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Antibody Patents in India

Explore the growth of biotech sector, patents granted, types of claims, and patentability issues surrounding antibody-related inventions in India. Learn about scope of claims, patentability criteria, and recent developments in the field.

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Antibody Patents in India

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  1. Antibody Patents in India Pravin Anand 14th October 2011 Anand and Anand

  2. Introduction • Size of Market • Number of patents granted • Types of claims allowed • Patentability issues • Biological deposits

  3. Size of Market • During 2010-11, Biotech sector grew at 21.5% • Total Size: Rs 17400 Crores

  4. Size of Market

  5. Patents granted • Antibody related inventions, granted patents going up (over 230 patents in 5 years) • 3.92% in 2005-6 (as percent of total Biotech patents granted) to • 10.46% in 2009-10

  6. Comparison- Patents Granted ( Total Vs. Biotechnology )

  7. Comparison - Patents Granted ( Biotechnology Vs. Antibody )

  8. Types of claims granted • Functionality based eg Antibody that binds to and neutralizes a specific Antigen • Structure based eg Antibodies defined by reference to specific amino acid sequences • Combination of Antibody and Composition claims • Process claims • Others eg hybridoma Cells ( A mAb produced by hybridoma ...),Phage Display etc

  9. Scope of claims (2011 manual) • Section 08.03.07 of the manual • New gene sequence A or amino acid sequence • A method of expressing sequence A • An antibody made to the protein of sequence A • A kit made from the antibody to sequence A

  10. Type of claims - Granted

  11. Type of claims - Granted

  12. Patentability issues • Usual standards apply (Novelty, non obviousness, Sufficiency and Industrial applicability) • Specific Exclusions: • S 3(c) : Substances occurring in Nature • S 3(d) : New form of known substance.. • S 3(e) : Mere admixture… • S 3 (i) : Process of medicinal Treatment.. • S 3 (j) : Plants, animals, other than micro-organisms

  13. Dimminaco AG vs Controller(Calcutta High Court) • Process for making Vaccine – approved for Poultry from infectious bursitis • Manner of manufacture – no bar if end product is living organism • Microorganisms are patentable eg Vectors, plasmids etc • Law modified thereafter- historical value

  14. Antigen unknown – Antibody unknown • If not found in nature – invention not discovery • Define antibody by functionality/structure - max scope Eg. A mAb or fragment thereof ..binding to one epitope of sH2a (antigen) - A human antibody or antibody fragment directed towards an oxidized fragment of apolipoprotein B whereby the oxidized fragment is IEIGLEGKGFEPTLEALFGK or an epitope thereof.

  15. Antigen unknown – Antibody unknown • If antigen found in nature- • Isolated antibody • Isolation- 3 (c) - Purification or modification • 3(d) not attracted as both unknown • Synthesized antibody • No 3 (c) or 3(d) objection

  16. Antigen known – Antibody unknown • Antibody unknown but discovered • Section 3(c) • Identification, isolation & Purification

  17. Antigen known – Antibody unknown • New antibodies to a known protein Eg. “Humanized antibody having one CDR of murine Mab produced by Hybridoma cell line deposited ………and a FR (framework region) derived from acceptor human immunoglobulin…retaining anti tumor activity of mBat-1 ….” • Obviousness critical issue ; Section 3(d) - Show improvement of antibody over known antibody specific to the known protein ( antigen) such as high affinity to the target (antigen );low immunogenicity

  18. Antigen known – Antibody known • Not patentable • Unless combination or composition or variant of known antibody (unknown antibody) • Section 3(d) • New use or new form • combination • Section 3(e) • Synergy required

  19. Composition /Combination Of antibodies • Eg A therapeutic composition comprising naked anti-CD22 antibody in an amount …….and one or more pharmaceutically acceptable carrier. • A pharmaceutical composition comprising a first specific binding agent which is a F(ab')2 or F(ab)2 fragment of an antibody ……. and a second specific binding agent comprising a small binding fragment of an antibody which binds the said toxin.

  20. Biological Deposits • Section 10(4) of the Patents Act • Sufficiency and enablement requirement • International Depositary Authority in India • MTCC (Microbial Type Culture Collection) in IMTECH, Chandigarh) and • MCC ( Microbial Culture Collection) in NCCS (National Centre for Cell Science, Pune)

  21. Conclusion • No case law to interpret the statute - lack of clarity • Manual of Patent Office Procedure (2011)– no discussion • Administrative orders issued from time to time to clarify issues • Courts likely to adopt the international standard- liberal approach

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