Patents and bioinformatics

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Patents and bioinformatics

  1. 1. CHENNAI3rd Floor, ‘Creative Enclave’,148-150, Luz Church Road,Mylapore,Chennai - 600 004.Tel: +91 - 44 - 2498 4821BANGALORESuite 920, Level 9,Raheja Towers,26-27, M G Road,Bangalore - 560 001.Tel: +91 - 80 - 6546 2400COIMBATOREBB1, Park Avenue,# 48, Race Course Road,Coimbatore - 641018.Tel: +91 - 422 – 6552921EMAILinfo@altacit.comWEBSITEwww.altacit.comPatents and BioinformaticsPatents &Bioinformatics-NANTHAKUMAR.P.KJUNIOR PATENT ANALYST
  2. 2. CHENNAI3rd Floor, ‘Creative Enclave’,148-150, Luz Church Road,Mylapore,Chennai - 600 004.Tel: +91 - 44 - 2498 4821BANGALORESuite 920, Level 9,Raheja Towers,26-27, M G Road,Bangalore - 560 001.Tel: +91 - 80 - 6546 2400COIMBATOREBB1, Park Avenue,# 48, Race Course Road,Coimbatore - 641018.Tel: +91 - 422 – 6552921EMAILinfo@altacit.comWEBSITEwww.altacit.comPatents Patents are a form of intellectual property.Intellectual property refers to creations of themind: inventions, literary and artistic works,symbols, names, images, and designs used incommerce. It refers to Monopoly protection forcreative works such as writing (copyright),inventions (patents), processes (trade secrets) andidentifiers (trademarks).
  3. 3. CHENNAI3rd Floor, ‘Creative Enclave’,148-150, Luz Church Road,Mylapore,Chennai - 600 004.Tel: +91 - 44 - 2498 4821BANGALORESuite 920, Level 9,Raheja Towers,26-27, M G Road,Bangalore - 560 001.Tel: +91 - 80 - 6546 2400COIMBATOREBB1, Park Avenue,# 48, Race Course Road,Coimbatore - 641018.Tel: +91 - 422 – 6552921EMAILinfo@altacit.comWEBSITEwww.altacit.comBio-informatics In biology, Bioinformatics is an interdisciplinaryfield that develops and improves upon methods forstoring, retrieving, organizing and analyzingbiological data. A major activity in bioinformaticsis to develop software tools to generate usefulbiological knowledge.
  4. 4. CHENNAI3rd Floor, ‘Creative Enclave’,148-150, Luz Church Road,Mylapore,Chennai - 600 004.Tel: +91 - 44 - 2498 4821BANGALORESuite 920, Level 9,Raheja Towers,26-27, M G Road,Bangalore - 560 001.Tel: +91 - 80 - 6546 2400COIMBATOREBB1, Park Avenue,# 48, Race Course Road,Coimbatore - 641018.Tel: +91 - 422 – 6552921EMAILinfo@altacit.comWEBSITEwww.altacit.comCont… Bioinformatics has become an important part ofmany areas of biology. In experimental molecularbiology, bioinformatics techniques such as imageand signal processing allow extraction of usefulresults from large amounts of raw data. In the fieldof genetics and genomics, it aids in sequencing andannotating genomes and their observed mutations.
  5. 5. CHENNAI3rd Floor, ‘Creative Enclave’,148-150, Luz Church Road,Mylapore,Chennai - 600 004.Tel: +91 - 44 - 2498 4821BANGALORESuite 920, Level 9,Raheja Towers,26-27, M G Road,Bangalore - 560 001.Tel: +91 - 80 - 6546 2400COIMBATOREBB1, Park Avenue,# 48, Race Course Road,Coimbatore - 641018.Tel: +91 - 422 – 6552921EMAILinfo@altacit.comWEBSITEwww.altacit.comCont… Bioinformatics can be categorized into threecategories:(A) Biological sequences such as DNA, RNA, andprotein sequences;(B) Databases in which these sequences are organized;and(C) software and hardware designed to access,organize, and analyze information contained withinthese sequences and databases.
  6. 6. CHENNAI3rd Floor, ‘Creative Enclave’,148-150, Luz Church Road,Mylapore,Chennai - 600 004.Tel: +91 - 44 - 2498 4821BANGALORESuite 920, Level 9,Raheja Towers,26-27, M G Road,Bangalore - 560 001.Tel: +91 - 80 - 6546 2400COIMBATOREBB1, Park Avenue,# 48, Race Course Road,Coimbatore - 641018.Tel: +91 - 422 – 6552921EMAILinfo@altacit.comWEBSITEwww.altacit.comThe need for patents inBioinformatics The worldwide market for bioinformatics toolsand services is estimated to exceed US$40 billionwithin the next five years. As with other biotechcompanies, patent protection will be key tosurvival in the marketplace. Although the totalnumber of issued bioinformatics patents is stillsmall, virtually all aspects of bioinformaticsconstitute patentable subject matter, and theopportunity to generate intellectual property valuefrom investment in bioinformatics should not beneglected.
  7. 7. CHENNAI3rd Floor, ‘Creative Enclave’,148-150, Luz Church Road,Mylapore,Chennai - 600 004.Tel: +91 - 44 - 2498 4821BANGALORESuite 920, Level 9,Raheja Towers,26-27, M G Road,Bangalore - 560 001.Tel: +91 - 80 - 6546 2400COIMBATOREBB1, Park Avenue,# 48, Race Course Road,Coimbatore - 641018.Tel: +91 - 422 – 6552921EMAILinfo@altacit.comWEBSITEwww.altacit.comCont… In cases where Bio-informatic components areprotected by multiple areas of intellectual propertylaw, it is important to determine which form ofprotection is most practical. These issues arecritical in performing a cost-benefit analysis of aninvestment in bioinformatics. If protection is available and practical, then highinvestment costs may be justified.
  8. 8. CHENNAI3rd Floor, ‘Creative Enclave’,148-150, Luz Church Road,Mylapore,Chennai - 600 004.Tel: +91 - 44 - 2498 4821BANGALORESuite 920, Level 9,Raheja Towers,26-27, M G Road,Bangalore - 560 001.Tel: +91 - 80 - 6546 2400COIMBATOREBB1, Park Avenue,# 48, Race Course Road,Coimbatore - 641018.Tel: +91 - 422 – 6552921EMAILinfo@altacit.comWEBSITEwww.altacit.comBIOINFORMATIC COMPONENTS Before one can understand intellectual propertyprotection for bioinformatics, it is necessary tounderstand the nature of the various componentsthat comprise the field of bioinformatics: Bioinformatics involves: The acquisition, organization, storage,analysis, and visualization of informationcontained within biological molecules.
  9. 9. CHENNAI3rd Floor, ‘Creative Enclave’,148-150, Luz Church Road,Mylapore,Chennai - 600 004.Tel: +91 - 44 - 2498 4821BANGALORESuite 920, Level 9,Raheja Towers,26-27, M G Road,Bangalore - 560 001.Tel: +91 - 80 - 6546 2400COIMBATOREBB1, Park Avenue,# 48, Race Course Road,Coimbatore - 641018.Tel: +91 - 422 – 6552921EMAILinfo@altacit.comWEBSITEwww.altacit.comPATENT PROTECTIONad Eligible subject matter must be a process,machine, apparatus, or composition of matter One of the most critical questions regardingwhether bioinformatic components are patentableis whether they qualify as statutory subject matterunder section 101 of the Patent Act
  10. 10. CHENNAI3rd Floor, ‘Creative Enclave’,148-150, Luz Church Road,Mylapore,Chennai - 600 004.Tel: +91 - 44 - 2498 4821BANGALORESuite 920, Level 9,Raheja Towers,26-27, M G Road,Bangalore - 560 001.Tel: +91 - 80 - 6546 2400COIMBATOREBB1, Park Avenue,# 48, Race Course Road,Coimbatore - 641018.Tel: +91 - 422 – 6552921EMAILinfo@altacit.comWEBSITEwww.altacit.comCont… Under section 101, “Whoever invents or discoversany new and useful process, machine, manufacture[apparatus], or composition of matter, or any newand useful improvement thereof, may obtain a patenttherefore”. Thus, to determine whether bio-informaticcomponents qualify as statutory subject matter, onemust determine whether bioinformatic componentsare a “new and useful process, machine, manufacture[apparatus], or composition of matter, or any newand useful improvement thereof.”
  11. 11. CHENNAI3rd Floor, ‘Creative Enclave’,148-150, Luz Church Road,Mylapore,Chennai - 600 004.Tel: +91 - 44 - 2498 4821BANGALORESuite 920, Level 9,Raheja Towers,26-27, M G Road,Bangalore - 560 001.Tel: +91 - 80 - 6546 2400COIMBATOREBB1, Park Avenue,# 48, Race Course Road,Coimbatore - 641018.Tel: +91 - 422 – 6552921EMAILinfo@altacit.comWEBSITEwww.altacit.comPatent Protection for DNA, RNA,and Protein Sequences Section 101 permits the patentability of“composition[s] of matter.” Courts have held thisas including “all compositions of two or moresubstances and all composite articles, whetherthey be the results of chemical union, or ofmechanical mixture, or whether they be gases,fluids, powders or solids.” The USPTO has specifically interpreted this toinclude DNA, RNA, and protein compositions65because they are composed of two or moresubstances—DNA and RNA are composed ofnucleotides while proteins are made up of aminoacids. Indeed, many DNA, RNA, and proteinmolecules have been patented as compositions.
  12. 12. CHENNAI3rd Floor, ‘Creative Enclave’,148-150, Luz Church Road,Mylapore,Chennai - 600 004.Tel: +91 - 44 - 2498 4821BANGALORESuite 920, Level 9,Raheja Towers,26-27, M G Road,Bangalore - 560 001.Tel: +91 - 80 - 6546 2400COIMBATOREBB1, Park Avenue,# 48, Race Course Road,Coimbatore - 641018.Tel: +91 - 422 – 6552921EMAILinfo@altacit.comWEBSITEwww.altacit.comCont… It was not always clear that biological moleculeswere patentable subject matter. Only after theSupreme Court’s decision in Diamond v.Chakrabarty did patents on biological moleculesbecome widespread. Writing for the majority, Chief Justice Burgerconcluded that section 101 permitted thepatenting of genetically modified bacteria. Sincethen, the USPTO has permitted the patenting ofbiological molecules under the premise that abiological molecule is a “composition made byman,” where the biological molecule has beenisolated and purified from its natural setting.
  13. 13. CHENNAI3rd Floor, ‘Creative Enclave’,148-150, Luz Church Road,Mylapore,Chennai - 600 004.Tel: +91 - 44 - 2498 4821BANGALORESuite 920, Level 9,Raheja Towers,26-27, M G Road,Bangalore - 560 001.Tel: +91 - 80 - 6546 2400COIMBATOREBB1, Park Avenue,# 48, Race Course Road,Coimbatore - 641018.Tel: +91 - 422 – 6552921EMAILinfo@altacit.comWEBSITEwww.altacit.comCont…While biological molecules are themselves patentableas compositions, the information within thecomposition, i.e., the abstract biological sequenceitself, arguably is not patentable subject matter.71Based on the Supreme Court’s holding in Diamond v.Diehr,72 to qualify as patentable subject matter thebiological sequence would have to be categorized asa process, machine, apparatus, or composition, anddo more than describe a “natural phenomenon.”The Diehr Court also excluded “laws of nature andabstract ideas” from patent protection. “An idea ofitself is not patentable” and neither is “[a] principle,in the abstract[,] a fundamental truth[,] an originalcause[, or] a motive.’
  14. 14. CHENNAI3rd Floor, ‘Creative Enclave’,148-150, Luz Church Road,Mylapore,Chennai - 600 004.Tel: +91 - 44 - 2498 4821BANGALORESuite 920, Level 9,Raheja Towers,26-27, M G Road,Bangalore - 560 001.Tel: +91 - 80 - 6546 2400COIMBATOREBB1, Park Avenue,# 48, Race Course Road,Coimbatore - 641018.Tel: +91 - 422 – 6552921EMAILinfo@altacit.comWEBSITEwww.altacit.comCont… For eg., As “Einstein could not patent his celebrated lawthat ‘E = mc2’ [and] Newton [could not] havepatented the law of gravity,” it is unlikely that onecould patent a biological sequence since it may becharacterized as a natural phenomenon. Therefore, patent protection for DNA, RNA, orprotein extends only to the physical/biologicalcomposition, and not to the abstract biologicalsequence information that describes thecomposition. Thus, a patentee could only preventanother from using the composition itself and notthe information within the molecule.
  15. 15. CHENNAI3rd Floor, ‘Creative Enclave’,148-150, Luz Church Road,Mylapore,Chennai - 600 004.Tel: +91 - 44 - 2498 4821BANGALORESuite 920, Level 9,Raheja Towers,26-27, M G Road,Bangalore - 560 001.Tel: +91 - 80 - 6546 2400COIMBATOREBB1, Park Avenue,# 48, Race Course Road,Coimbatore - 641018.Tel: +91 - 422 – 6552921EMAILinfo@altacit.comWEBSITEwww.altacit.comPatent Protection for BiologicalDatabases patent protection is unavailable to biologicalsequences, patent protection may also beunavailable for biological databases. Biological databases are compilations ofbiological sequences. If biological sequences areunpatentable information, then a biologicaldatabase is a compilation of unpatentableinformation. Thus, for a database to be patentable,the process of compiling and organizing thebiological sequences into a database must convertthe unpatentable information into statutory subjectmatter for a patent, i.e., a “tangible product.”
  16. 16. CHENNAI3rd Floor, ‘Creative Enclave’,148-150, Luz Church Road,Mylapore,Chennai - 600 004.Tel: +91 - 44 - 2498 4821BANGALORESuite 920, Level 9,Raheja Towers,26-27, M G Road,Bangalore - 560 001.Tel: +91 - 80 - 6546 2400COIMBATOREBB1, Park Avenue,# 48, Race Course Road,Coimbatore - 641018.Tel: +91 - 422 – 6552921EMAILinfo@altacit.comWEBSITEwww.altacit.comCont… Whether a database is a “tangible product” mightbe debatable, but the USPTO has said that if thedatabase is merely a “data structure” or“nonfunctional descriptive material,” it is notpatentable. Even if the database itself does not constitutepatentable subject matter, the manner of creatingthe database may constitute a patentable process.
  17. 17. CHENNAI3rd Floor, ‘Creative Enclave’,148-150, Luz Church Road,Mylapore,Chennai - 600 004.Tel: +91 - 44 - 2498 4821BANGALORESuite 920, Level 9,Raheja Towers,26-27, M G Road,Bangalore - 560 001.Tel: +91 - 80 - 6546 2400COIMBATOREBB1, Park Avenue,# 48, Race Course Road,Coimbatore - 641018.Tel: +91 - 422 – 6552921EMAILinfo@altacit.comWEBSITEwww.altacit.comCont… For instance, in State Street Bank and Trust Co. v.Signature Financial Group, Inc.,the FederalCircuit held that a data processing system for afinancial fund was patentable subject matter wherethe system produced a “useful, concrete, andtangible result” even though the data processingsystem produced only information. Of course, toreconcile the Federal Circuit’s holding andsemantics in State Street Bank with prior courts’holdings,85 we may have to assume that a“tangible result” is not
  18. 18. CHENNAI3rd Floor, ‘Creative Enclave’,148-150, Luz Church Road,Mylapore,Chennai - 600 004.Tel: +91 - 44 - 2498 4821BANGALORESuite 920, Level 9,Raheja Towers,26-27, M G Road,Bangalore - 560 001.Tel: +91 - 80 - 6546 2400COIMBATOREBB1, Park Avenue,# 48, Race Course Road,Coimbatore - 641018.Tel: +91 - 422 – 6552921EMAILinfo@altacit.comWEBSITEwww.altacit.comCont…necessarily to be equated with a “tangibleproduct.” Nonetheless, under State Street Bank,even if information per se is not patentable as a“tangible product,” a process of producinginformation may be patentable if it produces a“tangible result.” Applying this principle to bioinformatic databases,we can conclude that if the process of creating abioinformatic database produces a “useful,concrete, and tangible result,” i.e., a database thathas numerous applications, then the process ofcreating the databasemay be patentable.
  19. 19. CHENNAI3rd Floor, ‘Creative Enclave’,148-150, Luz Church Road,Mylapore,Chennai - 600 004.Tel: +91 - 44 - 2498 4821BANGALORESuite 920, Level 9,Raheja Towers,26-27, M G Road,Bangalore - 560 001.Tel: +91 - 80 - 6546 2400COIMBATOREBB1, Park Avenue,# 48, Race Course Road,Coimbatore - 641018.Tel: +91 - 422 – 6552921EMAILinfo@altacit.comWEBSITEwww.altacit.comPatent Protection for BioinformaticSoftware and Hardware In contrast to biological sequences and databases,computer software does constitute patentable subjectmatter if the software produces a “useful, concrete,and tangible result.” The Supreme Court andFederal Circuit have indicated that so long as asoftware program is more than a mere algorithm, theprogram may be eligible for patent protection. Bioinformatic software should be no exception. Theresults produced by bioinformatic software have abiological application and are therefore mostdefinitely “useful, concrete, and tangible.”
  20. 20. CHENNAI3rd Floor, ‘Creative Enclave’,148-150, Luz Church Road,Mylapore,Chennai - 600 004.Tel: +91 - 44 - 2498 4821BANGALORESuite 920, Level 9,Raheja Towers,26-27, M G Road,Bangalore - 560 001.Tel: +91 - 80 - 6546 2400COIMBATOREBB1, Park Avenue,# 48, Race Course Road,Coimbatore - 641018.Tel: +91 - 422 – 6552921EMAILinfo@altacit.comWEBSITEwww.altacit.comCont… Because bioinformatic software can be used to makemedical diagnoses, design drugs, or drawevolutionary conclusions, it would be difficult tohold bioinformatic software as unpatentable under aState Street Bank regime. Likewise, patent protection is available forbioinformatic hardware, where the hardwarequalifies as patentable subject matter under section101 as a “machine” or an “apparatus.”Bioinformatic hardware may be used to acquirebioinformatic information (e.g., as a sequencer or agene chip), and/or store, access, or organizebioinformatic information (e.g., as a computersystem).
  21. 21. CHENNAI3rd Floor, ‘Creative Enclave’,148-150, Luz Church Road,Mylapore,Chennai - 600 004.Tel: +91 - 44 - 2498 4821BANGALORESuite 920, Level 9,Raheja Towers,26-27, M G Road,Bangalore - 560 001.Tel: +91 - 80 - 6546 2400COIMBATOREBB1, Park Avenue,# 48, Race Course Road,Coimbatore - 641018.Tel: +91 - 422 – 6552921EMAILinfo@altacit.comWEBSITEwww.altacit.comCont… However, because a patent would only protect thepatentee from an infringer who uses a machine orapparatus that contains all the elements of theclaimed invention, the patentee could not protect abiological sequence or a database that is only acomponent of a protected machine or apparatus.I thank each and everyone for your patience and time.

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