reads as follows : ?It may not be prudent to award patent only for a new molecule discovery, something which requires billion dollars of R&D investment. No Indian companies can afford it. So we are looking for ways to award patent for discovery of a new form of a known substance which results in the enhancement of the known efficacy of that substance.? In regard to the above statement, it may be emphasized that certain technological innovations to pharmaceutical patented products may qualify for patentability under the patents system. Technological innovations when they satisfy the prescribed criteria can and should be protected only through process patents. The other possibility is that if there is significant technical advance over the invention claimed in the first patent, it is possible to grant dependent patent. Our Patents Act 1970 in Section 91 provides for licensing of related patents based on conditions stated therein. These available possibilities are sufficient and could be suitably availed by the industry. Government must not succumb to any pressure from the Multinational Corporations to liberalise the scope of patentability any further. Before any further flexibility is even considered about the patenting of incremental innovation, it is important that there should be adequate public debate. It is a well-known fact that USA is also extremely worried about the patent frequency in that country. ?No patent examiner has enough time in their life to examine all innovations completely? as stated by Mr. John Doll, US Commissioner for Patents. Even the American Supreme Court has raised the bar for what subject matter deserves to be given a patent. There is a serious debate going on in USA as to how grant of patent could be contained. Even an important I.P.R. Commission established by U.K. have suggested containing of patents by the developing countries. The W.H.O. Commission on IPR and Innovations have also made similar recommendation. These aspects must not be ignored by our government. Conclusion: To conclude, our Government has to consider in-depth and determine ways and mean for containing the scope of patentability.. This will serve public interest and also strengthen competitive environment and role of the domestic enterprises. TRIPS review under Article 71 of that Agreement is also over due. There are also a number of Doha Ministerial Declaration (November 2001) issues pending for decision. Government should also make all efforts with WTO to have decisions on these long pending issues expedited. (The writer is retired Commissioner of Payments, Government of India. Presently he is Convener, National Working Group on Patent Law and Managing Trustee and Secretary General of Centre for Study of Global Trade System and Development. He can be contacted at wgkeayla@delb.vsnl.net.in)

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