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Dr.K.S.Kardam IPO New Delhi WIPO TRAINING OF TRAINERS PROGRAM ON INTELLECTUAL PROPERTY ASSET MANAGEMENT BY BIOTECH SMES Indian Patent Law, Office Procedures.

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Presentation on theme: "Dr.K.S.Kardam IPO New Delhi WIPO TRAINING OF TRAINERS PROGRAM ON INTELLECTUAL PROPERTY ASSET MANAGEMENT BY BIOTECH SMES Indian Patent Law, Office Procedures."— Presentation transcript:

1 Dr.K.S.Kardam IPO New Delhi WIPO TRAINING OF TRAINERS PROGRAM ON INTELLECTUAL PROPERTY ASSET MANAGEMENT BY BIOTECH SMES Indian Patent Law, Office Procedures and Examination Practice for Biotechnology Patent Applications K.S. KARDAM Dr. K.S. KARDAM Deputy Controller of Patents & Designs Indian Patent Office, Boudhik Sampada Bhawan Sector-14,Dwarka New Delhi New Delhi Website:

2 Dr.K.S.Kardam IPO New Delhi WIPO TRAINING OF TRAINERS PROGRAM ON INTELLECTUAL PROPERTY ASSET MANAGEMENT BY BIOTECH SMES Provisions under the Indian Patent Act 1970 for Biotechnological inventions

3 Dr.K.S.Kardam IPO New Delhi WIPO TRAINING OF TRAINERS PROGRAM ON INTELLECTUAL PROPERTY ASSET MANAGEMENT BY BIOTECH SMES Any product or process which is Novel Involving inventive step(non - obvious) Capable of industrial application Sufficiently disclosed Patentable inventions Sec.(2(1)(j)

4 Dr.K.S.Kardam IPO New Delhi WIPO TRAINING OF TRAINERS PROGRAM ON INTELLECTUAL PROPERTY ASSET MANAGEMENT BY BIOTECH SMES Non-patentable inventions Sec.(3) Any invention – use or commercial exploitation of which would be contrary to public order or public health Causes serious prejudice to human, animal or plant life or health or to the environment Discovery of any living thing or non- living substance occurring in nature

5 Dr.K.S.Kardam IPO New Delhi WIPO TRAINING OF TRAINERS PROGRAM ON INTELLECTUAL PROPERTY ASSET MANAGEMENT BY BIOTECH SMES Mere Discovery of new form property of known substance without any enhancement in the efficacy or new property or new use of known substance Any process for the medicinal, surgical, curative, prophylactic,diagnostic or therapeutic or other treatment of human being and similar treatment of animals Method of Agriculture or horticulture Non-patentable inventions Sec.(3)

6 Dr.K.S.Kardam IPO New Delhi WIPO TRAINING OF TRAINERS PROGRAM ON INTELLECTUAL PROPERTY ASSET MANAGEMENT BY BIOTECH SMES Plants and animals in whole or any parts thereof other than micro-organisms Seeds Varieties and species Essentially biological processes for the production or propagation of plants and animals Traditional knowledge Non-patentable inventions Sec.(3)

7 Dr.K.S.Kardam IPO New Delhi WIPO TRAINING OF TRAINERS PROGRAM ON INTELLECTUAL PROPERTY ASSET MANAGEMENT BY BIOTECH SMES 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 application Also disclose the source and geographical origin of said material Non disclosure or wrong disclosure is a ground for opposition and revocation Deposition of biological material to supplement description

8 February 24, 2014K.S.Kardam PROCEDURE FOR GRANT OF PATENT PUBLICATION OF APPLICATION REQUEST FOR EXAMINATION EXAMINATION u/s 12 GRANT OF PATENT REVOCATION OF PATENT POST GRANT OPPOSITION AFTER 18 MONTHS FROM P.D. WITHIN 48 MONTHS FROM F.D. ALL OBJECTIONS TO BE COMPLIED WITHIN 12 MONTHS IF P.S.IS FILED C.S. TO BE FILED WITHIN 12 MONTHS FILING OF APPLICATION Decision of Controller Appellate Board High Court Pre-Grant Representation Refusal of Representation Rejection of opposition

9 Dr.K.S.Kardam IPO New Delhi WIPO TRAINING OF TRAINERS PROGRAM ON INTELLECTUAL PROPERTY ASSET MANAGEMENT BY BIOTECH SMES Judicial Precedence

10 Dr.K.S.Kardam IPO New Delhi WIPO TRAINING OF TRAINERS PROGRAM ON INTELLECTUAL PROPERTY ASSET MANAGEMENT BY BIOTECH SMES Kolkata High Court decision Dimminaco A.G v. Controller of Patents & Designs Invention claimed related to process of producing vaccine containing living organisms Controller 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 substance Controller decision was challenged in the high court The 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 Dr.K.S.Kardam IPO New Delhi WIPO TRAINING OF TRAINERS PROGRAM ON INTELLECTUAL PROPERTY ASSET MANAGEMENT BY BIOTECH SMES 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 infection 3. 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. Kolkata High Court decision

12 Dr.K.S.Kardam IPO New Delhi WIPO TRAINING OF TRAINERS PROGRAM ON INTELLECTUAL PROPERTY ASSET MANAGEMENT BY BIOTECH SMES 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 Kolkata High Court decision

13 Dr.K.S.Kardam IPO New Delhi WIPO TRAINING OF TRAINERS PROGRAM ON INTELLECTUAL PROPERTY ASSET MANAGEMENT BY BIOTECH SMES Patent office Decisions

14 Dr.K.S.Kardam IPO New Delhi WIPO TRAINING OF TRAINERS PROGRAM ON INTELLECTUAL PROPERTY ASSET MANAGEMENT BY BIOTECH SMES 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. Case decided by Patent Office (1377/Del/1999)

15 Dr.K.S.Kardam IPO New Delhi WIPO TRAINING OF TRAINERS PROGRAM ON INTELLECTUAL PROPERTY ASSET MANAGEMENT BY BIOTECH SMES The applicant argued the case on following grounds: 1.That the process is novel and has utility as fibroblast free langerhans islets are useful in the enhanced production of insulin to control diabetes. 2.Kolkata High Court has already allowed patenting of a substance containing living organisms. 3.Indian Patent law does not bar the grant patent for such invention. Case decided by the Patent office…………….(2)

16 Dr.K.S.Kardam IPO New Delhi WIPO TRAINING OF TRAINERS PROGRAM ON INTELLECTUAL PROPERTY ASSET MANAGEMENT BY BIOTECH SMES 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. Case decided by the Patent Office ……………(3)

17 Dr.K.S.Kardam IPO New Delhi WIPO TRAINING OF TRAINERS PROGRAM ON INTELLECTUAL PROPERTY ASSET MANAGEMENT BY BIOTECH SMES 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 M/s. AGA Medical Corporation, USA [Patent Application No.1283/DEL/2004],

18 Dr.K.S.Kardam IPO New Delhi WIPO TRAINING OF TRAINERS PROGRAM ON INTELLECTUAL PROPERTY ASSET MANAGEMENT BY BIOTECH SMES Claims related to METHODS FOR IDENTIFYING TUMORS THAT ARE RESPONSIVE TO TREATMENT WITH ANTI-ErbB2 ANTIBODIES After 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 description Applicant 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 GENENTECH INC. 4064/DELNP/2004

19 Dr.K.S.Kardam IPO New Delhi WIPO TRAINING OF TRAINERS PROGRAM ON INTELLECTUAL PROPERTY ASSET MANAGEMENT BY BIOTECH SMES 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 Act The controller rejected the opposition and proceeded to grant of patent Lonza Biologics PLC- 3871/DELNP/2005

20 Dr.K.S.Kardam IPO New Delhi WIPO TRAINING OF TRAINERS PROGRAM ON INTELLECTUAL PROPERTY ASSET MANAGEMENT BY BIOTECH SMES A method of producing mushroom plant (64/Cal/79) and a 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. Horticulture and agriculture methods related cases

21 Dr.K.S.Kardam IPO New Delhi WIPO TRAINING OF TRAINERS PROGRAM ON INTELLECTUAL PROPERTY ASSET MANAGEMENT BY BIOTECH SMES A method of treating Neoplastic or cancerous growths comprising administering 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 formulation comprising: (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 Patent application not allowed for (1)

22 Dr.K.S.Kardam IPO New Delhi WIPO TRAINING OF TRAINERS PROGRAM ON INTELLECTUAL PROPERTY ASSET MANAGEMENT BY BIOTECH SMES 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 Patent application not allowed for (2)

23 Dr.K.S.Kardam IPO New Delhi WIPO TRAINING OF TRAINERS PROGRAM ON INTELLECTUAL PROPERTY ASSET MANAGEMENT BY BIOTECH SMES Claim-1: Seed of hybrid maize variety designated 33N56, representative seed of said variety having been deposited under ATCC Accession Number PTA A maize plant, or a part thereof, produced by growing the seed of claim Pollen of the plant of claim An ovule of the plant of claim 2 Patent application not allowed for (3)

24 Dr.K.S.Kardam IPO New Delhi WIPO TRAINING OF TRAINERS PROGRAM ON INTELLECTUAL PROPERTY ASSET MANAGEMENT BY BIOTECH SMES Patents granted after 1 st January 2005

25 Dr.K.S.Kardam IPO New Delhi WIPO TRAINING OF TRAINERS PROGRAM ON INTELLECTUAL PROPERTY ASSET MANAGEMENT BY BIOTECH SMES Patents granted PATENT NUMBER APPLICATION NUMBERTITLE OF INVENTIONAPPLICANT NAME /MUM/2004 METHOD FOR SYNTHESIS OF HUMAN RECOMBINANT INSULIN WITH IMPROVED PROCESS EFFICIENCY RELIANCE LIFE SCIENCES PVT LTD /CHENP/2005VARIANT SUBTILISIN ENZYMES (SUBTILASES)NOVOZYMES A/S /MAS/1999A METHOD OF TREATING SUNFLOWER PLANTS INDIAN INSTITUTE OF SCIENCE /DELNP/2005"PLASMID-FREE CLONE OF E. COLI STRAIN DSM 6601" PHARMA-ZENTRALE GMBH /DELNP/2004 "POLYNUCLEOTIDE MOLECULE COMPRISING A NUCLEOTIDE SEQUENCE THAT IS THE STREPTOMYCES AVERMETILIS AVEC ALLELE" PFIZER PRODUCTS INC /MAS/1998 VACCINES 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 cDNA FUNDACAO OSWALDO CRUZ - FIOCRUZ /CHENP/2005 DNA CONSTRUCTS AND METHODS TO ENHANCE THE PRODUCTION OF COMMERCIALLY VIABLE TRANSGENIC PLANTS MONSANTO TECHNOLOGY, LLC /DEL/2001 "A PROCESS FOR TRANSFERRING FOREIGN DNA INTO CALLUS CELLS OF TAXUS SP." DABUR RESEARCH FOUNDATION IN/PCT/2001/01208/K OL LIM MINERALIZATION PROTEIN SPLICE VARIANTS TO INDUCE BONE FORMATION EMORY UNIVERSITY

26 Dr.K.S.Kardam IPO New Delhi WIPO TRAINING OF TRAINERS PROGRAM ON INTELLECTUAL PROPERTY ASSET MANAGEMENT BY BIOTECH SMES Patents granted PATENT NUMBER APPLICATION NUMBERTITLE OF INVENTIONAPPLICANT NAME /MAS/1998 A METHOD OF IDENTIFYING A PHARMACOLOGICALLY ACTIVE SUBSTANCE AND A DNA TEMPLATE FOR THE SAME HOECHST AKTIENGESELLSCHAFT /MUMNP/2006 INTACT MINICELLS AS VECTORS FOR DNA TRANSFER AND GENE THERAPY IN VITRO AND IN VIVO ENGENEIC MOLECULAR DELIVERY PTY LTD /CHENP/2004HEPATITIS C VIRUS VACCINE ISTITUTO DI RICERCHI DI BIOLOGIA MOLECOLARE P. ANGELETTI SPA /MAS/2003 PREPARATION OF OLIGOSACCHARIDE BIONANOPARTICLES FROM MORINGA OLEIFERA LAM DR. SAMBANDAM SHANMUGASUNDARAM /DEL/2004 A PLASMID CONSTRUCT FOR TESTING THE RESISTANCE OF HIV-1 SUBTYPE C VIRUS ISOLATES TO ANTIRETROVIRAL DRUGS IN VITRO. SETH PRADEEP /KOLNP/2004 A METHOD OF EXPRESSING A LIM MINERALIZATION PROTEIN IN A NON-OSSEOUS MAMMALIAN CELL WARSAW ORTHOPEDIC, INC /MUMNP/2004 METHOD FOR PRODUCTION OF RECOMBINANT PROTEINS IN MICROORGANISMS N-ZYME BIOTEC GMBH /MUM/2002 RECOMBINANT DNA MOLECULE ENCODING A NOVEL HUMAN INTERFERON ALPHA 2B LIKE POLYPEPTIDE METHOD FOR PRODUCING IT IN PICHIA AND ITS USE CADILA HEALTHCARE LIMITED /DEL/2002 "A PROCESS OF SYNTHESIZING HIGH QUANTITIES OF HUMAN INTERFERON ALPHA 2a PROTEIN"

27 Dr.K.S.Kardam IPO New Delhi WIPO TRAINING OF TRAINERS PROGRAM ON INTELLECTUAL PROPERTY ASSET MANAGEMENT BY BIOTECH SMES Patents granted PATENT NUMBER APPLICATION NUMBERTITLE OF INVENTIONAPPLICANT NAME /MUM/2000 STREPTOMYCES AVERMITILIS GENE DIRECTING THE RATIO OF B2:B1 AVERMECTINS PFIZER PRODUCTS INC IN/PCT/2001/58/CHEA METHOD FOR PREPARING A YEAST STRAINNOVO NORDISK A/S /DEL/2001 "A PROCESS FOR PREPARING A PROTEINS, USED FOR DETECTION OF HIV ANTIBODIES" UNIVERSITY OF DELHI /DEL/2002 "A PROCESS OF OBTAINING RECOMBINANT LAMBDOID BACTERIOPHAGE AND THE RESULTANT NOVEL PHAGE DISPLAY SYSTEM" UNIVERSITY OF DELHI /DEL/1998 "A PROCESS FOR PREPARATION OF AN IMPROVED PLASMID FRAGMENTS" IDEC PHARMACEUTICALS CORPORATION IN/PCT/2001/01140/MU M CHIMERIC EXPRESSION PROMOTERS ORIGINATING FROM COMMELINA YELLOW MOTTEL VIRUS AND CASSAVA VEIN MOSAIC VIRUS MERISTEM THERAPEUTICS IN/PCT/2001/01140/MU M CHIMERIC EXPRESSION PROMOTERS ORIGINATING FROM COMMELINA YELLOW MOTTEL VIRUS AND CASSAVA VEIN MOSAIC VIRUS MERISTEM THERAPEUTICS /DEL/2002 "A PAIR OF OLIGONUCLEOTIDE PRIMERS FOR SPECIFIC AMPLIFICATION OF THE HUPB GENE OF MYCOBACTERIUM SPECIES" DEPARTMENT OF BIOTECHNOLOGY /DEL/2000 "HUMAN ORAL CANCER CELL LINE ESTABLISHED AND PROPAGATED IN VITRO FROM ORAL" THE DIRCTOR, ALL INDIA INSTITUTE OF MEDICAL

28 Dr.K.S.Kardam IPO New Delhi WIPO TRAINING OF TRAINERS PROGRAM ON INTELLECTUAL PROPERTY ASSET MANAGEMENT BY BIOTECH SMES Isolated Nucleic acid encoding a gene Novel polypeptides Recombinant antibody Recombinant oligonucleotides and primers, genes Novel Peptide analogs Waste water and sewage treatment using microorganism Novel vaccines DNA related inventions such as preparing plasmids, vectors etc Primers Method of preparation of recombinant hormones Method of enzyme purification (recombinants) Trend of Biotech Inventions Filed In India

29 Dr.K.S.Kardam IPO New Delhi WIPO TRAINING OF TRAINERS PROGRAM ON INTELLECTUAL PROPERTY ASSET MANAGEMENT BY BIOTECH SMES Application Filing trend of Biotech inventions in India YearChemicalDrugFoodElectric al Mechan ical Compu ter/ Electro nics Bio- technol ogy

30 Dr.K.S.Kardam IPO New Delhi WIPO TRAINING OF TRAINERS PROGRAM ON INTELLECTUAL PROPERTY ASSET MANAGEMENT BY BIOTECH SMES THE FEE SCHEDULE On what payable Prov./Comp spec. PAGES EXCEEDING 30 CLAIMS EXCEEDING 10 *Request for extension of time REQUEST FOR EARLY PUBLICATION Request for Examination EXPRESS REQUEST FOR EXAMN. *Change of Applicant *Notice of Opposition *Certified Copy\Certificate *On a petition *Restoration of lapsed patent Form Individual /2000/ Legal Entity /8000/ RENEWAL FEES 3 rd to 6 th Year(per year) 6 th to 10 th Yeardo-- 11 th to 15 th Year---do th to 20 th year---- do

31 Dr.K.S.Kardam IPO New Delhi WIPO TRAINING OF TRAINERS PROGRAM ON INTELLECTUAL PROPERTY ASSET MANAGEMENT BY BIOTECH SMES For more details Visit our Website: or mail your query to


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