Presentation on theme: "Boudhik Sampada Bhawan Website:"— Presentation transcript:
1 Boudhik Sampada Bhawan Website: www.ipindia.nic.in Indian Patent Law, Office Procedures and Examination Practice for Biotechnology Patent ApplicationsDr. K.S. KARDAMDeputy Controller of Patents & DesignsIndian Patent Office,Boudhik Sampada BhawanSector-14,DwarkaNew DelhiWebsite:
2 for Biotechnological inventions Provisions under theIndian Patent Act 1970for Biotechnological inventions
3 Patentable inventions Sec.(2(1)(j) Any product or process which isNovelInvolving inventive step(non - obvious)Capable of industrial applicationSufficiently disclosed
4 Non-patentable inventions Sec.(3) Any invention –use or commercial exploitation of which would be contrary to public order or public healthCauses serious prejudice to human, animal or plant life or health or to the environmentDiscovery of any living thing or non-living substance occurring in nature
5 Non-patentable inventions Sec.(3) Mere Discovery of new form property of known substance without any enhancement in the efficacy or new property or new use of known substanceAny process for the medicinal, surgical, curative, prophylactic ,diagnostic or therapeutic or other treatment of human being and similar treatment of animalsMethod of Agriculture or horticulture
6 Non-patentable inventions Sec.(3) Plants and animals in whole or any parts thereof other than micro-organismsSeedsVarieties and speciesEssentially biological processes for the production or propagation of plants and animalsTraditional knowledge
7 Deposition of biological material to supplement description Section 10(4)(d)(ii)-If the applicant mentions a biological material in the specification and such material is not available to public-The applicant has to deposit said biological material in the International Depository Authority recognized under Budapest Treaty before filing of the applicationAlso disclose the source and geographical origin of said materialNon disclosure or wrong disclosure is a ground for opposition and revocation
8 PROCEDURE FOR GRANT OF PATENT IF P.S.IS FILED C.S. TO BE FILED WITHIN 12 MONTHSFILING OF APPLICATIONPUBLICATION OF APPLICATIONAFTER 18 MONTHS FROM P.D.Pre-Grant RepresentationREQUEST FOR EXAMINATIONWITHIN 48 MONTHS FROM F.D.EXAMINATION u/s 12ALL OBJECTIONS TO BE COMPLIEDWITHIN 12 MONTHSRefusal of RepresentationGRANT OF PATENTRejection of oppositionAppellateBoardDecision ofControllerPOST GRANT OPPOSITIONREVOCATION OF PATENTHigh CourtMarch 28, 2017K.S.Kardam
10 Kolkata High Court decision Dimminaco A. G v Kolkata High Court decision Dimminaco A.G v. Controller of Patents & DesignsInvention claimed related to process of producing vaccine containing living organismsController held the claims of invention relating to a process for preparation of infectious bursitis vaccine, not patentable as process claimed not a manner of manufacture under section 2(1)(j) of the Act as it contained living organisms and not resulting to substanceController decision was challenged in the high courtThe grounds taken by the applicant –Act does not bar such invention from patenting.Patents already granted on such matters.Process is a manner of manufacture
11 Kolkata High Court decision Court held that –1.Word manufacture not define, dictionary meaning attributed to in the particular trade or business can be accepted.2. The process for preparation of vaccine under specific scientific conditions is a new process and the said vaccine is useful for protecting poultry against contagious bursitis infection3. No statutory bar to accept a manner of manufacture as a patentable even if the end product contains a living organism.4.One of the common test is vendibility test.
12 Kolkata High Court decision Vendibility Test –1. Test is satisfied if the invention results in the production of some vendible items or it improves or restores former conditions of a vendible item or its effect is the preservation and prevention from deterioration of some vendible product.2. Vendible product means something which can be passed on from one men to another upon transaction of purchase and sale.In other words the product should be a commercial entity
14 Case decided by Patent Office (1377/Del/1999) Invention related to a method for in vitro production of isolated langerhans islets endocrine cells free from fibroblasts so as to be suitable for transplantation. The process discloses the steps of culturing and proliferating the cells and back and forth aspiration to separate fibroblast from the cells, which will be capable of differentiating into insulin producing cells.
15 Case decided by the Patent office…………….(2) The applicant argued the case on following grounds:That the process is novel and has utility as fibroblast free langerhans islets are useful in the enhanced production of insulin to control diabetes.Kolkata High Court has already allowed patenting of a substance containing living organisms.Indian Patent law does not bar the grant patent for such invention.
16 Case decided by the Patent Office ……………(3) The Controller refused the application under section 15 on the following grounds:1. The end product of the process is nothing but a cluster of cells or piece of tissues of human body.2. The invention claimed is not patentable under section 3(I) as a method of treatment of human being, since langerhans islets are freshly taken from the body of patient in order to treat them to remove fibroblast so as to increase secretion of insulin.3. The principles laid down in Kolkata High Court are not applicable as the end product of the process of present invention are not commercial entity and cannot be passed on from one person to another upon the transaction of purchase or sale.
17 M/s. AGA Medical Corporation, USA [Patent Application No M/s. AGA Medical Corporation, USA [Patent Application No.1283/DEL/2004],A method for determining the nominal or stretched diameter of an internal opening or defect was held a method of treatment as the said method was being performed within body of a patient and particularly determining the stretched diameter of a septal defect within the heart of a patient is inseparably connected with the method of treatment” and, therefore, was not patentable under section 3(i) of the Patent Act 1970.
18 GENENTECH INC. 4064/DELNP/2004Claims related to METHODS FOR IDENTIFYING TUMORS THAT ARE RESPONSIVE TO TREATMENT WITH ANTI-ErbB2 ANTIBODIESAfter determination that the patient suffers from cancer (such as, Castration- Resistant Prostate Cancer-CRPC or ovarian cancer) that is positive for HER2 phosphorylation, the patient will receive a loading dose of 840 mg of rhuMAb 2C4 on day 1 of cycle 1 (first 21-day treatment period), followed by 420 mg on day 1 of each subsequent 21-day cycle, as continuous intravenous infusion .The said MAb are already known as described in the descriptionApplicant submitted that improvement lies in new amounts of rhuMAb (420 and 840 mg )The controller refused the application under section 3(d) (new use of known substance) as being dosage and 3(i) method of treatment
19 Lonza Biologics PLC- 3871/DELNP/2005 Method of purifying an antibody, preferably an IgG antibody, comprising the steps in the following sequence: (a)harvesting the antibody from a cell culture; (b) purifying the antibody harvested in step (a) by means of protein A affinity chromatography; (c) obtaining purified antibody and protein A-contaminant upon eluting bound antibody from said protein A affinity chromatography column; (d) loading the purified antibody obtained in step (c) in combination with contaminant protein A, onto an anion exchange material under conditions of using a loading buffer having a displacer salt concentration of mM and pH of and allowing binding of the protein A to the anion exchange material and retaining the antibody in the flow-through; (e) collecting the antibody obtained in step (d) in the flow-through of the anion exchange material whilst the contaminant protein A is bound to the anion exchange material; and (f) further purifying the antibody by loading on, binding to and eluting it from a second ion exchanger, which is a cation exchanger; wherein a loading buffer having a pH of 4 to 7 and a salt gradient from 0.1 to 1.2 M salt are used and the elution takes place at pH of 7 to 8 to achieve the level of contaminant protein A in the pooled eluate to be <0.4 ng/mg antibody.The application was opposed under section 25(1)on the ground of Not an invention within the meaning of this Act or non Patentable under this ActThe controller rejected the opposition and proceeded to grant of patent
20 Horticulture and agriculture methods related cases A method of producing mushroom plant (64/Cal/79) anda method for cultivation of an algae (445/Del/93] were held not patentable under section 3(h) and section 2(1)(j) of the Act.
21 Patent application not allowed for (1) A method of treating Neoplastic or cancerous growths comprisingadministering to a patient in need thereof:(a) an admixture comprising a cancer or tumor antigen expressed by said cancer cells and a micro-fluidized antigen formulation, said antigen formulationcomprising:(i) a stabilizing detergent,(ii) a micelle-forming agent, and(iii) a biodegradable and biocompatible oil,said antigen formulation being formulated as a stable oil-in-water emulsion; wherein said admixture is administered to said patient in an amount sufficient to induce a cytotoxic T.lymphocyte response in said patient which is specific for the cancer or tumor antigen contained in said admixture, and(b) a therapeutically effective amount of at least one agent which is capable of neutralizing or down regulating the activity of tumor and host secreted immunosuppressive
22 Patent application not allowed for (2) A method for cloning an animal, particularly a mammal, with a cloning efficiency of better than ten percent (10%), said method comprising the steps of:(a) inserting a somatic cell, or nucleus isolated from said somatic cell, deriving from a somatic cell culture having undergone 5 or more passages, into an enucleated oocyte to form a cybrid;(b) activating the cybrid;(c) culturing the activated cybrid;(d) transferring the activated cybrid of step (c) into an appropriate host such that the activated cybrid develops into a fetus;(e) maintaining the fetus in the host until the fetus is capable of surviving and maturating into a viable animal outside of said host
23 Patent application not allowed for (3) Claim-1:Seed of hybrid maize variety designated 33N56, representative seed of said variety having been deposited under ATCC Accession Number PTA-6417.2. A maize plant, or a part thereof, produced by growing the seed of claim 1.3. Pollen of the plant of claim 2.4. An ovule of the plant of claim 2
25 Patents granted PATENT NUMBER APPLICATION NUMBER TITLE OF INVENTION APPLICANT NAME236079370/MUM/2004METHOD FOR SYNTHESIS OF HUMAN RECOMBINANT INSULIN WITH IMPROVED PROCESS EFFICIENCYRELIANCE LIFE SCIENCES PVT LTD.2313032898/CHENP/2005VARIANT SUBTILISIN ENZYMES (SUBTILASES)NOVOZYMES A/S231288168/MAS/1999A METHOD OF TREATING SUNFLOWER PLANTSINDIAN INSTITUTE OF SCIENCE2287051087/DELNP/2005"PLASMID-FREE CLONE OF E. COLI STRAIN DSM 6601"PHARMA-ZENTRALE GMBH2284921882/DELNP/2004"POLYNUCLEOTIDE MOLECULE COMPRISING A NUCLEOTIDE SEQUENCE THAT IS THE STREPTOMYCES AVERMETILIS AVEC ALLELE"PFIZER PRODUCTS INC.228220668/MAS/1998VACCINES AGAINST INFECTIONS CAUSED BY YF VIRUS; YF INFECTIOUS cDNA, METHOD FOR PRODUCING A RECOMBINANT YF VIRUS FROM THE YF INFECTIOUS cDNA AND PLASMIDS TO ASSEMBLE THE YF INFECTIOUS cDNAFUNDACAO OSWALDO CRUZ - FIOCRUZ2281822554/CHENP/2005DNA CONSTRUCTS AND METHODS TO ENHANCE THE PRODUCTION OF COMMERCIALLY VIABLE TRANSGENIC PLANTSMONSANTO TECHNOLOGY, LLC226291709/DEL/2001"A PROCESS FOR TRANSFERRING FOREIGN DNA INTO CALLUS CELLS OF TAXUS SP."DABUR RESEARCH FOUNDATION225008IN/PCT/2001/01208/KOLLIM MINERALIZATION PROTEIN SPLICE VARIANTS TO INDUCE BONE FORMATIONEMORY UNIVERSITY
26 Patents granted PATENT NUMBER APPLICATION NUMBER TITLE OF INVENTION APPLICANT NAME224298490/MAS/1998A METHOD OF IDENTIFYING A PHARMACOLOGICALLY ACTIVE SUBSTANCE AND A DNA TEMPLATE FOR THE SAMEHOECHST AKTIENGESELLSCHAFT221076629/MUMNP/2006INTACT MINICELLS AS VECTORS FOR DNA TRANSFER AND GENE THERAPY IN VITRO AND IN VIVOENGENEIC MOLECULAR DELIVERY PTY LTD218516740/CHENP/2004HEPATITIS C VIRUS VACCINEISTITUTO DI RICERCHI DI BIOLOGIA MOLECOLARE P. ANGELETTI SPA218499375/MAS/2003PREPARATION OF OLIGOSACCHARIDE BIONANOPARTICLES FROM MORINGA OLEIFERA LAMDR. SAMBANDAM SHANMUGASUNDARAM217619504/DEL/2004A PLASMID CONSTRUCT FOR TESTING THE RESISTANCE OF HIV-1 SUBTYPE C VIRUS ISOLATES TO ANTIRETROVIRAL DRUGS IN VITRO.SETH PRADEEP217407763/KOLNP/2004A METHOD OF EXPRESSING A LIM MINERALIZATION PROTEIN IN A NON-OSSEOUS MAMMALIAN CELLWARSAW ORTHOPEDIC, INC.213334423/MUMNP/2004METHOD FOR PRODUCTION OF RECOMBINANT PROTEINS IN MICROORGANISMSN-ZYME BIOTEC GMBH213289826/MUM/2002RECOMBINANT DNA MOLECULE ENCODING A NOVEL HUMAN INTERFERON ALPHA 2B LIKE POLYPEPTIDE METHOD FOR PRODUCING IT IN PICHIA AND ITS USECADILA HEALTHCARE LIMITED2120801276/DEL/2002"A PROCESS OF SYNTHESIZING HIGH QUANTITIES OF HUMAN INTERFERON ALPHA 2a PROTEIN"
27 Patents granted PATENT NUMBER APPLICATION NUMBER TITLE OF INVENTION APPLICANT NAME208414732/MUM/2000STREPTOMYCES AVERMITILIS GENE DIRECTING THE RATIO OF B2:B1 AVERMECTINSPFIZER PRODUCTS INC.208063IN/PCT/2001/58/CHEA METHOD FOR PREPARING A YEAST STRAINNOVO NORDISK A/S199888569/DEL/2001"A PROCESS FOR PREPARING A PROTEINS, USED FOR DETECTION OF HIV ANTIBODIES"UNIVERSITY OF DELHI199578566/DEL/2002"A PROCESS OF OBTAINING RECOMBINANT LAMBDOID BACTERIOPHAGE AND THE RESULTANT NOVEL PHAGE DISPLAY SYSTEM"189732616/DEL/1998"A PROCESS FOR PREPARATION OF AN IMPROVED PLASMID FRAGMENTS"IDEC PHARMACEUTICALS CORPORATION210988IN/PCT/2001/01140/MUMCHIMERIC EXPRESSION PROMOTERS ORIGINATING FROM COMMELINA YELLOW MOTTEL VIRUS AND CASSAVA VEIN MOSAIC VIRUSMERISTEM THERAPEUTICS2357411274/DEL/2002"A PAIR OF OLIGONUCLEOTIDE PRIMERS FOR SPECIFIC AMPLIFICATION OF THE HUPB GENE OF MYCOBACTERIUM SPECIES"DEPARTMENT OF BIOTECHNOLOGY2323321149/DEL/2000"HUMAN ORAL CANCER CELL LINE ESTABLISHED AND PROPAGATED IN VITRO FROM ORAL"THE DIRCTOR, ALL INDIA INSTITUTE OF MEDICAL
28 Trend of Biotech Inventions Filed In India Isolated Nucleic acid encoding a geneNovel polypeptidesRecombinant antibodyRecombinant oligonucleotides and primers, genesNovel Peptide analogsWaste water and sewage treatment using microorganismNovel vaccinesDNA related inventions such as preparing plasmids, vectors etcPrimersMethod of preparation of recombinant hormonesMethod of enzyme purification (recombinants)
29 Application Filing trend of Biotech inventions in India YearChemicalDrugFoodElectricalMechanicalComputer/ElectronicsBio-technology3916231619010793304278712145810221110112744734570015256354323912232371553658222774637542672332210642448421950588436723401844
30 THE FEE SCHEDULE On what payable Form 2 - 4 9 18 6 7 -- 15 Individual Prov./Comp spec.PAGES EXCEEDING 30CLAIMS EXCEEDING 10*Request for extension of timeREQUEST FOR EARLY PUBLICATIONRequest for ExaminationEXPRESS REQUEST FOR EXAMN.*Change of Applicant*Notice of Opposition *Certified Copy\Certificate*On a petition*Restoration of lapsed patentForm2-491867--15Individual10001002001000/2000/3000250035001500Legal Entity40004008004000/8000/1200100001400020006000RENEWAL FEES3rd to 6th Year(per year)6th to 10th Year—do--11th to 15th Year---do---16th to 20th year----do---500300050001200020000
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