Gunjan Jeswani

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Information about Gunjan Jeswani

Published on March 15, 2014

Author: gunjanbhambhani


Patent, TRIPS and Indian Pharmaceutical Industry: Issues and Prospects : Patent, TRIPS and Indian Pharmaceutical Industry: Issues and Prospects Presented by Mrs. Gunjan Jeswani Assistant Professor Faculty of Pharmaceutical Science Shri Shankaracharya Technical Campus Index: Index Introduction TRIPS Indian Patent Act Implications of TRIPS on Indian Patent Act Impact of Product Patents on the Pharmaceutical Sector White & Grey Side Future Scenario of the Indian Pharmaceutical Industry Gunjan Jeswani 2 Introduction : Introduction Pharmaceuticals industry is knowledge based and research oriented. It not only contributes to the economy but also provide drugs at affordable prices. India is among top 15 pharmaceutical manufacturing countries in the world. Total pharmaceutical products exported in July 2013 was worth US $ 834.62 Million, i.e. a increase of 20.69% as compared to June 2013 . * Nearly 95% of the domestic demand of drugs is fulfilled by the indigenous production. Imports are limited to few life saving drugs like AIDS, cancer etc. Indian Patent office granted 3,520 pharmaceutical patents from 2007 to 2012. *, India's premier research company in export import market research. Gunjan Jeswani 3 TRIPS: TRIPS The  General Agreement on Tariffs and Trade  ( GATT ) was a multilateral agreement regulating international trade. Its purpose was the "substantial reduction of tariffs and other trade barriers." GATT was signed in 1947 and lasted until 1994, when it was replaced by the World Trade Organization in 1995. The Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) is an international agreement administered by the World Trade Organization (WTO) that sets down minimum standards for many forms of intellectual property (IP) rights. It was negotiated at the end of the Uruguay Round of the  General Agreement on Tariffs and Trade (GATT) in 1995. 4 Gunjan Jeswani TRIPS: TRIPS 4. TRIPS is an agreement aimed at harmonizing national laws on protection of intellectual property and strengthening the overall IP regime for better protection and enforcement of intellectual property rights. 5. India is a signatory of TRIPs in the Uruguay Round agreement of 1995. 5 Gunjan Jeswani Indian Patent Act, 1970 : Indian Patent Act, 1970 The Patents Act, 1970 was amended in 1999, 2002 & 2005. The amended Act, in accordance with TRIPS, has provided for product patents in foods, medicines and chemical substances. A patent is a form of legal protection for an invention. It protect inventors with property rights that are intended to prevent anyone else from making, using, or selling the patented invention. Gunjan Jeswani 6 An Important milestones in the history of the pharmaceutical industry in India took place in 1970 - “Indian Patent Act ”. Indian Patent Act, 1970: Indian Patent Act, 1970 4. A patent may be defined as a statutory privilege granted by the government to inventors, and to other persons deriving their rights from the inventor. 5. It is a legal monopoly granted to the owner of new invention, which is capable of industrial use, for a limited period of time. The owner can sell, or grant licenses to other only to use it, its form of industrial property. After three years of the patent the enactment of the process patent contributed significantly to the local technological development via adaptation, reverse engineering and new process development. 7 Gunjan Jeswani Implications of TRIPS on Indian Patent Act: Implications of TRIPS on Indian Patent Act Patents may be granted for both products and processes for all the inventions in all fields of technology. The patent term is of 20 years from the date of application. Patents will be granted irrespective of the fact whether the drugs were produced locally or imported from another country. In the case of a dispute on infringement the responsibility lies with the accused rather than with the patent holder. Gunjan Jeswani 8 Impact of Product Patents on the Pharmaceutical Sector: Impact of Product Patents on the Pharmaceutical Sector Gunjan Jeswani 9 Prices of Medicines: Prices of Medicines The cost of developing a new drug molecule have escalated several fold (US $ 2 billion) IPR provides a platform for recovering the cost of development. Problem of access to medicine are related to the problem of non availability of disposable income among the population. For the countries which are unable to meet their basic healthcare needs, TRIPS recommended the provision of compulsory license and parallel import. Gunjan Jeswani 10 Prices of Medicines: Prices of Medicines 5. The prices of drugs in India are in fact much lower than the prices in other countries like Pakistan, U.K. and U.S.A., where product patents are in force. Ranitidine is sold by Glaxo in India at Rs. 7.20. The same product is sold by the same company in Pakistan at Rs. 65 and in the U.S.A. at Rs. 545. 7. While it is true that a positive association is observed between stronger protection and prices of drugs, it is also true that prices decline with the expiry of patent. Gunjan Jeswani 11 First Compulsory License (Nexavar Case Study): First Compulsory License (Nexavar Case Study) Hyderabad-based Natco Pharma Ltd was allowed Make and sell a generic version of German drug maker Bayer AG’s patented(2008) cancer treatment, Nexavar . Bayer AG’s INR 2.8 lakh for a month’s dosage Natco Pharma INR.8,880 for a month’s dosage  Royalty to Bayer - 6 percent of net sales. The ruling clarified that the decision was made based on the facts that: Bayer was able to supply its drugs to only 2 percent of the country's patient population and did not meet the 'reasonable public criteria' requirement. Its price was not ‘reasonably affordable’ It was imported and not manufactured in the country Gunjan Jeswani 12 Research and Development: Research and Development One of the advantages of the universal patent regime is that private venture capital firms become willing to invest in technology based start up companies . Technical knowledge flows more readily from university laboratories to the market place and local firms become willing to devote substantial resources to internal research. The higher cost of the R&D proves to be an effective entry barrier for new firms and hence only firms with large flow of funds become responsible for industrial inventive activity. Gunjan Jeswani 13 Research and Development: Research and Development Most of the R&D investment in the pre trips era was perhaps directed towards process improvements and adapting the technology to local conditions thus resulting in technology spillovers rather than in new product developments The more recent case is the case of viagra introduced by Pfizer. A patent for this drug was granted by the US patent office to Pfizer in 1993. The company spent about 13 years and several millions of dollars to develop the drug. Apparently what took Pfizer 13 years and millions of dollars in R&D to perfect, the Indian firms have managed to do in weeks, for a fraction of costs. Gunjan Jeswani 14 Research and Development: Research and Development 6. Very few companies were involved in R&D in India till 1995 and a considerable improvement in R&D has been observed post TRIPS agreement . 7. Rising R&D costs imply that only giant corporations with formidable R&D, marketing and financial capabilities will be able to afford extensive new drug developments and commercialisations. Since it is difficult for each unit to invest in R&D. 8. Pooling of R&D resources and mergers of firms have been identified as possible solutions to economise on scarce R&D resources . 9. Some of these mergers were: Sandoz (India) merged with Hindustan Ciba-Geigy to form Novartis (India) in 1996 . Gunjan Jeswani 15 R&D Expenditure of Leading Firms: R&D Expenditure of Leading Firms Gunjan Jeswani 16 Foreign Direct Investment: Foreign Direct Investment One of the expected outcomes of strengthening the IPR is the increase in foreign direct investment (FDI). FDI flows depend on skills availability, technology status, R&D capacity, enterprise level competence and institutional and other supporting technological infrastructure. The FDI flows to countries with allegedly low levels of IPR protection. Gunjan Jeswani 17 Technology Transfer : Technology Transfer The actual technology in a patent is often kept as a trade secret A sizeable level of technology currently available is due to `spill overs ’ or developing an alternative process that is very close to the existing one. The high cost of developme nt and rapid obsolescence prevents the transfer of technology . Fear of competition also dissuades the transfer of technology or demands a high royalty for the transfer . In the pharmaceutical industry technological self-reliance can be obtained if bulk drugs are indigenously produced from their basic stage. Gunjan Jeswani 18 White Side: White Side No. of patent applications filed have steadily increased . Attracted foreign investment, and there by stimulate joint ventures and research . Provided access to the latest inventions in drugs. Gunjan Jeswani 19 Grey Side : Grey Side Impediments to develop and introduce new patented products in the market . The cost of drugs is going to increase . Compulsory licensing will discourage further the commercial R & D necessary to new drugs to fight global epidemics. Gunjan Jeswani 20 The access to local firms to patented technology will become more difficult . Future Scenario of the Indian Pharmaceutical Industry: Future Scenario of the Indian Pharmaceutical Industry The impact of IPR largely depend on the developmental status of the economy such as the availability of technical manpower and infrastructure . Impending WTO regime will stimulate the R&D investment in India . Pharmaceutical outsourcing will increase world over . More mergers and amalgamations to pool the human and financial resources to strengthen the R&D in new product development . Indian pharma market will be amongst the top three global markets in terms of incremental growth by 2020.   Gunjan Jeswani 21 PowerPoint Presentation: Gunjan Jeswani 22 To my husband and son , who constantly inspire me to see the world in new fresh ways Dedicated PowerPoint Presentation: 23 Gunjan Jeswani

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