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Antibody Patents in India

Antibody Patents in India. Pravin Anand 14 th October 2011 Anand and Anand. Introduction. Size of Market Number of patents granted Types of claims allowed Patentability issues Biological deposits. Size of Market. During 2010-11, Biotech sector grew at 21.5%

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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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