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제약분야의 특허전략과 시장경쟁

Patent strategy and market competition in the pharmaceutical field

정윤택
한국보건경제정책학회 (The Korean Association of Health Economics and Policy)|2012.03|보건경제와 정책연구 (The Korean Journal of Health Economics and Policy)|제18권 제1호|pp. 109-136

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한미FTA제약산업KORUS FTApharmaceutical industrypatent strategy특허전략에버그리닝의약품 시장경쟁pharmaceutical market competion
주제분류사회과학일반

초록

본 연구의 목적은 한국 의약품 시장에서 오리지널 의약품과 제네릭 의약품간에 시장경쟁구조에서 특허전략이 어떠한 영향을 미치는가를 파악하였다. 이와 같은 연구목적을 달성하기 위해 선행연구의 주요한 변수와 특허전략과 관련된 변수들이 시장점유율에 어떤 영향을 미치는지를 파악하였다. 지난 10년간 특허분쟁이 있었던 14개 의약품 성분과 상위 매출액 50개 의약품 성분 중 특허분쟁이 있거나 제네릭 의약품이 미출시 되어 시장경쟁관계가 성립하지 않는 의약품을 제외한 28개 의약품 성분 등 총 42개 성분의 558개 의약품을 대상으로 시장자료(IMS Korea)를 활용하여 다중회귀 분석하였다. 연구 결과 선행 연구에서 의약품의 시장점유율에 주요하게 영향을 미치고 있는 각 변수들과 본 연구의 특허전략과 연계된 변수들은 의약품 시장경쟁에 있어 영향을 미치는 것으로 파악되었다. 모든 변수들을 적용한 모형(IV)에서 설명지수는 약 30%(R2 = 0.2871)로 경쟁기업의 매출액(0.273), 진입시차(-0.217), 진입순서(-0.168), 오리지널 의약품 발매 후 분쟁대상 특허만료일(0.140), 경쟁 제품 수(-0.107), 특허분쟁 여부(0.075) 순서로 시장점유율에 영향을 미쳤다. 한국 의약품 시장에서 특허전략과 관련된 변수인 오리지널 의약품 발매 후 분쟁대상 특허만료일, 특허분쟁 여부의 변수들이 상당한 영향을 주고 있는 것으로 분석되었다. 향후 한미FTA에 따라 특허 허가연계제도가 도입되면 의약품 시장에서 특허전략의 영향력이 더욱더 미칠 것으로 판단된다. 따라서 특허전략과 연계되고 있는 에버그리닝전략 등에 대응할 수 있는 준비와 논의가 필요할 것으로 판단된다.

Abstract

An objective of this paper is to find out how patent strategies related to patent conflicts influence the market competition between original drugs and generic drugs in the Korean pharmaceutical market. How variables related to the patent strategy effect the market share as comparing to those from preceding researches has been analyzed through multiple regression analysis by market sources(IMS Korea) database of one year-period(4th quarter of 2009~3rd quarter of 2010) with 42 APIs in total(558 of both original drugs and generic drugs). As a result of this paper, variables found from the previous papers that considerably effect the Korean pharmaceutical market and those of patent-strategic variables associated with patent conflicts and patent expiry date of conflicts after original drug's launch on market effect to be similar to other variables. In the model(IV) where applied by all the variables, coefficient of determination was about 30%(R2 = 0.2871) while market share was shown to be influenced by variables such as sales of rival companies(0.273), time difference in entry(-0.217), order of entry(-0.168), patent expiry date of conflicts after original drug's launch on market(0.140), number of competing drugs(-0.107) and patent conflicts(0.075) in the order of significance. In Korean pharmaceutical market, variables of patent-strategic purpose such as patent expiry date for the subject of conflicts after original drug's launch on market and patent conflicts were confirmed to be significant sources of effectiveness in Korean pharmaceutical market. According to the this paper results may be become more effective towards the Korean pharmaceutical market in the future KORUS FTA. Therefore, it is concluded that courses of provision and discussion preventive of variety of patent strategies, for example 'evergreening'

참고문헌 (58)

  1. 배은영, "의약품 시장점유율 결정요인에 대한 연구", 박사, pp.2000
  2. 사공진, "제약산업의 시장점유율 결정에 관한 Panel Study", 보건경제와 정책연구, 13(2), pp.71~96 (2007), 한국보건경제정책학회
  3. 오근엽, "제약산업에서 신약의 특허기간 만료 후 복제약의 시장 점유율 변화 추정", 보건경제와 정책연구, 13(1), pp.117~138 (2007), 한국보건경제정책학회
  4. 유미영, "복제약 진입이후 최초등재품목의 시장점유율 관련요인 연구", 석사, pp.2007
  5. 이의경, "건강보험 약가정책의 문제와 발전방향", 건강보험 포럼, (여름) (2006)
  6. 임진균, "제네릭의약품의 시장점유율 결정변수에 관한 연구", 석사, pp.2002
  7. 국내외 환경변화에따른 제약산업발전방안 연구, "장경원", 보건복지부, ~ (2007)
  8. 정갑영, "산업조직론" (2004), 박영사
  9. 제약분야의 에버그린 특허전략과 분쟁 사례 연구, "정윤택", 특허청, ~ (2009)
  10. 정윤택, "제약분야의 에버그리닝(Evergreening)특허전략과 FTA 연구", 지식재산연구, 6(2), pp.147~189 (2011), 한국지식재산연구원
  11. Aronsson, T., "The impact of generic drug competition on brand name market shares: Evidence from micro data", Review of Industrial Organization, 19(4), pp.425~435 (2001)
  12. Arundel, A., "What Percentage of Innovations are Patented?", Empirical Estimates for European Firms, Research Policy, 27, pp.127~141 (1998)
  13. Bae, J, "Drug patent expirations and the speed of generic entry", Health Services Research, 32(1), pp.87~101 (1997)
  14. Caves, R. E., "Patent expiration, entry and competition in the US pharmaceutical industry: An exploratory analysis", Brookings Papers on Economic Activity. Microeconomics, ~ (1992)
  15. Christian Sternitzke, "Knowledge sources, patent protection, and commercialization of pharmaceutical innovations", Research Policy, 39, pp.810~21 (2010)
  16. Cohen, W.M., "Innovation and learning: the two faces of R&D", Economic Journal, 99, pp.569~596 (1989)
  17. Coscelli, A, "The importance of doctors' and patients' preferences in the prescription decision", Journal of Industrial Economics, 48, pp.349~369 (2000)
  18. Danzon, P. M, "Does regulation drive out competition in pharmaceutical markets?", Journal of Law and Economics, 43(2), pp.311~358 (2000)
  19. Datamonitor, "Trends in Pharmaceutical Portfolio Management - Strategies to maintain profitability despite adversity", ~ (2008)
  20. DiMasi, J.A, "Cost of innovation in the pharmaceutical industry", Journal of Health Economics, 10, pp.107~142 (1991)
  21. DiMasi JA, "The price of innovation: new estimates of drug development costs", J Health Economic, pp.151~185 (2003)
  22. Dwivedi Gaurav, "Evergreening: A deceptive device in patent rights", Technology in Society, 32, pp.324~330 (2010)
  23. FTC, "Generic drug entry prior to patent expiration: an FTC study" (2002), US Government Printing Office
  24. Frank R.G, "Pricing patent loss and the market for pharmaceutical", Southern Economic Journal, 59(2), pp.165~179 (1992)
  25. Frank, R.G, "Generic Entry and the Pricing of Pharmaceuticals", Journal of Economics & Management strategy, 6, pp.75~90 (1997)
  26. Gönül, F. F, "Promotion of prescription drugs and its impact on physicians' choice behavior", The Journal of Marketing, 65(3), pp.79~90 (2001)
  27. Grabowski, H., "Brand loyalty, entry, and price competition in pharmaceuticals after the 1984 Drug Act", Journal of Law and Economics, 35 (1992)
  28. Grabowski, "Are the Economics of Pharmaceutical Research and Development Changing?", Pharmacoeconomics, 22(Suppl. 2), pp.15~24 (2004)
  29. Grebmer Klaus von, "Competition in a Structurally Changing, "Pharmaceutical Market: Some health economic considerations", Soc SCI Med, 15, pp.77~86 (1981)
  30. Hansen, R.W, "The pharmaceutical development process: Estimates of current development costs and times and the effects of regulatory changes, In Issues in pharmaceutical economics", pp.151~187 (1979), Lexington Books
  31. Hellerstein, J.K, "The importance of the physician in the generic versus trade-name prescription decision", Journal of Economics, 29(1), pp.108~136 (1998)
  32. Hurwitz, M.A, "Persuasion or information? Promotion and the shares of brand name and generic pharmaceuticals", Journal of Law and Economics, 1, pp.299~320 (1988)
  33. Hurwitz, M., "Patent expiration, entry, and competition in the US pharmaceutical industry", Brookings Papers, ~ (1991)
  34. Inderjit Singh Bansal, "Evergreening-A Controversial Issue in Pharma Milieu", Journal of intellectual property rights, 14, pp.299~309 (2009)
  35. Jacobzone, S, "Pharmaceutical policies in OECD countries: reconciling social and industrial goals, Labour Market and Social Policy, Occasional Papers", Organisation for Economic Cooperation and Development, 40 (2000)
  36. Market share retention after generic entry in a complex buying system: The case of pharmaceutical brands, "Jayachandran, S", ~ (2003)
  37. Jon Hess, "Battle for the market: Branded drug companies’ secret weapons generic drug makers must know", Journal of Generic Medicines, 3(1), pp.20~29 (2005)
  38. Jorge Gonzalez, "Can branded drugs benefit from generic entry? The role of detailing and price in switching to non-bioequivalent molecules", Intern. J. of Research in Marketing, 25(4), pp.247~260 (2008)
  39. Königbauer, I, "Advertising and generic market entry", Journal of Health Economics, 26, pp.613~642 (2007)
  40. Pharmaceutical price controls and entry strategies, "Kyle, M. K", Carnegie Mellon University, ~ (2003)
  41. Leffler, K.B, "Persuasion or information? The economics of prescription drug advertising", Journal of Law and Economics, 24, pp.45~74 (1980)
  42. Levin, R.C, "Appropriating the returnsfrom industrial research and development", Brookings Papers on Economic Activity, 3, pp.783~831 (1987)
  43. Lexchin Joel, "The effect of generic competition on the price of brand-name drugs", Health Policy, pp.47~54 (2004)
  44. Creative vs. uncreative destruction of innovative returns: An empirical examination of the U.S. pharmaceuticals market NBER, "Lichtenberg, F.", ~ (2000)
  45. Livio Garattini, "A comparative analysis of generics markets in five European countries", Health Policy, 51, pp.149~162 (2000)
  46. Lundin D, "Moral hazard in physician prescription behavior", Journal of Health and Economics, 19, pp.639~662 (2000)
  47. Magazzini L, "Dynamic Competition in Pharmaceuticals:On Patent Expiry, Generic Penetration and Industry Structure", European Journal of Health Economics, 5, pp.175~182 (2004)
  48. PhRMA, "Industry Profile" (2002), PhRMA
  49. Reiffen, D, "Generic drug industry dynamics", Review of Economic and Statistics, 87(1), pp.37~49 (2003)
  50. Rizzo, J.A, "Advertising and competition in the ethical pharmaceutical industry: the case of antihypertensive drugs", Journal of Law and Economics, 42, pp.89~116 (1999)
  51. Scherer, F.M, "The parmaceutical industry, In Handbook of Health Economics 1", pp.1297~1336 (2000), Elsevier
  52. Scott-Morton, F.M, "Entry decisions in the generic pharmaceutical industry", The Rand Journal of Economics, 30(3), pp.421~40 (1999)
  53. Scott-Morton, F. M, "Barriers to entry, brand advertising, and generic entry in the US pharmaceutical industry", International Journal of Industrial Organization, 18, pp.1085~1104 (2000)
  54. The demand for pharmaceuticals, "Stern, S", MIT, ~ (1996)
  55. Telser, L.G, "The theory of supply with applications to the ethical pharmaceutical industry", Journal of Law and Economics, 18(2), pp.449~478 (1975)
  56. Venkataraman, S, "The debate on influencing doctors' decisions: are drug characteristics the missing link?", Management Science, 53(11), pp.1688~1701 (2007)
  57. Vernon, J.M, "Concentration, promotion, and market share stability in the pharmaceutical industry", Journal of Industrial Economics, 19(3), pp.246~266 (1971)
  58. Wittink, D. R, "Analysis of ROI for pharmaceutical promotion (ARPP)" (2002), Presentation to the Association of Medical Publications

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