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 , Biotech sector grew at 21.5% Total Size: Rs Crores

Size of Market

Patents granted Antibody related inventions, granted patents going up (over 230 patents in 5 years) –3.92% in (as percent of total Biotech patents granted) to –10.46% in

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 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 - Granted Type of ClaimNo. of Granted Patent Composition/ combination Claims 20 Functional claims41 Structural Claims51 Specific11 Antibody defined by method of production 2 Modified Antibody3 Other81 Total209

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