Indian Patent Law, Office Procedures and Examination Practice for Biotechnology Patent Applications

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
• E-mail-kardam.ks_at_nic.in
• Website www.ipindia.nic.in

2

• Provisions under the
• Indian Patent Act 1970
• for Biotechnological inventions

3
Patentable inventions Sec.(2(1)(j)

• Any product or process which is
• Novel
• Involving inventive step(non - obvious)
• Capable of industrial application
• Sufficiently disclosed

4
Non-patentable inventionsSec.(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
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 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

6
Non-patentable inventions Sec.(3)

• 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

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 application
• Also disclose the source and geographical origin
  of said material
• Non 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 MONTHS

FILING OF APPLICATION
PUBLICATION OF APPLICATION

• AFTER 18 MONTHS FROM P.D.

Pre-Grant Representation
REQUEST FOR EXAMINATION

• WITHIN 48 MONTHS FROM F.D.

EXAMINATION u/s 12

• ALL OBJECTIONS TO BE COMPLIED
• WITHIN 12 MONTHS

Refusal of Representation
GRANT OF PATENT
Rejection of opposition
Appellate Board
Decision of Controller
POST GRANT OPPOSITION
REVOCATION OF PATENT
High Court
9
Judicial Precedence
10
Kolkata High Court decisionDimminaco 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
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 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.

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

13
Patent office Decisions
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.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/2004

• 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

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
  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 lt0.4 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

20
Horticulture and agriculture methods related cases

• 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.

21
Patent application not allowed for (1)

• 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

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

24
Patents granted after 1st January 2005
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 "PLASMID-FREE CLONE OF E. COLI STRAIN DSM 6601" PHARMA-ZENTRALE GMBH
228492 1882/DELNP/2004 "POLYNUCLEOTIDE MOLECULE COMPRISING A NUCLEOTIDE SEQUENCE THAT IS THE STREPTOMYCES AVERMETILIS AVEC ALLELE" 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 "A PROCESS FOR TRANSFERRING FOREIGN DNA INTO CALLUS CELLS OF TAXUS SP." DABUR RESEARCH FOUNDATION
225008 IN/PCT/2001/01208/KOL LIM MINERALIZATION PROTEIN SPLICE VARIANTS TO INDUCE BONE FORMATION EMORY UNIVERSITY
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 "A PROCESS OF SYNTHESIZING HIGH QUANTITIES OF HUMAN INTERFERON ALPHA 2a PROTEIN"
27
Patents granted
PATENT NUMBER APPLICATION NUMBER TITLE OF INVENTION APPLICANT NAME
208414 732/MUM/2000 STREPTOMYCES AVERMITILIS GENE DIRECTING THE RATIO OF B2B1 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 "A PROCESS FOR PREPARING A PROTEINS, USED FOR DETECTION OF HIV ANTIBODIES" UNIVERSITY OF DELHI
199578 566/DEL/2002 "A PROCESS OF OBTAINING RECOMBINANT LAMBDOID BACTERIOPHAGE AND THE RESULTANT NOVEL PHAGE DISPLAY SYSTEM" UNIVERSITY OF DELHI
189732 616/DEL/1998 "A PROCESS FOR PREPARATION OF AN IMPROVED PLASMID FRAGMENTS" 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 "A PAIR OF OLIGONUCLEOTIDE PRIMERS FOR SPECIFIC AMPLIFICATION OF THE HUPB GENE OF MYCOBACTERIUM SPECIES" DEPARTMENT OF BIOTECHNOLOGY
232332 1149/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 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)

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
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 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 3rd to 6th Year(per year) 6th to 10th Yeardo-- 11th to 15th Year---do--- 16th to 20th year----do--- 500 1500 3000 5000 2000 6000 12000 20000
31
Thanks
For more details Visit our Website www.ipindia.ni
c.in or mail your query to delhi-patent_at_nic.in