Provisions under the Indian Patent Act 1970 for Biotechnological inventions

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, BoudhikSampadaBhawan Sector-14,Dwarka New Delhi-110075 E-mail-kardam.ks@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 K.S.Kardam

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 <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

26. Patents granted

27. Patents granted

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

30. THE FEE SCHEDULE

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