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