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ISSN (Print): 1872-2083
ISSN (Online): 2212-4012

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Review Article

Patent and Marketing Exclusivities 101 for Drug Developers

Author(s): Bryan Oronsky*, Scott Caroen, Franck Brinkhaus, Tony Reid, Meaghan Stirn and Raj Kumar

Volume 17, Issue 3, 2023

Published on: 18 January, 2023

Page: [257 - 270] Pages: 14

DOI: 10.2174/1872208317666230111105223

Price: $65

Abstract

Despite an ever-increasing need for newer, safer, more effective, and more affordable therapies to treat a multitude of diseases and conditions, drug development takes too long, costs too much, and is too uncertain to be undertaken without the conferment of exclusionary rights or entry barriers to motivate and sustain investment in it. These entry barriers take the form of patents that protect intellectual property and marketing exclusivity provisions that are provided by statute. This review focuses on the basic ins and outs of regulatory and patent exclusivities for which new chemical entities (NCEs), referring to never-before approved drugs with an entirely new active ingredient, are eligible and uses RRx-001, a small molecule aerospace-derived NCE in development for the treatment of cancer, radiation toxicity, and diseases of the NLR family pyrin domain containing 3 (NLRP3) inflammasome, as a “real world” example. This is intended as a ‘101-type’ of primer; its aim is to help developers of original pharmaceuticals navigate the maze of patents, other IP regulations, and statutory exclusivities in major markets so that they can make proper use of them.

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[1]
Surh YJ. The 50-year war on cancer revisited: Should we continue to fight the enemy within? J Cancer Prev 2021; 26(4): 219-23.
[http://dx.doi.org/10.15430/JCP.2021.26.4.219] [PMID: 35047447]
[2]
Hinkson IV, Madej B, Stahlberg EA. Accelerating therapeutics for opportunities in medicine: A paradigm shift in drug discovery. Front Pharmacol 2020; 11: 770.
[http://dx.doi.org/10.3389/fphar.2020.00770] [PMID: 32694991]
[3]
Collier R. Drug patents: The evergreening problem. CMAJ 2013; 185(9): E385-6.
[http://dx.doi.org/10.1503/cmaj.109-4466] [PMID: 23630239]
[4]
Gelijns AC. Institute of Medicine (US) Committee on Technological Innovation in Medicine Technological Innovation: Comparing Development of Drugs, Devices, and Procedures in Medicine. Washington (DC): National Academies Press (US) 1989.
[5]
Berndt ER, Nass D, Kleinrock M, Aitken M. Decline in economic returns from new drugs raises questions about sustaining innovations. Health Aff 2015; 34(2): 245-52.
[http://dx.doi.org/10.1377/hlthaff.2014.1029]
[6]
Kiriiri GK, Njogu PM, Mwangi AN. Exploring different approaches to improve the success of drug discovery and development projects: A review. Fut J Pharm Sci 2020; 6(1): 27.
[http://dx.doi.org/10.1186/s43094-020-00047-9]
[7]
Aronson JK, Green AR. Me too pharmaceutical products: History, definitions, examples, and relevance to drug shortages and essential medicines lists. Br J Clin Pharmacol 2020; 86(11): 2114-22.
[http://dx.doi.org/10.1111/bcp.14327] [PMID: 32358800]
[8]
Lee M, Choi M. The determinants of research and development investment in the pharmaceutical industry: focus on financial structures. Osong Public Health Res Perspect 2015; 6(5): 302-9.
[http://dx.doi.org/10.1016/j.phrp.2015.10.013] [PMID: 26730355]
[9]
Beall RF, Hollis A, Kesselheim AS, Spackman E. Reimagining pharmaceutical market exclusivities: Should the duration of guaranteed monopoly periods be value based? Value Health 2021; 24(9): 1328-34.
[http://dx.doi.org/10.1016/j.jval.2021.04.1277] [PMID: 34452713]
[10]
Gronde TV, Uyl-de Groot CA, Pieters T. Addressing the challenge of high-priced prescription drugs in the era of precision medicine: A systematic review of drug life cycles, therapeutic drug markets and regulatory frameworks. PLoS One 2017; 12(8): e0182613.
[http://dx.doi.org/10.1371/journal.pone.0182613]
[11]
Kaplan WA, Wirtz VJ, Stephens P. The market dynamics of generic medicines in the private sector of 19 low and middle income countries between 2001 and 2011: A descriptive time series analysis. PLoS One 2013; 8(9): e74399.
[http://dx.doi.org/10.1371/journal.pone.0074399]
[12]
Druss BG, Marcus SC, Olfson M, Pincus HA. Listening to generic Prozac: Winners, losers, and sideliners. Health Aff 2004; 23(5): 210-6.
[http://dx.doi.org/10.1377/hlthaff.23.5.210] [PMID: 15371387]
[13]
IQVIA Institute for Human Data Science Medicine Use and Spending in the US.. 2019.
[14]
Oronsky B, Reid TR, Larson C, et al. REPLATINUM Phase III randomized study: RRx-001 + platinum doublet versus platinum doublet in third-line small cell lung cancer. Future Oncol 2019; 15(30): 3427-33.
[http://dx.doi.org/10.2217/fon-2019-0317] [PMID: 31509028]
[15]
Oronsky B, Goyal S, Kim MM, et al. A Review of clinical radioprotection and chemoprotection for oral mucositis. Transl Oncol 2018; 11(3): 771-8.
[http://dx.doi.org/10.1016/j.tranon.2018.03.014] [PMID: 29698934]
[16]
Oronsky B, Scicinski J, Ning S, et al. RRx-001, A novel dinitroazetidine radiosensitizer. Invest New Drugs 2016; 34(3): 371-7.
[http://dx.doi.org/10.1007/s10637-016-0326-y] [PMID: 26841903]
[17]
Oronsky B, Guo X, Wang X, et al. Discovery of RRx-001, a Myc and CD47 downregulating small molecule with tumor targeted cytotoxicity and healthy tissue cytoprotective properties in clinical development. J Med Chem 2021; 64(11): 7261-71.
[http://dx.doi.org/10.1021/acs.jmedchem.1c00599] [PMID: 34043360]
[18]
Morgensztern D, Rose M, Waqar SN, et al. RRx-001 followed by platinum plus etoposide in patients with previously treated small-cell lung cancer. Br J Cancer 2019; 121(3): 211-7.
[http://dx.doi.org/10.1038/s41416-019-0504-8] [PMID: 31231122]
[19]
Chen Y, He H, Lin B, et al. RRx-001 ameliorates inflammatory diseases by acting as a potent covalent NLRP3 inhibitor. Cell Mol Immunol 2021; 18(6): 1425-36.
[http://dx.doi.org/10.1038/s41423-021-00683-y] [PMID: 33972740]
[20]
Ma M, Li G, Qi M, Jiang W, Zhou R. Inhibition of the inflammasome activity of NLRP3 attenuates HDM-induced allergic asthma. Front Immunol 2021; 12: 718779.
[http://dx.doi.org/10.3389/fimmu.2021.718779] [PMID: 34413860]
[21]
Li N, Wang Y, Wang X, Sun N, Gong YH. Pathway network of pyroptosis and its potential inhibitors in acute kidney injury. Pharmacol Res 2022; 175: 106033.
[http://dx.doi.org/10.1016/j.phrs.2021.106033] [PMID: 34915124]
[22]
Fang J, She J, Lin F, et al. RRx-001 exerts neuroprotection against LPS-induced microglia activation and neuroinflammation through disturbing the TLR4 pathway. Front Pharmacol 2022; 13: 889383.
[http://dx.doi.org/10.3389/fphar.2022.889383] [PMID: 35462935]
[23]
Oronsky B, Knox S, Cabrales P, Oronsky A, Reid TR. Desperate times, desperate measures: The case for RRx-001 in the treatment of COVID-19. Semin Oncol 2020; 47(5): 305-8.
[http://dx.doi.org/10.1053/j.seminoncol.2020.07.002] [PMID: 32718560]
[24]
Jurgensen KJ, Skinner WKJ, Oronsky B, et al. RRx-001 Radioprotection: Enhancement of survival and hematopoietic recovery in gamma-irradiated mice. Front Pharmacol 2021; 12: 676396.
[http://dx.doi.org/10.3389/fphar.2021.676396] [PMID: 33967816]
[25]
Oronsky B, Caroen S, Abrouk N, Reid TR, Reid TR. RRx-001 and the right stuff: Protection and treatment in outer space. Life Sci Space Res 2022; 35: 69-75.
[http://dx.doi.org/10.1016/j.lssr.2022.05.001] [PMID: 36336372]
[26]
Cabrales P, Caroen S, Oronsky A, et al. The macrophage stimulating anti-cancer agent, RRx-001, protects against ischemia-reperfusion injury. Expert Rev Hematol 2017; 10(6): 575-82.
[http://dx.doi.org/10.1080/17474086.2017.1324779] [PMID: 28448172]
[27]
Gurgula O. Strategic patenting by pharmaceutical companies should competition law intervene? IIC Int Rev Ind Prop Copyr Law 2020; 51(9): 1062-85.
[http://dx.doi.org/10.1007/s40319-020-00985-0] [PMID: 33132411]
[28]
VSPTO. United States Patent and Trade Mark Office. Available from: www.uspto.gov
[29]
Shear RH, Kelley TE. A researchers guide to patents. Plant Physiol 2003; 132(3): 1127-30.
[http://dx.doi.org/10.1104/pp.103.022301] [PMID: 12857793]
[30]
Guerrini CJ, Majumder MA, McGuire AL. Persistent confusion and controversy surrounding gene patents. Nat Biotechnol 2016; 34(2): 145-7.
[http://dx.doi.org/10.1038/nbt.3470] [PMID: 26849516]
[31]
N. Am. Vaccine, Inc. v. Am. Cyanamid Co., 7 F.3d 1571, 1577 (Fed. Cir. 1993).
[32]
WTO. TRIPS and pharmaceutical patents: Obligations and exception. 2006. Available from: http://www.wto.org/english/tratop_e/trips_e/factsheet _pharm02_e.htm#art31
[33]
Konski AF, Wu LX. Inventorship and authorship. Cold Spring Harb Perspect Med 2015; 5(11): a020859.
[http://dx.doi.org/10.1101/cshperspect.a020859]
[34]
Storz U. International intellectual property strategies for therapeutic antibodies. MAbs 2011; 3(6): 596-606.
[http://dx.doi.org/10.4161/mabs.3.6.17788] [PMID: 22123063]
[35]
Available from: https://www.wipo.int/pct/en/pct_ contracting_states.html
[36]
Taubman A. The international patent system and biomedical research: reconciling aspiration, policy and practice. AAPS J 2008; 10(4): 526-36.
[http://dx.doi.org/10.1208/s12248-008-9049-0] [PMID: 18989789]
[37]
Lemley M, Sampat B. Is the patent office a rubber stamp? Emory Law J 2008; 58: 181-203.
[38]
CArdenas-Navia J. Thirty Years of Flawed Incentives: an Empirical and Economic Analysis of Hatch-Waxman Patent-Term Restoration. Berkeley Technol Law J 2015; 29(2)
[39]
Taylor LS, Braun DE, Steed JW. Crystals and crystallization in drug delivery design. Mol Pharm 2021; 18(3): 751-3.
[http://dx.doi.org/10.1021/acs.molpharmaceut.0c01157] [PMID: 33594892]
[40]
FDA. Regulatory classification of pharmaceutical co-crystals guidance for industry 2018.
[41a]
Clark L, Beadle D. Patent term extensions: Issues, challenges and implications for pharmaceuticals. Pharm Pat Anal 2012; 1(4): 427-35.
[41b]
Knox S, Cannizzo L, Warner K, et al. Cyclic nitro compounds, pharmaceutical compositions thereof and uses thereof. WO2007022225A2, 2007.
[41c]
Robinson MK, Morin MJ. CH3 domain epitope tags. WO2019222575, 2019.
[41d]
Oronsky B, Caroen S, Reid TR, Carter C. Medication infusion devices, systems, and methods. WO2019241276, 2019.
[http://dx.doi.org/10.4155/ppa.12.47] [PMID: 24236881]
[42]
Kumar Bandaru R, Rout SR, Kenguva G, et al. Re-cent advances in pharmaceutical cocrystals: From bench to market. Front Pharmacol 2021; 12: 780582.
[http://dx.doi.org/10.3389/fphar.2021.780582] [PMID: 34858194]
[43]
Eisenberg RS. Lecture: patents, product exclusivity, and information dissemination: How law directs biopharmaceutical research and development. Fordham Law Rev 2003; 72(3): 477-91.
[PMID: 14968794]
[44]
Diependaele L, Cockbain J, Sterckx S. Raising the barriers to access to medicines in the developing world - the relentless push for data exclusivity. Developing World Bioeth 2017; 17(1): 11-21.
[http://dx.doi.org/10.1111/dewb.12105] [PMID: 26818105]
[45]
Kingham RF, Castle GH. Data and market exclusivity for pharmaceuticals in the European Community. Food Drug Law J 2000; 55(2): 209-23.
[PMID: 12269365]
[46]
Gupta R, Shah ND, Ross JS. Generic drugs in the United States: Policies to address pricing and competition. Clin Pharmacol Ther 2019; 105(2): 329-37.
[http://dx.doi.org/10.1002/cpt.1314] [PMID: 30471089]
[47]
Food and Drug Administration, HHS.. Supplemental applications proposing labeling changes for approved drugs, biologics, and medical devices. Final rule. Fed Regist 2008; 73(164): 49603-10.
[PMID: 18958946]
[48]
Kesselheim AS, Sinha MS, Avorn J. Determinants of market exclusivity for prescription drugs in the United States. JAMA Intern Med 2017; 177(11): 1658-64.
[http://dx.doi.org/10.1001/jamainternmed.2017.4329] [PMID: 28892528]
[49]
Kannappan S, Darrow JJ, Kesselheim AS, Beall RF. The timing of 30 month stay expirations and generic entry: A cohort study of first generics, 2013 2020. Clin Transl Sci 2021; 14(5): 1917-23.
[http://dx.doi.org/10.1111/cts.13046] [PMID: 33982425]
[50]
Darrow JJ, Kesselheim AS. Incentivizing Antibiotic Development: Why isn’t the generating antibiotic incentives now (GAIN) act working? Open Forum Infect Dis 2020; 7(1): ofaa001.
[http://dx.doi.org/10.1093/ofid/ofaa001]
[51]
FDA. Qualified Infectious Disease Product Designation Questions and Answers Guidance for Industry. 2008. Available from: https://www.fda.gov/files/ drugs/published/Qualified-Infectious-Disease- Product-Designation-Questions-and-Answers.pdf
[52]
Seoane-Vazquez E, Rodriguez-Monguio R, Szeinbach SL, Visaria J. Incentives for orphan drug research and development in the United States. Orphanet J Rare Dis 2008; 3: 33.
[http://dx.doi.org/10.1186/1750-1172-3-33]
[53]
Kim J, Ross JS, Kapczynski A. Pediatric exclusivity and regulatory authority. JAMA 2018; 319(1): 21-2.
[http://dx.doi.org/10.1001/jama.2017.16477] [PMID: 29117365]
[54]
Kerr KW, Henry TC, Miller KL. Is the priority review voucher program stimulating new drug development for tropical diseases? PLoS Negl Trop Dis 2018; 12(8): e0006695.
[http://dx.doi.org/10.1371/journal.pntd.0006695]
[55]
Articles 67(2) and 67 bis of the Japanese Patent Act, Articles 14, 14 quater and 77 bis of the PMD Act; see also Notification from the Director of Division of Economy, Health Policy Bureau No. 0605001 2009.
[56]
Kondo H, Masamune K. Effectiveness of drug post-marketing all-case surveillance as a safety measure in Japan. Ther Adv Drug Saf 2021; 12.
[http://dx.doi.org/10.1177/20420986211065215] [PMID: 34987750]
[57]
Saitou H, Nakatani D, Myoui A, Kubota T, Ozono K. Pediatric drug development in Japan: Current issues and perspectives. Clin Pediatr Endocrinol 2020; 29(1): 1-7.
[http://dx.doi.org/10.1297/cpe.29.1] [PMID: 32029968]
[58]
Engel A. In this world nothing can be said to be certain, except death and taxes(tm) Benjamin Franklin, 1789. Colorectal Dis 2012; 14(4): 399-400.
[http://dx.doi.org/10.1111/j.1463-1318.2012.03001.x] [PMID: 22390145]
[59]
Nass SJ, Madhavan G, Augustine MR, Eds. National Academies of Sciences, Engineering, and Medicine; Health and Medicine Division; Board on Health Care Services; Committee on Ensuring Patient Access to Affordable Drug Therapies Making Medicines Affordable: A National Imperative. Washington, DC: National Academies Press (US) 2017.
[60]
Baker DE. High drug prices: So who is to blame? Hosp Pharm 2017; 52(1): 5-6.
[http://dx.doi.org/10.1310/hpj5201-5] [PMID: 28179734]
[61]
Gorlin DI. Staving off death: A case study of the pharmaceutical industry’s strategies to protect block-buster franchises. Food Drug Law J 2008; 823: 824-5.
[62]
Glasgow LJ. Stretching the limits of intellectual prop-erty rights: Has the pharmaceutical industry gone too far? The J Law And Technol 2001; 232-33: 237-8.

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