Product lifecycle management through patents and regulatory strategies

Journal of Medical Marketing

Volumn 13, Issue 3, 2013, Pages 171-180

  Prajapati, Vandana ^a   Tripathy, Swagat ^b   Dureja, Harish ^a  

^a MAHARSHI DAYANAND UNIVERSITY   (India)

^b Apotex Pharmachem India Pvt Ltd   (India)

Author keywords

Data exclusivity; Product lifecycle; Product lifecycle management; Secondary patents

Indexed keywords

EID: 84889065429     PISSN: 17457904     EISSN: 17457912     Source Type: Journal    
DOI: 10.1177/1745790413497388     Document Type: Article

References (90)

1. Hoogkamer H and Wernli MH. Product lifecycle and portfolio management, http://www.worldpharmaceuticals.net/pdfs/060-WPF010new.pdf (2006, accessed 7 July 2011).
2. Capegemini. Unlocking the value of pharmaceutical products: a new perspective for product lifecycle management, http://www.ru.capgemini.com/m/ru/ tl/Vision-amp-Reality-Research-2004.pdf (2004, accessed 2 July 2011).
3. Lindner JR (2004) Product lifecycle management: IBM product lifecycle management center of competency: consumer packaged goods (CPG) & pharmaceuticals/life sciences, http://www.purdue.edu/discoverypark/PLM/pdf/plm- johnlindner.pdf (2004, accessed 5 July 2011).
4. Dureja H and Prajapati V. Product lifecycle management in pharmaceuticals. J Med Mark 2012; 12(3): 150-158.
5. McKiernan J. Achieving business integration across the pharmaceutical value chain, http://ftp.software.ibm.com/software/integration/pdf/pharma- valuechain (2003, accessed 15 July 2011).
6. Manso PJ and Sokol AL. Life cycle management of ageing pharmaceutical assets. Pharmaceut Law Insight 2007; 3(7): 16-19.
7. Adair D. Blockbuster protection. Intellectual Property Right Magazine 2011; January: 35-37.
8. Brian J, Buono D and Kevin WC. Evolving product lifecycle management approaches, http://64.237.99.107/media/pnc/media.1001.pdf (2009, accessed 15 July 2011).
9. Prufungsarbeit W. Regulatory strategies for life-cycle management of chemical defined cytostatic drugs with regard to the new pharmaceutical legislation-two case studies, http://www.dgra.de/studiengang/pdfmaster- rosenkranz-k.pdf (2005, accessed 6 July 2011).
10. Ebookwide.com. Patent lifecycle management, http://ebookbrowse.com/ patent-life-cycle-management-ppt-d16388914 (2010, accessed 25 July 2011).
11. Tuttle E, Parece A and Hector A. Beyond lifecycle management-optimizing performance following patent expiry, http://www.analysisgroup.com/uploadedFiles/ Publishing/Articles/Patent-Expiry.pdf (2004, accessed 25 July 2011).
12. Davidson C. Product lifecycle management through patents, http://www.ddkpatent.com/pubs/PatentLifecycleMngmt.pdf (2004, accessed 25 July 2011).
13. Saigal N, Baboota S, Ahuja A, et al. USFDA generic approval process. Indian J Pharmaceut Edu Res 2009; 43(3): 232-240.
14. GSK. Evergreening, http://www.gsk.com/policies/GSK-andevergreening.pdf (2011, accessed 8 December 2011).
15. Patentable inventions, conditions for patentability, 35 U.S.C. § 101-3.
16. Pharmaceutical Sector Inquiry. Preliminary report fact sheet: originator-generic competition, http://ec.europa.eu/competition/sectors/ pharmaceuticals/inquiry/fact-sheet-2.pdf (2009, accessed 6 March 2012).
17. Chalmers R. Evergreen or deciduous? Australian trends in relation to the 'evergreening' of patents. Melbourne Univ Law Rev 2006; 30(1): 29-61.
18. Komninos I. Product life cycle management, http://urenio.org/tools/en/ Product-Life-Cycle-Management.pdf (2002, accessed 1 July 2011).
19. Oracle. Product lifecycle management in the pharmaceutical industry: Oracle white paper, http://www.oracle.com/us/industries/life-sciences/045821.pdf (2008, accessed 1 July 2011).
20. Health Canada. The progressive licensing framework, http://www.hc-sc.gc. ca/dhp-mps/homologation-licensing/develop/proglic-homprog-concept-eng.php (2007, accessed 28 January 2012).
21. Pollock RWand Johnston GR. A comparison of product development, lifecycle, and approval pathways: brand vs. generic products, https://secure.pharmacytimes.com/lessons/200205-01.asp (2002, accessed 26 April 2012).
22. FDA. Fast track, accelerated approval and priority review, http://www.fda.gov/forconsumers/byaudience/forpatientadvocates/ speedingaccesstoimportantnewtherapies/ucm128291.htm (2010, accessed 12 April 2012).
23. Zannou EA, Li P and Tong W. Product lifecycle management (LCM). In: Qiu Y, Chen Y, Liu L, et al. (eds) Developing solid oral dosage forms: pharmaceutical theory and practice. USA: Academic Press, 2009, pp.911-920.
24. Accenture. Achieving high performance through product launch management: accelerating launch uptake to maximise product value in patent protected life cycle, http://www.accenture.com/SiteCollectionDocuments/PDF/Accenture-HLS-PMP- Product-Launch-Management.pdf (2009, accessed 22 August 2011).
25. Dennis ZK. Product lifecycle management: marketing strategies for the pharmaceutical industry. J Med Mark 2008; 8(4): 293-301.
26. Devalapalli R, Gande M and Valiveti S. Product enhancement and product life cycle management through strategic pharmaceutical journey using science, technology, and innovation, http://riconpharma.com/html/docs/ProductEnhancement- and-LifeCyclePlanning.pdf (2009, accessed 7 July 2011).
27. People.arcada. New-product development and product lifecycle strategies, http://people.arcada.fi/-eldons/Marketing%202011]/Marketing%202011]/ Life%20cycle%20strategies%2014.ppt (2011, accessed 6 August 2011).
28. Kaitin KI. Deconstructing the drug development process: the new face of innovation. Clin Pharmacol Therapeut 2010; 87(3): 356-361.
29. King J. Can a drug live forever? http://65.17.196.124/pdf/live.pdf (2003, accessed 5 July 2011).
30. Thomsonreuters. The five myths of generic competition, http://thomsonreuters.com/content/science/pdf/ls/pharma/generic/myths (2009, accessed 10 January 2012).
31. Tevapharm. Generic drug lifecycle, http://www.tevapharm.com/ LinesOperations/Pages/GenericDrugLifecycle.aspx (accessed 26 April 2012).
32. Hixon DR. Postmarketing surveillance in the office of generic drugs, www.fda.gov/downloads/DrugsDevelopmentApprovalProcess/ HowDrugsareDevelopedandApproved/ApprovalApplications/ AbbreviatedNewDrugApplicationANDAGenerics/UCM292672 (2011, accessed 26 April 2012).
33. Ramesh T, Saravanan D and Khullar P. Regulatory perspective for entering global pharma markets. Pharma Times 2011; 43(9): 15-20.
34. Federal Food, Drug, and Cosmetic Act 21 USC 355(c)(3)(E)(iii).
35. Federal Food, Drug, and Cosmetic Act 21 USC 360cc.
36. Smith M. Patent term extensions for pharmaceutical products, http://publications.gc.ca/Collection-R/LoPBdP/MR/mr144-e.htm (1997, accessed 30 March 2012).
37. Pharmaceutical patent. Extension of term provisions, http://www.drugterm. com/country/canada.htm (2002, accessed 30 March 2012).
38. Furlanetto A and Mowatt G. Market exclusivity for innovative new drugs found to be constitutional by Federal Court, http://www.dimock.com/publications. php?article=77 (2009, accessed 30 March 2012).
39. Raredisorders. Canada's orphan drug policy: learning from the best, http://www.raredisorders.ca/documents/CanadaOrphanDPFinal (2005, accessed 30 March 2012).
40. Food and Drugs Act Regulations. Amending the food and drug regulations, Data Protectionhttp://www.gazette.gc.ca/archives/p2/2006/2006-10-18/html/sor- dors241-eng.html (2006, accessed 30 March 2012).
41. Pharmaceutical patent. Extension of term provisions, http://www.drugterm. com/country/europe.htm (2007, accessed 30 March 2012).
42. Official journal of the European communities. Regulation (EC) No 1901/2006 on medicinal products for paediatric use and amending regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004, http://ec.europa.eu/health/files/eudralex/vol-1/reg-2006-1901/reg- 2006-1901-en.pdf (2006, accessed 30 March 2012).
43. Official journal of the European communities. Directive 2004/ 27/EC amending Directive 2001/83/EC on the community code relating to medicinal products for human use, http://ec.europa.eu/health/files/eudralex/vol-1/dir- 2004-27/dir-2004-27-en.pdf (2004, accessed 30 March 2012).
44. Official journal of the European communities. Regulation (EC) No 141/2000 on orphan medicinal products, http://eur-lex.europa.eu/LexUriServ/LexUriServ. do?uri=OJ:L:2000:018:0001:0005:en:PDF (2000, 30 March 2012).
45. The Patents (Amendment) Act. Section 53(a), 2005. 46
46. Bhatnagar J and Garg V. India: data exclusivity, http://www.mondaq.com/ article.asp?articleid=79418 (2009, accessed 30 December 2011).
47. Ray T. India needs Orphan Drugs Act (ODA) to counter growing threat of dreaded rare diseases and simultaneously boost global growth potential of the Indian pharmaceutical industry, http://www.tapanray.in/profiles/blogs/india- needs-orphan-drugsact (2010, accessed 30 March 2012).
48. Contents and term of patent; provisional rights, 35 USC 154. 49
49. Patent term extension, 35 USC 155.
50. Extension of patent term, 35 USC 156.
51. Federal Food, Drug, and Cosmetic Act, 21 USC 355(c)(3)(E)(ii).
52. FDA/CDER. Guidance for industry: qualifying for pediatric exclusivity under section 505A of the Federal Food, Drug and Cosmetic Act, http://www.fda.gov/cder/guidance/2414fnl.htm (1998, accessed 30 March 2011).
53. The Drugs and Cosmetics Act, 1940. Import or manufacture of new drug for clinical trials or marketing. Part-XA. Rule 122A. Application for permission to import new Drug.
54. FDA. FDA backgrounder on FDAMA, http://www.fda.gov/RegulatoryInformation/ Legislation/FederalFoodDrugandCosmeticActFDCAct/ SignificantAmendmentstotheFDCAct/FDAMA/ucm089179.htm (2010, accessed 30 March 2012).
55. Nortonrose. CETA trade negotiations 2011-drug market exclusivity in the EU and Canada, http://www.nortonrose.com/files/ceta-trade-negotiations-2011- drug-market-exclusivity-in-the-eu-and-canada-pdf-109kb-57552 (2011, accessed 30 March 2012).
56. Health Canada. Generic drugs in a progressive framework, http://www.hc-sc.gc.ca/dhp-mps/homologation-licensing/docs/ima-aimm/ ima-aimm09-eng.php (2011, accessed 28 April 2012).
57. European Commission. Notice to applicants: volume 2A, procedures for marketing authorisation. Chapter 4. Centralised procedure, http://ec.europa.eu/ health/files/eudralex/vol-2/a/chap4rev200604-en.pdf (2006, accessed 12 April 2012).
58. Mangathayaru K, Sivakumar A, Chitra K, et al. Orphan diseases-an Indian perspective, http://www.pharmainfo.net/reviews/orphan-diseases-indian- perspective (2007, accessed 1 April 2012).
59. Research and markets. Competitive analysis of US pharmaceutical industry, http://www.businesswire.com/news/home/20110728005057/en/Research-Markets- Competitive-Analysis-U.S.-Pharmaceutical-Industry (2011, accessed 12 April 2012).
60. Federal Food, Drug, and Cosmetic Act, 21 USC 355 (j)(5)(B)(iii).
61. Range B. The ANDA patent certification requirement and thirty-month stay provision: is it necessary? http://leda.law.harvard.edu/leda/data/355/Range.pdf (2001, accessed 26 March 2012).
62. Pinco RG and Binzak BA. Pioneer and generic drugs: balance between product life cycle extensions and anticompetitive behavior. In: Berry IR and Martin RP (eds) The pharmaceutical regulatory process. New York: Marcel Dekker, 2005, pp.257-322.
63. Goldberg LA and Farid N. The FDA's generic "final rule". Modern Drug Discov 2004; 7(1): 50-51.
64. Glover GJ. The Influence of market exclusivity on drug availability and medical innovations. Am Assoc Pharmaceut Scientists J 2007; 9(3): 312-316.
65. Federal Food, Drug, and Cosmetic Act, 21 USC 355a.
66. Federal Food, Drug, and Cosmetic Act, 21 USC 355(j)(5)(B)(iv)(I).
67. Drugs.com. FDA announces initiative to bolster generic drug program, http://www.drugs.com/news/fda-announces-initiativebolster-program-6967.html (2007, 23 April 2012).
68. IP council. Innovation for a better tomorrow: closing Canada's intellectual property gap in the pharmaceutical sector, http://www.ipcouncil.ca/ uploads/Innovation%20for%20a%20Better%20Tomorrow.pdf (2011, accessed 30 March 2012).
69. Wilcox PR and McMahon EM. Intellectual property bulletin: federal court of Canada grants data protection to an old medicinal ingredient, http://www.torys.com/Publications/Pages/IP20122-Federal-Court-of-Canada-Grants- Data-Protection-to-an-Old-Medicinal-Ingredient.aspx (2012, accessed 30 March 2012).
70. Wall K. Federal court overturns the minister of health's decision and grants data protection for THALOMID, http://www.nortonrose.com/knowledge/ publications/62809/pharma-in-briefcanada-federal-court-overturns-the-minister- of-healths-decisionand-grants-data-protection-for-thalomid (2012, accessed 30 March 2012).
71. Health Canada. Guidance document: data protection under C.08.004.1 of the food and drug regulations, http://www.hcsc.gc.ca/dhp-mps/prodpharma/applic- demande/guide-ld/data-donnees-protection-eng.php (2011, accessed 26 March 2012).
72. Health Canada. Orphan drug policy, http://www.hc-sc.gc.ca/dhp-mps/alt- formats/hpfb-dgpsa/pdf/prodpharma/orph-pol-eng (1996, accessed 30 March 2012).
73. Health Canada. Publication of clarifications to the guidance document: data protection under C.08.004.1 of the food and drug regulations, http://www.hc-sc.gc.ca/dhp-mps/alt-formats/pdf/prodpharma/applic-demande/ guide-ld/data-donnees-protection-eng.pdf (2011, accessed 30 March 2012).
74. European Union. Basic information of European Union, http://europa.eu/ about-eu/basic-information/index-en.htm (accessed 12 April 2012).
75. Moore JW. Pharmaceutical products in Europe: the supplementary protection certificate. Canadian Intellect Prop Rev 1998; 14: 137-140.
76. Wilken M. New developments in European pharmaceutical law and implications on the lifecycle management of medicinal products, http://home.arcor.de/janna-schweim/6-Wilken (2008, accessed 7 July 2011).
77. European Commission. Notice to applicants: volume 2A. Procedures for marketing authorisation. Chapter 1. Market authorisation, http://ec.europa.eu/ health/files/eudralex/vol-2/a/vol2a-chap1-2005-11-en.pdf (2005, accessed 12 April 2012).
78. Voet MA. Drug product exclusivity. The generic challenge: understanding patents, FDA and pharmaceutical life-cycle management. Florida: Brown Walker Press, 2011, pp.89-103.
79. Pingle S. Indian pharma companies obtain 144 ANDA approvals from US FDA in 2011, http://pharmabis.com/NewsDetails.aspx?aid=66831&sid=2 (2012, accessed 12 April 2012).
80. Country & industry forecasting: IHS global insight. Indian companies garner 33% of ANDA approvals in 2011, http://www.ihs.com/products/global- insight/industry-economic-report.aspx?id=1065932080 (2012, 12 April 2012).
81. The Patents (Amendment) Act, 2005, Section 107A. 82. IDMA. Patents, http://www.idma-assn.org/patents.html (2009, accessed 12 April 2012).
82. Dalal P. Regulatory framework for data exclusivity in India, http://iprsi.blogspot.in/2011/07/regulatory-framework-for-data.html (2011, accessed 30 December 2011).
83. Gangil J, Thunga G and Nagaich R. Do intellectual property rights and data exclusivity encourage innovation in the pharmaceutical world? Syst Rev Pharmacy 2010; 1(2): 190-193.
84. Kak A. The eternal orphan, http://www.expresspharmaonline.com/20080831/ research01.shtml (2008, 30 March 2012).
85. Sharma A, Jacob A, Tondon M, et al. Orphan drug: development trends and strategies. J Pharmacy Bio Allied Sci 2010; 2(4): 290-299.
86. Gupta H, Kumar S, Roy SK, et al. Patent protection strategies. J Pharmacy Bio Allied Sci 2010; 2(1): 2-7.
87. Dureja H and Rohilla D. New drug approval process: regulatory view, http://www.pharmainfo.net/reviews/new-drug-approvalprocess-regulatory-view (2010, accessed 12 December 2011).
88. Innovation. Mid term appraisal for eleventh five year plan 2007-12, http://planningcommission.nic.in/plans/mta/11th-mta/chapterwise/ chap20-innovation.pdf (2007, accessed 28 April 2012).
89. Gulati M and Bhat K. The upcoming patent cliff: implications for indian pharmaceuticals, http://www.zephyrpeacock.com/files/Implications-for-Indian- Pharmaceuticals.pdf (2011, accessed 28 April 2012).
90. Ravichandran R. India: a hub for drug research outsourcing, http://www.financialexpress.com/news/india-a-hub-for-drugresearch-outsourcing/ 234906/ (2007, accessed 28 April 2012)