1. Boudhik Sampada Bhawan Website: www.ipindia.nic.in
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
Website:

2. for Biotechnological inventions
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 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. 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
March 28, 2017
K.S.Kardam

9. Judicial Precedence

10. Kolkata High Court decision Dimminaco A. G v
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. 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
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 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

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 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
"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"
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
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
3916
2316
190
1079
3304
2787
1214
5810
2211
101
1274
4734
5700
1525
6354
3239
1223
2371
5536
5822
2774
6375
4267
233
2210
6424
4842
1950
5884
3672
340
1844

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Form 2 - 4 9 18 6 7 -- 15
Individual
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100
200
1000/2000/3000
2500
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1500
Legal Entity
4000
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800
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