This article discusses the patent strategy underlying the world's best selling drug, AbbVie's Humira®. Despite a non-optimal starting position, AbbVie has established an extensive portfolio to fend off biosimilar competition. This article is the first part of a trilogy that discusses IP issues related to anti-Tumor Necrosis factorα (TNFα) biologics.
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GaBI Online - Biosimilars of adalimumab [www.gabionline. net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Aug 1]. Available at: http://www.gabion- line.net/Biosimilars/General/Biosimilars-of-adalimumab.
4.
StorzU., IP issues of therapeutic antibodies, in: Intellectual Property Issues: Therapeutics, Vaccines and Molecular Diagnostics, StorzU., FlascheW. and DriehausJ., eds, Springer.
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XueX., GerstenblithB. and HoltmanM.A., Claims to antibodies not adequately described by disclosing known antigens to which they bind, J Intellect Prop Law Pract6(10) (2011), 681-683.
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MattinaL., Humira could have been a Pfizer drug, Forbes Magazine, 8 May 2012.
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AggarwalB.B., KohrW.J., HassP.E., MoffatB., SpencerS.A., HenzelW.J. and HarkinsR.N., Human tumor necrosis factor, production, purification, and characterization, The Journal of Biological Chemistry260(4) (1985), 2345-2354.
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Can be downloaded at: http://hesiglobal.org/wp-content/ uploads/sites/11/2016/06/Fry-for-website-APPROVED.pdf.
9.
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EPO Board of Appeal decision T0617/07.
11.
StorzU., Extending the market exclusivity of therapeutic antibodies through dosage patents, MAbs8(1) (2016), 10-26.
12.
UK Patents Court decision [2016] EWHC 425 (Pat).
13.
AkersM.J., VasudevanV. and StickelmeyerM., Formulation development of protein dosage forms, Pharm Biotechnol14 (2002), 47-127.
14.
Decision [2016] EWCA Civ 780 of the England and Wales Court of Appeal.
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SteffeE.K., Nannenga-CombsB. and LongsworthJ.L., The impact of reformulation strategies on pharmaceuticals, Biologics Biosimilar Development, 14 March 2016.
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Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: Quality issues (revision 1), EMA/CHMP/BWP/247713/2012.
17.
Scientific Considerations in Demonstrating Biosimilarity to a Reference Product - Guidance for Industry. FDA, April 2015.
18.
EspostiL.D., SangiorgiD., PerroneV., RadiceS., ClementiE., PeroneF. and BudaS., Adherence and resource use among patients treated with biologic drugs: Findings from BEETLE study, ClinicoEconomics and Outcomes Research: CEOR6 (2014), 401-407. http://doi.org/10.2147/CEOR.S66 338.
19.
https://www.accessdata.fda.gov/scripts/opdlisting/oopd/ index.cfm Search Orphan Drug Designations and Approvals.
20.
EspostiL.D., SangiorgiD., PerroneV., RadiceS., ClementiE., PeroneF. and BudaS., Adherence and resource use among patients treated with biologic drugs: Findings from BEETLE study, ClinicoEconomics and Outcomes Research: CEOR6 (2014), 401-407. http://doi.org/10.2147/CEOR.S66 338.
21.
WiernickaA. et al. Adalimumab in pediatric Ulcerative colitis. Postȩpy Nauk Medycznych, t. XXVII, nr 3, 2014.
22.
Sánchez-CanoD. et al., Off-label uses of anti-TNF therapy in three frequent disorders: Behçet's disease, sarcoidosis, and noninfectious uveitis, Mediators of Inflammation2013 (2013), 286857. PMC. Web. 22 Aug 2016.
23.
Ditto.
24.
LisK., KuzawińskaO. and Baƚkowiec-IskraE., Tumor necrosis factor inhibitors - state of knowledge, Archives of Medical Science: AMS10(6) (2014), 1175-1185. PMC. Web. 22 Aug. 2016.
25.
Ditto.
26.
SandF.L. and ThomsenS.F., Adalimumab for the treatment of refractory acne conglobata, JAMA dermatology149(11) (2013), 1306-130.
27.
LisK., KuzawińskaO. and Baƚkowiec-IskraE., Tumor necrosis factor inhibitors - state of knowledge, Archives of Medical Science: AMS10(6) (2014), 1175-1185. PMC. Web. 22 Aug. 2016.
28.
SandF.L. and ThomsenS.F., Adalimumab for the treatment of refractory acne conglobata, JAMA dermatology149(11) (2013), 1306-1307.
29.
AtzeniF., StraubR.H., CutoloM. and Sarzi-PuttiniP., Anti-TNF therapy restores the hypothalamic-pituitary-adrenal axis, Annals of the New York Academy of Sciences1193 (2010), 179-181. http://doi.org/10.1111/j.1749-6632.2009.05366.
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Berthold-LoslebenM. and HimmerichH., Curr neuropharmacol, 6(3) (Sep 2008), 193-202.
31.
TaurogJ.D. et al. Ankylosing spondylitis and axial spondyloarthritis, N Engl J Med374(26) (2016), 2563-2574.
32.
WiernickaA. et al. Adalimumab in pediatric Ulcerative colitis, Postȩpy Nauk Medycznych, t. XXVII, nr 3, 2014.
33.
Sánchez-CanoD. et al., Off-label uses of anti-TNF therapy in three frequent disorders: Behçet's disease, sarcoidosis, and noninfectious uveitis, Mediators of Inflammation2013 (2013), 286857. PMC. Web. 22 Aug. 2016.
34.
LisK., KuzawińskaO. and Baƚkowiec-IskraE., Tumor necrosis factor inhibitors - state of knowledge, Archives of Medical Science: AMS10(6) (2014), 1175-1185. PMC. Web. 22 Aug. 2016.
35.
SandF.L. and ThomsenS.F., Adalimumab for the treatment of refractory acne conglobata, JAMA dermatology149(11) (2013), 1306-1307.
36.
MelloM.M., StuddertD.M. and BrennanT.A., Shifting terrain in the regulation of off-label promotion of pharmaceuticals, N Engl J Med360(15) (2009), 1557-1566.
37.
CahillJ., Don't mess with Humira, AbbVie's CEO warns, Chicagobusiness, 20 Nov 2015.
