AbstractPatenting bioinformatic inventions has become a ride on the rail to the scientists and inventors. Specifically in bioinformatics, drafting an invention in bounds of patentability criteria is one the most critical task for an inventor to protect his invention. As bioinformatics is a budding field of science, patentable subject matter in bioinformatics was not specifically defined by most of the patent offices in the world. In this regard, we have tried to explain patentable subject matter in bioinformatics by classifying bioinformatics into different subject fields. Additionally, we have tried to trace out patentable subject matter for bioinformatic inventions based on country-specific patentability standards and granted bioinformatic patents of US, Europe, India, Canada and Australia.
Dickson G, Gaff BM, Loren RA. Protecting Bioinformatics as Intellectual Property. Computer 2013; 46(1): 0015-17.
Saeys Y, Inza I, Larrañaga P. A review of feature selection techniques in bioinformatics. Bioinformatics 2007; 23(19): 2507-2517.
Trencheva ?, Trenchev I, Milanov P, et al. Bioinformatics and Intellectual Property. Proceedings of the 4th International Scientific Conference of SWU 2011; 132-136.
US Patent and Trademark Office. Examination guidelines for computer-related inventions. (1996), 61 Fed. Reg. 7478.
Hultquist SJ, Harrison R, Yang Y. Patenting bioinformatic inventions: Emerging trends in the United States. Nature biotechnology 2002; 20(7): 743-744.
Art. 52(2)(c) of the European Patent Convention.
T 0208/84 of 15 July 1986 “Computer-related Invention/VICOM.” Official J. Eur. Pat. Off 1987; 14–23.
Hultquist, SJ, Harrison R, Yang Y. Patenting bioinformatic inventions: Emerging trends in Europe. Nature biotechnology 2002; 20(5): 517-518.
Singh S. India takes an open source approach to drug discovery. Cell 2008; 133(2): 201-203.
Yuan Y, Van Allen EM, Omberg L, et al. Assessing the clinical utility of cancer genomic and proteomic data across tumor types. Nature biotechnology 2014; 32(7): 644-652.
Guidelines for Examination of Biotechnology Applications for Patent, (March 2013) Office of the Controller General of Patents, Designs and Trademarks, India.
Section 17.02.04. Manual of Patent Office Practice, Canadian Intellectual Property Office.
Australian Centre for Intellectual Property in Agriculture, Submission on the ACIP enquiry into ‘patenting of business systems’ (2002).
Advisory Council on Intellectual Property. Report on a review of patent business systems. 2003. http://www.acip.gov.au/pdfs/ACIP_Final_Report_Review_of_Patenting_of_Business_Systems_Archived.pdf (16 March 2016, date last accessed).
Bucknell D. (Ed). 2011. Pharmaceutical, Biotechnology and Chemical Inventions: World Protection and Exploitation. Oxford University Press.
Roger Y, Tsien S, James R, et al. Forming Three-dimensional Structure of a Fluorescent Protein, Constructing Model of Other Fluorescent Protein Using First as Template, Making Mutants by Replacing Amino Acid(s) within 5 Angstroms of Any Atom of Chromophore. 2014; The Regents of the University of California, assignee. Patent US6054321A &WO1998006737A1.
Yang WLR, Lee YE, Chen MH, et al. In-silico drug screening and potential target identification for hepatocellular carcinoma using Support Vector Machines based on drug screening result. Gene 2013; 518(1): 201-208.
Cern A, Barenholz Y, Tropsha A, et al. Computer-aided design of liposomal drugs: In silico prediction and experimental validation of drug candidates for liposomal remote loading. Journal of Controlled Release 2014; 173: 125-131.
Shimbo I, Nakajima R, Yokoyama S, Patent protection for protein structure analysis. Nature biotechnology 2004; 22(1): 109-112.
Harald K, Anne V Method for the identification of epitopes related to immunogenicity in biopharmaceuticals. 2010; Hoffmann-La Roche, assignee. Patent CA2542104C.
Chen RO, Patel V, Selvarajan S, et al. A Method for Identifying a Drug Discovery Target. 2009; Ingenuity Systems, Inc., assignee. Patent IN227170.
Langley SR, Dwyer J, Drozdov I, et al. Proteomics: from single molecules to biological pathways. Cardiovascular research 2013; 97(4): 612-622.
Zhang C, Du W, Shi X, et al. A Survey on Recent Patents of Biological Pathway Based on Computational Methods. Recent patents on DNA & gene sequences 2008; 2(3): 200-208.
Keith DA, Marie C. Computational method and system for identifying network patterns in complex biological systems data. 2013; Metabolon, Inc., assignee. Patent US8594942B2.
Peter P, Dennis S, Michael C, et al. System and process of determining a biological pathway based on a treatment of a biological specimen. 2010; New York University, assignee. Patent US7739053B.
Kleiman MJ, Sontag LB. Patenting pathways. Nature biotechnology, 2006; 24(6): 616-617.
Vipul P. Systems and methods for inferring biological networks. 2008; Gene Network Sciences, Inc. assignee. Patent EP1540505B1.
Costas M, Anthony PB. Method and system for modeling cellular metabolism. 2013; The Penn State Research Foundation, assignee. Patent CA2434224C.
Felciano RM, Selvarajan S, Richards DR. Drug discovery methods. 2010; Ingenuity Systems, Inc., assignee. Patent AU2009250971B2.
McBride MS. Bioinformatics and intellectual property protection. Berkeley Tech 2002; 17: 1331.
U.S. Department of Commerce, Manual of Patent Examining Procedure. Ed. 8. 2001; 2106:11-35.
McCubbin C. Legal issues in bioinformatics. Journal of commercial biotechnology 2003; 9(3): 249-265.
Section 12.06.02. Manual of Patent Office Practice, Canadian Intellectual Property Office.
Section 16.09.03. Manual of Patent Office Practice, Canadian Intellectual Property Office.
Australian Copyright Act 1968. Incorporating Amendments Up To Statute Law Revision Act (No. 1) 2014.
State St. Bank, 149 F.3d at 1375 (citing Alappat, 33 F.3d 1526, 1544 (Fed. Cir. 1994)).
Diamond v. Diehr, 450 U.S. 175, 185 (1981); Alappat, 33 F.3d at1544; State St. Bank, 149 F.3d at 1373.
Alice Corp. v. CLS Bank International, 573 U.S. __, 134 S. Ct. 2347 (2014).
Update of Interim Guidance on Subject Matter Eligibility (2015 IEG) published on July. 01, 2015 (79 Fed. Reg. 74618).
Article 52(2) (c) and (3) EPC, The European Patent Convention Manual, European Patent Organization.
Section 16.08.04. Manual of Patent Office Practice, Canadian Intellectual Property Office.
Australian Government Intellectual Property. http://www.ipaustralia.gov.au/get-the-right-ip/patents/about-patents/what-can-be-patented/patents-for-computer-related-inventions/ (16 March 2016, date last accessed).
35 U.S.C. § 101. Manual of Patent Examining Procedure, United States Patent and Trademark Office.
Utility Examination Guidelines. Federal Register January 5, 2001; 66(4): 1092-1099.
Diamond v. Chakrabarty, 447 U.S. 303 (1980).
Molecular Pathology v. Myriad Genetics, Inc., 569 U.S, 133 S. Ct. 2107 (2013).
Article 52(2) (a) EPC, The European Patent Convention Manual, European Patent Organization.
Lee Y, Lee S, Yun S. Genetically stable Jev cDNA basedon Japanese Encephalitis Virus (JEV). 2010; Young-Min Lee.,assignee. Patent IN243799.
Takamiya M, Sjoholm C. Polypeptides having phytaseactivity and polynucleotides encoding same. 2011; Novozymes A/S assignee. Patent. IN247044.
Allen GG, Mary D, Ashok KS. Promoter sequence obtained from rice and methods of use. 2014; Arcadia Biosciences, Inc., assignee. Patent.CA2633517C.
Hee-Sook S, Michael K, Jeffrey AB. Transcription termination sequence and use thereof. 2013; Basf Plant Science Gmbh., assignee. Patent.CA2573986C.
High Court of Australia. http://www.hcourt.gov.au/assets/publications/judgment-summaries/2015/hca-35-2015-10-07.pdf (16 March 2016, date last accessed).
Australian Government Intellectual Property. http://www.ipaustralia.gov.au/get-the-right-ip/patents/about-patents/what-can-be-patented/patents-for-biological-inventions/ (13 16 March 2016, date last accessed).
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