Indian Patent Law, Office Procedures and Examination Practice for Biotechnology Patent Applications Dr.   K.S. KARDAM Depu...
Provisions under the Indian Patent Act 1970 for Biotechnological inventions
<ul><li>Any product or process which is </li></ul><ul><ul><li>Novel </li></ul></ul><ul><ul><li>Involving inventive step(no...
Non-patentable inventions Sec.(3) <ul><li>Any invention  – </li></ul><ul><ul><li>use or commercial exploitation of which w...
<ul><li>Mere Discovery of new form property of known substance without any enhancement in the efficacy or new property or ...
<ul><li>Plants and animals in  whole or any parts  thereof other than micro-organisms </li></ul><ul><li>Seeds </li></ul><u...
<ul><li>Section 10(4)(d)(ii)-If the applicant mentions a biological material in the specification and such material is not...
PROCEDURE FOR GRANT OF PATENT April 30, 2010 K.S.Kardam PUBLICATION OF APPLICATION REQUEST FOR EXAMINATION EXAMINATION u/s...
Judicial Precedence
Kolkata High Court decision Dimminaco  A.G v. Controller of Patents & Designs <ul><li>Invention claimed related to process...
<ul><li>Court held that –  </li></ul><ul><li>1. Word  manufacture  not define, dictionary meaning attributed to in the par...
<ul><li>Vendibility Test – </li></ul><ul><ul><li>1. Test is satisfied if the invention results in the production of some v...
Patent office Decisions
<ul><li>Invention related to  a method for in vitro production of isolated langerhans islets endocrine cells free from fib...
<ul><li>The applicant argued the case on following grounds:  </li></ul><ul><li>That the process is novel and has utility a...
<ul><li>The Controller refused the application under section 15 on the following grounds: </li></ul><ul><li>1.  The end pr...
A  method for determining the nominal or stretched diameter  of an internal opening or defect was held a method of treatme...
<ul><li>Claims related to  METHODS FOR IDENTIFYING TUMORS THAT ARE RESPONSIVE TO TREATMENT WITH ANTI-ErbB2 ANTIBODIES </li...
<ul><li>Method of purifying an antibody, preferably an IgG antibody ,  comprising the steps in the following sequence: (a)...
<ul><li>A method of  producing mushroom plant  (64/Cal/79) and  </li></ul><ul><li>a method for  cultivation of an algae  (...
<ul><li>A method of treating Neoplastic or cancerous growths  comprising </li></ul><ul><li>administering to a patient in n...
<ul><li>A  method  for cloning an animal, particularly a mammal , with a cloning efficiency of better than ten percent (10...
<ul><li>Claim-1: </li></ul><ul><li>Seed of hybrid maize variety  designated 33N56, representative seed of said variety hav...
Patents granted  after 1 st  January 2005
Patents granted PATENT NUMBER  APPLICATION NUMBER TITLE OF INVENTION APPLICANT NAME 236079   370/MUM/2004  METHOD FOR SYNT...
Patents granted PATENT NUMBER  APPLICATION NUMBER TITLE OF INVENTION APPLICANT NAME 224298   490/MAS/1998  A METHOD OF IDE...
Patents granted PATENT NUMBER  APPLICATION NUMBER TITLE OF INVENTION APPLICANT NAME 208414   732/MUM/2000  STREPTOMYCES AV...
<ul><li>Isolated Nucleic acid encoding a  gene </li></ul><ul><li>Novel polypeptides </li></ul><ul><li>Recombinant antibody...
Application Filing trend of Biotech inventions in India Year Chemical Drug Food Electrical Mechanical Computer/ Electronic...
THE FEE SCHEDULE <ul><li>On what payable  </li></ul><ul><li>Prov./Comp spec. </li></ul><ul><li>PAGES EXCEEDING 30 </li></u...
For more details Visit our Website: www.ipindia.nic.in  or mail your query to  [email_address]
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Dr.K.S.Kardam IPO New Delhi

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Dr.K.S.Kardam IPO New Delhi

  1. 1. Indian Patent Law, Office Procedures and Examination Practice for Biotechnology Patent Applications Dr. K.S. KARDAM Deputy Controller of Patents & Designs Indian Patent Office, Boudhik Sampada Bhawan Sector-14,Dwarka New Delhi-110075 [email_address] Website: www.ipindia.nic.in
  2. 2. Provisions under the Indian Patent Act 1970 for Biotechnological inventions
  3. 3. <ul><li>Any product or process which is </li></ul><ul><ul><li>Novel </li></ul></ul><ul><ul><li>Involving inventive step(non - obvious) </li></ul></ul><ul><ul><li>Capable of industrial application </li></ul></ul><ul><ul><li>Sufficiently disclosed </li></ul></ul>Patentable inventions Sec.(2(1)(j)
  4. 4. Non-patentable inventions Sec.(3) <ul><li>Any invention – </li></ul><ul><ul><li>use or commercial exploitation of which would be contrary to public order or public health </li></ul></ul><ul><ul><li>Causes serious prejudice to human, animal or plant life or health or to the environment </li></ul></ul><ul><li>Discovery of any living thing or non-living substance occurring in nature </li></ul>
  5. 5. <ul><li>Mere Discovery of new form property of known substance without any enhancement in the efficacy or new property or new use of known substance </li></ul><ul><li>Any process for the medicinal, surgical, curative, prophylactic , diagnostic or therapeutic or other treatment of human being and similar treatment of animals </li></ul><ul><li>Method of Agriculture or horticulture </li></ul>Non-patentable inventions Sec.(3)
  6. 6. <ul><li>Plants and animals in whole or any parts thereof other than micro-organisms </li></ul><ul><li>Seeds </li></ul><ul><li>Varieties and species </li></ul><ul><li>Essentially biological processes for the production or propagation of plants and animals </li></ul><ul><li>Traditional knowledge </li></ul>Non-patentable inventions Sec.(3)
  7. 7. <ul><li>Section 10(4)(d)(ii)-If the applicant mentions a biological material in the specification and such material is not available to public- </li></ul><ul><li>The applicant has to deposit said biological material in the International Depository Authority recognized under Budapest Treaty before filing of the application </li></ul><ul><li>Also disclose the source and geographical origin of said material </li></ul><ul><li>Non disclosure or wrong disclosure is a ground for opposition and revocation </li></ul>Deposition of biological material to supplement description
  8. 8. PROCEDURE FOR GRANT OF PATENT April 30, 2010 K.S.Kardam PUBLICATION OF APPLICATION REQUEST FOR EXAMINATION EXAMINATION u/s 12 GRANT OF PATENT REVOCATION OF PATENT POST GRANT OPPOSITION <ul><li>AFTER 18 MONTHS FROM P.D. </li></ul><ul><li>WITHIN 48 MONTHS FROM F.D . </li></ul><ul><li>ALL OBJECTIONS TO BE COMPLIED </li></ul><ul><li>WITHIN 12 MONTHS </li></ul><ul><li>IF P.S.IS FILED C.S. TO BE FILED WITHIN 12 MONTHS </li></ul>FILING OF APPLICATION Decision of Controller Appellate Board High Court Pre-Grant Representation Refusal of Representation Rejection of opposition
  9. 9. Judicial Precedence
  10. 10. Kolkata High Court decision Dimminaco A.G v. Controller of Patents & Designs <ul><li>Invention claimed related to process of producing vaccine containing living organisms </li></ul><ul><li>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 </li></ul><ul><li>Controller decision was challenged in the high court </li></ul><ul><li>The grounds taken by the applicant – </li></ul><ul><ul><li>Act does not bar such invention from patenting. </li></ul></ul><ul><ul><li>Patents already granted on such matters. </li></ul></ul><ul><ul><li>Process is a manner of manufacture </li></ul></ul>
  11. 11. <ul><li>Court held that – </li></ul><ul><li>1. Word manufacture not define, dictionary meaning attributed to in the particular trade or business can be accepted. </li></ul><ul><li>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 </li></ul><ul><li>3. No statutory bar to accept a manner of manufacture as a patentable even if the end product contains a living organism. </li></ul><ul><li>4. One of the common test is vendibility test. </li></ul>Kolkata High Court decision
  12. 12. <ul><li>Vendibility Test – </li></ul><ul><ul><li>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. </li></ul></ul><ul><ul><li>2. Vendible product means something which can be passed on from one men to another upon transaction of purchase and sale. </li></ul></ul><ul><ul><li>In other words the product should be a commercial entity </li></ul></ul>Kolkata High Court decision
  13. 13. Patent office Decisions
  14. 14. <ul><li>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. </li></ul>Case decided by Patent Office (1377/Del/1999)
  15. 15. <ul><li>The applicant argued the case on following grounds: </li></ul><ul><li>That the process is novel and has utility as fibroblast free langerhans islets are useful in the enhanced production of insulin to control diabetes. </li></ul><ul><li>Kolkata High Court has already allowed patenting of a substance containing living organisms. </li></ul><ul><li>Indian Patent law does not bar the grant patent for such invention. </li></ul>Case decided by the Patent office…………….(2)
  16. 16. <ul><li>The Controller refused the application under section 15 on the following grounds: </li></ul><ul><li>1. The end product of the process is nothing but a cluster of cells or piece of tissues of human body. </li></ul><ul><li>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. </li></ul><ul><li>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. </li></ul>Case decided by the Patent Office ……………(3)
  17. 17. 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. M/s. AGA Medical Corporation, USA [Patent Application No.1283/DEL/2004],
  18. 18. <ul><li>Claims related to METHODS FOR IDENTIFYING TUMORS THAT ARE RESPONSIVE TO TREATMENT WITH ANTI-ErbB2 ANTIBODIES </li></ul><ul><li>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 . </li></ul><ul><li>The said MAb are already known as described in the description </li></ul><ul><li>Applicant submitted that improvement lies in new amounts of rhuMAb (420 and 840 mg ) </li></ul><ul><li>The controller refused the application under section 3(d) (new use of known substance) as being dosage and 3(i) method of treatme nt </li></ul> GENENTECH INC. 4064/DELNP/2004
  19. 19. <ul><li>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 1-150 mM and pH of 6.5-9.0 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. </li></ul><ul><li>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 </li></ul><ul><li>The controller rejected the opposition and proceeded to grant of patent </li></ul>Lonza Biologics PLC- 3871/DELNP/2005
  20. 20. <ul><li>A method of producing mushroom plant (64/Cal/79) and </li></ul><ul><li>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 . </li></ul>Horticulture and agriculture methods related cases
  21. 21. <ul><li>A method of treating Neoplastic or cancerous growths comprising </li></ul><ul><li>administering to a patient in need thereof: </li></ul><ul><li>(a) an admixture comprising a cancer or tumor antigen expressed by said cancer cells and a micro-fluidized antigen formulation, said antigen formulation </li></ul><ul><li>comprising: </li></ul><ul><li>(i) a stabilizing detergent, </li></ul><ul><li>(ii) a micelle-forming agent, and </li></ul><ul><li>(iii) a biodegradable and biocompatible oil, </li></ul><ul><li>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 </li></ul><ul><li>(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 </li></ul>Patent application not allowed for (1)
  22. 22. <ul><li>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: </li></ul><ul><li>(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; </li></ul><ul><li>(b) activating the cybrid; </li></ul><ul><li>(c) culturing the activated cybrid; </li></ul><ul><li>(d) transferring the activated cybrid of step (c) into an appropriate host such that the activated cybrid develops into a fetus; </li></ul><ul><li>(e) maintaining the fetus in the host until the fetus is capable of surviving and maturating into a viable animal outside of said host </li></ul>Patent application not allowed for (2)
  23. 23. <ul><li>Claim-1: </li></ul><ul><li>Seed of hybrid maize variety designated 33N56, representative seed of said variety having been deposited under ATCC Accession Number PTA-6417. </li></ul><ul><li>2. A maize plant, or a part thereof, produced by growing the seed of claim 1. </li></ul><ul><li>3. Pollen of the plant of claim 2. </li></ul><ul><li>4. An ovule of the plant of claim 2 </li></ul>Patent application not allowed for (3)
  24. 24. Patents granted after 1 st January 2005
  25. 25. Patents granted PATENT NUMBER APPLICATION NUMBER TITLE OF INVENTION APPLICANT NAME 236079 370/MUM/2004 METHOD FOR SYNTHESIS OF HUMAN RECOMBINANT INSULIN WITH IMPROVED PROCESS EFFICIENCY RELIANCE LIFE SCIENCES PVT LTD. 231303 2898/CHENP/2005 VARIANT SUBTILISIN ENZYMES (SUBTILASES) NOVOZYMES A/S 231288 168/MAS/1999 A METHOD OF TREATING SUNFLOWER PLANTS INDIAN INSTITUTE OF SCIENCE 228705 1087/DELNP/2005 &quot; PLASMID-FREE CLONE OF E. COLI STRAIN DSM 6601 &quot; PHARMA-ZENTRALE GMBH 228492 1882/DELNP/2004 &quot;POLYNUCLEOTIDE MOLECULE COMPRISING A NUCLEOTIDE SEQUENCE THAT IS THE STREPTOMYCES AVERMETILIS AVEC ALLELE&quot; PFIZER PRODUCTS INC. 228220 668/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 228182 2554/CHENP/2005 DNA CONSTRUCTS AND METHODS TO ENHANCE THE PRODUCTION OF COMMERCIALLY VIABLE TRANSGENIC PLANTS MONSANTO TECHNOLOGY, LLC 226291 709/DEL/2001 &quot;A PROCESS FOR TRANSFERRING FOREIGN DNA INTO CALLUS CELLS OF TAXUS SP .&quot; DABUR RESEARCH FOUNDATION 225008 IN/PCT/2001/01208/KOL LIM MINERALIZATION PROTEIN SPLICE VARIANTS TO INDUCE BONE FORMATION EMORY UNIVERSITY
  26. 26. Patents granted PATENT NUMBER APPLICATION NUMBER TITLE OF INVENTION APPLICANT NAME 224298 490/MAS/1998 A METHOD OF IDENTIFYING A PHARMACOLOGICALLY ACTIVE SUBSTANCE AND A DNA TEMPLATE FOR THE SAME HOECHST AKTIENGESELLSCHAFT 221076 629/MUMNP/2006 INTACT MINICELLS AS VECTORS FOR DNA TRANSFER AND GENE THERAPY IN VITRO AND IN VIVO ENGENEIC MOLECULAR DELIVERY PTY LTD 218516 740/CHENP/2004 HEPATITIS C VIRUS VACCINE ISTITUTO DI RICERCHI DI BIOLOGIA MOLECOLARE P. ANGELETTI SPA 218499 375/MAS/2003 PREPARATION OF OLIGOSACCHARIDE BIONANOPARTICLES FROM MORINGA OLEIFERA LAM DR. SAMBANDAM SHANMUGASUNDARAM 217619 504/DEL/2004 A PLASMID CONSTRUCT FOR TESTING THE RESISTANCE OF HIV-1 SUBTYPE C VIRUS ISOLATES TO ANTIRETROVIRAL DRUGS IN VITRO. SETH PRADEEP 217407 763/KOLNP/2004 A METHOD OF EXPRESSING A LIM MINERALIZATION PROTEIN IN A NON-OSSEOUS MAMMALIAN CELL WARSAW ORTHOPEDIC, INC. 213334 423/MUMNP/2004 METHOD FOR PRODUCTION OF RECOMBINANT PROTEINS IN MICROORGANISMS N-ZYME BIOTEC GMBH 213289 826/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 212080 1276/DEL/2002 &quot;A PROCESS OF SYNTHESIZING HIGH QUANTITIES OF HUMAN INTERFERON ALPHA 2a PROTEIN&quot;
  27. 27. Patents granted PATENT NUMBER APPLICATION NUMBER TITLE OF INVENTION APPLICANT NAME 208414 732/MUM/2000 STREPTOMYCES AVERMITILIS GENE DIRECTING THE RATIO OF B2:B1 AVERMECTINS PFIZER PRODUCTS INC. 208063 IN/PCT/2001/58/CHE A METHOD FOR PREPARING A YEAST STRAIN NOVO NORDISK A/S 199888 569/DEL/2001 &quot;A PROCESS FOR PREPARING A PROTEINS, USED FOR DETECTION OF HIV ANTIBODIES&quot; UNIVERSITY OF DELHI 199578 566/DEL/2002 &quot;A PROCESS OF OBTAINING RECOMBINANT LAMBDOID BACTERIOPHAGE AND THE RESULTANT NOVEL PHAGE DISPLAY SYSTEM&quot; UNIVERSITY OF DELHI 189732 616/DEL/1998 &quot; A PROCESS FOR PREPARATION OF AN IMPROVED PLASMID FRAGMENTS &quot; IDEC PHARMACEUTICALS CORPORATION 210988 IN/PCT/2001/01140/MUM CHIMERIC EXPRESSION PROMOTERS ORIGINATING FROM COMMELINA YELLOW MOTTEL VIRUS AND CASSAVA VEIN MOSAIC VIRUS MERISTEM THERAPEUTICS 210988 IN/PCT/2001/01140/MUM CHIMERIC EXPRESSION PROMOTERS ORIGINATING FROM COMMELINA YELLOW MOTTEL VIRUS AND CASSAVA VEIN MOSAIC VIRUS MERISTEM THERAPEUTICS 235741 1274/DEL/2002 &quot;A PAIR OF OLIGONUCLEOTIDE PRIMERS FOR SPECIFIC AMPLIFICATION OF THE HUPB GENE OF MYCOBACTERIUM SPECIES&quot; DEPARTMENT OF BIOTECHNOLOGY 232332 1149/DEL/2000 &quot;HUMAN ORAL CANCER CELL LINE ESTABLISHED AND PROPAGATED IN VITRO FROM ORAL&quot; THE DIRCTOR, ALL INDIA INSTITUTE OF MEDICAL
  28. 28. <ul><li>Isolated Nucleic acid encoding a gene </li></ul><ul><li>Novel polypeptides </li></ul><ul><li>Recombinant antibody </li></ul><ul><li>Recombinant oligonucleotides and primers, genes </li></ul><ul><li>Novel Peptide analogs </li></ul><ul><li>Waste water and sewage treatment using microorganism </li></ul><ul><li>Novel vaccines </li></ul><ul><li>DNA related inventions such as preparing plasmids, vectors etc </li></ul><ul><li>Primers </li></ul><ul><li>Method of preparation of recombinant hormones </li></ul><ul><li>Method of enzyme purification (recombinants) </li></ul>Trend of Biotech Inventions Filed In India
  29. 29. Application Filing trend of Biotech inventions in India Year Chemical Drug Food Electrical Mechanical Computer/ Electronics Bio-technology 2004-05 3916 2316 190 1079 3304 2787 1214 2005-06 5810 2211 101 1274 4734 5700 1525 2006-07 6354 3239 1223 2371 5536 5822 2774 2007-08 6375 4267 233 2210 6424 4842 1950 2008-09 5884 3672 340 1844
  30. 30. THE FEE SCHEDULE <ul><li>On what payable </li></ul><ul><li>Prov./Comp spec. </li></ul><ul><li>PAGES EXCEEDING 30 </li></ul><ul><li>CLAIMS EXCEEDING 10 </li></ul><ul><li>*Request for extension of time </li></ul><ul><li>REQUEST FOR EARLY PUBLICATION </li></ul><ul><li>Request for Examination </li></ul><ul><li>EXPRESS REQUEST FOR EXAMN. </li></ul><ul><li>*Change of Applicant </li></ul><ul><li>*Notice of Opposition *Certified CopyCertificate </li></ul><ul><li>*On a petition </li></ul><ul><li>*Restoration of lapsed patent </li></ul>Form 2 - - 4 9 18 18 6 7 -- 15 Individual 1000 100 200 1000/2000/3000 2500 2500 3500 1500 1000 1000 1500 1500 Legal Entity 4000 400 800 4000/8000/1200 10000 10000 14000 2000 6000 4000 4000 6000 RENEWAL FEES 3 rd to 6 th Year(per year) 6 th to 10 th Year—do-- 11 th to 15 th Year---do--- 16 th to 20 th year----do--- 500 1500 3000 5000 2000 6000 12000 20000
  31. 31. For more details Visit our Website: www.ipindia.nic.in or mail your query to [email_address]

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