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Anti Pharmaceutical Patent Ever-greening Law: Global Need in Support of Public Health


Affiliations
1 Vaccine R&D Unit, Research and Production Complex, Pasteur Institute of Iran, Alborz, Iran, Islamic Republic of
 

Drug patenting would be an effective tool to encourage introducing new drugs for prevention and treatment of diseases. The main goal of drug patenting is to protect all the interests of inventor and try to create a secure and confident way to encourage those who are involved in pharmaceutical industries. However, some pharmaceutical companies by using different strategies like, combination, finding new medical use, new formulation or slight changes in old drugs, abuse this tool to extend their patents (patent ever-greening) and obtain more economic advantages. These types of drugs, due to lack of full requirements of an invention such as novelty and inventive step, cannot be considered as new drugs, therefore, cannot be patented. Pharmaceutical patent ever-greening is in contradicted with the spirit of the innovation, invention and commercialization. By preventing the introduction of generic drugs into the market, it might endanger public health via continue selling of brand drugs with exorbitant prices. Pharmaceutical patent ever-greening is a global issue because practical approaches to patent ever-greening are currently seen in both developing and developed countries and it imposes a substantial burden on the public health. For this reason, passing a law to ban ever-greening of pharmaceutical patents is essential in all countries of in the world.

Keywords

TRIPS Agreement, US Food and Drug Administration, WHO Essential Medicines List, Public Health, Patent, Ever-greening, Drug Modification, Combined Drugs, Fixed-dose Combinations, Direct-to-Consumer Advertising.
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  • http://apps.who.int/medicinedocs/documents/s23068en/s23068en.pdf (accessed on 3 January 2019).

  • Hill A M, Barber M J & Gotham D, Estimated costs of production and potential prices for the WHO Essential Medicines List, BMJ Global Health, 3 (2018), e000571. doi:10.1136/bmjgh-2017-000571.

  • Danta M & Ghinea N, The complex legal and ethical issues related to generic medications, Viral Hepatitis: A case study, Journal of Virus Eradication, 3 (2017) 77-81.

  • Wouters O J, Kanavos P G & Mckee A M, Comparing generic drug markets in Europe and the United States: Prices, volumes, and spending, The Milbank Quarterly, 95 (2017) 554-601, doi:10.1111/1468-0009.12279.

  • Kumar A & Nanda A, Ever-greening in pharmaceuticals: Strategies, consequences and provisions for prevention in USA, EU, India and other countries, Pharmaceutical Regulatory Affairs, 6 (2017) 1000185, doi:10.4172/2167-7689.1000185.

  • http://www.wipo.int/patents/en/, (accessed on 5 January 2019).

  • http://www.wipo.int/edocs/mdocs/africa/en/wipo_pat_hre_15/wipo_pat_hre_15_t_3.pdf (accessed on 5 January 2019).

  • Dunne S, Shannon B & Dunne C et al., A review of the differences and similarities between generic drugs and their originator counterparts, including economic benefits associated with usage of generic medicines, using Ireland as a case study, BMC Pharmacology and Toxicology, 14 (2013) 1, doi:10.1186/2050-6511-14-1.

  • Midha S, Strategies for drug patent ever-greening in the pharmaceutical industry, International Journal of Pharmaceutical Sciences and Business Management, 3 (2015) 11-24.

  • Cohn J, The drug price controversy nobody notices, The Milbank Quarterly, 94 (2016) 260-26. doi:10.1111/1468-0009.12193.

  • Pharma overview, Chemical & Engineering Weekly Newsletter, 80 (2002) 39-49. http://plg-group.com/wp-content/uploads/2014/03/Pharma-Overview-Chemical-Engineering-News-Dec-2002.pdf, (accessed on 13 January 2019).

  • Mahoney S P, Is esomeprazole (Nexium) more effective than omeprazole (Prilosec) in reducing heartburn and in increasing the rate of esophageal healing in adults with endoscopically diagnosed erosive esophagitis (EE)?, PCOM Physician Assistant Studies Student Scholarship, Paper: 26 (2011)https://pdfs.semanticscholar.org/126b/1d98fc5f3b600b5b0f1d059ea053301abe2f.pdf, (accessed on 13 January 2019).

  • Asghar W, Pittman E & Jamali F, Comparative efficacy of esomeprazole and omeprazole: Racemate to single enantiomer switch, Daru Journal of Pharmaceutical Sciences, 23 (2015) 50, doi:10.1186/s40199-015-0133-6.

  • Gellad W F, Choi P, Mizah M et al., Assessing the chiral switch: Approval and use of single-enantiomer drugs, 2001 to 2011, The American Journal of Managed Care, 20 (2014) 90-97.

  • Valentová J & Hutt A J, Chiral switch: Pure enantiomers of drugs instead of racemic mixtures, Ceská a Slovenská Farmacie, 53 (2004) 285-293.

  • Shenfield G M, Fixed combination drug therapy, Drugs, 23 (1982) 462-480.

  • Bell D S, Combine and conquer: Advantages and disadvantages of fixed-dose combination therapy, Diabetes, Obesity and Metabolism, 15 (2013) 291-300, doi: 10.1111/dom.12015.

  • Squizzato A, Bellesini M, Takeda A et al., Clopidogrel plus aspirin versus aspirin alone for preventing cardiovascular events, The Cochrane Database of Systematic Reviews, 1 (2017) CD005158, doi:10.1002/14651858.CD005158.pub4.

  • Clarke P M & Avery A B, Evaluating the costs and benefits of using combination therapies, The Medical Journal of Australia, 200 (2014) 518-520, doi:10.5694/mja14.00199.

  • Gupta A K, Arshad S & Poulter N R, Compliance, safety, and effectiveness of fixed-dose combinations of anti-hypertensive agents: A meta-analysis, Hypertension, 55 (2010) 399-407, doi:10.1161/HYPERTENSIONAHA.109.139816.

  • Oh M, Park S E, Ghim J L et al., Comparative pharmacokinetics of a fixed-dose combination vs concomitant administration of telmisartan and S-amlodipine in healthy adult volunteers, Drug Design, Development and Therapy, 11 (2017) 3543-3550, doi:10.2147/DDDT.S148534.

  • Mc Gettigan P, Roderick P, Kadam A & Pollock A, Threats to global antimicrobial resistance control: Centrally approved and unapproved antibiotic formulations sold in India, British Journal of Clinical Pharmacology, 85 (1) (2019) 59-70, doi:10.1111/bcp.13503.

  • Wirtz VJ, Mol P G, Verdijk J et al., Use of antibacterial fixed-dose combinations in the private sector in eight Latin American countries between 1999 and 2009, Tropical Medicine & International Health, 18 (2013) 416-425. doi:10.1111/tmi.12068.

  • Gallardo C R, Rigau C D, Valderrama Rodríguez A et al., Fixed-dose combinations of drugs versus single-drug formulations for treating pulmonary tuberculosis, Cochrane Database of Systematic Reviews, 5 (2016) CD009913, doi:10.1002/14651858.CD009913.pub2.

  • Bouvenot G, Sassard J & Montastruc J L, For an optimal use of fixed drug combinations, Therapie, 72 (2017) 665-668, doi:10.1016/j.therap.2017.07.003.

  • Ugurlu T & Ozaydin T, An overview on fixed dose combinations, Asian Journal of Pharmaceutical Technology & Innovation, 2 (2014) 75-81.

  • Gautam C S & Saha L, Fixed dose drug combinations (FDCs): Rational or irrational: A view point, British Journal of Clinical Pharmacology, 65 (2008) 795-79, doi:10.1111/j.1365-2125.2007.03089.x.

  • Gupta Y K & Ramachandran S S, Fixed dose drug combinations: Issues and challenges in India, Indian Journal of Pharmacology, 48 (2016) 347-349, doi:10.4103/0253-7613.186200.

  • Ashburn T T & Thor K B, Drug repositioning: Identifying and developing new uses for existing drugs, Nature Reviews Drug Discovery, 3 (2004) 673-683, doi:10.1038/nrd146.

  • Tobinick E L, The value of drug repositioning in the current pharmaceutical market, Drug News & Perspectives, 22 (2009) 119-125, doi:10.1358/dnp.2009.22.2.1343228.

  • Vargesson N, Thalidomide-induced teratogenesis: History and mechanisms, Birth Defects Research Part C, Embryo Today, 105 (2015) 140-156, doi:10.1002/bdrc.21096.

  • https://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm107296.htm (accessed on 10 February 2019).

  • https://www.accessdata.fda.gov/drugsatfda_docs/label/2006/020151s044,020699s071lbl.pdf (accessed on 10 February 2019).

  • Wellington K & Perry C M, Venlafaxine extended-release: A review of its use in the management of major depression, CNS Drugs, 15 (2001) 643-669.

  • Wright C W, Aikman M S, Werts E et al., Bioequivalence of single and multiple doses of venlafaxine extended-release tablets and capsules in the fasted and fed states: Four open-label, randomized crossover trials in healthy volunteers, Clinical Therapeutics, 31 (2009) 2722-2734, doi:10.1016/j.clinthera.2009.11.025.

  • Cunningham L A, Once-daily venlafaxine extended release (XR) and venlafaxine immediate release (IR) in outpatients with major depression, Venlafaxine XR 208 Study Group, Annals of Clinical Psychiatry, 9 (1997) 157-164.

  • Olver J S, Burrows G D & Norman T R, The treatment of depression with different formulations of venlafaxine: A comparative analysis, Human Psychopharmacology: Clinical and Experimental, 19 (1) (2004) 9-16, doi:10.1002/hup.551.

  • http://www.ema.europa.eu/docs/en_GB/document_library/Other/2015/05/WC500187078.pdf (accessed on 17 February 2019).

  • Colvard M D, Key differences between Venlafaxine XR and Desvenlafaxine: An analysis of pharmacokinetic and clinical data, Mental Health Clinician, 4 (1) (2014) 35-39, doi:10.9740/mhc.n186977.

  • https://www.cadth.ca/sites/default/files/pdf/htis/2017/RC0921%20Desvenlafaxine_Final.pdf (accessed on 18 February 2019).

  • Gleeson D H, Moir H & Lopert R, Costs to Australian taxpayers of pharmaceutical monopolies and proposals to extend them in the Trans-Pacific Partnership Agreement, The Medical Journal of Australia, 202 (2015) 306-308, doi:10.5694/mja14.01682.

  • Gupta H, Kumar S, Roy S K et al., Patent protection strategies, Journal of Pharmacy & Bioallied Sciences, 2 (1) (2010) 2-7, doi:10.4103/0975-7406.62694.

  • Brog J P, Chanez C L, Crochet A et al., Polymorphism, what it is and how to identify it: A systematic review, RSC Advances, 3 (2013) 16905-16931, doi:10.1039/C3RA41559G.

  • Raza K, Kumar P, Ratan S et al., Polymorphism: The phenomenon affecting the performance of drugs, SOJ Pharmacy & Pharmaceutical Sciences, 1 (2014) 10, doi:10.15226/2374-6866/1/2/00111.

  • Tandon R, Tandon N & Kumar Thapar R, Patenting of polymorphs, Pharmaceutical Patent Analyst, 7 (2018) 59-63, doi:10.4155/ppa-2017-0039.

  • Kapczynski A, Park C & Sampat B, Polymorphs and prodrugs and salts (Oh My!): An empirical analysis of “Secondary” pharmaceutical patents, PloS ONE, 7 (2012) e49470, doi:10.1371/journal.pone.0049470.

  • http://www.who.int/intellectualproperty/topics/ip/en/Me-tooDrugs_Hollis1.pdf (accessed on 2 March 2019).

  • http://www.pmprbcepmb.gc.ca/CMFiles/Publications/Annual%20Reports/2017/2016_Annual_Report_Final_EN.pdf (accessed on 2 March 2019).

  • Nitsan C & Shadlen K C, Intellectual property, access to medicines, and health: New research horizons, Studies in Comparative International Development, 50 (2015) 143-156.

  • Sterckx S, Patents and access to drugs in developing countries: An ethical analysis, Developing World Bioethics, 4 (1) (2004) 58-74.

  • Frankel S, Challenging TRIPS-Plus agreements: The potential utility of non-violation disputes, Journal of International Economic Law, 12 (2009) 1023-1065, doi:10.1093/jiel/jgp039.

  • https://www.wto.org/english/docs_e/legal_e/27-trips.pdf (accessed on 15 March 2019).

  • Subhan J, Scrutinized: The TRIPS Agreement and public health, McGill Journal of Medicine, 9 (2006) 152-159.

  • Hoen E F M, Veraldi J, Toebes B et al., Medicine procurement and the use of flexibilities in the Agreement on Trade-Related Aspects of Intellectual Property Rights, 2001-2016, Bulletin of the World Health Organization, 9 (2018) 185-193, doi:10.2471/BLT.17.199364.

  • http://unctad.org/en/PublicationsLibrary/ictsd2006ipd17_en.pdf (accessed on 20 March 2019).

  • Bradford Kerry V & Lee K, TRIPS, the Doha Declaration and Paragraph 6 Decision: What are the remaining steps for protecting access to medicines? Global Health, 3 (2007) 3, doi:10.1186/1744-8603-3-3.

  • Cohen J C, Gyansa-Lutterodt M, Torpey K et al., TRIPS, the Doha Declaration and increasing access to medicines: Policy options for Ghana, Global Health, 1 (2005) 17, doi:10.1186/1744-8603-1-17.

  • https://www.iprsonline.org/resources/docs/Baker_TRIPS_Flex.pdf (accessed on 25 March 2019).

  • Oguanobi H L, Broadening the conversation on the TRIPS Agreement: Access to medicines includes addressing access to medical devices, The Journal of World Intellectual Property, 21 (2018) 70-87, doi:10.1111/jwip.12091.

  • http://www.undp.org/content/dam/undp/library/HIVAIDS/UNDP_patents_final_web_3.pdf (accessed on 30 March 2019).

  • Morgan S, Gischolar_mainendorst P, Lexchin J et al., The cost of drug development: A systematic review, Health Policy, 100 (1) (2011) 4-17, doi:10.1016/j.healthpol.2010.12.002.

  • Light D W & Warburton R, Demythologizing the high costs of pharmaceutical research, BioSocieties, 6 (1) (2011) 34-35, doi:10.1057/biosoc.2010.40.

  • DiMasi J A, Grabowski H G & Hansen R W, Innovation in the pharmaceutical industry: New estimates of R&D costs, Journal of Health Economics, 47 (2016) 20-33, doi:10.1016/j.jhealeco.2016.01.012.

  • Masood I, Ibrahim M I M, Hassali M A et al., Evolution of marketing techniques, adoption in pharmaceutical industry and related issues: A review, Journal of Clinical and Diagnostic Research, 3 (2009) 1942-1952.

  • Porter D M, Direct-to-consumer (DTC) pharmaceutical marketing: Impacts and policy implications, SPNHA Review, 7 (1) (2011) Article 5.

  • Ventola C L, Direct-to-consumer pharmaceutical advertising, Therapeutic or toxic? P&T®, 36 (10) (2011) 669-674, 681-684.

  • Parekh N & Shrank W H, Dangers and opportunities of direct-to-consumer advertising, Journal of General Internal Medicine, 33 (2018) 586-587, doi:10.1007/s11606-018-4342-9.

  • Schwartz L M & Woloshin S, Medical marketing in the United States, 1997-2016, The Journal of the American Medical Association, 321 (1) (2019) 80-96, doi:10.1001/jama.2018.19320.

  • Law M R, Soumerai S B, Adams A S et al., Costs and consequences of direct-to-consumer advertising for clopidogrel in Medicaid, Archives of Internal Medicine, 169 (2009)1969-1974, doi:10.1001/archinternmed.2009.320.

  • Rathod S K, Ever-greening: A status check in selected countries, Journal of Generic Medicines, 7 (3) (2010) 227-242, doi:10.2139/ssrn.2691251.

  • Bansal I S, Sahu D, Bakshi G & Singh S, Evergreening-A controversial issue in pharma milieu, Journal of Intellectual Property Rights, 14 (2009) 299-306.

  • Vawda Y A, After the Novartis judgment - 'Evergreening' will never be the same again!, Law, Democracy and Development, 18 (2014) 305-316, doi:10.4314/ldd.v18i1.15.

  • Abud M J, Hall B & Helmers C, An empirical analysis of primary and secondary pharmaceutical patents in Chile, PLoS One, 10 (4) (2015) e0124257, doi: 10.1371/journal.pone.0124257.

  • Sampat B N & Shadlen K C, The effects of restrictions on secondary pharmaceutical patents: Brazil and India in comparative perspective, https://pdfs.semanticscholar. org/4527/1e5d7c002400d4e3a8a6baff1fd75a9db583.pdf (accessed on 15 July 2019).

  • Sampat B N & Shadlen K C, Secondary pharmaceutical patenting: A global perspective, Research Policy, 46 (3) (2017) 693-707, doi:10.1016/j.respol.2017.01.005.

  • Kuan E S, Balancing patents and access to medicine, Singapore Academy of Law Journal, 21 (2009) 457-484.

  • Stevens H & Huys I, Innovative approaches to increase access to medicines in developing countries, Frontiers in Medicine, 4 (2017) 218, doi:10.3389/fmed.2017.00218.

  • https://www.cgdev.org/sites/default/files/better-health-procurement-tackling-triple transition.pdf (accessed on 27 July 2019).

  • Cameron A, Mantel-Teeuwisse A K, Leufkens H G & Laing R O, Switching from originator brand medicines to generic equivalents in selected developing countries: How much could be saved? Value in Health, 15 (5) (2012) 664-673, doi:10.1016/j.jval.2012.04.004.

  • Basheer S & Reddy P, The “Efficacy” of Indian patent law: Ironing out the creases in Section 3(d), Scripted, 5(2) (2008) 232-266, doi:10.2966/scrip.050208.232.

  • Kant A, Section 3(d) new Indian perspective, Journal of Intellectual Property Rights, 14 (2009) 385-396.

  • Kant A, 'Efficacy' factors under Section 3(d): A 'law and economics' perspective, Journal of Intellectual Property Rights, 18 (2013) 212-229.

  • Correa C M, TRIPS Agreement and access to drugs in developing countries, Sur Revista Internacional de Direitos Humanos, 2 (3) (2005) 26-39, doi:10.1590/S1806-64452005000200003.


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  • Anti Pharmaceutical Patent Ever-greening Law: Global Need in Support of Public Health

Abstract Views: 177  |  PDF Views: 97

Authors

Say-yed Hesameddin Tafreshi
Vaccine R&D Unit, Research and Production Complex, Pasteur Institute of Iran, Alborz, Iran, Islamic Republic of

Abstract


Drug patenting would be an effective tool to encourage introducing new drugs for prevention and treatment of diseases. The main goal of drug patenting is to protect all the interests of inventor and try to create a secure and confident way to encourage those who are involved in pharmaceutical industries. However, some pharmaceutical companies by using different strategies like, combination, finding new medical use, new formulation or slight changes in old drugs, abuse this tool to extend their patents (patent ever-greening) and obtain more economic advantages. These types of drugs, due to lack of full requirements of an invention such as novelty and inventive step, cannot be considered as new drugs, therefore, cannot be patented. Pharmaceutical patent ever-greening is in contradicted with the spirit of the innovation, invention and commercialization. By preventing the introduction of generic drugs into the market, it might endanger public health via continue selling of brand drugs with exorbitant prices. Pharmaceutical patent ever-greening is a global issue because practical approaches to patent ever-greening are currently seen in both developing and developed countries and it imposes a substantial burden on the public health. For this reason, passing a law to ban ever-greening of pharmaceutical patents is essential in all countries of in the world.

Keywords


TRIPS Agreement, US Food and Drug Administration, WHO Essential Medicines List, Public Health, Patent, Ever-greening, Drug Modification, Combined Drugs, Fixed-dose Combinations, Direct-to-Consumer Advertising.

References