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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% - PowerPoint PPT Presentation
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Antibody Patents in India
Pravin Anand
14th 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%
• Total Size: Rs 17400 Crores
Size of Market
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
Comparison- Patents Granted ( Total Vs. Biotechnology )
Comparison - Patents Granted ( Biotechnology Vs. Antibody )
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
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
Type of claims - GrantedType of Claim No. of Granted Patent
Composition/ combination Claims
20
Functional claims 41Structural Claims 51
Specific 11Antibody defined by method
of production2
Modified Antibody 3Other 81Total 209
Type of claims - Granted
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
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
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.
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
Antigen known – Antibody unknown
• Antibody unknown but discovered
• Section 3(c)• Identification, isolation & Purification
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
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
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.
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)
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