Transcript Antibody Patents in India

Antibody Patents in India
Pravin Anand
14th October 2011
Anand and Anand
Introduction
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•
•
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 )
18000
16061
16000
15316
14000
12000
10000
Total patents Granted
Biotechnology -Patent granted
8000
7539
6168
6000
4000
4320
2000
1157
0
51
2005-2006
89
2006-2007
449
341
2007-2008
2008-2009
2009-2010
Comparison - Patents Granted
( Biotechnology Vs. Antibody )
1400
1200
1157
1000
800
Biotechnology -Patent granted
Antibody related Inventions granted
600
449
400
341
200
89
0
51
2
2005-2006
7
2006-2007
86
47
27
2007-2008
2008-2009
2009-2010
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 - Granted
Type of Claim
Composition/ combination
Claims
Functional claims
Structural Claims
Specific
Antibody defined by method
of production
Modified Antibody
Other
Total
No. of Granted Patent
20
41
51
11
2
3
81
209
Type of claims - Granted
Antibody
defined by
method of
production
1%
Composition
Claims
10%
other
39%
Functional
claims
20%
Structural
Claims
24%
Specific
5%
Modified
Antibody
1%
Patentability issues
• Usual standards apply (Novelty, non
obviousness, Sufficiency and Industrial
applicability)
• Specific Exclusions:
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–
–
–
–
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