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Applied Drug Research, Clinical Trials and Regulatory Affairs

Author(s): Sankha Bhattacharya* and Dnyanesh Saindane

DOI: 10.2174/2667337108666211103105845

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Intellectual Property Rights and Computer Applications for Pharmaceutical Research and Development

Article ID: e031121197642 Pages: 13

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Abstract

Intellectual Property Rights (IPR) are intellectual privileges that allow authors and inventors to defend their original inventions from misuse or theft. With the assistance of algorithms, clinical science has taken on a different level in recent years. Various advanced tools can be used to investigate pharmacokinetics profiling, in silico experiments, receptor simulations, drug synergistic effects, and so on. Computational scientists are making continuous efforts to figure out how to connect business models in pharmacology. However, software theft and security rights remain major concerns for all. In order to avoid such violations, IPR compliance for R&D as well as promoting machine applications is critical. This compilation will illustrate diverse software concepts, the latest patent data structures, copyright management laws for software, trade secrets, compliance rights, software patenting and contracts, artificial technology priorities and problems, licenses, and case studies relating to IPR violations in pharmaceutical and other fields.

Keywords: IPR, IP protection, copyrights, patent, software licensing, artificial intelligence

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[1]
Kean T. Cryptographic rights management of FPGA intellectual property cores. Proceedings of the 2002 ACM/SIGDA 10th international symposium on Field-programmable gate arrays. 2002 Feb 24 – 26; California, USA; 113-8.
[http://dx.doi.org/10.1145/503048.503065]
[2]
Loshin D. Business intelligence: The savvy manager's guide. 2nd ed. Morgan Kaufmann 2012; 1-400.
[3]
Miller AR. Copyright protection for computer programs, databases, and computer-generated works: Is anything new since CONTU. Harv Law Rev 1992; 106: 977.
[http://dx.doi.org/10.2307/1341682]
[4]
Trappey A, Trappey CV, Hsieh A. An intelligent patent recommender adopting machine learning approach for natural language processing: A case study for smart machinery technology mining. Technol Forecast Soc Change 2021; 164: 120511.
[http://dx.doi.org/10.1016/j.techfore.2020.120511]
[5]
Liu H, Meusel P, Hirzinger G, Jin M, Liu Y, Xie Z. The modular multisensory DLR-HIT-Hand: Hardware and software architecture. IEEE/ASME Trans Mechatron 2008; 13(4): 461-9.
[http://dx.doi.org/10.1109/TMECH.2008.2000826]
[6]
Maskus KE. Intellectual property rights and economic development. Case Western Res J Int Law 2000; 32: 471.
[7]
Maskus KE. Intellectual property rights in the global economy. Washington: Peterson Institute for International Economics 2000. Available from: https://www.piie.com/bookstore/intellectual-property-rights-global-economy
[8]
Pandey N, Dharni K. Intellectual property rights. PHI Learning Pvt Ltd 2014; 2014: 2685653.
[9]
Green SP. Plagiarism, norms, and the limits of theft law: Some observations on the use of criminal sanctions in enforcing intellectual property rights. Hastings Law J 2002; 54: 167.
[http://dx.doi.org/10.2139/ssrn.315562]
[10]
Mutizwa J. Leading for the future: How to lead strategy across three time horizons, design the corporate dash-board, shape context and drive execution in a turbulent environment. Africa: Partridge Africa, Author Solutions, Incorporated, 2017.
[11]
Chaudhry PE, Walsh MG. Intellectual property rights: Changing levels of protection under GATT NAFTA and the EU. Columbia J World Bus 1995; 30(2): 80-92.
[http://dx.doi.org/10.1016/0022-5428(95)90027-6]
[12]
Hicks LL, Holbein JR. Convergence of national intellectual property norms in international trading agreements. Am UJ Int Law 1997; 12: 769.
[13]
Hertz AZ. Shaping the trident: intellectual property under nafta, investment protection agreements and at the world trade organization. 23 Can- US LJ 1997; 23: 261.
[14]
Stedman LC, Kaestle CF. Literacy and reading performance in the United States, from 1880 to the present. Res Q 1987; 8-46.
[http://dx.doi.org/10.2307/747719]
[15]
Flood J. The fires: How a computer formula, big ideas, and the best of intentions burned down New York city-and determined the future of cities. Penguin 2010; 2010: 114751072.
[16]
Ceruzzi PE, Paul E, Aspray W. A history of modern computing. London: MIT press 2003.
[17]
Rosen SJACS. Electronic computers: A historical survey. 1969; 1: 7-36.
[http://dx.doi.org/10.1145/356540.356543]
[18]
Denicola RC. Trademarks as speech: Constitutional implications of the emerging rationales for the protection of trade symbols. Wis Rev 1982; 2: 158.
[19]
Chisum DS, Ochoa TT, Ghosh S, LaFrance M. Understanding intellectual property law. (2nd ed.), New York: LexisNexis 2011.
[20]
Sell SK, Prakash A. Using ideas strategically: The contest between business and NGO networks in intellectual property rights. Int Stud Q 2004; 48(1): 143-75.
[http://dx.doi.org/10.1111/j.0020-8833.2004.00295.x]
[21]
Lucchi N. Intellectual property rights in digital media: A comparative analysis of legal protection, technological measures, and new business models under EU and US law. Buff L Rev 2005; 53: 1111.
[http://dx.doi.org/10.2139/ssrn.704101]
[22]
De Laat PB. Copyright or copyleft?: An analysis of property regimes for software development. Res Policy 2005; 34(10): 1511-32.
[http://dx.doi.org/10.1016/j.respol.2005.07.003]
[23]
Fogel K. Producing open source software: How to run a successful free software project. California: O'Reilly Media, Inc 2005; 2005: p. 28870222.
[24]
Laurent AM. Understanding open source and free software licensing: guide to navigating licensing issues in existing & new software. California: O'Reilly Media, Inc. 2004.
[25]
De Werra J. Moving beyond the conflict between freedom of contract and copyright policies: In search of a new global policy for online information licensing transactions-a comparative analysis between US Law and European Law. Colum JL & Arts 2001; 25: 239.
[26]
Lerner J, Tirole J. The scope of open source licensing. J Law Econ Organ 2005; 21(1): 20-56.
[http://dx.doi.org/10.1093/jleo/ewi002]
[27]
Battat R, Her M, Sundaresh C, Vinberg A, Wang S. Computer Associates Think Inc. Method and apparatus for maintaining data integrity across distributed computer systems. United States patent US 7,680,879, 2010.
[28]
Sander T, Freyss J, von Korff M, Rufener C. DataWarrior: An open-source program for chemistry aware data visualization and analysis. J Chem Inf Model 2015; 55(2): 460-73.
[http://dx.doi.org/10.1021/ci500588j] [PMID: 25558886]
[29]
Thomas T Jr. The patenting of the liberal professions. BcL REv 1998; 40: 1139.
[30]
Merges RP. As many as six impossible patent before breakfast: Property rights for business concepts and patent system reform. Berkeley Technol Law J 1999; 14: 577.
[31]
Tichy WF. Should computer scientists experiment more? Computer 1998; 31(5): 32-40.
[http://dx.doi.org/10.1109/2.675631]
[32]
Ehsani F, Knodt E. Speech technology in computer-aided language learning: Strengths and limitations of a new CALL paradigm. Lang Learn Technol 1998; 2(1): 54-73.
[33]
Vickers NJ, Baker TC. Chemical communication in heliothine moths. VII. Correlation between diminished responses to point-source plumes and single filaments similarly tainted with a behavioral antagonist. J Comp Physiol A Neuroethol Sens Neural Behav Physiol 1997; 180(5): 523-36.
[http://dx.doi.org/10.1007/s003590050069]
[34]
Hahn C, Cowhig J. System and method for linguist-based human/machine interface components. United States patent application US 14/300,733, 2015.
[35]
Graham S, Hall BH, Harhoff D, Mowery DC. Post-issue patent "quality control": A comparative study of US patent Re-examinations and European patent oppositions. NBER 2002; 2002: 15494823.
[36]
Prevost SA, Bickmore TW, Sullivan JW, Churchill E, Girgensohn A. Method and apparatus for embodied conversational characters with multimodal input/output in an interface device. United States patent US 6,570,555, 2003.
[37]
Hart RJ. Patentability of software at the european patent office. Int Intell Prop Pol 1998; 2: 1.
[38]
Srdoc A, Sluga A, Bratko I. A quality management model based on the “deep quality concept”. Int J Qual Reliab Manage 2005; 22(3): 278-302.
[http://dx.doi.org/10.1108/02656710510582499]
[39]
Pereira DA, Williams JA. Origin and evolution of high throughput screening. Br J Pharmacol 2007; 152(1): 53-61.
[http://dx.doi.org/10.1038/sj.bjp.0707373] [PMID: 17603542]
[40]
Roider HG, Pavlova N, Kirov I, et al. Drug2Gene: An exhaustive resource to explore effectively the drug-target relation network. BMC Bioinformatics 2014; 15(1): 68.
[http://dx.doi.org/10.1186/1471-2105-15-68] [PMID: 24618344]
[41]
Gallagher WT. Book Review of Patent Failure: How Judges, Bureaucrats, and Lawyers Put Innovators at Risk. Bureaucrats, and Lawyers Put Innovators at Risk 2009; 2009(Sep): 3.
[http://dx.doi.org/10.2139/ssrn.1467964]
[42]
Trask AV. An overview of pharmaceutical cocrystals as intellectual property. Mol Pharm 2007; 4(3): 301-9.
[http://dx.doi.org/10.1021/mp070001z] [PMID: 17477544]
[43]
Park J. Has patentable subject matter been expanded? -a comparative study on software patent practices in the european patent office, the united states patent and trademark office and the japanese patent office. Int J Law Inf Technol 2005; 13(3): 336-77.
[44]
Ali-Yrkkö J, Hyytinen A, Pajarinen M. Does patenting increase the probability of being acquired? Evidence from cross-border and domestic acquisitions. Appl Financ Econ 2005; 15(14): 1007-17.
[http://dx.doi.org/10.1080/09603100500186978]
[45]
McDowall RD. Data Integrity and Data Governance: Practical Implementation in Regulated Laboratories. 2018. Available from: https://pubs.rsc.org/en/content/ebook/978-1-78801-281-2
[46]
Duan F, Wang EQ, Lam MG, et al. Superselective chemoembolization of HCC: Comparison of short-term safety and efficacy between drug-eluting LC beads, quadraspheres, and conventional ethiodized oil emulsion. Radiology 2016; 278(2): 612-21.
[http://dx.doi.org/10.1148/radiol.2015141417] [PMID: 26334787]
[47]
Shang Y, Nguyen H, Bui XN, Tran QH, Moayedi H. A novel artificial intelligence approach to predict blast-induced ground vibration in open-pit mines based on the firefly algorithm and artificial neural network. Nat Resour Res 2020; 29(2): 723-37.
[http://dx.doi.org/10.1007/s11053-019-09503-7]
[48]
McCorduck P, Cfe C. Machines who think: A personal inquiry into the history and prospects of artificial intelligence. Floride: CRC Press 2004.
[49]
Kasabov NK. Foundations of neural networks, fuzzy systems, and knowledge engineering. Massachusetts: Marcel Alencar 1996.
[50]
Ge Z, Song Z, Ding SX, Huang B. Data mining and analytics in the process industry: The role of machine learning. IEEE Access 2017; 5: 20590-616.
[http://dx.doi.org/10.1109/ACCESS.2017.2756872]
[51]
Sloman A. Interactions between philosophy and artificial intelligence: The role of intuition and non-logical reasoning in intelligence. Artif Intell 1971; 2(3-4): 209-25.
[http://dx.doi.org/10.1016/0004-3702(71)90011-7]
[52]
Harrer S, Shah P, Antony B, Hu J. Artificial intelligence for clinical trial design. Trends Pharmacol Sci 2019; 40(8): 577-91.
[http://dx.doi.org/10.1016/j.tips.2019.05.005] [PMID: 31326235]
[53]
Froberg S. Distributed and cloud computing from parallel processing to the internet of things by Kai Hwang, Geoffry C. Fox, and Jack J. Dongarra. Softw Eng Notes 2013; 38(2): 34.
[http://dx.doi.org/10.1145/2439976.2439991]
[54]
Song H, Liu H. Predicting tourist demand using big data in Analytics in smart tourism design. (1st ed..). Switzerland: Springer 2017; pp. 13-29.
[http://dx.doi.org/10.1007/978-3-319-44263-1_2]
[55]
Barr DJ. Pragmatic expectations and linguistic evidence: Listeners anticipate but do not integrate common ground. Cognition 2008; 109(1): 18-40.
[http://dx.doi.org/10.1016/j.cognition.2008.07.005] [PMID: 18760407]
[56]
Moravec HP. Robot: Mere machine to transcendent mind. USA: Oxford University Press on Demand 2000.
[57]
Rosen JM, Kun L, Mosher RE, et al. Cybercare 2.0: Meeting the challenge of the global burden of disease in 2030. 2016; 6: 35-51.
[58]
Velásquez JD, Ríos SA. Eds. Knowledge-Based and Intelligent Information and Engineering Systems 13th International Conference, KES; September 28-30, 2009; Santiago, Chile. Heidelberg: Springer 2009.
[59]
Fahlman SE, Hinton GE. Connectionist architectures for artificial intelligence. Computer 1987; 20(01): 100-9.
[http://dx.doi.org/10.1109/MC.1987.1663364]
[60]
Staw BM, Epstein LD. What bandwagons bring: Effects of popular management techniques on corporate performance, reputation, and CEO pay. Adm Sci Q 2000; 45(3): 523-56.
[http://dx.doi.org/10.2307/2667108]
[61]
Curtin J, Kauffman RJ, Riggins FJ. Making the ‘MOST’out of RFID technology: A research agenda for the study of the adoption, usage and impact of RFID. Inf Technol Manag 8(2): 87-110.
[62]
Matta V, Moberg C. The development of a research agenda for RFID adoption and effectiveness in supply chains. Issues Inf Syst 2006; 7(2): 246-51.
[63]
Park YL, Chau K, Black RJ, Cutkosky MR. Force sensing robot fingers using embedded fiber Bragg grating sensors and shape deposition manufacturing. Proceedings 2007 IEEE International Conference on Robotics and Automation. 10-14 April 2007; Roma, Italy; pp. 1510-6.
[http://dx.doi.org/10.1109/ROBOT.2007.363538]
[64]
Joseph KJ. Growth of ICT and ICT for development: realities of the myths of the Indian experience. WIDER Discussion Paper 2002; 2002: 16780205.
[65]
Liu JP. Owning digital copies: Copyright law and the incidents of copy ownership. Wm & Mary L Rev 2000; 42: 1245.
[66]
Dam KW. Some economic considerations in the intellectual property protection of software. J Legal Stud 1995; 24(2): 321-77.
[http://dx.doi.org/10.1086/467962]
[67]
Huang O. US copyright office orphan works inquiry: Finding homes for the orphans. Berkeley Technol Law J 2006; 21: 265.
[68]
Franke N, Von Hippel E. Satisfying heterogeneous user needs via innovation toolkits: the case of Apache security software. Res Policy 2003; 32(7): 1199-215.
[http://dx.doi.org/10.1016/S0048-7333(03)00049-0]
[69]
Chiappetta V. Myth, chameleon or intellectual property olympian-a normative framework supporting trade secret law. Geo Mason L Rev 1999; 8: 69.
[70]
Rajan RG, Zingales L. The great reversals: The politics of financial development in the twentieth century. J Financ Econ 2003; 69(1): 5-0.
[http://dx.doi.org/10.1016/S0304-405X(03)00125-9]
[71]
Brakman S, Garretsen H, Van Marrewijk C, Van Witteloostuijn A. Nations and firms in the global economy: An introduction to international economics and business. Cambridge university press 2006.
[http://dx.doi.org/10.1017/CBO9780511811791]
[72]
Langvardt AW, Langvardt KT. Unqise or unconstitutional: The copyright term extension act, the eldred decision, and the freezing of the public domain for private benefit. Minn Intell Prop Rev 2003; 5: i.
[73]
El Ayadi M, Kamel MS, Karray F. Survey on speech emotion recognition: Features, classification schemes, and databases. Pattern Recognit 2011; 44(3): 572-87.
[http://dx.doi.org/10.1016/j.patcog.2010.09.020]
[74]
Eigenbrod F, Armsworth PR, Anderson BJ, et al. The impact of proxy-based methods on mapping the distribution of ecosystem services. J Appl Ecol 2010; 47(2): 377-85.
[http://dx.doi.org/10.1111/j.1365-2664.2010.01777.x]
[75]
Amano T, Sutherland WJ. Four barriers to the global understanding of biodiversity conservation: wealth, language, geographical location and security. Proceedings of the Royal Society B: Biological Sciences 2013; 280(1756): 20122649.
[76]
Drassinower A. Sweat of the brow, creativity, and authorship: On originality in Canadian copyright law. U Ottawa L & Tech J 2003; 1: 105.
[77]
Al-Aali AY, Teece DJ. Towards the (strategic) management of intellectual property: Retrospective and prospective. Calif Manage Rev 2013; 55(4): 15-30.
[http://dx.doi.org/10.1525/cmr.2013.55.4.15]
[78]
Saha CN, Bhattacharya S. Intellectual property rights: An overview and implications in pharmaceutical industry. J Adv Pharm Technol Res 2011; 2(2): 88-93.
[http://dx.doi.org/10.4103/2231-4040.82952] [PMID: 22171299]